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Effectiveness and cost-effectiveness of home palliative care services for adults with advanced illness and their caregivers

  1. Barbara Gomes1,*,
  2. Natalia Calanzani2,
  3. Vito Curiale3,4,
  4. Paul McCrone5,
  5. Irene J Higginson6

Editorial Group: Cochrane Pain, Palliative and Supportive Care Group

Published Online: 6 JUN 2013

Assessed as up-to-date: 31 DEC 2012

DOI: 10.1002/14651858.CD007760.pub2


How to Cite

Gomes B, Calanzani N, Curiale V, McCrone P, Higginson IJ. Effectiveness and cost-effectiveness of home palliative care services for adults with advanced illness and their caregivers. Cochrane Database of Systematic Reviews 2013, Issue 6. Art. No.: CD007760. DOI: 10.1002/14651858.CD007760.pub2.

Author Information

  1. 1

    Cicely Saunders Institute, King's College London, Department of Palliative Care, Policy and Rehabilitation, London, UK

  2. 2

    The University of Edinburgh, Centre for Population Health Sciences, Edinburgh, UK

  3. 3

    Centre Hospitalier Princesse Grace, Unité Court Séjour Gériatrique, Principauté de Monaco, Monaco

  4. 4

    Ente Ospedaliero Ospedali Galliera, Dipartimento di Gerontologia e Scienze Motorie, Genova, Italy

  5. 5

    King's College London, Institute of Psychiatry, London, UK

  6. 6

    King's College London, Department of Palliative Care, Policy and Rehabilitation, Cicely Saunders Institute, London, UK

*Barbara Gomes, Department of Palliative Care, Policy and Rehabilitation, Cicely Saunders Institute, King's College London, Bessemer Road, Demark Hill, London, SE5 9PJ, UK. barbara.gomes@kcl.ac.uk.

Publication History

  1. Publication Status: Stable (no update expected for reasons given in 'What's new')
  2. Published Online: 6 JUN 2013

SEARCH

 
Characteristics of included studies [ordered by study ID]
Ahlner-Elmqvist 2008

MethodsDesign: CCT (patient and caregiver)

Methodological quality: 1.5/6a (EPOC RCT/CCT checklist)


ParticipantsCountry and regions: Sweden, Malmö, metropolitan area

Recruitment (1995-1998, 30 months): physician referrals or self referrals from departments of Oncology, Respiratory Medicine, Haematology, Surgery, Otorhinolaryngology, Urology and Gynaecology at Malmö University Hospital; patients living in the city of Malmö, with cancer (histological verified), life expectancy from 2 to 12 months (not stated who estimated), informed about diagnosis, about the palliative care situation and possibility to get care at home and additional hospital treatment if needed. Exclusion criteria: non-Swedish speaking, mentally or physically unable to fill in questionnaires

Number of patients (allocated according to their preference): 297 (119 intervention and 178 control)

Diseases: cancer (297)

Patient characteristics: median age 67 years intervention, 68 years control; 48% female intervention, 54% female control; 29% lived alone

Number of caregivers (consented): 204 (102 in each group)

Caregiver characteristics: median age 63 years intervention, 65 years control; 64% female; 77% spouses 

Deaths at end of study: 117 intervention (98%) and 163 control (92%) 

Withdrawals/other drop-outs: "no patients are lost for follow-up"


InterventionsHome palliative care vs. usual care

"Advanced Home Care (AHC)"

Type: intermediate palliative care

Service base: hospital oncology department (Malmö University Hospital)

Team: 9 experienced nurses, oncologist, social worker, physiotherapist, secretary; priest associated on consultation basis; all with long experience in advanced cancer care with no formal training but attended palliative care training programme prior to service start; nurses worked day and evening shifts and on night emergency services; other staff worked daytime hours; weekly meetings; able to care for 25 patients at a time

Responsibility: not stated

Description: new 7-days-a-week service to complement existing inpatient and community care; included symptom treatment, counselling and emotional, social and family support; team home visits planned according to patient's needs and with degree of flexibility, could include injections, intravenous fluid therapy, blood transfusions, chemotherapy, nasogastric intubation and catheterisation of the urine bladder and other forms of technical support; access to on-call service from service base (evenings, nights and weekends with on-call oncologist home visits if need be); 3 'back-up' beds available (2 at hospice and 1 at the oncology unit)

Duration: not stated but likely to be from enrolment to death or study end (median survival for intervention group was 94 days, only 2 patients were still alive at study end)

Control: CC provided jointly by hospital and community services, including inpatient and outpatient hospital care, primary care and access to inpatient hospice care (public health system); basic ideology was for patients to be cared for at 'lowest' possible level, implying that patients who do not need hospital care were cared for at home by primary care physicians and district nurses; generally, patients had to visit primary care centres and the primary care physician only visited at home in exceptional circumstances; HC on a 24-hour basis was difficult due to organisational limitations in primary care thus if patients need advanced medical and nursing care, they had to be admitted to hospital or possibly offered a bed in a hospice


OutcomesDeath at home (primary outcome)

Death in hospital

Death in inpatient hospice

Survival

Caregiver pre- and post-bereavement outcomes (quality of life; general health; vitality; physical, psychological and social functioning; bodily pain)

Assessment points: caregivers were assessed every second month until death and then 1, 3, 6 and 13 months after death 

Analysis: backwards from death and forwards from death


Resource use/costsHospitalisations (admission, proportion of time in hospital)

Time horizon: enrolment to death or study end (admission and proportion of time in hospital); month before death (proportion of time in hospital)


NotesPower considerations: "the planned sample size was 150 patients in each group. (...) This number of patients is adequate to detect a 14% absolute change in place of death (...) power 90%, significant level 0.05"

Return of the first completed questionnaire was regarded as written consent. Those with a preference for HC who refused to participate still received HC. No patients changed from intervention to control or vice-versa


Risk of bias

BiasAuthors' judgementSupport for judgement

Concealment of allocation (RCT / CCT)High riskAllocation based on patient preference

Follow-up (RCT / CCT)Unclear risk117 intervention (98%) and 163 control (92%) for primary outcome and survival (patients alive at the end of study were excluded from survival analysis); 122/204 (60%) for caregiver pre-bereavement outcomes (first assessment) and 130/204 (64%) for caregiver post-bereavement outcomes (1 month after death)

Blinding (RCT / CCT)Unclear riskSource of primary outcome not stated; blinding not stated

Baseline measurement (RCT / CCT)High riskIntervention patients preferred to be cared for at home (variable influencing in same direction as results). In addition, there were significant differences in physical function (intervention poorer KPS), primary cancer diagnosis (controls had more often lung and gastrointestinal) and weeks from diagnosis to inclusion (intervention longer time)

Reliability of outcome measurement (RCT / CCT)Unclear riskSource of primary outcome not stated, although it was objective; others were self completed

Protection against contamination (RCT / CCT)High risk Patient allocation

Aiken 2006

MethodsDesign: RCT (patient)

Methodological quality: 3/6a (EPOC RCT/CCT checklist)


ParticipantsCountry and regions: US, Phoenix, Arizona, metropolitan area

Recruitment (1999-2001, 20 months): from community agencies, hospitals, 7 HMOs, physicians, family/friends and self referral; patients aged ≥ 18 years with CHF and COPD disease-specific criteria of life expectancy ≤ 24 months (expert judgement) with ED or urgent care facility or hospital admissions in last 3 months and marked limitation in physical function with activity resulting in fatigue, palpitations, dyspnoea or angina

Number of patients (randomised): 192 (101 intervention and  91 control)

Diseases: CHF (130), COPD (62)

Patient characteristics: "average" age 68.5 years; 64% female

Deaths at end of study: 16% intervention and 13% control 

Withdrawals/other drop-outs: 41% intervention and 54% control (entered hospice care or skilled nursing facilities, declined continued participation, left the HMO)


InterventionsHome palliative care vs. usual care

"PhoenixCare intervention"

Type: intermediate palliative care

Service base: Hospice of the Valley – largest community-based hospice care provider in the US

Team: physician (medical director), 2 or 3 nurses (RN case managers with 30-35 patient caseload), half-time social worker, half-time pastoral counsellor; staff training (2 weeks on FairCare communication model and other monthly training)

Responsibility: team's nurse (with primary care physician and HMO case manager); nurse went with patient to physician visits to discuss progress and care options

Description: intervention grounded on patient empowerment model and behaviour change theory (shift from crisis-response to self empowerment and prevention); without forgoing curative treatment; included disease and symptom management, patient and caregiver education (included self monitoring, home safety, equipment and medication), psychosocial and spiritual support, co-ordination of care and case management; needs assessment (including psychological and spiritual); referral to counselling and community resources (custodial care, transportation, help with finances); management protocols by phase of illness (initially unstable, stable, unstable following exacerbation); individualised emergency response plan at home (used in hospice care) and on-call nurse contact; advanced care planning with patient and family; patient notebook at home (with goals patient was working towards, emergency plans, information material, reviewed in calls and visits); nurses telephone calls and home visits ("average" 6, 5, 4, 4, 3 and 3 in first 6 months and stable from then onwards; half calls, half visits); visits from other staff (45% saw social worker, "average" 6 times); on-call nursing

Duration: from enrolment to death, transfer to hospice care or skilled nursing care facility, or study end (length of stay not stated)

Control: usual care focused on technical care (medication and laboratory monitoring, weight/blood pressure and blood glucose monitoring, implementation of prior authorisation mechanisms) and most patients had HMO case management (51% intervention vs. 62% control; P value = 0.12). 7 HMOs had telephone monitoring and 5 had occasional home visits. Other services included disease and symptom education, nutrition and psychological counselling, transportation and care co-ordination. During the study, HMOs greatly narrowed criteria for case management and reduced services, due to financial pressures. 5 HMOs ended use of telephone calls and all terminated home visits and other support services. 3 HMOs reinstated some services in last study quarter, when enrolment was sparse


OutcomesPhysical symptoms (pain, most troublesome symptom)

Quality of life

General health and vitality

Physical, psychological and social functioning

Self management of illness and knowledge of resources

Advance care planning (preparation for end of life)

Assessment points: baseline and 3, 6 and 9 months after

Analysis: forwards from enrolment


Resource use/costsED visits

HMO case manager assigned to patient

Time horizon: from enrolment to death or study end


NotesPower considerations: "Statistical power to detect moderate effect size differences between intervention and control participants fell from 0.93 to 0.74 to 0.64 at time 0, 3, and 6, respectively"

Data at 9 months were not analysed except for quality of life (reason not stated). Data on hospitalisations (presence and number of days) were assessed but could not be analysed because of "inadequately reported hospital claims data" related to problems in pairing admission and discharge dates and to reporting based on primary diagnosis regardless of treatment provided


Risk of bias

BiasAuthors' judgementSupport for judgement

Concealment of allocation (RCT / CCT)Low risk"Randomization was carried out within diagnosis, in blocks of 30 patients (15 intervention, 15 control) by a member of the project administration staff. Sealed envelopes, colour-coded by diagnosis and containing the assignment to condition, were shuffled and assigned to participants in order of shuffling"

Follow-up (RCT / CCT)High risk62% intervention and 54% control follow-up at 3 months

Blinding (RCT / CCT)Unclear riskSingle-blind: "interviewers were blind to condition and diagnosis", but participants not stated

Baseline measurement (RCT / CCT)Low riskStatistical tests of differences in sociodemographics not reported. Trend towards significant differences at baseline SF-36 subscales (same direction as treatment effect): "PhoenixCare participants tended to have higher scores on the SF-36 Social Functioning Scale, F(1,189) = 3.45, P = 0.07, g = 0.27, and on the SF-36 Mental Health Scale, F(1,190) = 3.35, P = 0.07, g = 0.26." Analysis was adjusted for baseline scores and authors reported all effects were maintained when controlling for SF-36 baseline differences

Reliability of outcome measurement (RCT / CCT)Unclear riskCollected from patients by interviewers on the telephone. "Proxy respondents could read or translate for patients. Proxy responses were not accepted"

Protection against contamination (RCT / CCT)High riskPatients randomised

Axelsson 1998

MethodsDesign: cluster CCT (patient) 

Methodological quality: 2.5/6a (EPOC RCT/CCT checklist)


ParticipantsCountry and regions: Sweden, Östersund, County of Jämtland, metropolitan area (sparsely populated region)

Recruitment (1991-1993, 30 months): mainly from Department of General Surgery at County Hospital of Östersund but also from other departments and other GPs; patients with symptomatic incurable cancer (disease within the realm of general surgery), who wished to stay at home and had a caregiver; patients living within 40 km of the hospital (9 primary care health centres) were allocated to the intervention; controls met all inclusion criteria but the latter (unknown number of primary care health centres)

Number of patients (allocated): 72 (57 intervention and 15 control; authors referred to the control group as "reference group")

Diseases: cancer (72)

Patient characteristics: median age 72 years intervention, 71 years control; 46% female

Deaths at end of study: 72

Withdrawals/other drop-outs: 17 intervention (1 actively dying, 16 who were not matched to a third historical control group, see notes)


InterventionsHome palliative care vs. usual care

"Palliative Support Service (PSS)"

Type: specialist palliative care

Service base: Department of General Surgery at County Hospital of Östersund

Team: full-time nurse (15 years' experience of practical cancer care on a surgical ward, trained in pain relief and symptom control, worked weekdays 8 a.m. to 5 p.m.), surgeon (half-day per week basis); leasing car and mobile telephone; weekly conference to review cases; collaboration with the 9 local primary care centres

Responsibility: not stated

Description: new programme; nurse role - acted as link between home and hospital, supported patient, caregiver and district nurse, district nurse education on management of infusors, epidural catheters, central venous catheters and other technical devices, administered blood transfusions, low-dose chemotherapy and parenteral nutrition at home when needed; surgeon role - scrutinised all referrals to select patients for whom support could imply improved palliation and extended time at home, reviewed patients at weekly conference with nurse, occasional home visits if needed (supported by 6 interested colleagues); patient dossier – given to the patient on discharge to improve communication between the hospital and primary healthcare service, included copies of essential information from medical records, with 3 specific fact sheets (1. sheet listed all names and telephone numbers of staff involved, namely surgeon, ward, GP, district nurse, HC assistant, consultant nurse, emergency telephone numbers for nights and weekends; 2. all prescribed drugs, information on effects and administration instructions; 3. exact wording used by doctor informing the patient of their disease and its dissemination, stating clearly whether patient had been informed of a lump, a tumour or a cancer and which metastases the patient knew of, also noted the family member(s) who had received the same information)

Duration: median length of stay in intervention 70 days

Control: usual care, mainly home care and conventional primary and hospital care


OutcomesDeath at home

Death in hospital

Death in nursing home

Percentage of time and days spent at home

Survival

Assessment points: prospectively for intervention and retrospectively for control group, through medical records


Resource use/costsHospitalisations (number of admissions, terminal hospitalisation days)

Institutional days (in hospital and nursing homes)

HC (hours of contact with intervention consultant nurse and surgeon, district nurse, assistant nurse, GP, home service, night sitting)

Informal care (days next of kin off work) 

Time horizon: from enrolment to death; from diagnosis to death (institutional days); last 6 months before death (hospital admissions, institutional days)


NotesPower considerations: none stated

Analysis involved only part of the intervention group, those matched to a third historical control group who died locally prior to service start (1990); patients aged ≥ 58 years were matched for age, diagnosis, place of residence and as far as possible for gender and marital status (younger patients could not be adequately matched). This excluded 16 of 57 eligible patients, resulting in a sample of 41 in the intervention group

Longer recruitment for intervention patients (30 months) than for controls (4 months)


Risk of bias

BiasAuthors' judgementSupport for judgement

Concealment of allocation (RCT / CCT)High riskAllocation based on area proximity to service (not random)

Follow-up (RCT / CCT)High risk56/72 (78%)

Blinding (RCT / CCT)Unclear riskNot stated

Baseline measurement (RCT / CCT)Unclear riskNo significant differences in age, sex distribution, marital status and KPS; however, groups differed in distance to hospital

Reliability of outcome measurement (RCT / CCT)Unclear riskPatient and staff filled sheets in patient's dossier

Protection against contamination (RCT / CCT)Low riskAllocation was by area

Bakitas 2009

MethodsDesign: RCT (patient and caregiver)

Methodological quality: 3.5/6a (high quality, EPOC RCT/CCT checklist)


ParticipantsCountry and regions: US, New Hampshire and Vermont, rural areas

Recruitment (2003-2007, 42 months): from weekly management meetings of tumour boards for gastrointestinal, genitourinary, breast and thoracic cancers at the Norris Cotton Cancer Center in New Hampshire (National Cancer Institute-designated comprehensive cancer centre) and affiliated outreach clinics and the VA medical centre in White River Junction, Vermont; newly diagnosed (from 8 to 12 weeks) gastrointestinal, lung, genitourinary or breast cancers with specific clinical markers of advanced illness and life expectancy of approximately 1 year (assessor not stated). Exclusion criteria: impaired cognition, axis I psychiatric disorder, active substance use

Number of patients (randomised): 322 (161 intervention and 161 control)

Diseases (outcome sample): cancer (279): gastrointestinal (119), lung (93), genitourinary (37), breast (30)

Patient characteristics (outcome sample): mean age 65.4 years intervention, 65.2 years control; 39.8% female

Number of caregivers (

): 220 (116 intervention and 104 control)

Caregiver characteristics (outcome sample of 198 caregivers): mean age 58.0 years intervention, 59.9 years control; 77% female; 71% spouse/partner

Deaths at end of study: 231 (72%); 112 intervention (70%) and 119 control (74%)

Withdrawals/other drop-outs: 57 patients (18%): 29 intervention (18%) and 28 control (17%) (reasons not stated); 134 caregivers (61%): 66 intervention (57%) and 68 control (65%) (due to withdrawal, refusal or completion of initial form of the questionnaire)


InterventionsHome palliative care vs. usual care

"Project ENABLE II"

Type: specialist palliative care

Service base: palliative care programme, Dartmouth-Hitchcock Medical Center

Team: certified palliative care physician, advanced practice nurses with high speciality training in palliative care (acting as case managers with caseload balanced by diagnosis and gender); staff training (12-20 hours on problem solving and group medical appointments provided by study psychologist; methods included didactic presentations, written treatment manuals, role-playing with feedback – training materials available from authors); biweekly reviews of audio-taped educational sessions and feedback on difficult patient management issues  

Responsibility: team's nurse (but final responsibility rested with primary clinical team for medical decisions including medication and inpatient care management, although intervention nurses, in consultation with primary team, could facilitate referrals to ancillary resources)

Description: grounded on chronic care model and previous demonstration project; without forgoing curative treatment; included case management, crisis prevention, and patient and caregiver education to encourage activation, self management and empowerment; telephone-based format (for rural population); 4 initial structured educational and problem-solving modular sessions (31-40 minutes each) and at least monthly telephone follow-ups; initial full needs assessment on practical problems (e.g. work or school), family, emotional, spiritual or religious and physical problems (made use of Distress Thermometer following National Comprehensive Cancer Network guidelines – if distress rated > 3, sources of distress and problem solving explored); education manual with 4 modules (problems solving, communication and social support, symptom management, advance care planning and unfinished business) and list of supportive care resources (available from authors); referral to other resources (e.g. palliative care team, hospice, spiritual counsellor); nurse encouraged or offered to contact oncology and palliative care team when problems were identified (e.g. unrelieved pain); nurse readily available by telephone; monthly group shared medical appointments with physician and nurse for patients and caregivers to ask about medical problems and related issues, more in-depth than clinic visits; follow-up call in bereavement

Duration: from enrolment into bereavement or study end (median survival 14 months in intervention group)

Control: all oncology and supportive services without restrictions including referral to the institutions' interdisciplinary palliative care service; 1 of the sites (VA Medical Center in Vermont) had an advanced illness co-ordinated care programme that provided consultation to oncology staff for inpatients with life-limiting illness


OutcomesQuality of life (primary outcome)

Symptom intensity (primary outcome)

Depression

Death at home

Death in hospital

Death in nursing home

Death in inpatient hospice

Survival

Caregiver satisfaction with care

Caregiver pre-bereavement outcomes (burden)

Caregiver post-bereavement outcomes (grief intensity)

Assessment points: baseline, 1 month after, and then every 3 months until death of study end; approximately 4-6 months after death

Analysis: forwards from enrolment and backwards from death


Resource use/costsHospital inpatient days

ED visits

Intensive care unit days

Referral to palliative care

Referral to hospice care

Time horizon: from referral to death or study end (median 14 months intervention and 8.5 months control)


NotesPower considerations: "Original target sample size of 400 was chosen to provide 80% power to detect treatment effects of at least 0.35 SDs for scores on the Functional Assessment of Chronic Illness Therapy for Palliative Care, ESAS, and CES-D based on a t test comparing the treatment groups with respect to the last observed value with a 2-sided α of .01. However, at the planned study completion date, the final total study enrolment was 322 due to slightly slower accrual than anticipated"

Authors conducted semi-structured interviews of a subsample of intervention and control participants and caregivers, as well as oncology clinicians, to obtain in-depth data about their experience with intervention and usual care


Risk of bias

BiasAuthors' judgementSupport for judgement

Concealment of allocation (RCT / CCT)Low risk"stratified randomization scheme developed for each of the 2 primary sites (...) stratified by disease and blocked within strata (block lengths of 2 and 4 varied randomly)"

Follow-up (RCT / CCT)Unclear risk108 intervention (67%) and 97 control (60%) 1 month follow-up for quality of life; 109 intervention (68%) and 100 control (62%) for symptoms; 102 intervention (63%) and 98 control (61%) for depression; 112 intervention (70%) and 119 control (74%) for place of death; 161/161 intervention (100%) and 161/161 control (100%) for survival; 50/116 intervention (43%) and 36/104 control (35%) for caregiver burden 

Blinding (RCT / CCT)High riskBlinded at baseline but not subsequently: "research assistants notified the participant of group allocation when the baseline assessment was returned"

Baseline measurement (RCT / CCT)Low riskNo statistically significant differences at baseline between intervention and control for demographic and clinical characteristics, the 3 patient reported outcomes and care use. "Each analysis was adjusted for the respective baseline instrument score"

Reliability of outcome measurement (RCT / CCT)Low riskPatients and caregivers completed the baseline questionnaires upon enrolment and the follow-up questionnaires mailed to them

Protection against contamination (RCT / CCT)High riskPatients/caregivers randomised

Brumley 2007

MethodsDesign: RCT (patient)

Methodological quality: 3.5/6a (high quality, EPOC RCT/CCT checklist)


ParticipantsCountry and regions: US, Hawaii and Colorado, metropolitan areas

Recruitment (2002-2004, 18 months): from discharge planners, primary care and specialist physicians in 2 non-profit HMOs (Kaiser Permanente Group), life expectancy ≤ 12 months with ED or hospital admissions in last year and physical function ≤ 70 in Palliative Performance Scale (from 0 death to 100 normal)

Number of patients (randomised): 310 (155 intervention and 155 control)

Diseases: cancer (138), CHF (97), COPD (62)

Patient characteristics: mean age 73.8 years; 49% female; 26.3% lived alone

Deaths at end of study: 225 (73%)

Withdrawals/other drop-outs: 5 withdrawals (2 in the intervention and 3 in the control); 8 patients died after randomisation but prior intervention (all in the intervention group)


InterventionsHome palliative care vs. usual care

"In-Home Palliative Care – IHPC"

Type: intermediate palliative care

Service base: 2 non-profit Kaiser Permanente Group HMOs – 1) Hawaii: 18 medical offices of 317 medical group physicians providing all outpatient care and most inpatient care (with internal home health agency, contracts with external providers for hospice care only); 2) Colorado: 16 ambulatory medical offices of more than 500 physicians representing all medical specialities and subspecialities (contracts with external providers for ED, hospital, home health and hospice care)

Team: physician, nurse, social worker with support from others (spiritual counsellor/chaplain, bereavement co-ordinator, home health aide, pharmacist, dietician, volunteer, physiotherapist, occupational therapist, speech therapist)

Responsibility: team's physician (but allowed primary provider to continue)

Description: modelled on hospice programmes but without forgoing curative treatment; patients assigned to palliative care physician to co-ordinate care from a variety of healthcare providers; included medical care, symptom management, education, biopsychosocial support, co-ordination, continuous assessment and management of care across all settings; initial inter-disciplinary assessment (physical, medical, psychological, social and spiritual needs); joint care plan to decide frequency of visits on individual basis; advance directives with patient and family; training patients and caregivers on use of medication, self management and crisis intervention at home; patient wrist band for ED staff to know patient was in home palliative care and had advance directives on file (1 site only); physicians home visits and nursing care 24 hours on-call

Duration: from enrolment to death or transfer to hospice care (mean survival 196 days in the intervention group)

Control: usual care with various amounts and levels of primary care services, home health services (when Medicare criteria met), acute care services and hospice care


OutcomesDeath at home

Patient satisfaction with care

Survival

Assessment points: satisfaction with care measured at baseline, 30, 60, 90 and 120 days after enrolment

Analysis: forwards from enrolment


Resource use/costsHospitalisations (admission and inpatient days)

ED visits

Hospice care (referral and days)

Time horizon: from enrolment to death, transfer to hospice care or study end

Costs: mean adjusted total costs and mean adjusted total costs per day (included those associated with physician visits, ED visits, hospital days, skilled nursing facility days, and home health or palliative days)

Currency: 2002 USD


NotesPower considerations: study powered for cost differences (planned 300; randomised 310; analysed 297) 

Data on satisfaction with care at 120 days were not analysed due to "significant reduction in sample size" (n = 136) 


Risk of bias

BiasAuthors' judgementSupport for judgement

Concealment of allocation (RCT / CCT)Low risk"blocked randomization using a computer generated random number chart, stratified according to study site"

Follow-up (RCT / CCT)Unclear risk70% follow-up for patient satisfaction with care at 30 days (n = 216); 73% follow up for place of death (n = 225); 145/155 intervention (94%) and 152/155 control for survival (98%)

Blinding (RCT / CCT)Unclear riskSingle-blind: research assistants blinded but patients not stated

Baseline measurement (RCT / CCT)Low riskBaseline differences in care satisfaction scores (intervention higher satisfaction; P value = 0.03) but analysis conducted with binary variable (no baseline differences)

Reliability of outcome measurement (RCT / CCT)Unclear riskCollected from patients or their caregivers by research assistants (care satisfaction), HMO's records, death certificates and family report (death at home, survival)

Protection against contamination (RCT / CCT)High riskPatients randomised

Buckingham 1978

MethodsDesign: cluster CCT (patient and caregiver)

Methodological quality: 3/6a (EPOC RCT/CCT checklist)


ParticipantsCountry and regions: US, New Haven, metropolitan area

Recruitment (1975-1977, 21 months): referrals from oncologists; patients aged ≥ 18 years with terminal cancer (primary site lung, colon or breast) with life expectancy ≤ 6 months and ≥ 14 days survival after enrolment, living with friend or relative with potential for being primary caregiver; areas within hospice geographical region allocated to intervention and other areas allocated to control (allocation according to area where patient lived); control group matched to age (within 10 years), gender and cancer primary site of intervention group

Number of patients (allocated): 70 (35 intervention and 35 control)

Number of caregivers (allocated): 70 (35 intervention and 35 control)

Diseases: cancer (70); primary site lung, colon or breast

Patient and caregiver characteristics: not stated

Deaths at end of study: not stated

Withdrawals/other drop-outs: not stated


InterventionsHome palliative care vs. usual care

"Hospice home care program"

Type: intermediate palliative care

Service base: not stated

Team: not stated 

Responsibility: not stated

Description: hospice HC programme of terminal care, 'experienced services', "providing for many needs that often cannot be met in acute care settings"

Duration: not stated

Control: usual care with "differing therapeutic philosophies of organizations charged with their care"


OutcomesAnxiety and depression

Social adjustment

Caregiver pre-bereavement outcomes (anxiety, depression, social adjustment)

Assessment points: not stated 

Analysis: forwards from enrolment


Resource use/costsTime spent in an acute hospital or institutional setting

Hospitalisations

HC

Time horizon: not stated


NotesPower considerations: none stated


Risk of bias

BiasAuthors' judgementSupport for judgement

Concealment of allocation (RCT / CCT)High riskAllocation based on area proximity to service (not random)

Follow-up (RCT / CCT)Unclear riskNot stated

Blinding (RCT / CCT)Unclear riskNot stated

Baseline measurement (RCT / CCT)Unclear riskNot stated

Reliability of outcome measurement (RCT / CCT)Unclear riskSelf report questionnaires (unclear who provided)

Protection against contamination (RCT / CCT)Low riskAllocation by area

Grande 1999

MethodsDesign: RCT (patient and caregiver)

Methodological quality: 3/6a (EPOC RCT/CCT checklist)


ParticipantsCountry and regions: UK, Cambridge health district

Recruitment (date not stated, 15 months): mainly from primary care (admission avoidance) and less than one-third from secondary care (enabling discharge); any diagnosis with life expectancy ≤ 2 weeks (estimated by clinicians) and need for terminal care or cancer/MND/AIDS patients with need for respite care. Exclusion criteria: emergency cases without usual care and those enrolled in periods where service was 'empty' (these were given the intervention without entering trial)

Number of patients (randomised): 241

Diseases (outcome sample of 229 patients): cancer (198), non-cancer (31)

Patient characteristics: mean age 72.1 years intervention, 72.6 years control; 50.2% female; 20.6% lived alone

Number of caregivers (randomised): 198

Caregiver characteristics (subsample of 96 bereaved caregivers): mean age 63.6 years intervention, 62.3 years control; 49.0% female; 71.9% spouses

Deaths at end of study: 229 (95%); 186 intervention and 43 control 

Withdrawals/other drop-outs: 13 patients who were still alive at end of study and 31 with no caregiver were excluded from caregiver after death follow-ups; non-response from 55 caregivers to 6 weeks after death questionnaire; 102 caregiver drop-outs at 6 months after death (83 did not agree to take part and 19 non-responses)


InterventionsHome palliative care versus usual care 

"Cambridge Hospital At Home - HAH - for palliative care"

Type: intermediate palliative care

Service base: Marie Curie nursing service and inpatient hospice, under the same palliative care manager (ran separately with separate funding). Location appeared to ease informal service cooperation and access to specialist medical advice

Team: 6 qualified nurses (2 ENs and 4 RGNs), 2 nursing auxiliaries and 1 co-ordinator (RGN); most with Marie Curie Nursing experience (i.e. non-profit nursing service supporting people in their last months of life spending several hours at a time in their home with nursing care and emotional support, often overnight); extra help from agency nurses; service resourced to accommodate 100 people per year

Responsibility: not stated

Description: aimed to provide practical home palliative nursing care, improve care for terminally ill patients and increase their choice of place of care; limited description of components; care available up to 24 hours a day

Duration: maximum of 2 weeks

Control: usual care included care in hospital/hospice/home with input from general practice, Marie Curie nursing, Macmillan nursing (i.e. non-profit nursing service supporting cancer patients often since diagnosis, spending up to 1 hour in their home with advice on pain management and symptom control together with emotional support), day and evening district nursing (i.e. senior HC nurses), social services, private care and a Flexible Care nursing service (i.e. home nursing service, similar to Marie Curie nursing, but funded by primary care authority from national health system and available for all diagnosis)


OutcomesDeath at home (primary outcome)

Death in hospital

Death in inpatient hospice

Death in nursing home

Patient spent time at home in last 2 weeks of life

Appropriateness of place of death (to caregiver)

Physical symptoms (pain, nausea/vomiting, constipation, diarrhoea, breathlessness)

Psychological well-being (anxiety, depression)

Patient unmet support needs

Survival

Caregiver pre-bereavement outcomes (caregiver unmet support needs)

Caregiver post-bereavement outcomes (quality of life and grief intensity)

Assessment points: questionnaires posted to caregiver 6 weeks after death (symptoms and needs) and 6 months after death (bereavement outcomes); questionnaire posted to primary care team (GP and district nurse) 6 weeks after death (patient spent time at home) 

Analysis: backwards from death and forwards from death


Resource use/costsInstitutional days (included hospice, acute hospital and continuing care beds)

Hours of home nursing care (generic and palliative care nursing)

GP visits (daytime during week, daytime during weekend, evening, night)

Other primary and secondary care

Time horizon: last year before death (inpatient days and home nursing care); last 2 weeks before death (GP visits and other primary and secondary care)


NotesPower considerations: "The study attained less statistical power than initially planned." Authors planned a 1:1 random allocation of 180 patients to each trial arm to achieve 80% power to detect a 15% difference (from 50% to 65%) in numbers of patients dying at home α = 0.05. Factors contributing to study underpower: unequal randomisation ratio of 4:1 requiring 450 intervention and 110 controls to achieve same power (change from 1:1 to 4:1 was needed to allow for attrition and ensure intervention places were filled for service to operate at full capacity and gain cooperation from health professionals); limited time available for the study (15 months); and the high base rate of death at home in the control group (58%)

Of patients randomised to intervention, 73 (39%) were not admitted to service (intention-to-treat analysis performed)


Risk of bias

BiasAuthors' judgementSupport for judgement

Concealment of allocation (RCT / CCT)Low risk"The randomization sequence was generated from a statistical table of random numbers and concealed in sequentially numbered, opaque, sealed envelopes"

Follow-up (RCT / CCT)Unclear risk95% for primary outcome (n = 229); 60% at 6 weeks after death (n = 144); 49% at 6 months after death (96/198 caregivers)

Blinding (RCT / CCT)Unclear riskObjective and standardised primary outcome assessment (death certificate); remaining outcomes: "It was not possible to blind recipients to the fact that the hospital at home service was provided". Researcher blinding not stated

Baseline measurement (RCT / CCT)Unclear riskComparison of groups limited to percentage with cancer and living alone, age, gender (no significant differences)

Reliability of outcome measurement (RCT / CCT)Unclear riskCollected from death certificates for primary outcome and from caregivers (self completed questionnaire; retrospective proxy report for symptoms and patient unmet needs; cross-sectional self report for post-bereavement outcomes)

Protection against contamination (RCT / CCT)High riskPatients/caregivers randomised

Greer 1986

MethodsDesign: CBA (patient and caregiver)

Methodological quality: 3.5/6a (EPOC CBA checklist)


ParticipantsCountry and regions: US, Southern New England, Northern Midwest and Southern California, metropolitan and rural areas

Recruitment (1981-1983, 19 months): trained staff interviewers screened records from 39 hospices (20 community-based and 19 hospital-based, both groups provided hospice home care and are hereby called community-based intervention and hospital-based intervention, respectively) and 14 conventional oncology care settings (outpatient clinics and oncology units) representing "good" oncology care according to knowledgeable area physicians (control, hereby called conventional care - CC); Medicare and non-Medicare patients aged ≥ 21 years with cancer confirmed by tissue diagnosis (except for brain and pancreatic cancer), remote metastasis (except for lung, brain and pancreatic cancer), presence of caregiver (this requirement excluded nursing home patients); additional criteria for controls KPS ≤ 50 (i.e. requiring assistance in daily activities) and poor life expectancy in the relatively short-term (judged by referring physician)

Number of patients (outcome sample): 1754 (833 community-based intervention, 624 hospital-based intervention, 297 control)

Diseases: cancer (1754)

Patient characteristics: median age band 65-74 years; 52% female; 6.7% community-based intervention, 16.1% hospital-based intervention, 16.6% controls lived alone ("average" 11.7%)

Number of caregivers (outcome sample): 1754 (833 community-based intervention, 624 hospital-based intervention, 297 control)

Caregiver characteristics: not stated

Deaths at end of study: 1754 (100%)

Withdrawals/other drop-outs: 4.4% with no differences among settings


InterventionsHome palliative care vs. usual care

"Hospice care"

Type: intermediate palliative care

Service base: 20 community-based hospices without inpatient beds (intervention1 - HC), 19 hospital-based hospices with inpatient beds (intervention2 - HB)

Team: medically supervised interdisciplinary teams composed of several individuals with appropriate skills including professionals and volunteers

Responsibility: not stated (although team is medically supervised)

Description: intervention grounded on hospice and humanistic philosophy of caring for terminally ill patients and their families (as per National Hospice Organization's 1979 standards of hospice programme of care); palliative, preventive, supportive, less resource-intensive and with more informal care (family and volunteers) than CC; repertoire of services including palliative care and control of symptoms, physical, emotional and spiritual distress, with emphasis placed upon care in the home, individualised care plan and provision, choices about treatment and place of death; supportive care for the family during the dying process and bereavement (this may include follow-up visits), maximum accessibility to care regardless time of day or ability to pay, and treating the patient and caregivers as a unit; inpatient and HC services closely integrated to ensure continuity and co-ordination of care; care available 24/7; education programme (for patient, family and team)

Duration: "average" length of stay - intervention 1: 72 days and intervention 2: 63 days, half of all patients dead within 35 days of admission, nearly 20% stayed 10 days or less

Control: CC "promotes aggressive care rather than palliative care; is directed by a physician with limited input from other professionals, focuses treatment on only the identified patient; generally ceases to provide services after death occurs; and varies greatly in quality depending upon the financial resources of the patient and the time at which services are most needed"


OutcomesQuality of life (primary outcome)

Death at home

Patient at home as long as wanted

Caregiver satisfaction with place of death

Pain

Symptom severity

Psychological well-being (emotional quality of life)

Social functioning (social quality of life, hours of social visiting, chatting with household members)

Spiritual well-being

Quality of death

Awareness

Physical function

Survival

Patient and caregiver satisfaction with care

Caregiver pre-bereavement outcomes (anxiety/depression, caregiver burden, increased drinking, medication use for anxiety and depression)

Caregiver post-bereavement outcomes (grief intensity, medication use for anxiety and depression)

Assessment points: baseline, 7 days after and 14 days thereafter until death (last measure "on average" 7 days before death and penultimate measure approximately 21 days before death with no differences among settings); 90-120 days after death for post-bereavement outcomes

Analysis: forward from enrolment, backwards from death and forwards from death


Resource use/costsInstitutional days

Home nursing visits, home health/homemaker visits, social services/other therapies visits, physician and outpatient clinic visits

Social services (general counselling, legal/financial counselling, paperwork assistance, help getting services, self care training)

Aggressive interventions (radiotherapy, surgery, chemotherapy or hormonal therapy, thoracentesis)

Diagnostic tests (blood tests, x-rays, or scans)

Respiratory support intervention (oxygen, respiratory therapy)

Analgesics (for a subsample of 181 patients)

Palliative radiation (for a sub-sample of 2 clinical profiles)

Informal care (hours of direct care help from primary care person)

Caregiver post-bereavement healthcare use (hospitalisation, number of physician's visits) and bereavement absenteeism from work

Time horizon: from enrolment to death; last 3, 2 and 1 week before death

Costs: inpatient, HC, physician visits, outpatient clinic visits, drugs, supplies and equipment expenditures, total costs per study day (included all the former)

Currency: 1982 USD


NotesPower considerations: "Sample sizes are predicated upon a 95% confidence limit, or at α = 0.05. The differences between samples are expressed as percentages of the mean on the QLI scale which ranges from 0 to 10. A difference of at least 15% on this scale will be accepted as a true difference. A sample size of 304 conventional care patients will be required to assure that 80% of the time we will be correct in assuming a true difference actually exists"; "a minimum of a 20% difference in the terminal care health costs associated with the two samples will be accepted as a true difference. At a desired power level of 0.8, a sample size of 404 patients in the conventional care group will be required"

Considerations about hospice care sites (i.e. intervention): initial number of hospices involved was 40 but 1 hospital-based hospice was excluded from all analyses since it provided virtually no HC service; 26 were demonstration sites (receiving Medicare demonstration waiver allowing payment for normally non-covered services) but analyses of patterns of care and of quality of life showed no differences between demonstration and non-demonstration hospices thus these were aggregated

Only patients who died during the study period were included in analyses since outcomes were assessed in relation to proximity to death

Self report data are from first and second patient interview rather than those interviews closest to death; most patients were unable to communicate as they approached death (e.g. patient self reports on pain could not be completed by 50% patients at 2 weeks before death and 80% at 1 week before death) thus caregiver reports were used


Risk of bias

BiasAuthors' judgementSupport for judgement

Baseline measurement (CBA)High riskSignificant differences in age, family income, living alone, caregiver employment, KPS (hospital-based intervention group was more functionally impaired than community-based intervention), hospitalisation in 2 months prior to study (control and hospital-based intervention more often than community-based intervention); analysis adjusted for differences in patient case mix

Characteristics of intervention and control providers (CBA)Unclear riskLimited information on providers' characteristics

Blinded assessment of outcomes (CBA)Unclear riskBlinding not stated; source of some information not stated; mix of self and proxy reports

Protection against contamination (CBA)Low riskSecond sites used as controls

Reliable outcome measurement (CBA)Unclear riskSource of some information not stated (e.g. place of death); mix of self and proxy reports

Follow-up of patients/caregivers (CBA)Low risk4.4% drop-outs with no differences among settings

Gómez-Batiste 2010

MethodsDesign: CBA (patient)

Methodological quality: 3/6a (EPOC CBA checklist)


ParticipantsCountry and regions: Spain, all 19 country regions, urban and rural areas

Recruitment (2007, 3 months): consecutive new referrals in 5 days to 105 palliative care services, patients > 18 years with advanced or terminal cancer, not receiving chemotherapy or radiotherapy in previous 30 days. Exclusion criteria: unavailable on the telephone

Number of patients (included): 265 (158 intervention and 107 control)

Diseases: cancer (265)

Patient characteristics: mean age 72.2 years; 39% female

Deaths at end of study: 43 (drop-outs)

Withdrawals/other drop-outs: 19 (14 due to severe impairment, 5 reasons not stated)


InterventionsHome vs. hospital palliative care

Type: specialist palliative care

Service base: 62 services, base not stated

Team: typically included doctor, 2 or 3 nurses and psychosocial worker (social worker or psychologist) with advanced training in palliative care; listed in national directory of palliative care services; according to a previous study, each team cared for a mean of 112 advanced or terminal patients/year

Responsibility: not stated although services aimed to advise other conventional teams in the community (primary physician/team likely to remain in charge)

Description: no specific information about intervention aims, components and availability of on-call; according to previous study the teams performed a mean of 9 interventions per patient and telephone calls were the second most frequent activity

Duration: not stated (median length from day of first clinical visit to death or last monitoring visit within study period was 42 days)

Control: specialist palliative care provided in hospitals (43 services) including palliative care units in acute bed hospitals, palliative care units in medium-term stay facilities, hospital support teams and outpatient clinics


OutcomesSymptoms (pain, anorexia, nausea/vomiting, constipation, insomnia, breathlessness, anxiety, depression)

Assessment points: baseline, 7 and 14 days after


Resource use/costsNot assessed


NotesPower considerations: none stated

Of 318 services invited to take part, 223 accepted (70%) and 105 (33%) were able to recruit patients; excessive clinical workload was main reason for refusal


Risk of bias

BiasAuthors' judgementSupport for judgement

Baseline measurement (CBA)Unclear riskBaseline characteristics for intervention patients and controls not reported separately

Characteristics of intervention and control providers (CBA)Unclear riskLimited information on providers' characteristics

Blinded assessment of outcomes (CBA)Unclear riskSource not stated

Protection against contamination (CBA)Low riskSecond sites used as controls (hospital palliative care services)

Reliable outcome measurement (CBA)Unclear riskSource not stated

Follow-up of patients/caregivers (CBA)High risk203 (77%) patients followed-up (drop-out reasons: 69% death, 23% severe impairment, 8% reasons not stated)

Harding 2004

MethodsDesign: CCT (patient and caregiver)

Methodological quality: 2/6a (EPOC RCT/CCT checklist)


ParticipantsCountry and regions: UK, London, metropolitan area

Recruitment (date and length not stated): from clinical nurse specialists of 2 home palliative care services; patients with life expectancy ≥ 3 weeks and with adult caregivers (staff estimated); allocated to intervention or control according to caregiver preference. Exclusion criteria: lack of fluency in spoken English

Number of patients (initial inclusion): 77 (40 intervention and 37 control)

Diseases (baseline sample): cancer (63), HIV (4), MND (2), Bechet's disease (1), CHF (1), Leigh's syndrome (1), Parkinson's disease (1)

Patient characteristics: mean age 65 years

Number of caregivers (initial inclusion): 77 (40 intervention and 37 control)

Caregiver characteristics: mean age 59.2 years; 69% female

Deaths at end of study: not stated

Withdrawals/other drop-outs: 4 intervention caregivers (unable to do baseline measures)


InterventionsReinforced vs. standard home palliative care

Additional component: "90 Minute Group"

Type: specialist palliative care

Service base: 2 home palliative care teams (base not stated) 

Team: additional component delivered by a facilitator-led multi-professional group (1 facilitator per site); standard home palliative care team composition not stated

Responsibility: for additional component – group facilitator (1 per site); for standard home palliative care team – not stated 

Description: research-based short-term caregiver group intervention (following literature review and qualitative study); aimed to promote self care by combining informal teaching with group support (addressing information and support needs of caregivers); 4 principles: 1) lack of identification with the label of 'carer', 2) provision of safe and legitimate time and space away from caring, 3) time limited, 4) respectful of existing coping strategies; 6 weekly 90-minute sessions with consistent facilitator to introduce multi-professional input from a changing weekly speaker (welfare benefits advice, occupational therapy and physiotherapy, clinical nurse specialist, and aromatherapy) and to subsequently facilitate group discussion of the weekly themes for a maximum of 12 carers; group initially focused on patient issues in order to provide legitimacy for attending, and to address the patient-oriented sources of distress; transport and patient-sitting provided when needed; detailed programmed objectives for each session, weekly facilitators' peer supervision (for intervention consistency); 2 groups delivered at each site; usual home palliative care included 24-hour home access to specialist nursing, advice and support

Duration: additional component lasted 6 weeks; standard home palliative care likely to be provided from enrolment to death (length not stated)

Control: specialist home palliative care with 24-hour home access to specialist nursing, advice, and support (any other service provided by the palliative care teams but no other carer-specific services were available at the time of the study)


OutcomesPhysical function

Caregiver pre-bereavement outcomes (burden, coping, general health, anxiety)

Assessment points: baseline, 8 weeks (post-intervention) and 5 months after

Analysis: forwards from enrolment


Resource use/costsNot assessed


NotesPower considerations: "lack of significant quantitative outcome differences in the present study may primarily be a result of the small sample size"

Qualitative data on processes and experience of the intervention


Risk of bias

BiasAuthors' judgementSupport for judgement

Concealment of allocation (RCT / CCT)High riskAllocation based on caregiver preference

Follow-up (RCT / CCT)High risk24 intervention (60%) and 17 control (46%) post-intervention, 15 intervention (38%) and 11 control (30%) at 5 months

Blinding (RCT / CCT)Unclear riskBlinding not stated

Baseline measurement (RCT / CCT)Low risk"the two groups did not differ significantly on age, sex, months of caring, patient physical scores, POS family score, depression, anxiety, or any of the eight composite coping scales"

Reliability of outcome measurement (RCT / CCT)Unclear riskCollected from caregivers by researchers

Protection against contamination (RCT / CCT)High riskPatient/caregiver allocation

Higginson 2009

MethodsDesign: phase II RCT (patient and caregiver)

Methodological quality: 3.5/6a (high quality, EPOC RCT/CCT checklist)


ParticipantsCountry and regions: UK, South East London, metropolitan area

Recruitment (2004-2005, 11 months): from local health and social professionals and in a few instances via voluntary groups and self referrals; patients with MS living in South East London, deemed (by clinicians) to have specialist palliative care needs (i.e. 1 or more unresolved symptoms, psychosocial concerns, end of life issues, progressive illness or complex needs); referrals screened by consultant in palliative medicine independent to study. Exclusion criteria: very urgent needs or rapid deterioration (immediate referral to service offered) 

Number of patients (randomised): 52 (26 intervention and 26 control)

Diseases: MS (52)

Patient characteristics: mean age 53 years; 69% female; 17.3% lived alone

Number of caregivers (randomised): 52 (26 intervention and 26 control)

Caregiver characteristics: not stated

Deaths at end of study: 4 (1 in the intervention and 3 in the control)

Withdrawals/other drop-outs: 2 controls (1 protocol violation, 1 severely ill)


InterventionsHome palliative care vs. usual care (fast-track design with a 12-week wait)

Type: specialist palliative care

Service base: King's College Hospital (general public teaching hospital) 

Team: part-time consultant in palliative medicine with training in neurology and special interest in MS, part-time clinical nurse specialist (working in neurology and with some palliative care training), full-time administrator; easy access to consultant neurologist through weekly multi-professional MS clinic (in addition to telephone and email contact) to joint review by neurology and palliative care and other relevant professionals; team worked closely with the existing hospital palliative care team, using time from their psychosocial worker (on maternity leave for 7 months during project); weekly meetings to discuss caseload and for consultant to input into management of all patients

Responsibility: not stated, "the service aimed to complement and not to replace existing services"

Description: new short-term intervention grounded in previous work (pre-clinical and phase I comprising systematic reviews and qualitative studies, as per the Medical Research Council framework for the evaluation of complex interventions); referral form – referrers were asked to identify the main issues requiring team's involvement and record in a standard form with criteria based on palliative care need criteria and specific triggers identified by team (hydration and nutrition, advance directives, competency and consent); initial comprehensive assessment – conducted by team member including demographics, ability to communicate, main symptom issues, current medication, psychological concerns, social issues (including care package and agencies involved), caregiver concerns and advance care planning (this took an "average" 110 minutes of direct contact and 90 minutes of liaison/administration); action plan and follow-up – following assessment, communicated to primary team and other professionals as appropriate, and followed through calls or visits depending on need; specialist welfare benefits advice; bereavement support; crisis prevention; education and support for primary and secondary care; patients were seen in their place of choice (often at home and sometimes at outpatient clinics, nursing home, hospital); 1-3 contacts per patient (visits or telephone calls or both); referral to longer-term specialist community palliative care – identification of specialist need by consultant based on WHO definition of palliative care (specifically physical symptoms, integration of psychological and spiritual aspects of care, need for ongoing support for patients and families, terminal care and bereavement support) and referral to local teams for those in need (12%)

Duration: 1-3 contacts

Control: usual care, including community and hospital services (e.g. neurologists, MS nurses, district nurses, GPs, rehabilitation, neurological, social services) in first 12 weeks after enrolment, topped up with access to intervention from then onwards; a few patients received home physiotherapy, occupational therapy, specialist rehabilitation services, continence advice, psychological and psychiatric care; emergency access to intervention in case of very urgent needs or rapid deterioration


OutcomesPalliative outcomes (primary outcome)

Pain

Symptom burden

Physical and psychological disease impact

Caregiver pre bereavement outcomes (burden, mastery, positivity)

Assessment points: baseline, 6 and 12 weeks after (primary analysis), 18 weeks (only controls – after receiving intervention) and 24 weeks after

Analysis: forwards from enrolment


Resource use/costsFormal care (included a range of health, social and voluntary services – inpatient care, respite care, day centre, contacts with district/practice, MS nurse, palliative care nurse, other nurse, general practice, specialist at home, in hospital, in a ward and in other places, occupational therapist, physiotherapist, dietician, chiropodist, dentist, speech therapist, social services, day centre, inpatient care, respite care); informal care (hours of care)

Time horizon: 12 weeks following enrolment  

Costs: mean costs for each of the categories above; difference in total costs per patient: a) including formal and informal care, and b) excluding inpatient and informal care as above

Currency: 2005 GBP

Cost-effectiveness: cost-effectiveness planes for palliative outcomes (primary outcome) and caregiver burden


NotesPower considerations: "We estimated that a sample of more than 25 patients in each arm would enable us to detect differences of >2 on the POS-8 at P < 0.05, power 80% (with a standard deviation [SD] of 2.25) at 12 weeks"


Risk of bias

BiasAuthors' judgementSupport for judgement

Concealment of allocation (RCT / CCT)Low risk"The researcher e-mailed relevant data to independent statisticians who conducted the randomization using the minimization method to give an equal balance of gender, age, date of diagnosis, and according to whether patients could or could not communicate. (...) The statistician informed researchers who then informed patients of their allocation"

Follow-up (RCT / CCT)Low risk46/52 (89%) at study end

Blinding (RCT / CCT)High risk"We were unable to blind the interviewers or participants from group allocation"

Baseline measurement (RCT / CCT)Low riskNo significant baseline differences: gender, age, ethnicity, type of MS, education, caregiver  characteristics, functional status and outcomes (analysis adjusted for baseline scores)

Reliability of outcome measurement (RCT / CCT)Unclear riskFace-to-face interview with patients using standard measures; self complete questionnaires with caregivers

Protection against contamination (RCT / CCT)High riskPatients/caregivers randomised

Hudson 2005

MethodsDesign: RCT (caregiver)

Methodological quality: 2.5/6a (EPOC RCT/CCT checklist)


ParticipantsCountry and regions: Australia, Melbourne, Victoria, metropolitan area

Recruitment (date not stated, 12 months): from 2 home palliative care services (similar annual admissions and similar to national "average" length of stay of 75 days); new patient referrals (within 1 week) with ECOG Performance Status from 0 to 3, i.e. at least capable of minimal self care; up and about more than 50% of waking hours (criteria to minimise attrition). Exclusion criteria: no caregiver living with patient, patient with intellectual or psychiatric illness or lack of English language skills

Diseases: cancer (106)

Number of caregivers (randomised): 106 (54 intervention and 52 control)

Caregiver characteristics: mean age 60.78 years; 65.1% female

Deaths at end of study: not stated

Withdrawals/other drop-outs: 34 intervention and 27 control (non-response to questionnaire)


InterventionsReinforced vs. standard home palliative care

Additional component: "psychoeducational intervention"

Type: specialist palliative care

Service base: 2 home palliative care teams (base not stated)

Team: additional component delivered by nurse; standard home palliative care team comprised specialist nurses, doctors, and allied health professionals (similar range of disciplines in each service, including nurses, social workers, medical consultants, pastoral care workers, volunteers and bereavement counsellors)

Responsibility: for additional component - nurse; for standard home palliative - team's nurse (not clear if responsibility rested with primary physician/team)

Description: additional component grounded on literature and focus groups with nurses and caregivers (current and bereaved); aimed to top up home palliative care with a psychoeducational component to enhance support and guidance for caregivers – this consisted of 2 fortnightly home visits with follow-up call between visits, structured around and complemented by audiotape with reflections from caregivers and self care strategies and structured relaxation exercise, and guidebook with information on typical aspects of caring for dying person (link provided in paper); caregivers read guidebook sections and noted questions prior to visits - first visit prepared for caregiver role and aspects of caregiving (section 1 and 2 of guidebook); telephone call focused on evaluating plans, self care (section 3), new issues and caregiver desire to go on to next section; second visit focused on evaluating previous strategies, new issues and preparing for dying phase (final section of guidebook)

Duration: additional component lasted 2 weeks; standard home palliative care likely to be provided from enrolment to death (length not stated)

Control: specialist home palliative care including information and access to services outside the team and spiritual guidance; emergency visits from nurses in addition to pre-scheduled home visits from team members; 24/7 phone advice


OutcomesCaregiver pre- and post -bereavement outcomes (preparedness, competence, self efficacy, caregiving rewards, anxiety)

Assessment points: baseline, 5 weeks after (questionnaire posted 28 days after baseline), and 8 weeks after death

Analysis: forwards from enrolment and forwards from death


Resource use/costsNot assessed


NotesPower considerations: "There was insufficient power to detect differences based on a simultaneous comparison of data obtained at all three assessment times (...) only moderate to large effects were likely to be found."; "Owing to time and financial constraints, sample size was not calculated on the basis of a predetermined power and effect size"; "Cohen's power tables were used to determine the power associated with each statistical test based on the pre-specified effect and sample size (alpha levels were set at 0.05; all tests were two tailed). Power values ranged from 0.70 (t-test for two independent samples) to 0.99 (t-test for related samples)"


Risk of bias

BiasAuthors' judgementSupport for judgement

Concealment of allocation (RCT / CCT)Low risk"Randomization to group occurred via a computer-generated software system"

Follow-up (RCT / CCT)High risk40 intervention (74%) and 35 control (67%) follow-up 5 weeks after baseline; 20 intervention (37%) and 25 control (48%) 8 weeks after death

Blinding (RCT / CCT)Unclear riskBlinding not stated

Baseline measurement (RCT / CCT)Unclear risk"Chi-squared tests and t-tests for independent samples were used to assess the possibility of pre-existing differences between the standard care and intervention groups based on baseline data"; no results stated, descriptive data not shown

Reliability of outcome measurement (RCT / CCT)Unclear riskCollected from caregivers by research assistants at baseline and 8 weeks after death (home); self completed by caregivers 5 weeks after baseline (mail)

Protection against contamination (RCT / CCT)High riskPatients randomised

Hughes 1992

MethodsDesign: RCT (patient and caregiver)

Methodological quality: 3/6a (EPOC RCT/CCT checklist)


ParticipantsCountry and regions: US, Hines, Illinois, metropolitan area

Recruitment (1984-1987, 37 months): from medicine, surgery and neurology acute wards at Edward Hines Jr. VA Hospital; new inpatient admissions with life expectancy < 6 months (estimated by primary physician), presence of caregiver, residence within 30-mile (48-km) catchment area 

Number of patients (randomised): 175 (87 intervention and 88 control)

Diseases (baseline sample): cancer (80% of intervention, 73% of control), genitourinary system (5% of intervention, 4% of control), other respiratory (3% of intervention, 4% of control), other (12% of intervention, 19% of control) 

Patient characteristics: mean age 65.73 years intervention, 63.26 years control; gender distribution not given but stated "predominantly male veterans"

Number of caregivers (randomised): 175 (87 intervention and 88 control)

Caregiver characteristics: mean age 55.5 years intervention, 56.4 years control; 92% female; 88% intervention caregivers and 97% controls lived with patient; 58% intervention caregivers and 72% controls were spouses

Deaths at end of study: 79% intervention and 78% control

Withdrawals/other drop-outs: 2 in the intervention and 2 in the control (entered nursing home before receiving intervention or control)


InterventionsHome palliative care vs. usual care

"Hospital based home care (HBHC)"

Type: intermediate palliative care

Service base: Edward Hines Jr. VA Hospital (department not stated)

Team: physician-led interdisciplinary team including nurses, social worker, physiotherapist, dietician, health technicians (physician also managed hospital's inpatient intermediate care unit thus maximised potential for continuity of care between home and hospital); team meetings

Responsibility: not stated

Description: existing service (for 13 years) emphasising on provision of care to high-risk patients, comprehensive services based on need, importance of timely communication about patients across team members, and instruction and involvement of informal caregivers in patient care to the maximum extent possible; both patient and family constituted unit of care, with education being a strong service component; goal-oriented, interdisciplinary patient care plans developed at team meetings; scheduled visits according to individual patient needs; physician home visits, pharmaceuticals, and supplies are also included

Duration: up to 6 months (mean survival in intervention group 76 days)

Control: traditional community HC services, customary care within or outside the VA hospital with exception of access to intervention; control patients could be seen by VA discharge planners and receive community HC or hospice care


OutcomesPhysical function

Cognitive functioning

Morale

Survival

Patient and caregiver satisfaction with care

Caregiver pre-bereavement outcome (morale)

Assessment points: baseline and 1 and 6 months after (or if patient died before 6 months after), the caregiver was interviewed within 1 month after death) 

Analysis: forwards from enrolment


Resource use/costsHospital admission

VA services (total hospital inpatient days, intensive care days, rehabilitation days, intermediate bed days, general bed days; ED visits; extended care days; nursing home days; intervention team's visits; outpatient clinic visits)

Non-VA services (private hospital inpatient days, ED visits, ambulatory care visits, community nursing visits, private HC visits, nursing home days)

Time horizon: 6 months following enrolment

Costs: institutional (VA hospital, private hospital, total hospital costs, total institutional costs including all hospital and nursing home); non-institutional (outpatient clinic, intervention team, community nursing, total HC costs); total VA costs, total non-VA costs, total costs including VA and non-VA costs

Currency: 1985 USD


NotesPower considerations: none stated

As the study took place at a VA Hospital, 65% patients were male veterans cared for by spouses (92% of caregivers were female)


Risk of bias

BiasAuthors' judgementSupport for judgement

Concealment of allocation (RCT / CCT)Unclear riskPatients with caregivers "randomly assigned"; details of process not stated

Follow-up (RCT / CCT)Unclear risk96 patients at 1-month follow-up (55%) and 34 at 6 months; 149 caregivers at 1 month (85%) and 72 at 6 months (41%); 59 at 1 or 6 months after death (34%)

Blinding (RCT / CCT)Unclear riskBlinding not stated 

Baseline measurement (RCT / CCT)Low riskNo significant differences at baseline (demographic, clinical and outcomes)

Reliability of outcome measurement (RCT / CCT)Unclear riskCollected from patients or caregivers or both by interviewers face-to-face

Protection against contamination (RCT / CCT)High riskPatients/caregivers randomised

Jordhøy 2000

MethodsDesign: cluster RCT (patient and caregiver)

Methodological quality: 3.5/6a (high quality, EPOC RCT/CCT checklist)


ParticipantsCountry and regions: Norway, Trondheim, 6 metropolitan and 2 rural areas

Recruitment (1995-1997, 32 months): from hospital departments, particularly gastrointestinal surgery, urological surgery, oncology and gynaecology, lung and gastrointestinal departments of internal medicine (through professionals, lead nurse and researchers screening visits once or twice per week) and primary care professionals in 8 healthcare districts; patients aged > 18 years with incurable cancer, life expectancy 2-9 months (not stated who estimated) living in 8 community healthcare districts (clusters) stratified into 3 pairs according to number of inhabitants > 60 years and urban/rural status (2 smaller urban districts merged with larger ones) and randomised to intervention or control. Exclusion criteria: haematological malignant disorders other than lymphomas, patient not informed about their diagnosis and that the disease was incurable, participation in other trials with quality of life as outcome, unable to fill in questionnaire 

Number of patients (randomised): 434 (235 intervention and 199 control)

Diseases: cancer (434): gastrointestinal (181), lung (52), breast and female genitals (67), prostate and male genitals (41), kidney or vesica (29), lymphomas (13), skin (12), others (39)

Patient characteristics: median age 70 years intervention, 69 years control; 47% female; 32.5% lived alone

Number of caregivers (consented): 313 (183 intervention and 130 control)

Caregiver characteristics: median age 57.6 years intervention, 53.9 years control; 68.3% female 

Deaths at end of study: 395 (219 intervention (93%) and 176 control (88%)) 

Withdrawals/other drop-outs: 6 intervention and 10 control (reasons not stated)


InterventionsHome palliative care vs. usual care

Type: specialist palliative care

Service base: palliative medicine unit at University Hospital of Trondheim (12 beds, outpatient clinic and consultant team in and out of hospital)

Team: 1 full-time physician; 2 palliative care nurses, social worker, priest, nutritionist, part-time physiotherapist; staff worked daytime hours only; weekly meetings

Responsibility: consultant nurse was the care co-ordinator; primary family physician and community nurse maintained as main professional carers

Description: new intervention grounded on holistic philosophy, included multidisciplinary approach to the patient's needs and co-ordination of care; consultant team who co-ordinated care; initial care plan set up in meeting of patient, caregivers, family physician, community nurse, and consultant nurse or physician from team; follow-up routine consultations by community staff supervised by team (available for joint home visits); no additional out of hours or on-call service; service linked the palliative medicine unit to community services under pre-defined guidelines to keep interaction at optimum level; education programme (including bedside training and 6-12 hours of lecturers every 6 months on symptoms and difficulties in palliative care); inpatient and outpatient services provided at unit except when required for medical reasons (e.g. surgery or acute intensive care for intercurrent disease)

Duration: from enrolment to death or study end (median survival 99 days in the intervention group)

Control: usual care shared among University hospital departments and community services according to diagnosis and medical needs (no well-defined routines existed and poor communication between levels of services had been addressed as general problem); despite minor variations, community services were similar in all districts, including family physicians, HC nursing (nurses and nurse-assistants) and nursing homes (when extensive need for attention or basic nursing care but not specialised hospital care is required); all except smallest urban district had 24 hours HC; limited night coverage (generally only short visits or telephone consultations); HC and nursing home services co-ordinated at district level (common community nursing office - decisions based on patient's medical and social needs and current availability of community resources); no specialist palliative care service available other than the intervention


OutcomesQuality of life (primary outcome)

Physical symptoms (pain – primary outcome; breathlessness, nausea/vomiting, constipation, diarrhoea, sleep disturbance, fatigue, appetite loss)

Physical function (primary outcome)

Psychological well-being (primary outcome; emotional functioning and psychological stress)

Death at home (primary outcome)

Death in hospital

Death in hospital palliative care unit

Death in nursing home

Percentage of time spent at home

General health and vitality

Social functioning

Survival

Caregiver satisfaction with care

Caregiver pre-bereavement outcomes (quality of life, general health, vitality, physical, psychological and social functioning, bodily pain)

Caregiver post-bereavement outcomes (quality of life, general health, vitality, physical, psychological and social functioning, bodily pain, grief intensity)

Assessment points: baseline and monthly until death (or up to 2 years to avoid research burden); satisfaction with care measured 1 month after death; caregivers assessed 1, 3, 6 and 13 months after death

Analysis: forwards from enrolment, backwards and forwards from death (caregivers' outcomes)


Resource use/costsHospitalisations (admission, number of admissions, mean length of admission, inpatient days, proportion of time in hospital)

Care in nursing homes (admission, number of admissions, nursing home days, proportion of time in nursing homes)

Time horizon: from enrolment to death or study end; last month before death


NotesPower considerations: "Pre-planned sample size was 200 patients in each group, based on quality of life."; "Because there was uncertainty about the likely difference, the impact of a variety of effect sizes was explored. Between 50 to 75 patients per group would be realistic to detect differences as small as 0.5 SDs in an ordinary randomized clinical trial (RCT), an effect size that is commonly regarded as a moderate change, and for which the EORTC QLQ-C30 scores are roughly comparable to a change of 10 units. This represented a plausible and realistic effect of the intervention policy. However, for a cluster randomized design, the statistical power will be reduced because of within-cluster correlation. This can be taken into account by increasing the total number of clusters, or to a lesser extent, by increasing the number of subjects per cluster. In this trial, for practical and economical reasons, participation had to be restricted to the clusters (health care districts) located within close reach from the palliative medicine unit, and it was decided to include 200 patients in each treatment group"

Authors discuss issues related to recruitment attrition, and compliance in a methodological paper.


Risk of bias

BiasAuthors' judgementSupport for judgement

Concealment of allocation (RCT / CCT)Unclear risk"Cluster randomised design"; unit of allocation was health district but random process not explicit

Follow-up (RCT / CCT)Unclear riskPatients: 153 intervention (65%) and 116 control (58%) follow-up at 1 month on questionnaire-based measures (including primary outcomes); 219 intervention (93%) and 176 control (88%) on place of death

Caregivers: 113 (49%) intervention and 70 control (36%) 1 month after death 

Blinding (RCT / CCT)Unclear riskNot stated

Baseline measurement (RCT / CCT)Unclear riskSignificant differences in diagnosis (intervention more gastrointestinal/lung, less breast/prostate/kidney/vesica/lymphoma/skin), housing (intervention higher proportion living in villa/apartment), access to informal help (intervention higher) and receipt of HC nursing (intervention lower); unclear if all are in same direction as results. No significant baseline differences in quality of life (1 of primary outcomes)

Reliability of outcome measurement (RCT / CCT)Unclear riskQuestionnaire-based measures were self completed; source of data on place of death not stated

Protection against contamination (RCT / CCT)Low riskHealth districts randomised

McCorkle 1989

MethodsDesign: RCT (patient and caregiver)

Methodological quality: 2.5/6a (EPOC RCT/CCT checklist)


ParticipantsCountry and regions: US, Washington, King County, rural and urban areas

Recruitment: (1983-1985, 18 months): from cancer registries and pathology reports in 19 hospitals and 1 radiation outpatient facility; newly diagnosed stage II lung cancer patients (included squamous cell, adenocarcinoma, small cell, giant cell cancer), King County residence, meeting Medicare criteria for homebound (i.e. unable to use public transportation on a routine basis without assistance). Exclusion criteria: judged by physician as too ill to participate, receiving standard home nursing care in prior 6 months, enrolled in home health agency

Number of patients (randomised): 166; (outcome sample): 78; 24 intervention, 27 control1, 26 control2 (group for 1 patient not stated)

Diseases: cancer (166); all primary site lung

Patient characteristics: aged 18-89 years; 37% female

Number of caregivers (eligible): 127; (outcome sample): 46

Caregiver characteristics: not stated

Deaths at end of study: 87 (52%)

Withdrawals/other drop-outs: 24 patients (11 too sick to handle interviews, 5 caregivers refused interview, 3 caregiver or patients or both unable to cope with questions, 3 patients moved out of King County, 2 unknown); 81 caregivers at bereavement follow-up (30 refused, 9 did not complete first interview, 21 patients still alive, 10 lost to follow-up, 11 incomplete data) 


InterventionsHome palliative care vs. usual care (2 control groups)

"Specialized Oncology Home Care Program – OHC"

Type: intermediate palliative care

Service base: not stated

Team: nurses with masters' degrees and trained to give personalised clinical care to persons with advanced cancer and their families; advanced training on knowledge of symptom management, cancer treatments, pain management, physical assessment, psychosocial assessment, grief and mourning theory, communications systems, community resources and agencies, systems analysis, self support, professional role development, pathophysiology of death, and research theory and methodology; specialised services by other disciplines called upon as needed

Responsibility: nurse was care co-ordinator (not clear if patient's primary physician remained in charge)

Description: intervention grounded on Oncology Transition Services model (personalised care in home setting with key features including advanced education in cancer symptom management, nurse being central care co-ordinator, 24-hour access to nursing staff)

Duration: not stated but likely to be from enrolment to death

Control: control1 (HC) consisted of care provided by an interdisciplinary team (RNs, physiotherapists, home health aides, medical social work, occupational therapist and a speech pathologist); upon referral, the patient was assigned to team members appropriate to meet the patient's needs as identified on referral and approved by the patient's physician; entire team discussed treatment and case management plans, co-ordination of visits, length and intensity of services, need for consultation, co-ordination with physician, family and community resources, and discharge from care; this represented standard Medicare-reimbursed services available in the community. Control2 (outpatient care) consisted of care provided by the patient's physician and outpatient staff (traditional treatment for cancer patients) with no general or specialised home nursing care


OutcomesPain

Symptom distress

General health

Physical function (enforced social dependency)

Psychological distress (mood, psychosocial concerns)

Caregiver post-bereavement outcomes (psychological distress)

Assessment points: baseline (from 8 to 10 weeks of diagnosis), and 6, 12, 18, 24 weeks after; baseline, 6 weeks after death and then 6, 13 and 25 months after 

Analysis: forwards from enrolment and forwards from death


Resource use/costsHospitalisations (admission, number of admissions, inpatient days)

Time horizon: 6 months following enrolment  


NotesPower considerations: none stated

Data collected on fifth and last time point (24 weeks after baseline) not analysed because of small sample size (n = 55, 33% of initial sample)


Risk of bias

BiasAuthors' judgementSupport for judgement

Concealment of allocation (RCT / CCT)Unclear risk"subjects were assigned randomly after the initial interview was completed"; no details of process

Follow-up (RCT / CCT)High risk78 patients (47%) follow-up at fourth interview (18 weeks after baseline); 46/127 (36%) caregivers 

Blinding (RCT / CCT)Unclear riskDouble-blind at baseline; not stated for follow-up

Baseline measurement (RCT / CCT)Unclear risk"Chi-square tests indicated no statistically significant group differences on demographic variables"; intervention group did "notably better" at baseline on most outcomes; analyses adjusted for baseline scores (covariates); no differences in caregivers baseline psychological distress

Reliability of outcome measurement (RCT / CCT)Low riskPatients and caregivers completed the baseline questionnaires upon enrolment and the follow-up questionnaires mailed to them

Protection against contamination (RCT / CCT)High riskPatients randomised

McKegney 1981

MethodsDesign: cluster RCT (patient)

Methodological quality: 4/6a (high quality, EPOC RCT/CCT checklist)


ParticipantsCountry and regions: US, Vermont, rural area

Recruitment (date not stated, "four-year study"): from radiotherapy and medical oncology clinics at Vermont Regional Cancer Center; new patients with cancer (histologically confirmed) aged ≥ 16 years with life expectancy from 3 months to 1 year (judged by experienced oncologist) living in Vermont counties; counties randomly allocated to intervention and control (number of counties not stated, paired based on population density, distance from centre, socioeconomic status, local medical facilities, referral patterns and local social services). Exclusion criteria: patients mentally incompetent

Number of patients (allocated): 199 (98 intervention and  101 control)

Diseases: cancer (199)

Patient characteristics (primary outcome sample of 83 patients): mean age 58.7 years intervention, 56.1 years control; 42% female

Deaths at end of study: 139 (70%)

Withdrawals/other drop-outs: not stated


InterventionsHome palliative care vs. usual care

"Intensive home care"

Type: intermediate palliative care

Service base: Vermont Regional Cancer Center (department not stated) 

Team: trained oncology nurse practitioners with "extensive experience in care of the patients with advanced cancer" backed up by usual multidisciplinary team of nurses, medical and radiation oncologists, dieticians, enterostomal therapist, physiotherapists, occupational therapists, psychiatrists, social workers and clergymen at the cancer centre; formal interdisciplinary training on extended assessment skills (sophisticated approach to physical, psychological, nutritional and financial assessments of both patients and families); weekly team conferences

Responsibility: team's nurse (acting as link between the multidisciplinary team and care co-ordinator responsible for following patients through home visits, clinic visits and hospitalisations to ensure continuity of care; primary physician informed and collaborating in complex medical problems)

Description: intervention designed to improve patient's quality of life and communication between the conventional cancer rehabilitation team and the patient by assigning oncology nurses to closely monitor and co-ordinate patient care; assumed nurses would anticipate and solve medical and psychosocial problems and that their expertise would improve quality and extend survival; initial interdisciplinary assessment (by each team member) followed by care plan build by nurse; frequency of home visits defined based on prognosis (life expectancy < 3 months – biweekly; ≥ 3 months – monthly); home visits (35-40 minutes) focused on patient needs ("incidental interactions with family"); physical care, talking with patient about illness and implications, mobilising family and social resources and co-ordinating with patient's physician; protocol for pain management (in varying degrees of pain), nausea, vomiting and administration of intravenous chemotherapy drugs at home (available from authors); pain killers given regularly to ensure continuous control

Duration: not stated but likely to be from enrolment to death or study end (mean survival in intervention group was 345 days)

Control: usual care provided by multidisciplinary team at cancer centre and patient's local/private physician


OutcomesPain (primary outcome)

Physical activity/function

Nutrition

Psychological well-being (optimism)

Survival

Assessment points: baseline and then timed with nurse visits (biweekly for patients with life expectancy < 3 months; monthly for those with ≥ 3 months)

Analysis: backwards from death


Resource use/costsHospital inpatient days  

Time horizon: not stated


NotesPower considerations: none stated

Potential for measurement bias: less frequent assessments for patients with longer life expectancy (assessment timed with nurse visits, frequency of visits decided based on patient estimated life expectancy)


Risk of bias

BiasAuthors' judgementSupport for judgement

Concealment of allocation (RCT / CCT)Unclear risk"paired counties were randomly separated into two groups"; process not stated 

Follow-up (RCT / CCT)Unclear risk38 intervention (39%) and 45 control (45%) follow-up (minimum of 3 time points on pain backwards from death, primary outcome); not stated for other outcomes

Blinding (RCT / CCT)Unclear riskNot stated

Baseline measurement (RCT / CCT)Low risk"A comparison of patient characteristics for these two groups demonstrated similarities in cancer diagnosis, sex, age, social class, and religious preference. The initial, on-study scores on the CMI, I-E, and KPS did not differ significantly"; "When pain levels (…) were compared over time, in 30-day periods before death, the two groups had essentially the same mean pain scores until the last 90 days before death"

Reliability of outcome measurement (RCT / CCT)Unclear risk"by trained independent raters, using structured interviews in the patients' homes, done at the same frequency as the nurses' visits, which were based upon the patients' prognosis. Follow-up interviews were carried out in the patients' homes because earlier data had indicated greater validity of home vs. clinical evaluations for some measures. Initial and follow-up rater training took place during the pilot phase of the project using videotapes. At the end of the first year the raters had achieved acceptable interrater agreement on major scale items (Pearson correlation coefficient 0.70)"

Protection against contamination (RCT / CCT)Low riskCounties randomised

McMillan 2007

MethodsDesign: RCT (patient and caregiver)

Methodological quality: 2.5/6a (EPOC RCT/CCT checklist)


ParticipantsCountry and regions: US, Tampa, Florida, metropolitan area

Recruitment (1999-2003, 50 months): sample drawn from large non-profit community-based hospice face sheets; consecutive new cancer patients aged ≥ 18 years living in study county, with a caregiver and problems with at least 2 symptoms (pain, breathlessness, constipation). Exclusion criteria: patient low level of consciousness (assessed by admission team), excessively debilitated (≥ 40 score on Palliative Performance Scale) or actively dying, admitted to inpatient hospice or assisted-living facility or nursing home; patient and caregiver < sixth grade education, unable to read or understand English, ≥ 7 in Short Portable Mental Status Questionnaire, caregiver in active treatment for cancer themselves

Number of patients (randomised): 329 (111 intervention, 109 control1, 109 control2)

Diseases: cancer (329)

Patient characteristics: mean age 70.84 years intervention, 71.02 years control1 and

70.12 years control2; 39.9% female

Number of caregivers (randomised): 329 (111 intervention, 109 control1, 109 control2)

Caregiver characteristics: mean age 63.06 years intervention, 61.53 years control1, 59.98 years control2; 85.4% female

Deaths at end of study: not stated 

Withdrawals/other drop-outs: "Most commonly, attrition was due to patient decline (29%) or death (21%), and the caregiver feeling overwhelmed (23%), which was largely associated with patients' worsening condition"


InterventionsReinforced vs. standard home palliative care (2 control groups)

Additional component: "COPE Intervention"

Type: specialist palliative care

Service base: large non-profit community-based hospice 

Team: additional component delivered by newly hired nurses (1 full-time and 1 back-up) and home health aides with hospice experience; 4 day training on intervention with role-play; composition of standard home hospice care team not stated (cared for 850 patients/day)

Responsibility: for additional component – nurse; for standard home hospice care team – not stated

Description: home hospice care with new additional brief psychoeducational support (COPE intervention); caregiver problem-solving education component grounded on conceptual and research literature on stress process models and problem solving training and therapy; 9-day intervention with 3 visits (first 45 minutes, second and third 30 minutes) and continued support in between with calls to assess problems, offered support and answer questions and nurse pager contact; intervention adapted to teach a problem-solving method to assess and manage patient symptoms (focus on pain, dyspnoea and constipation); 4 components:

  1. Creativity (viewing problems from different perspectives to develop new strategies for solving caregiving problems, e.g. distract patient from pain);
  2. Optimism (positive but realistic attitude towards problem-solving process, including communicating realistic optimism to patient by showing understanding and hope and involving them in planning as much as possible;
  3. Planning (setting reasonable caregiving goals and thinking out, in advance, the steps necessary to reach those goals, e.g. family holiday);
  4. Expert information (what family caregivers need to know about nature of problem, when to get professional help, and what they can do on their own to deal with problem, e.g. where to get help); Home Care Guide for advanced cancer (for patients and caregivers) with 23 patient problems with easy reference for caregivers; caregivers encouraged to use the assessment scales for pain and dyspnoea at least twice daily and constipation scale at least daily and record findings in patient symptom diary – ratings were foundation for action to call hospice staff and manage symptoms at home; intervention manual (available from authors) and audiotapes of sessions reviewed monthly to ensure protocols were followed


Duration: 9 days for additional component; duration of standard home hospice care not stated but likely to be from admission to death

Control: control1 - standard specialist home hospice care with additional supportive visits from intervention nurse and home health aide (same visit frequency and length as intervention); nurse provided individual caregiver support, discussed feelings, fears, and relationship with patient; trained not to give advice about managing problems and not to teach structured problem-solving skills (e.g. dealt with questions asking about advice given by hospice nurse); manual and audiotapes of sessions reviewed monthly to ensure protocols were followed; home health aide provided respite staying with patient during supportive visits; control2 - standard specialist home hospice care, which included some caregiver education and support about symptom management and what to expect with disease progression


OutcomesCaregiver pre-bereavement outcomes (3 primary outcomes - quality of life, burden, mastery; distress with patient symptoms, coping) 

Physical symptoms (pain, breathlessness and constipation)

Symptom distress

Quality of life

Assessment points: at baseline, 16 days after baseline (1 week post intervention) and 30 days after (2 weeks post intervention)

Analysis: forwards from enrolment


Resource use/costsNot assessed


NotesPower considerations: based on power calculations, 160 patient-caregiver dyads were sought for each group (n = 480)

Authors discussed challenges of recruitment in methodological paper: large amount of time spent screening face sheets (to bypass nurse gatekeeping) for very low proportion of eligible patients (5%), need to delay recruiting from 24 up to 48 hours after hospice care admission (to avoid time of transition and opt out of curative treatment), attrition due to decline and death (69% 30 days after baseline); this led to extension of recruitment period, problems with generalisability and adjustments to study budget


Risk of bias

BiasAuthors' judgementSupport for judgement

Concealment of allocation (RCT / CCT)Low risk"randomly assigned to the three treatment conditions at baseline by using a computerized randomization procedure by telephone"

Follow-up (RCT / CCT)High risk42 intervention (38%), 47 control1 (43%), 60 control2 (55%) at 16 day follow-up; 31 intervention, 32 control1, 40 control2 at 30-day follow-up

Blinding (RCT / CCT)Unclear riskSingle-blind: self completed questionnaires administered without offer of information or assistance; "research assistants were blind to treatment conditions and had contact with intervention staff only at regularly scheduled staff meetings where individual cases were not discussed"

Baseline measurement (RCT / CCT)Unclear riskNo significant sociodemographic differences in patient and caregiver characteristics (P value > 0.10); outcome baseline data not reported

Reliability of outcome measurement (RCT / CCT)Unclear riskSelf completed questionnaires administered by blinded research assistants (see above); caregivers overestimated symptom intensity for pain (the difference in mean scores was 1.33 in a 0 to 10 scale), breathlessness (0.78 difference in mean scores in a 0 to 10 scale) and constipation (1.08 difference in mean scores in 0 to 16 scale); all 3 differences were very significant (paired t-tests; P value < 0.001). Pearson correlation coefficients were 0.40, 0.46 and 0.51, respectively

Protection against contamination (RCT / CCT)High riskPatients/caregivers randomised

McWhinney 1994

MethodsDesign: RCT (patient and caregiver)

Methodological quality: 3/6a (EPOC RCT/CCT checklist)


ParticipantsCountry and regions: Canada, London, Ontario, metropolitan area

Recruitment (date and length not stated): from family physicians and HC nurses (with "strenuous efforts to attract referrals, including an information sheet for family doctors and presentations to medical meetings" resulting in short lived increases); patients aged ≥ 18 years with symptomatic cancer metastasised or spread to surrounding tissues, life expectancy ≥ 2 months and being cared for at home by an eligible caregiver

Number of patients (randomised): 146

Number of caregivers (randomised): 146

Diseases: cancer (146)

Patient and caregiver characteristics: not stated

Deaths at end of study: 36 within the first month (25%) 

Withdrawals/other drop-outs: 14 patients (10%) and 72 caregivers (49%) failed to complete 1-month questionnaire; 3 patients with reasons unknown


InterventionsHome palliative care vs. usual care (fast-track design with 4 weeks' wait)

"Palliative care home support team"

Type: specialist palliative care

Service base: 14 bed palliative care unit (host organisation not stated)

Team: physician, 2 experienced palliative care nurses (working 1 week on, 1 off) and a part-time social worker

Responsibility: family physician and HC nurses (team was consulting and support service only)

Description: existing service (available for 18 months) with weekly team meetings but limited description of its aim and components; included initial full nurse assessment at home within 3 days of referral; care plan was then discussed with team's physician and copies sent to family physician, home nurse and case manager; involvement of team after assessment varied from no further contact to monitoring telephone calls to periodic visits and close relationship (dependent on wishes of patient and family and negotiation with family physician and home nurse); 24-hour on-call nursing with physician back up and contact given (if family physician and home nurse not available); team's physician consultation available on request (not clear if at home)

Duration: not stated

Control: range of HC services from family physician, HC nurses and case manager (without 24-hour coverage) and admission to palliative care unit if needed in first 4 weeks after enrolment, topped up with access to home palliative care team from then onwards; emergency consultation with team's physician available to waiting list group in first 4 weeks if requested by family physician


OutcomesPhysical symptoms (primary outcomes – pain and nausea)

Quality of life

Caregiver pre-bereavement outcome (depression)

Assessment points: baseline and 1 and 2 months after

Analysis: forwards from enrolment


Resource use/costsNot assessed


NotesPower considerations: "The number of patients necessary for the trial was calculated on the basis of a reduction of 33% in the main outcomes of pain and nausea. With a α level of 0.05 and a β of 0.20, it was calculated that 110 patients would be required for each group, allowing for 20% attrition."; "because of early deaths, problems with recruitment, and a low compliance rate for completion of questionnaires, the required sample size was not attained"

Authors discussed challenges of recruitment in a methodological paper: problems emerged within 3 months of start of study: some patients who did not enter the study because of a predicted early death were found to be eligible when assessed by the team; eligible referrals varied widely from month to month, with the "average" (3.7 per week) being less than predicted; inpatient admission to palliative care unit soon after baseline assessment either due to inaccurate prognosis or unexpected deterioration (exposure to standard of palliative care equivalent to offered by home team); failure of some patients and caregivers to complete questionnaires at 1 month (due to weakness, exhaustion, cognitive impairment)


Risk of bias

BiasAuthors' judgementSupport for judgement

Concealment of allocation (RCT / CCT)Low risk"Conducted randomisation using a computer generated table of random numbers"

Follow-up (RCT / CCT)High risk93 patients (64%) and 74 caregivers (51%) follow-up at 1 month

Blinding (RCT / CCT)Unclear riskSingle-blind: a research assistant blinded to assignment provided and collected questionnaires from patients and caregivers at home; patient and caregiver blinding not stated

Baseline measurement (RCT / CCT)Unclear riskSample characteristics at baseline not reported nor discussed

Reliability of outcome measurement (RCT / CCT)Low riskQuestionnaires with outcome measures self completed by patients and caregivers and collected from their home by research assistant (blinded)

Protection against contamination (RCT / CCT)High riskPatients/caregivers randomised

Rabow 2004

MethodsDesign: Cluster RCT (patient)

Methodological quality: 3.5/6a (high quality, EPOC RCT/CCT checklist)


ParticipantsCountry and regions: US, San Francisco, California, metropolitan area

Recruitment (date not stated, 14 months): from 70 physicians in a general medicine practice at University of California Medical Center (tertiary care), adult patients with diagnoses of cancer (metastatic, albumin less than 2.5 mg/dL or a 6-month weight loss > 10%), advanced COPD (FEV1 < 30% predicted, oxygen saturation < 88% or dyspnoea at rest) or advanced CHF (ejection fraction < 20% or NYHA class IV symptoms) with life expectancy 1-5 years and not yet ready for hospice care; 1 clinic module randomly assigned to intervention and second module assigned to control (each comprised separate patients and physicians originally assigned based on space and appointment availability, housed in the same building, but with separate waiting areas and nursing and clerical staff). Exclusion criteria: non-melanoma skin cancers, dementia, psychosis, enrolled in hospice care, unable to complete a written survey in English or Spanish

Number of patients (allocated): 90 (50 intervention and 40 control)

Diseases: cancer (30), CHF (31), COPD (29)

Patient characteristics: mean age 67.9 years intervention, 69.4 years control; 64% female; 43.3% lived alone

Deaths at end of study: 15 (17%); 10 intervention (20%) and 5 control (13%)

Withdrawals/other drop-outs: 5 in the intervention (6%) and 4 in the control (10%) (reasons not stated)


InterventionsHome palliative care vs. usual care

'Comprehensive Care Team (CCT)'

Type: intermediate palliative care

Service base: general medicine practice at University of California Medical Center

Team: 3 physicians, nurse, social worker, chaplain, pharmacist, psychologist, art therapist, volunteer co-ordinator (all except latter had expertise in palliative care), volunteer medical and pharmacy student patient advocates; regularly scheduled physician led meetings; the team collaborated with spiritual care service, art for recovery programme, centre for collaborative primary care, nationally recognised family support programme, local non-profit community hospice

Responsibility: social worker responsible for case management; team's physician advised primary physician who retained responsibility for medical care

Description: new intervention (demonstration project) grounded on social work centred case management approach with interdisciplinary team consultation integrated with family caregivers and primary physicians; "mixed management" model allowing simultaneous palliative and curative management care for multiple types of illness; aimed to improve advance care planning, reduce healthcare utilisation, and support caregivers; included primary care physician consultation, case management, group, volunteer and chaplaincy support, artistic expression; focused on 7 components:

  1. formal consultations at 3 points (entry, midway, end) and informal discussions with primary physician based on comprehensive initial and follow-up patient assessments by the social worker (discussed at team meetings to identify care priorities and palliative care opportunities); written recommendations (letter or email) at 3 time points conveyed by team's physician to primary physician  covering 5 domains - physical symptoms, psychological well-being, social support, spiritual well-being, advance care planning (based on validated patient surveys and social worker assessments, physician rarely directly interviewed or examined patient)
  2. case management and psychological support (in person and by phone): led by social worker, included discussions on advance care planning, surrogate decision makers, prognosis, funeral arrangements, and wills ("average" 3.8 in-person contacts, 13.0 telephone calls)
  3. family caregiver training and support: led by nurse through formal classes and informal individual consultation ("average" 3.6 contacts)
  4. medical chart review: led by pharmacist, looking in particular for drug interactions and unnecessarily complex medication regimens (all patients reviewed at least once)
  5. spiritual and psychological support: led by chaplain (all patients contacted at least once)
  6. monthly patient and family support groups (symptom management, advance care planning) and art projects designed to explore emotions relating to illness and relationships (34% patients attended)
  7. patient support and advocacy (weekly calls, monthly visits and regular communication with team about patient needs): led by volunteer medical and pharmacy students (86% patients received "average" 6.5 visits)


Duration: 1 year

Control: described as usual primary care


OutcomesPlace of death

Physical symptoms (primary outcome: pain; breathlessness and sleep)

Psychological well-being (anxiety, depression)

Quality of life

Patient satisfaction with care

Spiritual well-being

Advance care planning

Assessment points: baseline and 6 and 12 months after

Analysis: forwards from enrolment


Resource use/costsPrimary care clinic visits

Speciality clinic visits

Urgent care clinic visits

ED visits

Hospitalisations (number of admissions and inpatient days)

Time horizon: from enrolment to death or study end

Costs: primary care visits, urgent care clinic visits, ED visits, inpatient services, other charges, total medical centre charges

Currency: USD (date not stated)


NotesPower considerations: "Power calculations were made based on the ability to detect a 10% change in pain score on a 0–10 scale. Study sample size was recalculated once preliminary data from the initial surveys was available to customise the power assessment. Based on the close similarity between intervention and control patients as well as the unexpectedly high severity of baseline symptoms, recruitment goals were amended from 150 to 50 in each group"

Patients meeting inclusion criteria were identified through computerised searches of electronic medical records and recruited to intervention or control based on module affiliation. Primary physicians were given lists of patients they had seen in last 3 months and asked to identify the "sickest patients" with cancer, CHF or COPD who were expected to die within 1-5 years

4 USD10 grocery store incentive gifts provided to controls


Risk of bias

BiasAuthors' judgementSupport for judgement

Concealment of allocation (RCT / CCT)Low risk"On the basis of a coin flip, patients in one clinic module (GMA) were assigned to be the intervention group and patients in the second module (GMB) were assigned to the control group"

Follow-up (RCT / CCT)High risk35 intervention (70%) and 31 control (78%) completed study

Blinding (RCT / CCT)Unclear riskNot stated

Baseline measurement (RCT / CCT)Low riskNo significant baseline differences on outcomes, demographic and clinical characteristics apart from gender (more female patients in intervention; P value = 0.05). Analysis controlled for baseline scores (entered as covariates)

Reliability of outcome measurement (RCT / CCT)Unclear risk"A member of the CCT clinical team (for intervention patients) or research staff (for controls) brought the survey to the study subject at home or during a clinic visit and supervised its completion"

Protection against contamination (RCT / CCT)Unclear riskClinics within same practice randomised

Tramarin 1992

MethodsDesign: RCT (patient)

Methodological quality: 2.5/6a (EPOC RCT/CCT checklist)


ParticipantsCountry and regions: Italy, Vicenza health district and surroundings, metropolitan and rural areas  

Recruitment (1990, 1 month): from infectious diseases department at San Bortolo General Hospital;

  1. patients with stage 2/3 of severity classification system for AIDS hospitalisation (terminal stage of disease or heavy motor or vision deficit, making hospital attendance difficult)
  2. residence within 10 km of hospital, sufficient economic and family support (budget 3 times higher than basic social security allowance and with caregiver),
  3. willingness to accept HC


Number of patients (allocated): 42 (10 intervention and 32 control; 7 randomised controls and 25 non-randomised who did not meet ≥ 1criteria above)

Diseases: AIDS (42)

Patient characteristics: median age 28.0 and 31.3 years intervention (stage 2 and 3, respectively), 30.6 and 32.5 years control (stage 2 and 3, respectively); 21% female

Deaths at end of study: 22 (5 intervention and 17 control)

Withdrawals/other drop-outs: 1 intervention (care refusal) and 2 controls (attending other AIDS clinics)


InterventionsHome palliative care vs. usual care

"Home-care Assistance"

Type: intermediate palliative care

Service base: infectious diseases department at San Bortolo Hospital, with 15 beds, outpatient clinic and hospice offering HC

Team: multidisciplinary team of 4 trained nurses, 1 psychologist, 10 volunteers, social workers (where available), 2 infectious disease specialists; family doctor seen as part of team

Responsibility: consultant doctor; "personnel (medical and paramedical) employed in the referral infectious disease department are responsible for home care"; "other caregivers (family doctors, volunteers, social care agencies) should participate under supervision of consultant doctors of the referral department"

Description: integrated package of HC "based on the principles of palliative care"; aimed to improve quality of life whenever possible through symptom control; aligned with National Health AIDS Plan guidelines, aiming to limit use of inappropriate inpatient services by substituting with more suitable palliative care; chemotherapy, parenteral nutrition, blood transfusion and fluids administered if needed at home using a tunnelled catheter

Duration: "average" 74.1 days

Control: usual care, mainly HB treatment and care


OutcomesQuality of life (QWB)

Assessment points: weekly from enrolment to death or up to 6 months

Analysis: forwards from enrolment


Resource use/costsInpatient (number of hospital admissions, hospital inpatient days, hospital length of stay)

Outpatient clinics (number of day admissions)

Home palliative care (length of stay, staff hours, nurse and specialist visits)

Time horizon: from study entry to death or up to 6 months (multiplied by 2 to produce estimates per person-year)

Costs: inpatient, outpatient, HC and total costs per person-year

Currency: 1990 ITL (converted to 1990 USD using healthcare-specific purchasing power parities)

Cost-effectiveness: cost-utility ratio (expressed as cost per well-week)


NotesPower considerations: none stated

Risk of selection bias as 25/32 controls were not randomised

Death at home and time spent at home reported for intervention group only (4/9 home deaths; 74.1 days/patient spent at home) 


Risk of bias

BiasAuthors' judgementSupport for judgement

Concealment of allocation (RCT / CCT)High risk17 patients were randomised to intervention (10) and control (7); process not stated; remaining 25 controls not randomly allocated

Follow-up (RCT / CCT)Low risk39/42 (93%)

Blinding (RCT / CCT)Unclear riskNot stated  

Baseline measurement (RCT / CCT)Unclear risk25/32 controls failed to meet ≥ 1 of the following criteria – adequate economic and family support, living within 10 km from hospital, willingness to accept HC and stage 2/3 (as opposed to 1); however, comparisons were made only with stage 2/3 patients with no significant differences in age, baseline quality of life scores and risk behaviour categories

Reliability of outcome measurement (RCT / CCT)Unclear riskUnclear if self report or proxy-report; "individual QWB scores were calculated each week by a trained caregiver using a standard checklist"

Protection against contamination (RCT / CCT)High riskPatients randomised

Walsh 2007

MethodsDesign: RCT (patient and caregiver) 

Methodological quality: 2/6a (EPOC RCT/CCT checklist)


ParticipantsCountry and regions: UK, London, metropolitan area

Recruitment (2001-2003, 28 months): from 7 home palliative care services covering 3 regional cancer networks; new patients likely to survive the time taken to introduce the intervention (not stated who estimated) with caregiver scoring > 5/6 in GHQ-28. Exclusion criteria: caregiver lack of English skills

Number of patients (randomised): 271 (137 intervention and 134 control)

Diseases: cancer (271): lung (79), gastrointestinal (55), genitourinary (40), head and neck (24), breast (18), others (55)

Patient characteristics: not stated

Number of caregivers (randomised): 271 (137 intervention and 134 control)

Caregiver characteristics: mean age 56.3 years; 79% female

Deaths at end of study: 109 (40%); 47 intervention (34%) and 62 control (46%) 

Withdrawals/other drop-outs: 21 intervention and 18 control (refusals)


InterventionsReinforced vs. standard home palliative care

Additional component: "Carer Advisor Intervention"

Type: specialist palliative care

Service base: 2 hospital-based, 2 community-based, 3 hospice-based

Team: clinical nurse specialists with specialist medical support and sometimes social work support; caregiver advice component delivered by 2 part-time carer advisors with experience in community nursing and social work (1 month's training involving fieldwork in palliative care in community, hospice and hospital settings); advisors met weekly with research team for debriefing, advice on any emerging issues and to ensure all domains of need were covered; half-day in-service training session on carer advice component after 1 year of service

Responsibility: for additional component – carer advisor; for standard home palliative care – not stated

Description: new caregiver advice component grounded on literature and pilot work with caregivers on preferred mode of extra support (> 80% preferred weekly visit from trained advisor over respite care, practical help, written information and telephone advice); brief caregiver-focused intervention (6 visits over 6 weeks); aimed to meet caregiver alone (meetings outside home or at workplace, evenings or weekends if needed); mainly face-to-face but sometimes on phone (enabled flexibility and helped some caregivers to approach issues difficult to discuss face-to-face; calls discussed with team to decide whether equivalent to full visit); included comprehensive needs assessment, discussion and advice on past, present and future issues, information and emotional support; covered needs in terms of physical psychological health, for time away from patient in short and long term, to plan the future, relationships and social networks, relationship with health and social care services, finances; kept to giving advice and support rather than taking action on behalf of caregivers (but advice went as far as helping caregivers to calculate benefit entitlements); bereavement support and advice; mean 5 contacts and mean 3.6 contacts up to death; intervention manual (available from authors)

Duration: additional component lasted up to 6 weeks (screening introduced at second or third contact with palliative care team) and if patient died before sixth contact, visits took place after death; duration of standard home palliative care not stated but likely to be from start to death and into bereavement (median survival 13 weeks in intervention group, range 2-41 weeks)

Control: existing specialist home palliative care provided by team of clinical nurse specialists, with specialist medical support and sometimes specialist social work support, giving advice to patients at home, to families and primary clinical teams; patients assisted with control of pain and other physical symptoms, social, psychological, emotional and spiritual issues 


OutcomesCaregiver pre-bereavement outcomes (primary outcome - general health; strain; quality of life) 

Caregiver post-bereavement outcomes (grief intensity)

Caregiver satisfaction with care

Survival

Assessment points: baseline, 4, 9 and 12 weeks after; 4 months after death

Analysis: forwards from enrolment and forwards from death


Resource use/costsNot assessed


NotesPower considerations: "power calculation indicated that in order to detect a drop to 50% caseness in the experimental group at 90% power and the 5% level of significance, 124 carers would be required in each arm. To cover an expected 10% attrition from the trial we needed to recruit 280 carers, a sample that would also provide sufficient power for examination of GHQ–28 score as a continuous measure"

Brief, semi-structured interviews at the final follow-up provided a qualitative assessment of acceptability and helpfulness of the support given by the caregiver advice component


Risk of bias

BiasAuthors' judgementSupport for judgement

Concealment of allocation (RCT / CCT)Unclear risk"Participants were randomised using a block randomisation design, stratified according to the seven participating teams"

Follow-up (RCT / CCT)High risk100 intervention (73%) and 91 control (68%) at 4-week follow-up; 58 intervention (42%) and 46 control (34%) at 12 weeks; 84 intervention (61%) and 97 control (72%) at 4 months after death

Blinding (RCT / CCT)Unclear riskQuestionnaires self completed and mailed back; "interviewers were masked to the block size of 12"

Baseline measurement (RCT / CCT)Unclear risk"No major difference occurred between the randomised groups at baseline on demographic

variables, GHQ–28 score or the patient's physical performance status assessed using the criteria of the ECOG. However, there was some imbalance in carer strain and quality of life." Lower carer strain scores and higher quality of life scores in intervention group (statistical significance not stated)

Reliability of outcome measurement (RCT / CCT)Unclear riskQuestionnaires self completed and mailed back; "interviewers were masked to the block size of 12"

Protection against contamination (RCT / CCT)High riskPatients/caregivers randomised

Ward 1987

MethodsDesign: ITS with nested CBA

Methodological quality: 5/8a (EPOC ITS checklist); 3.5/6a (EPOC CBA checklist)


ParticipantsCountry and regions: UK, Trent and Yorkshire health regions, metropolitan and rural areas

Recruitment (date not stated): all deaths from neoplasms (ICD 140 to 209) in 3 years before and 3 years after 8 Macmillan HC nursing services started (identified from Office of Population, Censuses and Surveys Classification of Surgical Operations and Procedures); CBA included patients newly referred to the 8 services during 1 year or until 100 patients were enrolled

Number of patients: 40,072 for ITS (17,864 in 3 years before and 22,208 in 3 years after the introduction of the 8 services); 957 for CBA

Diseases: cancer (40,072) for ITS; not stated for CBA but likely to be all cancer as Macmillan nurses provide care to people with cancer

Patient characteristics: not stated

Deaths at end of study: 100% (ITS); not stated for CBA

Withdrawals/other drop-outs: none stated 


InterventionsHome palliative care vs. usual care

"Macmillan home care nursing care"

Type: intermediate palliative care

Service base: 4 inpatient hospice; 4 non-hospice base (1 hospital, 1 non-inpatient hospice, 1 in grounds of future in-patient hospice, 1 in primary care community team offices)

Team: members ranged from 2 to 8; 7 teams were multidisciplinary and 1 was of nurses only; all had nurses (from 81 to 182 patients per nurse/year for hospice based services vs. from 33 to 70 for non-hospice based), 7 had medical input, 5 had social workers; 2 had case conferences (1 daily, 1 weekly)

Responsibility: not clear although services' aim was to augment but not replace care from district nursing, GPs and families (primary physician/team likely to be in charge)

Description: services varied in provision but also had common components; all were in operation for ≥ 18 months; mean from 2.3 to 7.7 home visits per patient/month for hospice-based services and mean from 7.9 to 12.5 for non-hospice based) – visits aimed to monitor current situation, reassure/support, monitor pain and other symptoms, assess need for community care, inpatient or day unit, give advice, deliver equipment/ medication, practical nursing care; arrangements for out-of-hours crisis - all had 24/7 coverage (e.g. hospice out of hours, bleeps, radio paging, nursing message systems and nurses home number, coverage by inpatient hospice staff for advice); out of hours visits ranged from 0 to 9 except in 1 hospice-based service (40 visits) and in 1 non-hospice based service (81 visits); patients from hospice-based services could access hospice beds, day centres, family relief and other hospice services

Duration: from enrolment to death (median 32 days, range 21.5-44.5 days across services)

Control: usual care including district nursing and care from GPs


OutcomesDeath at home

Preference for place of death met


Resource use/costsTerminal institutional days (before death in hospital or hospice)

Time horizon: variable (identified backwards from death)


NotesPower considerations: none stated

For 2 of the 8 services, the authors could only provide 2 or 1 year data prior to their introduction; as this did not meet our ITS inclusion criteria we analysed outcome data only for the remaining 6 services (this is referred to in the review as the Trent and Yorkshire analysis, with 31,890 deaths)

The authors collected other outcome data on a small sample (40 patients): on pain, activities of daily living, quality of life, patient preference for place of death and satisfaction with care - but did not use these to compare services


Risk of bias

BiasAuthors' judgementSupport for judgement

Baseline measurement (CBA)Unclear riskCharacteristics not reported

Characteristics of intervention and control providers (CBA)Unclear riskProviders' characteristics in text but no data presented

Blinded assessment of outcomes (CBA)Unclear riskSource of information on place of death not stated

Protection against contamination (CBA)Low riskSecond sites used as controls (non-hospice-based services)

Reliable outcome measurement (CBA)Unclear riskSource of information on place of death not stated

Follow-up of patients/caregivers (CBA)Unclear riskNot stated if some were still alive

Intervention dependent of other changes (protection against secular trends) (ITS)Unclear riskNot specified

Data analysed appropriately (ITS)High riskData described only (no ARIMA models or time series regression models used)

Reason for number of points pre- and post-intervention (ITS)High riskRationale for choice of 3 years pre- and post-intervention not given; sample size calculation not reported

Shape of intervention effect specified (ITS)Unclear riskRationale for shape of intervention effect not reported 

Intervention likely to affect data collection (protection against detection bias) (ITS)Low riskSources and methods of data collection were the same before and after intervention

Blinded assessment of outcomes (ITS)Low riskObjective outcome variable (using standard and official statistics)

Completeness of data set (ITS)Low risk100% of total number of deaths in study

Reliable outcome measurement (ITS)Low riskOutcome obtained from standard and official statistics

Zimmer 1985

MethodsDesign: RCT (patient)

Methodological quality: 3/6a (EPOC RCT/CCT checklist)


ParticipantsCountry and regions: US, Rochester, New York, metropolitan area

Recruitment (1979-1982; 27 months): from "variety of sources" following publicity campaign informing health professionals and the community; homebound patients living in study county with chronic illness or terminal illness (the latter were largely cancer patients receiving palliative care only and with life expectancy ≤ 3 months) who had a caregiver not necessarily living in same household and who wished to remain at home, with no physician to make home visits. Exclusion criteria: primary psychiatric illness, unable to fill in questionnaires

Number of patients (randomised): 167 (85 intervention and 82 control); (baseline): 158 (82 intervention and 76 control) ; 22% intervention and 18% control classified as terminal (subanalysis performed) 

Diseases (overall baseline sample): cancer (21% intervention, 17% control), stroke (12% intervention, 17% control), arthritis/rheumatism (9% intervention, 12% control), others, all below 10% (59% intervention, 54% control); those classified as terminal were "largely cancer" patients

Patient characteristics: mean age 76 years, median age 77 years; 68% female; 23.2% intervention patients and 18.4% controls lived alone

Deaths at end of study: 48 (29 intervention and 19 control, including 3 patients who died before the initial interview)

Withdrawals/other drop-outs: 21: 5 drop-outs/changed their minds and 1 patient moved away before initial interview; 15 drop-outs after initial interview (17 deliberate dropped out: 4 intervention and 13 control)


InterventionsHome palliative care vs. usual care

"Home Health Care Team"

Type: intermediate palliative care

Service base: ambulatory care unit at University of Rochester Medical Center

Team: physician-led multiprofessional team with geriatric nurse practitioner (Masters' medical nurse practitioner) and social worker; weekly team conferences to assure co-ordination of patient care

Responsibility: 1 team member designated as primary provider in care plan following initial interdisciplinary assessment

Description: existing service (since 1977) aimed to provide care for home-bound, chronically or terminally ill, or disabled patients (largely elderly) for whom transportation to clinic had become too costly or cumbersome; initial home visit by each team member for initial assessment; interdisciplinary care plan then established which designated 1 team member as primary provider with consultative visits by others as needed; nurse conducted physical assessments in community (routine and emergency), was responsible for the nursing plan and supported medical care in close cooperation with physician; physician conducted home visits and evaluation at intake and follow-ups as needed, and acted as patient's attending physician during any hospitalisations; social worker helped to deal with social, financial and emotional problems, freeing physician and nurse to devote mostly to medical and nursing care; encouraged informal care by family and friends by providing them with needed physical and psychological support and education to take on or continue HC; 24-hour telephone service backed up by physician (all patients advised to restrict calls and service requests to office hours if possible, but were given nurse and physician's home numbers for emergencies and the physician's pager as ultimate resource); low number of out-of-hours calls (> 70% handled on telephone)

Duration: not stated

Control: usual care, including HC services available in community (area described as with well-developed long-term care services in general)


OutcomesDeath at home 

Survival

Assessment points: not stated


Resource use/costsOut-of-home care (hospital admission, hospital inpatient days, ED visits, clinic visits, MD office visits, ambulance or chairmobile rides, nursing home days)

In-home care (MD home visits, nurse home visits, social worker home visits, RN/LPN hours, aide/homemaker visits, laboratory technician home visits, meals-on-wheels visits)

Time horizon: terminal 2 weeks before death (subanalysis relevant to this review)

Costs: out-of-home, in-home, total costs (mean costs per patient of terminal 2 weeks)

Currency: USD (date not stated)


NotesPower considerations: none stated: "A sample size of 200 to 250 was desired over the period of study based on ability of the team to care for half that number (estimated from previous team experience of turnover, visit frequency, and case load)"

The analyses relevant for our review were those conducted with the subsample of terminal patients/deaths, and the outcomes were:

  1. death at home for patients who died during 6 months' follow-up (45; 28 intervention and 17 control)
  2. survival, with analysis adjusted for terminal/non-terminal status
  3. healthcare use subanalysis of patients who died during 6 months follow-up and who had at least 2 weeks in study before death with care utilisation data (33; 21 intervention and 12 control). Other outcomes included physical and psychosocial health, morale, and patient and caregiver care satisfaction but no subanalysis was conducted


Risk of bias

BiasAuthors' judgementSupport for judgement

Concealment of allocation (RCT / CCT)Unclear riskSample stratified into terminal and non-terminal; "randomized into experimental (team) and control groups"; process not stated

Follow-up (RCT / CCT)Unclear risk45 (27%) for place of death; 80/85 intervention (94%) and 66/82 control for survival (81%)

Blinding (RCT / CCT)Unclear riskDouble-blind at baseline only: "The patients were informed of the result of randomization immediately following the initial interview, in order to keep the base-line information as free as possible of bias from knowledge of the result either by the patient or interviewer"

Baseline measurement (RCT / CCT)Low risk"The only demographic variable which showed a statistically significant difference was sex, with 61 per cent females in the team group compared with 76 per cent in the controls; this is taken into account in the analysis by adjustment for sex. Previous health care utilization and diagnoses in the two groups were quite similar"

Reliability of outcome measurement (RCT / CCT)Unclear riskInterviewers (10/14 had previous survey experience) trained by study co-ordinator with practice of interviews, role play, biweekly feedback meetings

Protection against contamination (RCT / CCT)High riskPatients/caregivers randomised

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Addington-Hall 1992Intervention does not meet criteria for palliative care; co-ordinators did not provide "practical nursing care" or "specialist palliative care advice"; co-ordination only

Brumley 2003CBA not meeting criteria, conducted in only 1 intervention site and 1 control site

Feldman 2011Intervention focused on staff education and mentoring with the main goal of increasing hospice admissions; not specifically aimed to support patients or caregivers at home  

Hebert 2006Televisits provided in addition to standard home palliative care; additional component procedural only and non-comprehensive addition to care

Kane 1984Intervention focused on inpatient care with a component of home care; however, inpatients and patients at home are shown together (both part of the hospice group); no subanalysis and frequent transits between inpatient and home care mentioned

McCorkle 2000Study conducted with post-surgical patients and only a few died, thus population was not considered terminal/advanced

Morita 2012Study designed to be a cluster RCT but authors decided to adopt a mixed-method approach because "1) the intervention itself should be applied to all populations over the country and clear distinction between intervention and control groups is difficult, 2) a concealment problem is likely to occur, and 3) the most important mission at a national level is not to clarify if one specific intervention actually changes outcomes, but to obtain comprehensive insights into how to disseminate palliative care throughout the country". The resulting study is an ITS that does not meeting the criteria for our review, where data collected in the two years prior the program was implemented (2007-2008) was compared to data collected in the two years after program implementation (2010-2011)

Smeenk 1998aIntervention does not meet criteria for palliative care; "care specially tailored to meet his [patients] individual needs, and provided by professional caregivers from primary and hospital teams"

Temel 2010Intervention focused on outpatient meetings with patients at a large academic medical centre; not specifically aimed to support patients or caregivers at home

 
Characteristics of studies awaiting assessment [ordered by study ID]
Hwang 2009

MethodsDesign: CCT (awaiting confirmation from authors)

ParticipantsCountry and regions: South Korea (included regions to be confirmed by authors)

Recruitment: to be confirmed by authors

Number of patients: 46 (24 intervention and 22 control)

Diseases: cancer (46): digestive system (22), lung (11), liver, biliary or pancreatic (10), others (3)

Patient characteristics: mean/median age not stated, 59% male, 76% married

Deaths at end of study: to be confirmed by authors

Withdrawals/other drop-outs: to be confirmed by authors

InterventionsType: to be confirmed by authors

Service base: to be confirmed by authors

Team: to be confirmed by authors

Responsibility: to be confirmed by authors

Description: several components for patients, caregivers or both: pain and symptom control (drug and non-drug therapy, care co-ordination); empowering (providing information, promoting control of emotions and supporting patient and family); finding the meaning (thinking about life and facing death); and networking (making and maintaining relationships, connecting and referring).

Duration: to be confirmed by authors

Control: to be confirmed by authors

OutcomesPain
Symptom burden (decreasing symptom experience)
Psychological well-being (improving psychological QoL)
Caregiver pre bereavement social well-being (improving family-related and social QoL)
Spiritual well-being (relieving spiritual pain and improving spiritual QoL)
Caregiver burden

Assessment points: to be confirmed by authors

Analysis: to be confirmed by authors

Notes

Park 2011

MethodsDesign: CCT (awaiting confirmation from authors)

ParticipantsCountry and regions: South Korea (included regions to be confirmed by authors)

Recruitment: to be confirmed by authors

Number of patients: 40 (20 intervention and 20 control)

Diseases: breast cancer (40)

Patient characteristics: mean age 50.2 intervention and 47.2 control, 80% married

Deaths at end of study: to be confirmed by authors

Withdrawals/other drop-outs: to be confirmed by authors

InterventionsType: to be confirmed by authors

Service base: to be confirmed by authors

Team: to be confirmed by authors

Responsibility: to be confirmed by authors

Description: Either face-to-face or phone “Hospice Smart Service” at least once a week for 5 months for patients and families. Provision of cancer and hospice related services. Cancer related services involved needs assessment; provision of information on cancer and its management (such as signs and symptoms, diagnosis, prognosis, treatment and rehabilitation); provision of emotional and practical support (such as control of negative emotion and management of body image); education about communication skill strategy of patient and family; provision of spiritual care and family support. Hospice related services involved provision of information on DNR/advance directives and decision making; provision of information on hospice; information on complementary and alternative therapy; referral to specialist; provision of information on funeral process and insurance; following up bereaved family; assisting to participate in self-help group.

Duration: to be confirmed by authors

Control: to be confirmed by authors

OutcomesSatisfaction
Quality of life
Communication skills

Decision making skills

Mastery sense

Understanding of hospice and palliative care

Assessment points: to be confirmed by authors

Analysis: to be confirmed by authors

Notes

 
Characteristics of ongoing studies [ordered by study ID]
Abernethy 2006

Trial name or titlePalliative Care Trial (PCT)

MethodsDesign: cluster RCT (patient and general practitioner)

ParticipantsCountry and regions: South Australia

Recruitment (2002-2004, 26 months): every patient referred to SAPS was screened by a triage nurse who assessed eligibility. Inclusion criteria: patients mentally competent at enrolment as documented by an MMSE score ≥ 24, or who had a GP-identified caregiver or legal healthcare proxy who could provide informed consent. Patient and subsequent GP consent were further required for enrolment and randomisation. Exclusion criteria: patients not living within the region served by the palliative care services or expected to die within 48 hours of referral.

Number of patients: pending for full sample

Diseases: pending for full sample

Patient characteristics: pending for full sample

Deaths at end of study: pending for full sample

Withdrawals/other drop-outs: pending for full sample

Interventions"GP Educational Outreach visiting in addition to standard palliative care" (intervention 1); "Structured patient and caregiver educational outreach visiting in addition to standard palliative care" (intervention 2)

"Case conferencing in addition to standard palliative care" (intervention 3) vs. "standard palliative care"'

"Palliative Care Trial (PCT)"

Type: specialist palliative care

Service base: organised as regional whole-population networks with consultative specialist medical, nursing and allied health support for GPs and community nurses

Team: at least the GP, a palliative care nurse and a trained educator (GP) employed for the study, plus 1 educator for the GP intervention (intervention 1); weekly palliative care team meetings. Medical specialists from other disciplines, district nurses, domiciliary care representatives, social worker, volunteers, pharmacists and pastoral care workers were also available according to patients' needs.

Responsibility: not clear

Description: intervention 1: GP Educational Outreach Visiting in addition to standard palliative care. Educational sessions took place in GP's office, 2 x 20- to 30-minute sessions with GPs 2-4 weeks apart. Evidence-based messages on palliative care pain management derived from structure literature review. Key message focused on knowledge and attitude deficits. Intervention based on the "educational outreach visiting" or "academic detailing" model that "demonstrated to change physician practice". Intervention 2: standard palliative care plus structured patient and caregiver educational outreach visiting. Trained educator conducted 2 x 30- to 40-minute sessions with patient with or without their caregivers in place chosen by patients. Evidence-based messages on palliative care pain management derived from structure literature review. Key message focused on knowledge and attitude deficits. Intervention derived from a blend of "patient coaching" and "educational outreach visiting". Intervention 3: case conferencing in addition to palliative care. Used a case conferencing model, minimally including the patient, the caregiver, or both, the GP and the palliative care nurse. Other professionals took part based on patients' needs. Conferences organised by the palliative care nurse and conducted within 28 days of randomisation. Agenda set by patients and caregivers by identifying functional, physical, or emotional goals and concerns. GPs paid for participation.

Duration: not clear

Control: described as standard palliative care

OutcomesPlace of death

Pain

Symptom burden

Physical function

Quality of life

Assessment points: from baseline until death

Analysis: forwards from enrolment

Starting dateApril 2002

Contact information

NotesBoth intervention and control groups received standard palliative care

Allen 2012

Trial name or titlePromoting Effective Advance Care for Elders (PEACE) study

MethodsDesign: RCT (patient)

ParticipantsCountry and regions: Ohio, United States

Recruitment (pending): New PASSPORT (Ohio's community-based, long-term care Medicaid waiver program) enrollees randomised either to the intervention or the usual care. Inclusion criteria: > 60 years old who passed a mental status screening (the Mental Status Questionnaire) and had one of the following: congestive heart failure and being actively treated (American Heart Association stage C); chronic obstructive pulmonary disease and on home oxygen; diabetes with renal disease, neuropathy, visual problems, or coronary artery disease; end-stage liver disease or cirrhosis; cancer (active, not history of) except skin cancer; renal disease and actively receiving dialysis; Amyotrophic Lateral Sclerosis with history of aspiration; Parkinson’s disease stages 3 and 4; or pulmonary hypertension. Exclusion criteria: active alcoholics (i.e., those who drink >2 drinks per day "on average") and illegal substance users as well as clients who have schizophrenia or are psychotic; consumers who could not pass the Mental Status Questionnaire and those were already enrolled in hospice

Number of patients: pending for full sample (80 in pilot study; 40 intervention and 40 usual care)

Diseases: pending for full sample

Patient characteristics: pending for full sample

Deaths at end of study: pending for full sample

Withdrawals/other drop-outs: pending for full sample

InterventionsIntervention

['Promoting Effective Advance Care for Elders (PEACE)'] versus usual care

Type: pending

Service base: pending

Team: PASSPORT care manager, interdisciplinary team (details pending) and primary care physician

Responsibility: not clear

Description: Intervention based on Wagner's Chronic Care Model and includes comprehensive interdisciplinary care management for frail elders with chronic illnesses. It emphasises patient activation, and integrates with community-based long-term care and other community agencies. Intervention involves an in-home geriatrics/palliative care needs assessment by a trained PASSPORT case manager. The case manager presents the findings to an interdisciplinary team who develops and individualised care plan based on the consumer’s goals and best practice guidelines. The case manager then implements the plan with the consumer. Family and primary care physician.

Duration: not clear

Control: described as usual care

OutcomesSymptom management

Quality of life

Mood

Decision making/care planning

Spirituality

Assessment points: pending

Analysis: pending

Starting datepending

Contact information

Notes

Battaglia 2012

Trial name or titlePalliative Network for Severely Affected Adults with MS in Italy (PeNSAMI) study

MethodsDesign: RCT

ParticipantsCountry and regions: Northern, Central and Southern Italy

Recruitment (pending): patients with MS, details pending

Number of patients: pending

Diseases: MS

Patient characteristics: pending

Deaths at end of study: pending

Withdrawals/other drop-outs: pending

InterventionsPalliative care integrated with standard MS care versus standard MS care alone

Type: pending

Service base: pending

Team: pending

Responsibility: pending

Description: Contents of the intervention will be obtained from a Phase I study composed of individual semi-structured interviews of adults with severe MS, three focus group meetings with caregivers of people with severe MS and two focus group meetings with health professionals caring for MS patients. A phase II RCT will follow to examine the acceptability, feasibility and effectiveness of the intervention. In order to cover a range of experiences, participants will be selected from Northern, Central and Southern Italy.

Duration: pending

OutcomesPending

Assessment points: pending

Analysis: pending

Starting datePhase II RCT planned for 2013

Contact information

Notes

Butler 2012

Trial name or titleHospice rapid response community service

MethodsDesign: cluster RCT

ParticipantsCountry and regions: East Kent, England

Recruitment (pending): All new referrals to the hospice who are assessed by a member of the hospice team during the study period are potentially eligible for inclusion in the study, but only those referred who die within the intervention or control period will be included in the analysis.

Number of patients: pending (441 patients needed according to sample size calculations)

Diseases: pending

Patient characteristics: pending

Deaths at end of study: pending

Withdrawals/other drop-outs: pending

InterventionsRapid response service ('Hospice rapid response community service') plus usual care vs usual care only

fast-track design applied to three centres (intervention rolled out sequentially in the three centres with six months between the start of provision in each site)

Type: specialist palliative care

Service base: hospice-based (three hospice centres with inpatient beds, community outreach service and day centre)

Team: Rapid response teams (details below)

Responsibility: pending

Description: Intervention provided by rapid response teams was developed in line with best practice and following a literature review, Its main features are: 1) available to patients in their homes (or care homes); 2) has a robust ‘hospice standard’ assessment which takes account of: patient preferences, caregiver/family preferences, patient needs, and patient prognosis; 3) provides hands on care; 4) responds rapidly to crises using human and material resources available 24/7 with access to health care assistants, service coordinator, palliative care nursing, medical advice, and small pieces of equipment which can be carried by car; 5) works in coordination with other community services

Duration: pending

OutcomesDying in the preferred place (primary patient outcomes)

Preferences and change of preferences for place of death

Actual place of death

Caregiver quality of life (primary caregiver outcome)

Caregiver anxiety and depression (HADS)

Caregiver health status (EQ-5D)

Caregiver demand

Satisfaction with care (caregiver)

Service utilisation costs (including intervention costs such as staff time, mileage travelled to patient homes and consumables; general practice and community resources, outpatient, inpatient stays, out-of-hours service, Marie Curie nurse visits, and social care packages)

Assessment points: baseline until death, timepoints not stated (patients); baseline and eight months after enrolment, and six to eight months after the patient died (caregiver)

Analysis: pending

Starting datepending

Contact information

Notes

Chvetzoff 2006

Trial name or titleTRAPADO study

MethodsDesign: CCT

ParticipantsCountry and regions: Lyon, France

Recruitment (2000-2002, 24 months): Inclusion criteria: ≥ 18 years, cancer diagnosis, prognosis (estimated by clinician) of < 3 months, plus 2 of the following 3 criteria: performance status > 2, LDH levels higher than normal, albumin < 30 g/L. Participants also needed to be living in the Lyon area for home care intervention and have someone available to answer the questionnaires. After being informed of their prognosis, patients were invited to take part in the study by their oncologist, hospital doctor or the home care physician co-ordinator. Informed consent was done in writing and patients expressed their choice of cohort (TRA, PA or DO), knowing that a change was possible at any time

Number of patients: 52 (at the time of interim analysis - aimed to have 100 patients, this was achieved in 2005 but complete data not yet published)

Diseases: cancer (52)

Patient characteristics (interim analysis): median age 61 years, 56% male

Deaths at end of study: 46 (at the time of interim analysis)

Withdrawals/other drop-outs: 1 (at the time of interim analysis)

InterventionsStandard hospitalisation (TRA), Palliative Care Unit (PA) (presented together) vs. home care or hospitalisation at home (DO)

'TRAPADO study'

Type: pending

Service base: hospital-based

Team: the project is co-ordinated by a nurse or a psychologist, further information pending

Responsibility: pending

Description: main objective to measure the quality of care and quality of life in palliative patients in the 3

cohorts. The goal was to examine the settings instead of comparing them. The secondary objective of the study was to describe the patient's choices, the characteristics of the 3 populations and the impact on families

Duration: pending

OutcomesQuality of care

Quality of life

Anxiety

Depression

Pain

General health

Assessment points: baseline, 15 days after baseline, 30 days after baseline and every month until death, for a maximum of 4 months

Analysis: pending

Starting date2002

Contact information

Notes

Duursma 2011

Trial name or titleOptimization of complex palliative care at home via telemedicine

MethodsDesign: cluster RCT

ParticipantsCountry and regions: Nijmegen region, the Netherlands

Recruitment (starting date and duration not stated but ongoing and planned to continue at least until December 2013): clustering took place on the level of the GP, who is invited with a letter describing the aim of the study and its procedures. Inclusion criteria for patients are: to live in the area where the study is taking place; be a Dutch-speaking patient, aged 18 years or older; have a progressive oncological disease; have a score of ≤ 60 on the Karnofsky Performance Scale (assessed by the GP); have a life expectancy of ≤ 3 months

Number of patients: pending

Diseases: cancer

Patient characteristics: pending

Deaths at end of study: pending

Withdrawals/other drop-outs: pending

InterventionsIntervention vs. “care as usual

Type: specialist palliative care

Service base: hospital-based

Team: nurse practitioner, palliative care specialist, GP

Responsibility: remains with the GP

Description: The intervention consists of a weekly consultation by means of telemedicine between the patient and a specialist nurse practitioner, when the nurse checks for problems in palliative care following a predefined consultation protocol. After the first teleconsultation, the specialist nurse and a palliative care specialist advise the GP on the treatment policy for the patient. In addition to the weekly teleconsultations, the patient can also videophone the 24/7 support service of the homecare organization. The patient also has access to an information database, an

internet-browser and some entertainment options via the telemedicine application.

Duration: pending

OutcomesSymptom burden (primary outcome)

Depression

Anxiety

Place of death

Experienced problems and needs for palliative care

Patient and caregiver satisfaction with the teleconsultation

Experienced continuity of medical care in the last phase of life

Experienced burden of the family caregiver

Resource use (including number of contacts by telephone with the GP practice,

number of home visits by the GP,

number of contacts with the GPs out of hours service,

number of and indications for hospital admissions)

Assessment points: patient: baseline and every four weeks (symptom burden every week as it is the primary outcome). Family caregiver: baseline and every two weeks

Analysis: pending

Starting dateApril 2011

Contact information

Notes

 
Comparison 1. Home palliative care versus usual care

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Death at home71222Odds Ratio (M-H, Random, 95% CI)2.21 [1.31, 3.71]

    1.1 RCTs
5886Odds Ratio (M-H, Random, 95% CI)1.73 [1.28, 2.33]

    1.2 CCTs
2336Odds Ratio (M-H, Random, 95% CI)3.44 [0.60, 19.57]

 2 death at home with only high quality RCTs3614Odds Ratio (M-H, Random, 95% CI)1.75 [1.24, 2.47]

 3 Death in hospital61179Odds Ratio (M-H, Random, 95% CI)0.31 [0.12, 0.79]

    3.1 RCTs
4843Odds Ratio (M-H, Random, 95% CI)0.29 [0.08, 1.13]

    3.2 CCTs
2336Odds Ratio (M-H, Random, 95% CI)0.32 [0.07, 1.46]

 4 death in hospital with only high quality RCTs3614Odds Ratio (M-H, Random, 95% CI)0.19 [0.03, 1.11]

 5 Death in nursing home5899Odds Ratio (M-H, Random, 95% CI)0.64 [0.40, 1.03]

    5.1 RCTs
4843Odds Ratio (M-H, Random, 95% CI)0.63 [0.38, 1.02]

    5.2 CCTs
156Odds Ratio (M-H, Random, 95% CI)1.11 [0.11, 11.53]

 6 death in nursing home with only high quality RCTs3614Odds Ratio (M-H, Random, 95% CI)0.66 [0.39, 1.10]

 7 Death in inpatient hospice/palliative care unit51123Odds Ratio (M-H, Random, 95% CI)1.46 [0.51, 4.19]

    7.1 RCTs
4843Odds Ratio (M-H, Random, 95% CI)1.98 [0.36, 10.98]

    7.2 CCTs
1280Odds Ratio (M-H, Random, 95% CI)1.30 [0.77, 2.19]

 8 death in inpatient hospice/palliative care unit with only high quality RCTs3614Odds Ratio (M-H, Random, 95% CI)3.71 [0.25, 54.92]

 
Summary of findings for the main comparison.

Outcomes: home palliative care vs. usual care

Patient or population: adult patients with a severe or advanced disease (malignant or non-malignant)

Settings: Canada, Italy, Norway, Sweden, UK, US

Intervention: home palliative care

Comparison: usual care, which could include community care (primary or specialist care at home and in nursing homes), hospital care (inpatient and outpatient) and in some instances palliative or hospice care (or both)

OutcomesNumber needed to treat to benefit (NNTB)a (95% CI)Odds ratio
(95% CI)
No of participants
(studies)
Level of evidenceb

(adapted from Van Tulder 2003)
Comments

Home death

follow-up: 3 to 24 months

 Analysis 1.1 and  Analysis 1.2
With study population control risk

(307 home deaths/1000 deaths)

NNTB 5 (3 to 14), meaning that for one additional patient to die at home five more would need to receive home palliative care as opposed to usual care

With low home death population assumed control risk (ACR)

(128 home deaths/1000 deaths)

NNTB 9 (5 to 26)

With medium home death population ACR

(278 home deaths/1000 deaths)

NNTB 6 (3 to 15)

With high home death population ACR

(454 home deaths/1000 deaths)

NNTB 5 (3 to 13)
OR 2.21

(1.31 to 3.71)
1222

(7 studies, 3 of high quality; 5 RCTs and 2 CCTs)
Strong The majority of patients had cancer but 3 trials also included non-cancer conditions. 3 interventions provided specialist palliative care and 4 provided intermediate palliative care

The direction of the effect was consistent across all studies but did not reach statistical significance in 3; ORs ranged from 1.36 (95% CI 0.80 to 2.31) to 2.86 (95% CI 0.78 to 10.53)

Sensitivity analyses showed that exclusion of the 2 CCTs (both of Swedish hospital-based services with a pooled OR 3.44, 95% CI 0.60 to 19.57) and inclusion of only high quality RCTs resulted in a reduction of the OR to 1.28 (95% CI 1.28 to 2.33) and 1.75 (95% CI 1.24 to 2.47) respectively, with more precision and less heterogeneity

Symptom burden

follow-up: 1 month from enrolment to the week of death

 Table 6
Not calculated, data were not pooled due to the high degree of heterogeneity. See comments2107

(4 studies, 2 of high quality; 3 RCTs and 1 CBA)
StrongStrong evidence of a positive effect on symptom burden: statistically significant reduction of symptom burden in 3 studies (one UK RCT of high quality) further to marginally significant positive effect among 209 patients in Bakitas 2009 (US RCT of high quality; P value = 0.06)

Effect sizes were small (ranging from difference in mean scores of 0.08 in a 0 to 7 scale to a difference of 2.1 in a 0 to 20 scale). All studies used different measures

1 study evaluated a specialist palliative care intervention for patients with MS. The other 3 included only patients with cancer (1 evaluated a specialist service and 2 evaluated intermediate palliative care)

Pain

follow-up: 1 week from enrolment to week of death

 Table 7
Not calculated, data were not pooled due to the high degree of heterogeneity. See comments2735

(9 studies; 4 high quality; 8 RCTs and 1 CBA)
Conflicting2 UK RCTs (one of high quality) and Greer 1986 found statistically significant positive effects (the latter favouring the hospital-based intervention); a marginally significant positive effect was found among 83 patients in McKegney 1981 in the last month before death (high quality RCT; P value = 0.06). The remaining 6 trials (including 1 high quality RCT) found no statistically significant group differences

High variability in outcome measures (only the McGill-Melzack Pain Questionnaire was used more than once)

Physical function

follow-up: 1 month from enrolment to week of death

 Table 21
Not calculated, data were not pooled due to the high degree of heterogeneity. See comments2408

(7 studies, 3 high quality; 6 RCTs and 1 CBA)
InconclusiveStatistical significance unknown in 2 out of 7 studies hence the evidence was deemed inconclusive

3 RCTs in the UK, Norway and the US (all of high quality) found no statistically significant group differences, while two RCTs of intermediate palliative care services in the US (McCorkle 1989; Aiken 2006) detected significantly better physical functioning trajectories in the intervention group through longitudinal analysis up to 9 months following enrolment

Quality of life

follow-up: 1 month from enrolment to week of death

 Table 18
Not calculated, data were not pooled due to the high degree of heterogeneity. See comments2487

(7 studies; 3 of high quality; 6 RCTs and 1 CBA)
InconclusiveStatistical significance unknown in 2 out of 7 studies hence the evidence was deemed inconclusive. 3 RCTs (2 of high quality) found no statistically significant group differences

2 US RCTs, 1 of a specialist service (high quality; Bakitas 2009) and 1 of an intermediate service (Aiken 2006) detected significantly better quality of life through longitudinal analysis up to the month of death

Effects were statistically significant both forwards from enrolment and backwards from death in analyses by Bakitas 2009; they were statistically significant in physical functioning, general health and vitality but not in pain-related, social, emotional and mental health dimensions of quality of life in Aiken 2006

Caregiver burden

follow-up: 1 month from enrolment to the patients' "last weeks of life"

 Table 30
Not calculated, data were not pooled due to the high degree of heterogeneity. See comments1888

(3 studies; 2 of high quality; 2 RCTs and 1 CBA)
Conflicting Conflicting findings from 2 high quality RCTs of specialist home palliative care interventions, 1 in the US with cancer patients (Bakitas 2009 reported no group main effects or group by time interactions 1-10 months after enrolment) and 1 in the UK with MS patients (Higginson 2009 found differences in change scores from baseline at 12 weeks' follow-up (P value = 0.01)

Greer 1986 found a small but significant difference in the last weeks of the patient's life, with higher caregiver burden in the community-based intervention

Caregiver grief

follow-up: from moment the patient died to 13 months after

 Table 34
Not calculated, data were not pooled due to the high degree of heterogeneity. See comments2113 (4 studies, 2 of high quality; 3 RCTs and 1 CBA)StrongStrong evidence of no effect on caregiver grief: no statistically significant differences in three RCTs in the UK and the US (two of high quality)

Outcome measures varied (only the Texas Revised Inventory of Grief was used more than once but scored in different ways)

Greer 1986 found significant higher emotional distress as measured by the modified Grief Experience Inventory among caregivers in the community-based intervention assessed 90 to 120 days after the patient died

Satisfaction with care

follow-up: 1 month from enrolment to approximately 4-6 months after the patient died(caregiver report)

 Table 37
Not calculated, data were not pooled due to the high degree of heterogeneity. See comments2497

(6 studies; 4 of high quality; 5 RCTs and 1 CBA)
Conflicting3 RCTs (2 of high quality) found statistically significant positive effects; the other 2 RCTs (bothhigh quality studies in the US) reported no statistically significant differences. Positive effects were related to a hospital-based specialist service in Norway (Jordhøy 2000) and 2 intermediate services in the US (Brumley 2007; Hughes 1992)

Greer 1986 found significant higher satisfaction with care among caregivers in the hospital-based intervention assessed 90-120 days after the patient died

 CBA: controlled before and after study; CCT: controlled clinical trial; CI: confidence interval; MS: multiple sclerosis; OR: odds ratio; RCT: randomised controlled trial.
aNumbers needed to treat to benefit (NNTBs) were calculated for the study population control risk and for three other assumed control risks (ACR). These were based on recent cancer home deaths rates from a population-based study across six European countries (Cohen 2010): 1) low home death population assumed the lowest rate of 128 deaths at home per 1000 cancer deaths (Norway); 2) medium home death population assumed the mean across the six European countries (278 deaths at home per 1000 cancer deaths); 3) high home death population assumed the highest rate of 454 deaths at home per 1000 cancer deaths (the Netherlands). We applied rates related to cancer as the included studies involved largely cancer patients.
bLevels of evidence:
Strong: findings from meta-analysis or consistent findings across all studies including at least two high quality RCTs
Moderate: consistent findings across all studies including at least two low quality RCTs/CCTs or one high quality RCT
Limited: one RCT/CCT not reaching high quality
Conflicting: inconsistent findings among at least two studies with at least one RCT/CCT
Inconclusive: statistical significance of differences unknown in > 25% of all studies
No evidence from trials: no RCTs or CCTs
Consistent (conflates assessment of direction and precision): statistically significant effect in same direction in ≥ 75% of all studies
High quality RCTs/CCTs: ≥ 3.5 methodological quality score (ranging from zero to six)
 
Summary of findings 2.

Economic data: home palliative care vs. usual care

Patient or population: adult patients with a severe or advanced disease (malignant /or non-malignant)

Settings: Italy, UK, US

Intervention: home palliative care

Comparison: usual care, which could include community care (primary or specialist care at home and in nursing homes), hospital care (inpatient and outpatient) and in some instances palliative or hospice care (or both)

Economic dataNo of participants
(studies)
Level of evidencea

(adapted from Van Tulder 2003)
Comments

ED visits

Time horizon: 6 months following enrolment; from enrolment to death, transfer to hospice care or study end; last 2 weeks before death

 Table 58
1103

(6 RCTs; 3 high quality)
ModerateModerate evidence of no statistically significant effect on ED visits: consistent across 4 RCTs. In addition, subanalysis of last 2 weeks of life for 33 patients that died in Zimmer 1985 found no ED visits in either group

A significant reduction in ED use as a result of receiving home palliative care was found only in Brumley 2007 (high quality RCT conducted with patients with cancer, CHF and COPD in the US), where 20% of intervention patients had ED visits during the study period as opposed to 33% of those in usual care (P value = 0.01)

Total care costs

time horizon: 12 weeks or 6 months following enrolment; from enrolment to death, transfer to hospice care or study end; last 2 weeks before death

 Table 74
2047

(6 studies; all high quality economic evaluations; 5 RCTs and 1 CBA)
InconclusiveAll studies reported lower costs in the intervention group with differences ranging from 18% to 35% (in Greer 1986 costs under the hospital-based intervention were 2% lower than usual care as opposed to 32% lower under community-based intervention). However, differences were statistically significant only in Brumley 2007 (the study with the largest sample size and only slightly underpowered by 3 patients as planned by authors to detect cost differences)

Statistical significance not reported in 3 RCTs

Cost-effectiveness

time horizon: 6 months following enrolment; from enrolment to death, transfer to hospice care or study end; last 2 weeks before death

 Table 74
2047 patients and 1678 caregivers

(6 studies; all high-quality economic evaluations; 5 RCTs and 1 CBA)
inconclusiveHome palliative care were cost-effective compared to usual care in Brumley 2007 (297 people with cancer, CHF and COPD) and Higginson 2009 (50 people with MS and their caregivers). However, cost-effectiveness is unclear in the other 4 studies, as there were positive, null and negative clinical effectiveness results while costs did not differ (Hughes 1992) and the statistical significance of differences in outcomes or costs, or both, was not reported (2 trials and Greer 1986)

Only Tramarin 1992 calculated a summary cost-effectiveness measure ("average" cost-effectiveness ratio reported in 1990 USD was USD482 per well-week in intervention group and USD791 in control group) but with unknown statistical significance of difference or uncertainty around the estimates. In addition, Higginson 2009 plotted cost-effectiveness planes for 2 of their outcomes. The plane for overall palliative care outcomes showed 33.8% replications in the quadrant indicating better outcomes and lower costs in the intervention group, and 54.9% in the quadrant indicating worse outcomes but lower costs. In contrast, the plane on caregiver burden showed 47.3% replications in the quadrant indicating lower costs and better outcomes and 48.0% in the quadrant showing higher costs and better outcomes

 CBA: controlled before and after study; CCT: controlled clinical trial; CHF: congestive heart failure; COPD: chronic obstructive pulmonary disease; ED: emergency department; MS: multiple sclerosis; RCT: randomised controlled trial
aLevels of evidence:
Strong: findings from meta-analysis or consistent findings across all studies including at least two high quality RCTs
Moderate: consistent findings across all studies including at least two low quality RCTs/CCTs or one high quality RCT
Limited: one RCT/CCT not reaching high quality
Conflicting: inconsistent findings among at least two studies with at least one RCT/CCT
Inconclusive: statistical significance of differences unknown in > 25% of all studies
No evidence from trials: No RCTs or CCTs
Consistent (conflates assessment of direction and precision): statistically significant effect in same direction in ≥ 75% of all studies
High quality RCTs/CCTs: ≥ 3.5 methodological quality score (ranging from zero to six)
 
Table 1. Levels of evidencea

StrongFindings from meta-analysis or consistent findings across all studies including at least 2 high-quality RCTs

ModerateConsistent findings across all studies including at least 2 low-quality RCTs/CCTs or 1 high-quality RCT

Limited1 RCT/CCT not reaching high quality

ConflictingInconsistent findings among at least 2 studies with at least 1 RCT/CCT

InconclusiveStatistical significance of differences unknown in > 25% of all studies

No evidence from trialsNo RCTs or CCTs

Consistent (conflates assessment of direction and precision): statistically significant effect in same direction in ≥ 75% of all studies
High-quality RCTs/CCTs: ≥ 3.5 methodological quality score (ranging from 0 to 6)

 aadapted from Van Tulder 2003.
CCT: controlled clinical trial; RCT: randomised controlled trial.
 
Table 2. Nineteen models of specialist and intermediate home palliative care

Study, country, setting Type of care Service base

 
Core team, responsibilityTheoretical frameworkIntervention Contacts, duration

Axelsson 1998 Sweden, Östersund, county of Jämtland, metropolitan (sparsely populated region)SpecialistDepartment of General Surgery at County Hospital of ÖstersundFull-time nurse (weekdays from 8 a.m. to 5 p.m., equipped with leasing care and phone) with 15 years' experience of practical cancer care in a surgical ward, trained in pain relief and symptom control, surgeon (half-day per week); responsibility not stated but service worked with primary care centres; weekly review meetings"Palliative Support Service"

new programme

* nurse role - link between home and hospital; patient, caregiver and staff support; district nurse education on care management; administration of blood transfusions, low-dose chemotherapy and parenteral nutrition at home

* surgeon role - screening of referrals; case review with nurse at weekly conference; occasional home visits

* dossier given to patient at discharge
Median 14.5 hours of contact with nurse and 2 hours of contact with surgeon; 70 days median length of stay in intervention; all intervention patients analysed died within study period

Bakitas 2009

US, New Hampshire and Vermont, rural
SpecialistPalliative care programme, Dartmouth-Hitchcock Medical Center (National Cancer Institute-designated comprehensive cancer centre)Palliative care physician, advanced practice nurses with high specialty training in palliative care; nurses acted as case managers but primary team held final responsibility for medical decisions; 12-20 hours of staff training (materials available from authors); biweekly reviews of audio-taped sessions and feedback on difficult patient management issuesChronic care model"Project ENABLE II"

followed a demonstration project

* without forgoing curative care

* needs assessment using Distress Thermometer

* case management

* crisis prevention

* patient and caregiver education

* education manual (available from authors)

* monthly group shared medical appointments

* referral to other resources (e.g. palliative care team, hospice, spiritual counsellor)

* nurse readily available by phone

* follow-up call in bereavement

* intervention manual (available from authors)
Telephone-based format, 4 sessions (31-40 min), at least monthly telephone follow-ups (14 months median survival in intervention group, 112/161 deaths in intervention group during mean 14.6 months' follow-up), bereavement follow-up call

Gómez-Batiste 2010 Spain, all 19 regions, mix of metropolitan and ruralSpecialist63 teams, base not statedTeams typically included doctor, 2 or 3 nurses, psychosocial worker (social worker or psychologist) with advanced training in palliative care; not stated who held responsibility but services aimed to advise other conventional teams in the communityExisting teams

no specific information about intervention components
According to previous study, teams performed a mean of 9 interventions per patient and telephone calls were second most frequent activity; 42 days median length from day of first clinical visit to death or last monitoring visit; 42 patients died and considered drop-outs

Higginson 2009

UK, London,

metropolitan
SpecialistIntra-hospital palliative care team at King's College Hospital (general public teaching hospital)part-time palliative medicine consultant with training in neurology and interest in MS, part-time clinical nurse specialist working in neurology and with some palliative care training, full-time administrator; responsibility not stated but service aimed to complement and not to replace existing services; weekly review meetings for consultant to input into management of all patientsPhase II study

followed previous steps of MRC framework for the evaluation of complex interventions

* service referrals used standard form

* initial needs assessment

* action plan and follow-up (communicated to primary team and other professionals)

* joint review with neurologist and other professionals in weekly multi-professional MS clinics (in addition to phone and email contact) 

* crisis prevention

* welfare benefits advice

* bereavement support

* staff education and support

* referral to longer-term specialist home palliative care services based on need (WHO definition)
Short-term: 1-3 contacts (initial needs assessment with "average" 110 min direct contact and 90-min liaison/administration; further visits or telephone calls, or both); patients seen in their place of choice (often home, sometimes outpatient clinics, nursing home, hospital); 4/52 patients died during study period

Jordhøy 2000 Norway, Trondheim, 6metropolitan and 2rural areasSpecialistPalliative medicine unit at University Hospital of Trondheim (unit with 12 beds, outpatient clinic and consultant team in and out of hospital)Full-time physician; 2 palliative care nurses, social worker, priest, nutritionist, part-time physiotherapist (all worked day hours only); nurse acted as care co-ordinator but primary family physician and community nurse remained main professional carers; weekly review meetings"Grounded on holistic philosophy"New intervention

* multidisciplinary approach to patient's needs

* care co-ordination

* link between palliative medicine unit and community services under predefined guidelines

* initial care plan set up in meeting with patient, caregivers, family physician, community nurse

* follow-ups by community staff supervised by team (available for joint home visits)

* staff education programme (bedside training, 6-12 hours of lecturers every 6 months on symptoms and difficulties in palliative care)

* inpatient and outpatient services provided at unit except when required for medical reasons

* no out of hours or on-call service
Contacts and duration not described; 99 days' median survival in intervention group; 219/235 intervention patients died during study period

McWhinney 1994 Canada, London, Ontario, metropolitanSpecialist14-bed palliative care unit (host organisation not stated)Physician, 2 experienced palliative care nurses (working 1 week on, 1 off) and a part-time social worker; responsibility remained with family physician and home care nurses (consulting and support service only)"Palliative care home support team"

service existed for 18 months

* nurse assessment within 3 days of referral

* care plan with team's physician, copies sent to family physician, home nurse and case manager

* follow-ups varied from no further contact to monitoring phone calls to periodic visits (as per wishes of patient and family and negotiation with family physician and home nurse)

* 24 hours on-call nursing with physician back up and contact given (if family physician and home nurse not available)
Initial nurse assessment at home and follow-ups varied from no contact to periodic visits; duration not described; 36/146 patients died within the first month

Ahlner-Elmqvist 2008

Sweden, Malmö, metropolitan
IntermediateHospital oncology department at Malmö University Hospital9 experienced nurses (day and evening shifts and night emergencies); oncologist, social worker, physiotherapist, secretary (day hours only); priest associated on consultation basis; all with long experience in advanced cancer care with no formal training but attended palliative care training programme prior to service start; weekly meetings"Advanced Home Care - AHC"

new 7-days/week service

* symptom treatment, counselling and emotional, social and family support

* team home visits planned according to patient's needs and with degree of flexibility

* administration of injections, intravenous fluid therapy, blood transfusions, chemotherapy, nasogastric intubation, catheterisation of urine bladder and other forms of technical support

* access to on-call service from service base

* 3 'back-up' beds available (2 at hospice and 1 at the oncology unit)
Contacts and duration not described; 94 days median survival in intervention group, 117/119 intervention patients died during study period

Aiken 2006

US, Phoenix, Arizona, metropolitan
IntermediateHospice of the Valley (largest community-based hospice care provider in the US)Physician (medical director), from 2 or 3 registered nurse case managers, half-time social worker, half-time pastoral counsellor; staff training (2 weeks on FairCare communication model and other monthly training); team's nurse responsible for care with primary care physician and HMO case manager; nurse went with patient to physician visits to discuss progress and care optionsPatient empowerment model and behaviour change theory"PhoenixCare Intervention"

* without forgoing curative treatment

* disease and symptom management, patient/ caregiver education, psychosocial and spiritual support, needs assessment, care co-ordination, case management

* management protocols by phase of illness (initially unstable, stable, unstable following exacerbation)

* individualised emergency response plan at home (used in hospice care) with contacts

* advance care planning with patient/family

* referral to counselling and other resources

* patient notebook at home

*on-call nursing
Nurses contacts ("average" 6, 5, 4, 4, 3 and 3 in first 6 months and stable from then onwards; half calls, half visits); visits from other staff (45% saw social worker, on "average" 6 times); duration from enrolment to death (16% intervention patients died within study period), transfer to hospice care or skilled nursing care facility, or study end

Brumley 2007

US, Hawaii and Colorado, metropolitan
Intermediate2 non-profit Kaiser Permanente Group HMOsPhysician, nurse, social worker with support from others (spiritual counsellor/chaplain, bereavement co-ordinator, home health aide, pharmacist, dietician, volunteer, physiotherapist, occupational therapist, speech therapist); patients could maintain primary care provider while receiving home visits team"Modelled after hospice programs""In-Home Palliative Care – IHPC"

* without forgoing curative care

* patients assigned to palliative care physician to co-ordinate care from a variety of healthcare providers

* medical care, symptom management, patient and caregiver education, biopsychosocial support, continuous needs assessment, care management

* joint care plan to decide frequency of visits

* advance directives with patient and family

* patient wrist band for emergency department staff to know patient was in home palliative care and had advance directives (1 site only)

* physicians home visits, nursing care 24 hours/day
Contacts not described; duration from enrolment to death or transfer to hospice care; 196 days mean survival in intervention group; 225/310 patients died within study period

Buckingham 1978

US, New Haven, metropolitan
IntermediateNot statedDescribed as "experienced services"; not stated who held responsibility for care"Hospice home care program"

* aimed to provide for many needs that often cannot be met in acute care settings
Contacts and duration not described

Grande 1999

UK, Cambridge health district
IntermediateMarie Curie nursing service and inpatient hospice6 qualified nurses, 2 nursing auxiliaries, co-ordinator, most with Marie Curie nursing experience; not stated who held responsibility for care"Cambridge Hospital At Home - HAH"

* practical home palliative nursing care

* care available up to 24 hours a day
Median 18 hours of HAH for a maximum of 2 weeks; 11 days median survival in intervention group

Greer 1986

US, Southern New England, Northern Midwest and Southern California, metropolitan and rural
Intermediate20 community-based hospices without inpatient beds, 19 hospital-based hospices with inpatient bedsMedically supervised interdisciplinary teams composed of several individuals with appropriate skills including professionals and volunteers; teams medically supervised but not stated who held responsibility for careGrounded on hospice and humanistic philosophy of caring for terminally ill patients and their families as per National Hospice Organization's 1979 standards of hospice programme of care"Hospice care"

* palliative, preventive, supportive, less resource-intensive and with more informal care (family and volunteers) than conventional care

* palliative care and control of symptoms, physical, emotional and spiritual distress

* emphasis placed upon care in the home

* individualised care plan and provision

* choices about treatment and place of death

* family supportive care during dying process and bereavement (this may include follow-up visits)

* maximum access regardless ability to pay

* treating patient and caregivers as a unit

* inpatient and home care services closely integrated to ensure continuity and co-ordination

* education programme (for patient, family and team)

* availability 24 hours/day
Contacts not described; "average" 72 days length of stay in intervention for community-based hospices and 63 days for hospital-based hospices; half of all patients died within 35 days of admission, nearly 20% stayed ≤ 10 days; all patients analysed died within study period

Hughes 1992

US, Hines, Illinois, metropolitan
IntermediateEdward Hines Jr. VA Hospital (department not stated)Physician-led team including nurses, social worker, physiotherapist, dietician, health technicians (physician also managed the hospital's inpatient intermediate care unit thus maximised potential for continuity of care across home and hospital); team meetings; not stated who held responsibility for care"Hospital-based home care - HBHC"

service existed for 13 years

* emphasis on care to high-risk patients

* comprehensive services based on need

* timely communication across team members

* involvement and training of informal caregivers in patient care to the maximum extent possible

* patient and family as unit of care

* education strong service component

* goal-oriented, interdisciplinary care plan

* scheduled visits according to individual needs

* physician home visits, pharmaceuticals, supplies
Mean 17.93 team visits in 6 months from enrolment (duration of intervention); 76 days mean survival in intervention group; 79% intervention patients died within study period

McCorkle 1989

US, King County, Washington, metropolitan and rural
IntermediateNot statedNurses with masters' degrees and trained to give personalised clinical care to people with advanced cancer and their families; other specialised services called upon as needed; nurse was care co-ordinator but not stated who held responsibility for careOncology transition services model"Specialized Oncology Home Care Program - OHC"

* personalised care in home setting

* advanced education in symptom management

* nurse acting as central care co-ordinator

* 24-hour access to nursing staff
Contacts and duration not described; 87/166 patients died during study period

McKegney 1981

US, Vermont, rural
IntermediateVermont Regional Cancer Center (department not stated)Trained oncology nurse practitioners with extensive experience in care of the patients with advance cancer backed up by usual multidisciplinary team at the cancer centre; formal interdisciplinary training on extended assessment skills; weekly team conferences; nurses acted as link between the multidisciplinary team and as care co-ordinator responsible for patients through home visits, clinic visits, and hospitalisations to ensure continuity; primary physician informed and collaborated in complex medical problems"Intensive home care"

*aimed to improve patient's quality of life and communication between conventional cancer rehabilitation team and patient

* patients assigned oncology nurses to closely monitor and co-ordinate care, anticipate and solve medical and psychosocial problems

* initial interdisciplinary assessment followed by care plan build by nurse

* home visits focused on patient needs ("incidental interactions with family"), physical care, talking with patient about illness and implications, mobilising family and social resources and co-ordinating with patient's physician

* protocol for pain management, nausea, vomiting, home administration of intravenous chemotherapy drugs (available from authors)

* pain killers given regularly for continuous control
Home visits (35-40 min) with frequency defined based on prognosis (life expectancy < 3 months biweekly visits; ≥ 3 months monthly visits); duration not stated; 345 days mean survival in intervention group; 139/199 patients died within study period

Rabow 2004

US, San Francisco, California, metropolitan
IntermediateGeneral medicine practice at  University of California Medical Center (tertiary care)3 physicians, nurse, social worker, chaplain, pharmacist, psychologist,  art therapist (all with expertise in palliative care), volunteer co-ordinator, volunteer medical/pharmacy student patient advocates; regular physician-led meetings; collaboration with other services; social worker responsible for case management; team's physician advised primary physician who retained responsibility for medical careSocial work centred case management approach"Comprehensive Care Team"

demonstration project

* without forgoing curative care

* 7 components:

1) formal consultations

2) case management

3) caregiver education and support

4) medical chart review

5) spiritual and psychological support

6) patient/caregiver support groups

7) patient support and advocacy
3 consultations, "average" 3.8 social worker in-person contacts and 13.0 telephone calls; at least 1 chaplain contact and 1 medical chart review (pharmacist), mean 2.2 hospital visits to hospitalised patients, "average" 6.5 advocates' contacts (telephone calls, home visits, hospital visits); 1-year duration; 10/50 intervention patients died within study period

Tramarin 1992

Italy, Vicenza health district and surroundings, metropolitan and rural
IntermediateInfectious diseases department at San Bortolo Hospital, with 15 beds, outpatient clinic and hospice offering home careMultidisciplinary team of 4 trained nurses, psychologist, 10 volunteers, social workers (where available), 2 infectious disease specialists; patient's family doctor viewed as part of team; consultant doctors at the department supervised other caregivers (family doctors, volunteers, social care agencies)"Based on the principles of palliative care (...) in line with National Health AIDS Plan guidelines" (Tramarin 1992)"Home-care Assistance"

pilot study

* integrated package of home care

* aimed to improve quality of life whenever possible through symptom control

* aimed to limit use of inappropriate inpatient services, substituting with palliative care

* chemotherapy, parenteral nutrition, blood transfusion and fluids administered if needed at home using a tunnelled catheter
"Average" of 33.1 staff hours, 29.1 nurse visits and 4.5 specialist visits in 6 month following enrolment; "average" duration of 74.1 days; 5/10 intervention patients died within study period

Ward 1987 UK, Trent and Yorkshire health regions, metropolitan and ruralIntermediate4 teams based at an inpatient hospice and 4 teams with a non-hospice base (1 hospital, 1 non-inpatient hospice, 1 in grounds of future in-patient hospice, and 1 in primary care team offices)7 teams were multidisciplinary and 1 was of nurses only, members ranged from 2 to 8; all teams had nurses, 7 had medical input, 5 had social workers; not clear who held responsibility for care although services' aim was to augment but not replace care from district nursing, GPs and families"Macmillan home care nursing care"

services existed for ≥ 18 months

* home visits to monitor situation, pain and other symptoms, reassure/support, assess need for community care, inpatient or day unit, give advice, deliver equipment/ medication, practical nursing

* out-of-hours cover - all teams had 24/7 coverage (e.g. hospice out of hours, bleeps, radio paging, nursing message systems, nurses home number, coverage by inpatient hospice staff for advice)

* patients from teams based at inpatient hospices could access hospice beds, day centres, family relief and other hospice services
Service routine data showed mean home visits per patient/month ranged from 2.3 to 7.7 for hospice-based services and from 7.9 to 12.5 for non-hospice based; out-of-hours visits ranged from 0 to 9, except in 1 hospice-based team (40 visits) and in 1 non-hospice based (81 visits); duration from enrolment to death (median 32 days, range 21.5 to 44.5 days)

Zimmer 1985

US, Rochester, New York, metropolitan
IntermediateAmbulatory care unit at University of Rochester Medical CenterPhysician, geriatric nurse practitioner (Masters' medical nurse practitioner); social worker; weekly team conferences to assure co-ordination of patient care; 1 team member designated as primary provider in care plan following initial interdisciplinary assessment

 
"Home Health Care Team"

service existed for 2 years

* aimed for home-bound, chronically or terminally ill, or disabled patients (largely elderly) when attending clinics was too difficult

* initial home assessment by each team member

* interdisciplinary care plan with designated primary professional care provider

* nurse role - physical assessments (routine and emergency), responsible for nursing plan, supported medical care

* physician role - evaluation at intake, home visits, follow-ups as needed, patient's attending physician during hospitalisations

* social worker role - help deal with social, financial and emotional problems; caregiver support and education

* 24-hour phone service with physician back-up
Contacts not described but authors referred to low number of out-of-hours calls (over 70% handled on telephone); duration not stated; by 3 months 23/32 of the terminally ill patients had died

 GP: general practitioner; HMO: health maintenance organisation; MRC: Medical Research Council; MS: multiple sclerosis; VA: Veterans Affairs; WHO: World Health Organization
 
Table 3. Four models of reinforced home palliative care

Study, country, setting Type of care Service base

 
Core team, responsibilityTheoretical frameworkAdditional component  Contacts, duration

Harding 2004

UK, London, metropolitan
Specialist2 home palliative care teams (base not stated)Composition of home palliative care teams not stated; additional component delivered by a facilitator-led multiprofessional group (1 facilitator per site); weekly facilitators' peer supervision (intervention consistency)"90 Minute Group"

new brief caregiver group intervention (research-based, grounded on literature and qualitative study)

* aimed to promote self care

* informal teaching

* group support (caregiver information and support)

* maximum of 12 carers/group (2 at each site)

* 4 principles:

1) lack of identification with the label of 'carer', 2) safe and legitimate time/space away from caring,

3) time limited, 4) respectful of existing coping strategies

* facilitator introduced multiprofessional input from a changing weekly speaker (welfare benefits advice, occupational and physical therapy, clinical nurse specialist, aromatherapy) and subsequently facilitate group discussion of the weekly themes

* group initially focused on patient issues in order to provide legitimacy for attending, and to address the patient-oriented sources of distress

* detailed programmed objectives for each session

* transport and patient-sitting when needed
Additional component was a 6-week intervention (6 weekly 90-minute sessions); survival and mortality not stated

Hudson 2005

Australia, Melbourne, Victoria, metropolitan
Specialist2 home palliative care teams (base not stated)Home palliative care teams of specialist nurses, doctors, and allied health professionals (including nurses, social workers, medical consultants, pastoral care workers, volunteers, bereavement counsellors); additional component delivered by nurse"Psychoeducational intervention"

new brief caregiver psychoeducational support

(research-based, grounded on literature and focus groups with nurses and caregivers)

* aimed to enhance support/guidance for caregivers

* visits structured around and complemented by audiotape with reflections from caregivers, self care strategies, structured relaxation exercise, and guidebook with information on typical aspects of caring for dying person (link provided in paper)

* caregivers read guidebook sections and noted questions prior to visits and call:

* first visit - prepared for caregiver role and aspects of caregiving (section 1 and 2 of guidebook)

* telephone call - focused on evaluating plans, self care (section 3), new issues and caregiver desire to go on to next section

* second visit - focused on evaluating previous strategies, new issues and preparing for dying phase (final section of guidebook)
Additional component was a 2-week intervention (2 fortnightly home visits with follow-up call between visits); survival and mortality not stated

McMillan 2007

US, Tampa, Florida, metropolitan
SpecialistLarge non-profit community-based hospiceComposition of home hospice care team not stated (cared for 850 patients/day); additional component delivered by newly hired nurses (1 full-time, 1 back-up) and home health aides with hospice experience; 4-day training on intervention with role play and audiotapes of sessions reviewed monthly to ensure protocols were followedAdditional component grounded on stress process models and problem solving training and therapy"COPE Intervention"

new brief caregiver psychoeducational support

* aimed to teach a problem solving method to assess and manage patient symptoms (focus on pain, dyspnoea and constipation)

* 4 components:

1) creativity (viewing problems from different perspectives to develop new strategies for solving caregiving problems)

2) optimism (positive but realistic attitude toward problem-solving process, including communicating realistic optimism to patient)

3) planning (setting reasonable caregiving goals and thinking out, in advance, the steps necessary to reach those goals, e.g. family holiday)

4) expert information (about nature of problem, when and where to get professional help, and what to do on one's own to deal with problem)

* Home Care Guide for advanced cancer (for patients and caregivers) with 23 patient problems with easy reference for caregivers

* caregiver use of assessment scales for pain, dyspnoea and constipation, findings recorded in symptom diary; ratings were foundation for action to call hospice staff and manage symptoms at home

* nurse pager contact

* intervention manual (available from authors)
Additional component was a 9-day intervention with 3 visits (first 5 min, second and third 30 min) with continued support in between with calls to assess problems, offered support and answer questions; survival and mortality not stated

Walsh 2007

UK, London, metropolitan
Specialist7 home palliative care services covering 3 regional cancer networks (2 hospital-based, 2 community-based, 3 inpatient hospice-based teams)Home palliative care teams of clinical nurse specialists, specialist medical support and sometimes social work; additional component delivered by 2 part-time carer advisors experienced in community nursing and social work (1 month's training with fieldwork in palliative care in home, hospice, hospital settings); weekly meetings between advisors and researchers for debriefing, advice on emerging issues and to ensure all domains of need were covered; half-day training session on intervention after 1 year"Carer advisor"

new brief caregiver-focused intervention

(research-based, grounded on literature and pilot with caregivers on preferred mode of extra support)

* aimed to meet caregiver alone (outside home, at workplace, evenings or weekends if needed)

* mainly face-to-face but sometimes on phone (enabled flexibility and helped approach issues difficult to discuss face-to-face)

* comprehensive needs assessment, discussion and advice on past, present and future issues

* information and emotional support

* covered physical and psychological health, need for time away from patient in short and long term and to plan future, relationships and social networks, relationships with services, finances

* kept to giving advice and support rather than taking action on behalf of caregivers (advice went as far as helping to calculate benefit entitlements)

* bereavement support and advice

* intervention manual (available from authors)
additional component was a 6-week intervention (6 visits over 6 weeks), introduced at second/third contact with team and if patient died before sixth contact, visits took place after death; mean 5 contacts and mean 3.6 contacts up to death; 13 weeks median survival in intervention group; 47/137 intervention patients died during study period

 
Table 4. Time the patient spent at home: home palliative care versus usual care

StudyAnalysisFollow-upSignificance and directionDetails

Jordhøy 2000

Norway

(high quality)
Forwards from enrolmentEntire follow-up

(up to 2 years with mean survival 99 days for intervention patients and 127 days for controls)
n.s.

P value = 0.6
M percentage time at home

Intervention: 65%

Control: 63%

Backwards from deathLast monthPercentage of time at home

marginally significant difference favours intervention

P value = 0.06

 

n.s.

adjusted for other predictive factors (gender and living with spouse)

P value = 0.15

 

Number of inpatient-days

marginally significant difference favours intervention

adjusted for sex as only predictive factor

P value = 0.06
M percentage time at home

Intervention: 48%

Control: 41%

  

Percentage of patients with no inpatient-days

Intervention: 28/219 (13%)

Control: 11/176 (6%)

Grande 1999

UK
Backwards from deathLast 2 weeks

(based on primary care team report 6 weeks after death)
n.s.

Chi2 0.557

P value = 0.455
Percentage of patients who spent time at home

Intervention: 82%

Control: 77%

Buckingham 1978

US
Not statedNot statedAuthors stated difference favouring intervention but statistical significance was not stated"It is estimated that nonhospice patients spent 50 percent more time in either an acute care hospital or some other form of institutional setting than hospice patients" (Buckingham 1978)

Axelsson 1998

Sweden
Forwards from enrolmentEntire follow-up (median 70 days for intervention patients and 55 days for controls)Favours intervention

P value < 0.05
Median percentage of time spent at home

Intervention (n = 41): 86% (range 0% to 100%)

Control (n = 15): 72% (range 0% to 100%)

Backwards from deathLast 2 monthsn.s.Median number of days spent at home

Intervention (n = 41): 44 days (range 0 to 60)

Control (n = 15): 39 days (range 15 to 60)

Greer 1986

(CBA)
Backwards from deathNot stated

(based on caregiver report 90-120 days after death)
Favours community-based intervention

 "HC PCPs were significantly more likely than HB and CC PCPs to report that the patient had been able to remain at home as long as he/she wanted" (Greer 1986)
Patient able to remain at home as long as she/he wanted

(adjusted estimatesa)

Community-based intervention: 82% (SE 0.04)

Hospital-based intervention: 69% (SE 0.05)

Control (conventional care): 56% (SE 0.09)

 CC: conventional care (control); HB: hospital-based (hospital-based intervention); HC: home care (community-based intervention); M: mean; n.s.: non-significant; PCP: primary care person; SE: standard error.
aOutcomes adjusted for sample differences; standard errors based on a logistic regression equation.
 
Table 5. Caregiver view on place of death: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Grande 1999

UK
Item on perceived appropriateness of place of death

score: definitely yes, probably yes, probably not, definitely not; caregiver report 6 weeks after death
NANANot tested"Only four caregivers rated place of death as 'definitely' or ‘probably inappropriate'. One of these represented a home death, three an inpatient death. Numbers were therefore too small in the 'inappropriate' category to analyze perceived appropriateness of place of death" (Grande 2004, Grande 1999)

Greer 1986

(CBA)
Item on satisfaction with place of death

score: yes/no; caregiver report 90-100 days after death
NANAAuthors stated there were differences but significance not stated

"PCPs in both types of hospices were satisfied with where the patients died; however, both hospice PCP groups were more satisfied with where the patient died than were CC PCPs" (Greer 1986)
Adjusted estimatesa

Community-based intervention: 91% (SE 0.04)

Hospital-based intervention: 88% (SE 0.06)

Control (conventional care): 74% (SE 0.02)

 CC: conventional care (control); NA: not applicable; PCP: primary care person; SE: standard error.
aOutcomes adjusted for sample differences; standard errors based on a logistic regression equation.
 
Table 6. Symptom burden: home palliative care versus usual care

Study and countryMeasureAnalysis

 
Follow-upSignificance and directionDetails

Bakitas 2009

US

(high quality)
Edmonton Symptom Assessment Scale (ESAS)

measure of 9 symptoms (rated from 0 to 9): pain, activity, nausea, depression, anxiety, drowsiness, appetite, sense of well-being, shortness of breath; scores: from 0 to 900, higher scores equal greater symptom intensity; patient report
Forwards from enrolment1 monthMarginally significant difference favours interventiona

 Mean treatment effect (intervention-control) −27.8 (SE 5);

P value = 0.06

 

 

 

 

 

 
Intervention (n = 109): LSM 241.81 (95% CI 216.35 to 267.28)

Control (n = 100): LSM 288.53 (95% CI 262.03 to 315.03)

4 monthsIntervention (n = 73): LSM 254.67 (95% CI 224.55 to 284.78)

Control (n = 76): LSM 271.87 (95% CI 242.11 to 301.64)

7 monthsIntervention (n = 62): LSM 238.77 (95% CI 206.60 to 270.95)

Control (n = 54): LSM 268.59 (95% CI 234.34 to 302.83)

10 monthsIntervention (n = 48): LSM 271.57 (95% CI 235.83 to 307.31)

Control (n = 45): LSM 294.20 (95% CI 257.27 to 331.12)

13 monthsIntervention (n = 28): LSM 295.56 (95% CI 250.65 to 340.47)

Control (n = 31): LSM 251.66 (95% CI 208.51 to 294.82)

Backwards from deathThird last assessmentn.s.a

Mean treatment effect (intervention-control) −24.2 (SE 20.5)

P value = 0.24
Intervention (n = 52): LSM 262.76 (95% CI 222.61 to 302.91)

Control (n = 48): LSM 263.90 (95% CI 222.13 to 305.68)

Second last assessmentIntervention (n = 81): LSM 274.69 (95% CI 240.63 to 308.76)

Control (n = 75): LSM 304.93 (95% CI 269.53 to 340.33)

Last assessmentIntervention (n = 80): LSM 322.29 (95% CI 288.08 to 356.51)

Control (n = 74): LSM 353.90 (95% CI 318.33 to 389.47)

Higginson 2009

UK

(high quality)
Palliative care Outcome Scale MS Symptoms subscale (POS-MS-S5)

measure of 5 symptoms (rated from 0 to 4): pain, nausea, vomiting, mouth problems and sleeping difficulty; scores: from 0 to 20, higher scores equal greater symptom intensity; patient report
Forwards from enrolment6 weeksn.s.b

ES -0.5

F = 1.08

P value = 0.31
M change from baseline

Intervention (n = 24): M -0.7 (SD 2.3; 95% CI -1.7 to 0.3)

Control (n = 20): M 0.6 (SD 3.2; 95% CI -1.0 to 2.1)

12 weeksFavours interventionb

ES -0.8

F = 4.75

P value = 0.04
M change from baseline

Intervention (n = 25): M -1.0 (SD 2.7; 95% CI -2.1 to 0.1)

Control (n = 21): M 1.1 (SD 2.8; 95% CI -0.2 to 2.4)

McCorkle 1989

US

 
Symptom Distress Scale

measure of 13 symptoms (not stated which); scores: from 13 to 65, higher scores equal greater symptom distress; patient report
Forwards

from enrolment

 
6 weeksFavours interventionc

F = 5.01

P value = 0.03

Graphs showed that the entire sample experienced increased symptom distress over time but control2 (i.e. those receiving usual outpatient care) experienced elevated distress 1 occasion sooner (at 6 weeks) than the intervention and control1 (i.e. those receiving cancer home care)
Adjusted estimates

Intervention: M 26.1

Control1 (cancer home care): M 24.88

Control2, (usual outpatient care): M 24.32

12 weeksAdjusted estimates

Intervention: M 24.23

Control1 (cancer home care): M 24.71

Control2 (usual outpatient care): M 26.79

18 weeksAdjusted estimates

Intervention: M 25.42

Control1 (cancer home care): M 26.14

Control2 (usual outpatient care): M 26.70

Greer 1986 (CBA)Composite symptom severity scale modified from Melzack-McGill Questionnaire

measure of symptoms including nausea or vomiting, constipation, dizziness, fever or chills, dry mouth, breathlessness; scores: from 0 to 7, higher scores equal greater symptom severity; caregiver report
Backwards

 from death
3 weeksFavours hospital-based interventiond

"patients in HB hospices were likely to experience fewer symptoms than HC or CC patients, although at one week prior to death this difference was statistically significant only in the HB-CC comparison. Subgroup analyses revealed that statistically significant differences persisted regardless of the level of symptoms at intake" (Greer 1986)
Adjusted estimatesd

Community-based intervention: M 2.89 (SE 0.09)

Hospital-based intervention: M 2.46 (SE 0.13)

Control (conventional care): M 2.97 (SE 0.16)

1 weekFavours intervention regardless service basedd

see comment above
Adjusted estimatesd

Community-based intervention: M 3.05 (SE 0.08)

Hospital-based intervention: M 2.78 (SE 0.12)

Control (conventional care): M 3.38 (SE 0.15)

 ANCOVA: analysis of covariance; CBA: controlled before and after study; CC: conventional care (control); CI: confidence interval; ES: estimated effect size; HB: hospital-based (hospital-based intervention); HC: home care (community-based intervention); LSM: estimated least mean square; M: mean; n.s.: not significant; SD: standard deviation; SE: standard error.

aResults from repeated measures analysis of covariance (mixed-effects model applied to longitudinal data using random-subject effects to account for correlation between repeated outcome measurements on same individual).
bResults from F-tests of non-imputed data; authors stated that imputed data gave similar results. 

cThe authors used repeated measures analysis and analysis of variance; analysis included 78 patients who completed the three follow-up interviews (i.e. up to 18 weeks after enrolment); adjusted means were used due to baseline differences despite randomisation.
dThe authors undertook hypothesis testing on adjusted estimates of outcomes in each of the groups derived through linear regression; estimates adjusted for sample differences; standard errors based on the linear regression equation.
 
Table 7. Pain: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Higginson 2009

UK

(high quality)
Palliative care Outcome Scale (POS) pain item

score: from 0 to 4, higher score equals greater pain; negative change equals reduction; patient report
Forwards

from enrolment

 
6 weeksn.s.Mean change from baseline

Intervention (n = 25): -0.23 (95% CI -0.66 to 0.20)

Control (n = 23): 0.09 (95% CI -0.36 to 0.54)

12 weeksFavours intervention 

F = 5.15; P value = 0.028
Mean change from baseline

Intervention (n = 26): -0.46 (95% CI -0.98 to 0.05)

Control (n = 24): 0.30 (95% CI -0.16 to 0.76)

Adjusted for baseline scores, the difference between scores was 0.56 (95% CI - 0.75 to 1.19)

Jordhøy 2000

Norway

(high quality)
EORTC QLQ-C30 2-item pain scale

transformed score: from 0 to 100, higher score equals greater pain; patient report
Forwards

from enrolment

 
1 monthn.s.a

P value = 0.35

 
Intervention (n = 153): M 36

Control (n = 116): M 36

2 monthsIntervention (n = 108): M 38

Control (n = 93): M 37

4 monthsIntervention (n = 71): M 41 

Control (n = 65): M 37

6 monthsDifferences and statistical significance not statedIntervention (n = 56): M 39 

Control (n = 52): M 34

McKegney 1981

US

(high quality)
Sternbach Pain Estimate score

score: from 0 to 100; higher score equals greater pain; patient report

 
Backwards from death180 to 150 daysAuthors stated there were no differences but statistical significance was not stated

 
"The two groups had essentially the same mean pain scores until the last 90 days before death." (McKegney 1981); this statement is corroborated by graph of mean pain scores in the 2 groups

150 to 120 days

120 to 90 days

90 to 60 daysAuthors stated there were differences but statistical significance was not stated"The 'Intensive' group of patients has lower mean pain scores than the 'non-intensive' group over the last 90 days before death. In these last 90 days, the mean pain scores in the non-intensive group of patients continued to rise until death, whereas the mean pain scores in the intensive group of patients plateaued" (McKegney 1981). The difference in the 30 to 0 days period was marginally significant (P value = 0.06)

60 to 30 days

30 to 0 daysMarginally significant difference favours intervention

P value = 0.06

Rabow 2004

US

(high quality)
Brief Pain Inventory

measure with 6 items: worst pain, least pain and "average" pain in last 24 hours (from 0 to 10); 'right now' pain (from 0 to 10); relief (from 0 to 100); interference with activities (from 0 to 70); higher scores equal greater pain; patient report
Forwards

from enrolment
6 monthsn.s.b

P values ranged from 0.94 (ANCOVA between groups for interference with activities) to 0.10 (ANCOVA between groups for least pain in last 24 hours)
Mean adjusted for baseline differences

Intervention (n = 50) vs. control (n = 40)

  • worst pain: 5.9 vs. 5.5
  • least pain: 2.7 vs. 3.9
  • "average" pain: 4.8 vs. 4.9
  • 'right now' pain: 3.0 vs. 3.1
  • relief: 58.7 vs. 60.7
  • interference with activities: 43.1 vs. 39.9

12 monthsMean adjusted for baseline differences

Intervention (n = 50) vs. control (n = 40)

  • worst pain: 4.8 vs. 5.6
  • least pain: 1.8 vs. 2.8
  • "average" pain: 3.6 vs. 4.5
  • 'right now' pain: 2.3 vs. 2.1
  • relief: 68.7 vs. 59.8
  • interference with activities: 36.4 vs. 40.8

Aiken 2006

US
SF-36 2-item bodily pain subscale

transformed score: from 0 to 100; lower score equal greater pain; negative slope equals reduction; patient report
Forwards

from enrolment
3 monthsn.s.cGrowth modelling analysis (separate for COPD and CHF patients)

COPD slope: intervention: 2.98 vs. control: -0.45

CHF slope: intervention: -0.57 vs. control: -0.45

6 months

9 months

Grande 1999

UK
Cartwright/Addington Hall surveys pain item

4-point item, score range not stated; higher score equal greater pain; caregiver report 6 weeks after death
Backwards

 from death
Last 2 weeksFavours intervention 

P value < 0.05
Intervention (n = 107): M 2.52 (SD 0.93)

Control (n = 21): M 3.00 (SD 1.10)

Although analysis used Mann–Whitney U-tests, authors reported Ms and SDs for clarity

McCorkle 1989

US
McGill-Melzack Pain Questionnaire

score: range not stated; higher score equal greater pain; patient report
Forwards

from enrolment

 
6 weeksn.s.

 
"The three groups did not differ significantly with respect to McGill-Melzack Pain Questionnaire" (McCorkle 1989); no data provided to support this statement

12 weeks

6 months

McWhinney 1994

Canada
McGill-Melzack Pain Questionnaire

score: range not stated; higher score equals greater pain; patient/caregiver report through diary
Forwards

from enrolment

 
1 monthn.s."There were no clinically or statistically significant differences between the experimental and control groups on any of the measures at one month" (McWhinney 1994); no data provided to support this statement

 

High attrition (53 /146) mainly due to death; 2 months data not analysed due to further attrition

Greer 1986

(CBA)

 
McGill-Melzack Pain Questionnaire

score range not stated; higher score equals greater pain; patient report
Forwards

from enrolment

 
1 weekn.s.d"the average level of pain for all three patient groups was between mild and discomforting with no statistically significant differences among the groups" (Morris 1986, Greer 1986); no data provided to support this statement

5 weeks

1) Composite pain index modified from Spitzer Quality of Life Index

score: from 0 to 4; higher score equals greater pain; caregiver report  

 

2) Item on being pain-free

score: yes/no; caregiver report

3) Item on persistent pain

score: yes/no; caregiver report

 

 
Backwards

 from death
3 weeksComposite pain index

n.s.d

  

Pain-free

n.s.d

 

Persistent pain

favours hospital-based interventiond

P value < 0.01
Adjusted estimatesd

Composite pain index

Community-based intervention: M 1.41 (SE 0.08)

Hospital-based intervention: M 1.10 (SE 0.10)

Control (conventional care): M 1.53 (SE 0.16)

Patients pain-free

Community-based intervention: 7% (SE 0.02)

Hospital-based intervention: 12% (SE 0.02)

Control (conventional care): 9% (SE 0.04)

Patients with persistent pain

Community-based intervention: 7% (SE 0.02)

Hospital-based intervention: 3% (SE 0.02)

Control (conventional care): 14% (SE 0.04)

1 weekComposite pain index

n.s.

 

Pain-free

n.s.d

 

Persistent pain  

favours hospital-based interventiond

P value < 0.001

 
Adjusted estimatesd

Composite pain index

Community-based intervention: M 1.61 (SE 0.06)

Hospital-based intervention: M 1.48 (SE 0.07)

Control (conventional care): M 1.65 (SE 0.12)

Patients pain-free

Community-based intervention: 9% (SE 0.01)

Hospital-based intervention: 10% (SE 0.02)

Control (conventional care): 16% (SE 0.04)

Patients with persistent pain

Community-based intervention: 13% (SE 0.02)

Hospital-based intervention: 5% (SE 0.02)

Control (conventional care): 22% (SE 0.05)

Patient self reports failed to confirm these findings, but at 1 week to death 80% patients could not report

 ANCOVA: analysis of covariance; CBA: controlled before and after study; CHF: congestive heart failure; CI: confidence interval; COPD: chronic obstructive pulmonary disease; M: mean; n.s.: not significant; SD: standard deviation; SE: standard error.
aThe authors calculated mean changes from baseline at one to four months after enrolment by dividing the area under the curve scores by time; differences between groups were tested by bootstrap estimation to fit regression models allowing for clustering and predictive factors.
bANCOVAs tested for differences between groups and for group by time interaction, controlling for baseline differences in pain but not for clustering.

cThe authors used growth modelling analysis, calculated slopes of "average" linear trajectory within a group, averaged across slopes of individual linear trajectories of individual within the group and compared intercepts at each time point and slopes for COPD and CHF patients separately.
dThe authors undertook hypothesis testing on adjusted estimates of outcomes in each of the groups derived through linear regression; estimates adjusted for sample differences; standard errors based on the linear regression equation for continuous variables and on logistic regression equation for dichotomous variables.
 
Table 8. Breathlessness: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Jordhøy 2000

Norway

(high quality)
EORTC QLQ-C30 dyspnoea item

score: from 0 to 100, higher scores equal greater dyspnoea; patient report
Forwards

from

enrolment
1 monthn.s.a

SAUC intervention 2.8 vs. SAUC control 1.9

P value = 0.95

 
Intervention (n = 153): M 32

Control (n = 116): M 39

2 monthsIntervention (n = 108): M 30

Control (n = 93): M 37

4 monthsIntervention (n = 71): M 38 

Control (n = 65): M 37

6 monthsDifferences and statistical significance not statedIntervention (n = 56): M 40 

Control (n = 52): M 42

Rabow 2004

US

(high quality)
University of California San Diego Shortness of Breath Questionnaire

measure with 2 subscales: 1) degree to which dyspnoea interference with daily activities (21 items; range 9 to 105) and 2) degree to which dyspnoea limits daily life (3 items; range 0 to 18); higher scores equal greater interference/limitation; patient report
Forwards

from

enrolment
6 monthsI nterference with daily activities

group main effect: favours intervention

F = 7.06

P value = 0.01

group by time interaction: n.s.

F = 1.67

P value = 0.21

Limitations to daily life

group main effect: marginally significant difference favours intervention

F = 3.64

P value = 0.07

group by time interaction: favours intervention

F = 6.83

P value = 0.01

Presence of breathlessness

favours intervention

Controlling for the presence of breathlessness at baseline, the odds of reporting any breathlessness at 12 months were higher for controls than for intervention patients (OR 6.07; 95% CI 1.04 to 35.56)
Adjusted estimatesb

Interference with daily activities

Intervention (n = 50): M 32.6

Control (n = 40): M 40.3

Limitations to daily life

Intervention (n = 50): M 5.8

Control (n = 40): M 6.5

12 monthsAdjusted estimatesb

Interference with daily activities

Intervention (n = 50): M 25.4

Control (n = 40): M 32.6

Limitations to daily life

Intervention (n = 50): M 3.6

Control (n = 40): M 7.1

Grande 1999

UK
Cartwright/Addington Hall surveys breathlessness item

4-point item, range not stated; higher scores equal greater breathlessness; caregiver report 6 weeks after death
Backwards

 from death
Last 2

weeks
n.s.

P value ≥ 0.05
Intervention (n = 107): M 2.43 (SD 1.17)

Control (n = 18): M 2.17 (SD 1.15)

 

Although analysis used Mann–Whitney U-tests, authors reported Ms and SDs for clarity

 CI: confidence interval; EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life questionnaire; M: mean; n.s.: non-significant; OR: odds ratio; SAUC: standardised area under the curve; SD: standard deviation.

aThe authors calculated mean changes from baseline at one to four months after enrolment by dividing the area under the curve scores by time; differences between groups were tested by bootstrap estimation to fit regression models allowing for clustering and predictive factors.
bMeans adjusted for baseline scores.
 
Table 9. Sleep disturbance: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Jordhøy 2000

Norway

(high quality)
EORTC QLQ-C30 sleep disturbances item

score: from 0 to 100, higher scores equal greater sleep disturbances; patient report
Forwards

from

enrolment
1 monthn.s.a

SAUC intervention -4.7 vs. SAUC control -2.2

P value = 0.56
Intervention (n = 153): M 32

Control (n = 116): M 34

2 monthsIntervention (n = 108): M 33

Control (n = 93): M 33

4 monthsIntervention (n = 71): M 32

Control (n = 65): M 28

6 monthsDifferences and statistical significance not statedIntervention (n = 56): M 28

Control (n = 52): M 32

Rabow 2004

US

(high quality)
Medical Outcomes Study 6sleep items

measure of sleep quality and duration in preceding 4 weeks; scores: sleep quality (from 6 to 24); higher scores equal better sleep; sleep duration (0-24 hours); patient report
Forwards

from

enrolment
6 monthsSleep quality

group main effect: favours intervention

F = 4.05

P value = 0.05

group by time interaction: n.s.

F = 0.14

P value = 0.71

Sleep duration

group main effect: n.s.

F = 2.43

P value = 0.13

group by time interaction: n.s.

F = 1.98

P value = 0.17
Adjusted estimatesb

Sleep quality

Intervention (n = 50): M 11.9

Control (n = 40): M 10.0

Sleep duration

Intervention (n = 50): M 6.0

Control (n = 40): M 6.3

12 monthsAdjusted estimatesb

Sleep quality

Intervention (n = 50): M 12.5

Control (n = 40): M 11.0

Sleep duration

Intervention (n = 50): M 5.8

Control (n = 40): M 6.6

 EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life questionnaire; M: mean; n.s.: non-significant; SAUC: standardised area under the curve.

aThe authors calculated mean changes from baseline at one to four months after enrolment by dividing the area under the curve scores by time; differences between groups were tested by bootstrap estimation to fit regression models allowing for clustering and predictive factors.
bMeans adjusted for baseline scores.
 
Table 10. Nausea/vomiting: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Jordhøy 2000

Norway

(high quality)
EORTC QLQ-C30 2-item nausea/vomiting scale

score: from 0 to 100, higher scores equal greater nausea/vomiting; patient report
Forwards

from

enrolment
1 monthn.s.a

SAUC intervention -0.7 vs. SAUC control 2.1

P value = 0.27

 
Intervention (n = 153): M 15

Control (n = 116): M 21

2 monthsIntervention (n = 108): M 17

Control (n = 93): M 20

4 monthsIntervention (n = 71): M 14 

Control (n = 65): M 14

6 monthsDifferences and statistical significance not statedIntervention (n = 56): M 21 

Control (n = 52): M 15

Grande 1999

UK
Cartwright/Addington Hall surveys nausea/vomiting item

4-point item, range not stated; higher scores equal greater nausea/vomiting; caregiver report 6 weeks after death
Backwards

 from death
Last 2

weeks
n.s.

P value ≥ 0.05
Intervention (n = 105): M 1.91 (SD 0.90)

Control (n = 21): M 2.33 (SD 1.06)

 

Although analysis used Mann–Whitney U-tests, authors reported Ms and SDs for clarity

McWhinney 1994

Canada
Melzack nausea questionnaire

score: range and interpretation not stated; patient/caregiver report through diary
Forwards

from enrolment

 
1 monthn.s."There were no clinically or statistically significant differences between the experimental and control groups on any of the measures at one month" (McWhinney 1994); no data provided to support this statement

 

High attrition (53/146) mainly due to death; 2 month data not analysed due to further attrition

 EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life questionnaire; M: mean; n.s.: non-significant; SAUC: standardised area under the curve; SD: standard deviation.

aThe authors calculated mean changes from baseline at one to four months after enrolment by dividing the area under the curve scores by time; differences between groups were tested by bootstrap estimation to fit regression models allowing for clustering and predictive factors.
 
Table 11. Constipation: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Jordhøy 2000

Norway

(high quality)
EORTC QLQ-C30 constipation item

score: from 0 to 100, higher scores equal greater constipation; patient report
Forwards

from

enrolment
1 monthn.s.a

SAUC intervention -6.7 vs. SAUC control -0.5

P value = 0.12

 
Intervention (n = 153): M 33

Control (n = 116): M 37

2 monthsIntervention (n = 108): M 31

Control (n = 93): M 32

4 monthsIntervention (n = 71): M 34 

Control (n = 65): M 30

6 monthsDifferences and significance not statedIntervention (n = 56): M 37 

Control (n = 52): M 31

Grande 1999

UK
Cartwright/Addington Hall surveys constipation item

4-point item, range not stated; higher scores equal greater constipation; caregiver report 6 weeks after death
Backwards

 from death
last 2

weeks
n.s.

P value ≥ 0.05
Intervention (n = 102): M 2.24 (SD 1.10)

Control (n = 21): M 2.62 (SD 0.97)

 

Although analysis used Mann–Whitney U-tests, authors reported Ms and SDs for clarity

 EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life questionnaire; M: mean; n.s.: non-significant; SAUC: standardised area under the curve; SD: standard deviation.

aThe authors calculated mean changes from baseline at one to four months after enrolment by dividing the area under the curve scores by time; differences between groups were tested by bootstrap estimation to fit regression models allowing for clustering and predictive factors.
 
Table 12. Diarrhoea: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Jordhøy 2000

Norway

(high quality)
EORTC QLQ-C30 diarrhoea item

score: from 0 to 100, higher scores equal greater diarrhoea; patient report
Forwards

from

enrolment
1 monthn.s.a

SAUC intervention -0.4 vs. SAUC control -2.0

P value = 0.68

 
Intervention (n = 153): M 25

Control (n = 116): M 23

2 monthsIntervention (n = 108): M 20

Control (n = 93): M 23

4 monthsIntervention (n = 71): M 19 

Control (n = 65): M 21

6 monthsDifferences and statistical significance not statedIntervention (n = 56): M 19 

Control (n = 52): M 22

Grande 1999

UK
Cartwright/Addington Hall surveys diarrhoea item

4-point item, range not stated; higher scores equal greater diarrhoea; caregiver report 6 weeks after death
Backwards

 from death
last 2 weeksn.s.

P value ≥ 0.05
Intervention (n = 98): M 1.51 (SD 0.89)

Control (n = 20): M 1.55 (SD 0.94)

 

Although analysis used Mann–Whitney U-tests, authors reported Ms and SDs for clarity

 EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life questionnaire; M: mean; n.s.: non-significant; SAUC: standardised area under the curve; SD: standard deviation.

aThe authors calculated mean changes from baseline at one to four months after enrolment by dividing the area under the curve scores by time; differences between groups were tested by bootstrap estimation to fit regression models allowing for clustering and predictive factors.
 
Table 13. Fatigue: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Jordhøy 2000

Norway

(high quality)
EORTC QLQ-C30 3-item fatigue scale

score: from 0 to 100, higher scores equal greater fatigue; patient report
Forwards

from

enrolment
1 monthn.s.a

SAUC intervention 4.6 vs. SAUC control 1.2

P value = 0.23

 
Intervention (n = 153): M 60

Control (n = 116): M 57

2 monthsIntervention (n = 108): M 56

Control (n = 93): M 55

4 monthsIntervention (n = 71): M 54 

Control (n = 65): M 53

6 monthsdifferences and statistical significance not statedIntervention (n = 56): M 52 

Control (n = 52): M 53

 EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life questionnaire; M: mean; n.s.: non-significant; SAUC: standardised area under the curve.

aThe authors calculated mean changes from baseline at one to four months after enrolment by dividing the area under the curve scores by time; differences between groups were tested by bootstrap estimation to fit regression models allowing for clustering and predictive factors.
 
Table 14. Appetite loss: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Jordhøy 2000

Norway

(high quality)
EORTC QLQ-C30 appetite loss item

score: from 0 to 100, higher scores equal greater appetite loss; patient report
Forwards

from

enrolment
1 monthn.s.a

SAUC intervention 1.7 vs. SAUC control 3.4

P value = 0.70

 
Intervention (n = 153): M 37

Control (n = 116): M 44

2 monthsIntervention (n = 108): M 34

Control (n = 93): M 36

4 monthsIntervention (n = 71): M 32 

Control (n = 65): M 32

6 monthsDifferences and statistical significance not statedIntervention (n = 56): M 33 

Control (n = 52): M 33

 EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life questionnaire; M: mean; n.s.: non-significant; SAUC: standardised area under the curve.

aThe authors calculated mean changes from baseline at one to four months after enrolment by dividing the area under the curve scores by time; differences between groups were tested by bootstrap estimation to fit regression models allowing for clustering and predictive factors. 
 
Table 15. Advance care planning: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Rabow 2004

US

(high quality)
3items on completion of durable power of attorney for health care, funeral plans and plans for disposition of possessions

score: yes/no; patient report

 
Forwards from enrolment12 monthsDurable power of attorney

n.s.

P value = 0.12

 

Funeral arrangements

favours intervention

P value = 0.03

 

Plans for disposition of possessions

n.s.

P value = 0.11
Subanalysis of patients without advance care planning arrangements at baseline

Completion of durable power of attorney

Intervention: 12/22 (55%)

Control: 5/18 (28%)

Completion of funeral arrangements

Intervention: 8/23 (35%)

Control: 1/19 (5%)

Completion of plans for disposition of possessions

Intervention: 16/20 (80%)

Control: 5/11 (46%)

Aiken 2006

US
4items on completion of living will or advance directives, documents such as medical power of attorney and discussion of legal documents with family and friends and physician responsible for care

score: yes/no; patient report
Forwards from enrolment3 months

 

 

 

 
Living will/advance directive

favours intervention

adjusted proportions

P value < 0.05; h 0.67

OR 4.47 (95% CI 1.10 to 18.18)

 

Items on completion of documents such as medical power of attorney, and discussion of legal documents

n.s.

 

 
n = 111

Completion of living will/advance directive

Intervention: 71%

Control: 65%

Completion of documents such as medical power of attorney

Intervention: 66%

Control: 69%

Discussion of legal documents with physician responsible for care

Intervention: 48%

Control: 59%

Discussion of legal documents with family and friends

Intervention: 78%

Control: 90%

6 monthsAll items

n.s.

P value ≥ 0.05
n = 90

Completion of living will/advance directive

Intervention: 70%

Control: 73%

Completion of documents such as medical power of attorney

Intervention: 68%

Control: 76%

Discussion of legal documents with physician responsible for care

Intervention: 34%

Control: 62%

Discussion of legal documents with family and friends

Intervention: 82%

Control: 94%

 CI: confidence interval; n.s.: non-significant; OR: odds ratio.
 
Table 16. Self management of illness: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Aiken 2006

US

 

 

 
2items on self management of illness, 3  items on knowledge about resources and 1item on experience of event for which patient was unprepared in last 4weeks

scores: ranged from 1 to 4 except for experience (yes/no); higher scores equal better self management and knowledge of resources; patient report
Forwards from enrolment3 monthsReceipt of sufficient information to manage illness at home 

n.s.

 

Receipt of sufficient information to handle illness emergency 

n.s.

 

Receipt of education about community resources

favours intervention

F = 5.80; P value < 0.05; g 0.45

 

Receipt of information about how family and friends can assist

n.s.

 

Receipt of information about who to talk to about a medical problem

n.s.

 

Experience of event for which patient was unprepared for in the last 4 weeks 

favours intervention

logistic regression with group by diagnosis interaction

OR 6.07 (95% CI 1.01 to 36.53)
M adjusted for baseline

 

Receipt of sufficient information to manage illness at home

Intervention: 3.73

Control: 3.55

Receipt of sufficient information to handle illness emergency

Intervention: 3.72

Control: 3.52

Receipt of education about community resources

Intervention: 2.57

Control: 2.02

Receipt of information about how family and friends can assist

Intervention: 2.24

Control: 1.98

Receipt of information about who to talk to about a medical problem

Intervention: 2.72

Control: 2.45

Experience of event for which patient was unprepared for in the last 4weeks

Intervention: 32%

Control: 40% 

COPD patients: intervention patients were much less likely to have had such an experience they felt unprepared for than were controls; OR 0.23 (95% CI 0.05 to 0.97), 32% and 58% in intervention and control, respectively

6 monthsReceipt of sufficient information to manage illness at home

n.s.

  

Receipt of sufficient information to handle illness emergency 

favours intervention

F = 8.19; P value < 0.05; g 0.59

 

Receipt of education about community resources

n.s.

 

Receipt of information about how family and friends can assist 

n.s.

  

Receipt of information about who to talk to about a medical problem 

favours intervention

F = 5.12; P value < 0.05; g 0.50

 

Experience of event for which patient was unprepared for in the last 4 weeks

favours control

logistic regression with group main effect

OR 3.22 (95% CI 1.10 to 9.44)
M adjusted for baseline

 

Receipt of sufficient information to manage illness at home

Intervention: 3.75

Control: 3.70

Receipt of sufficient information to handle illness emergency

Intervention: 3.90

Control: 3.51

Receipt of education about community resources

Intervention: 2.14

Control: 1.74

Receipt of information about how family and friends can assist

Intervention: 1.97

Control: 1.94

Receipt of information about who to talk to about a medical problem

Intervention: 2.63

Control: 2.19

Experience of event for which patient was unprepared for in the last 4weeks

Intervention: 42%

Control: 21%

 CI: confidence interval; COPD: chronic obstructive pulmonary disease; M: mean; n.s.: non-significant; OR: odds ratio.
 
Table 17. Patient unmet needs: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Grande 1999

UK
Cartwright/Addington Hall surveys items on need for more support in 4 areas: night nursing, medical care, personal care and psychological support

3-point items, range not stated; higher scores equal greater unmet needs; caregiver report 6 weeks after death
Backwards

 from death
last 2

weeks
n.s.

P value ≥ 0.05
Night nursing

Intervention (n = 108): M 1.42 (SD 0.73)

Control (n = 18): M 1.39 (SD 0.70)

Medical care

Intervention (n = 108): M 1.15 (SD 0.45)

Control (n = 21): M 1.29 (SD 0.64)

Personal care

Intervention (n = 107): M 1.19 (SD 0.52)

Control (n = 20): M 1.20 (SD 0.52)

Psychological support

Intervention (n = 104): M 1.25 (SD 0.54)

Control (n = 18): M 1.28 (SD 0.67)

 

Although analysis used Mann–Whitney U-tests, authors reported Ms and SDs for clarity

 M: mean; n.s.: non-significant; SD: standard deviation.
 
Table 18. Quality of life: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Rabow 2004

US

(high quality)
Multidimensional Quality of Life Scale – Cancer Version

scores: single item (from 0 to 10) and total scale score from 17 items (from 0 to 100); higher scores equal better quality of life; patient report
Forwards from enrolment6 monthsn.s.a

P values ranged from 0.32 (ANCOVA group by time interaction for total scale score) to 0.72 (ANCOVA group main effect for total scale score)
Adjusted estimatesa

Single item

Intervention (n = 50): M 7.6

Control (n = 40): M 7.0

Total scale score

Intervention (n = 50): M 69.7

Control (n = 40): M 65.4

12 monthsAdjusted estimatesa

Single item

Intervention (n = 50): M 7.5

Control (n = 40): M 7.1

Total scale score

Intervention (n = 50): M 69.3

Control (n = 40): M 67.7

Jordhøy 2000

Norway

(high quality)
EORTC-QLQ-C30 9scales and 6single items

transformed scores: from 0 to 100; higher scores on functioning scales equal better functioning; higher scores on symptom scales equal more symptomatology; patient report
Forwards from enrolment1 monthn.s.b

P values ranged from 0.95 for the dyspnoea item to 0.10 for the social functioning scale and the financial impact item
Mean ratings at each assessment point for each group and SAUCs for the various scores provided in Jordhoy 2001a (Jordhøy 2000)

 

2 months

4 months

6 monthsDifferences and statistical significance not stated

Bakitas 2009

US

(high quality)
Functional Assessment of Chronic Illness Therapy for Palliative Care (FACIT-Pal)

score: from 0 to 184, higher scores equal better quality of life; patient report
Forwards from enrolment1 monthFavours interventionc

M treatment effect (intervention-control) 4.6 (SE 2); P value = 0.02
Intervention (n = 108): LSM 137.25 (95% CI 133.91 to 140.59)

Control (n = 97): LSM 135.34 (95% CI 131.83 to 138.86)

4 monthsIntervention (n = 69):LSM 137.50 (95% CI 133.50 to 141.49)

Control (n = 74): LSM 133.40 (95% CI 129.43 to 137.36)

7 monthsIntervention (n = 59): LSM 141.27 (95% CI 136.98 to 145.55)

Control (n = 54): LSM 131.14 (95% CI 126.63 to 135.66)

10 monthsIntervention (n = 48): LSM 136.33 (95% CI 131.66 to 141.00)

Control (n = 44): LSM 128.78 (95% CI 123.85 to 133.70)

13 monthsIntervention (n = 27):LSM 138.12 (95% CI 132.20 to 144.03)

Control (n = 31): LSM 133.44 (95% CI 127.68 to 139.20)

Backwards from deathThird last assessmentFavours interventionc

M treatment effect (intervention-control) 8.6 (SE 3.6); P value = 0.02
Intervention (n = 51): LSM 139.48 (95% CI 133.34 to 145.61)

Control (n = 47): LSM 130.58 (95% CI 124.20 to 136.97)

Second last assessmentIntervention (n = 79):LSM 134.19 (95% CI 128.70 to 139.67)

Control (n = 75): LSM 127.79 (95% CI 122.13 to 133.46)

Last assessmentIntervention (n = 78): LSM 130.13 (95% CI 124.63 to 135.63)

Control (n = 72): LSM 119.74 (95% CI 113.74 to 125.18)

McWhinney 1994

Canada
Functional Living Index – Cancer

score: range and interpretation not stated; patient/caregiver report
Forwards from enrolment1 monthn.s."There were no clinically or statistically significant differences between the experimental and control groups on any of the measures at one month" (McWhinney 1994); no data provided to support this statement

 

High attrition (53/146) mainly due to death; 2 month data not analysed due to further attrition

Aiken 2006

US
SF-36 8subscales

transformed score from 0 to 100; higher scores equal better functioning; patient report
Forwards from enrolment3 monthsPhysical functioning

favours intervention

(slope: z 2.50, P value < 0.05; intercept at 9 months: z 2.16, P value < 0.05, g 0.41)

General health

favours intervention

(slope: z 2.16, P value < 0.05; intercept at 9 months: z 2.51, P value < 0.05, g 0.47)

Vitality

favours intervention

(intercept at 3 months for COPD only: z 2.36, P value < 0.05, g 0.76)

 

Social functioning, role-physical, bodily pain, role-emotional, mental health subscales

n.s.
Growth modelling analysis (separate for COPD and CHF patients)

Slopes of "average" linear trajectory within COPD and CHF groups ("averaged across slopes of individual linear trajectories of individual within the group") provided in Aiken 2006

 

Physical functioning: intervention patients in both diagnoses remained the same over time (CHF) or improved (COPD) over time, while control patients declined over time. At the 9-month point, intervention patients' physical functioning exceeded that of controls

General health: the "average" slope for intervention patients was higher than for controls and the intervention intercept exceeded that of controls at 9 months

Vitality: there was an intercept difference for COPD at 3 months, with intervention patients having higher vitality scores than controls; no difference between conditions was observed for CHF

6 months

9 months

Tramarin 1992

Italy
Quality Well-Being (QWB) Scale

score: from 0 (death) to 1.0 (asymptomatic optimal functioning); higher scores equal better health; patient report 
Forwards from enrolment 

 
Weekly time points (authors plotted data from 6 to 12 months after enrolment)Authors stated there were differences but  statistical significance was not stated

 
"Although QWB scores declined progressively in both groups, an increment in well-being was detectable in the HC group shortly after the beginning of care" (Tramarin 1992); graph showed the increase in the intervention group occurred shortly before month 7 to month 8 (followed by a plateau at around a mean score of 0.54), while controls decreased from same initial level to mean score of around 0.44 at month 8)

Greer 1986

(CBA)
1) HRCA Quality of Life Index modified from Spitzer's Quality of Life Index

Score: from 0 to 10; higher scores equal better quality of life; patient report

2) Uniscale A Unidimensional Q-L

 score: from 0 to 14; higher scores equal better quality of life; patient report
Backwards from death3 weeksAuthors stated there were no differences but statistical significance was not stated

"Other measures, such as the HRCA Quality of Life Index (...) were comparable in the three systems of care"; "the three samples exhibited similar decreases in functional performance as measured by the (...) Uniscale" (Greer 1986)
Adjusted estimatesd

HRCA

Community-based intervention: M 3.90 (SE 0.13)

Hospital-based intervention: M 4.15 (SE 0.16)

Control (conventional care): M 3.64 (SE 0.27)

Uniscale

Community-based intervention: M 3.31 (SE 0.09)

Hospital-based intervention: M 3.51 (SE 0.12)

Control (conventional care): M 3.60 (SE 0.19)

1 weekAdjusted estimatesd

HRCA

Community-based intervention: M 2.99 (SE 0.08)

Hospital-based intervention: M 3.04 (SE 0.10)

Control (conventional care): M 3.24 (SE 0.16)

Uniscale

Community-based intervention: M 2.92 (SE 0.07)

Hospital-based intervention: M 3.10 (SE 0.07)

Control (conventional care): M 3.09 (SE 0.11)

 ANCOVA: analysis of covariance; CHF: congestive health failure; CI: confidence interval; COPD: chronic obstructive pulmonary disease; EORTC-QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life questionnaire; LSM: estimated least mean square; M: mean; n.s.: not significant; SAUC: standardised area under the curve; SE: standard error.

aANCOVAs tested for differences between groups and for group by time interaction, controlling for baseline differences in pain but not for clustering; means adjusted for baseline scores.
bThe authors calculated mean changes from baseline at one to four months after enrolment by dividing the area under the curve scores by time; differences between groups were tested by bootstrap estimation to fit regression models allowing for clustering and predictive factors. 
cResults from repeated measures analysis of covariance (mixed-effects model applied to longitudinal data using random-subject effects to account for correlation between repeated outcome measurements on same individual).
dEstimates adjusted for sample differences; standard errors based on the linear regression equation.
 
Table 19. General health: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Jordhøy 2000

Norway

(high quality)
EORTC-QLQ-C30 global health scale (2 items)

transformed score: from 0 to 100, higher scores equal better global health; patient report
Forwards

from enrolment

 
1 monthn.s.a

SAUC intervention -1.1 vs. SAUC control 1.1

P value = 0.48

 
Intervention (n = 153): M 49

Control (n = 116): M 48

2 monthsIntervention (n = 108): M 51

Control (n = 93): M 49

4 monthsIntervention (n = 71): M 50

Control (n = 65): M 53

6 monthsDifferences and statistical significance not statedIntervention (n = 56): M 55

Control (n = 52): M 52

McCorkle 1989

US
General Health Rating index (22 items)

score: from 22 to 110, lower scores equal better health perceptions; patient report
Forwards

from enrolment

 
6 weeksFavours intervention

F = 4.06

P value = 0.05 b
Adjusted estimates

Intervention: M 61.11

Control1 (home cancer care): M 61.26

Control2 (usual outpatient care): M 59.05

12 weeksAdjusted estimates

Intervention: M 59.53

Control1 (home cancer care): M 60.14

Control2 (usual outpatient care): M 59.66

18 weeksAdjusted estimates

Intervention: M 57.04

Control1 (home cancer care): M 57.84

Control2 (usual outpatient care): M 60.64

Aiken 2006

US
SF-36 general health subscale

transformed score: from 0 to 100, higher scores equal better general health, negative slope equal reduction; patient report
F

from enrolment
9 monthsFavours intervention for both COPD and CHFc 

slope:

z 2.16, P value < 0.05

intercept at 9 months: z 2.52; P value < 0.05; g 0.47

 
Growth modelling analysis (separate for COPD and CHF patients)

Slope declined for controls while health remained stable for intervention patients, and the intervention intercept exceeded that of controls at 9 months

COPD slope: 0.54 intervention vs. -1.67 control

CHF slope: 0.16 intervention vs. -0.17 control

 CHF: congestive heart failure; COPD: chronic obstructive pulmonary disease; EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life questionnaire; M: mean; n.s.: non-significant; SAUC: standardised area under the curve.

aThe authors calculated mean changes from baseline at one to four months after enrolment by dividing the area under the curve scores by time; differences between groups were tested by bootstrap estimation to fit regression models allowing for clustering and predictive factors.
bThe authors used repeated measures analysis and analysis of variance; analysis included 78 patients who completed the three follow-up interviews (i.e. up to 18 weeks after enrolment); adjusted means were used due to baseline differences despite randomisation; graphs showed that patients receiving the intervention and the control1 (i.e. those receiving cancer home care) experienced better health perceptions over time while control2 patients (i.e. those receiving usual outpatient care) experienced a decrease over time.
cThe authors used growth modelling analysis, calculated slopes of "average" linear trajectory within a group, averaged across slopes of individual linear trajectories of individual within the group and compared intercepts at each time point and slopes for COPD and CHF patients separately.
 
Table 20. Survival: home palliative care versus usual care

StudyMeasureAnalysisSignificance and directionDetails

Bakitas 2009

US

(high quality)
Months from enrolment to death or study endKaplan-Meier and log rank test (post-hoc exploratory analysis, patients alive at end of study censored on study last day)n.s.

P value = 0.14
Intervention (n = 161): median 14 months (95% CI 10.6 to 18.4 months)

Control (n = 161): median 8.5 months (95% CI 7.0 to 11.1 months)

Brumley 2007

US

(high quality)
Days in studyt-test, Kaplan-Meier and log rank test (patients alive at end of study censored on study's last day)n.s. with log rank test 2.98; P = 0.08 (favours control with t-test P = 0.03)Intervention: "average" 196 days (± 164)

Controls: "average" 242 days (± 200)

Jordhøy 2000

Norway

(high quality)
'Survival' daysKaplan-Meier and log-rank test adjusted for 3 cancer diagnostic groups (not clear how patients alive at end of study were analysed)n.s.

P value = 0.1

(adjusted for diagnosis)
Intervention: median 99 days (95% CI 79 to 119 days) 

Control: median 127 days (95% CI 88 to 166 days)

McKegney 1981

US

(high quality)
'Length of survival'Not statedNo differences stated but significance not stated"It should be briefly noted that the intensive and non-intensive patients did not differ in terms of length of survival" (McKegney 1981)

Grande 1999

UK
Days from referral to death

 
Mann­Whitney U testsn.s.

z 1.666; P value = 0.096

 

Favours control

vs. those who received intervention service

(113/186 of intervention)

z 3.005; P value = 0.003
Intervention (n = 186): median 11 days (quartiles from 4 to 34 days)

Control (n = 43): median 11 days (quartiles from 3 to 26 days)

 

Subanalysis of intervention patients

Patients who received service (n = 113): median 16 days (quartiles from 5 to 42.5 days)

Patients who did not receive service (n = 73): median 8 days (quartiles from 3 to 18 days)

Zimmer 1985

US
'Survival profiles'log-likelihood ratio Chi2 using Aitken and Clayton method assuming exponential survival and adjusting for terminal/ non-terminal status (unclear how patients alive at end of study were analysed)n.s.

log-likelihood ratio Chi2 1.4; P value > 0.10
No descriptive data provided

Hughes 1992

US
'Survival days'Not statedn.s.

(authors stated "n.s.")
Intervention: M 76.2 days (SD 67.1)

Control: M 83.1 days (SD 68.1)

 

Decedents only

Intervention: M 48.0 days (SD 43.3)

Control: M 54.5 days (SD 47.7)

Ahlner-Elmqvist 2008

Sweden
Days after enrolmentKaplan-Meier and log-rank test (patients alive at end of study were excluded)Favours control

log rank 12.04; P value = 0.0005
Intervention: median 94 days

Control: median 160 days

 

Axelsson 1998

Sweden
Months from

diagnosis to death
Wilcoxon signed rank (comparisons included 3 groups: intervention and control groups and a third historical group)Favours intervention

P value = 0.043
Intervention: median 23 months (M 35 ± 42)

Control: median 6 months (M 16 ± 19) 

Greer 1986

(CBA)
'Survival'Not statedn.s.

 
"We tested the differences in patient survival in the study groups, controlling for disease, performance status, selected symptoms, as well as the amount of time patients were able to be followed, and found no statistically significant differences" (Greer 1986); no data provided to support this statement

 CI: confidence interval; M: mean; n.s.: non-significant; SD: standard deviation.
 
Table 21. Physical function: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Higginson 2009

UK

(high quality)
MS Impact Scale (MSIS) Physical subscale

score: range not stated; higher scores equal greater physical impact; patient report
Forwards from enrolment6 weeks

 

 
n.s.a

ES 0.2

F = 0.15

P value = 0.70
M change from baseline

Intervention (n = 16): M 1.3 (SD 17.0; 95% CI -7.7 to 10.4)

Control (n = 7): M -1.7 (SD 17.5; 95% CI -17.9 to 10.4)

12 weeksn.s.a

ES 0.4

F = 0.37

P value = 0.55
M change from baseline

Intervention (n = 16): M -0.3 (SD 17.5; 95% CI -9.7 to 9.0)

Control (n = 7): M -7.1 (SD 21.3; 95% CI -26.8 to 12.5)

Jordhøy 2000

Norway

(high quality)
EORTC-QLQ-C30 Physical functioning scale (5 items)

transformed score: from 0 to 100; higher scores equal better functioning; patient report
Forwards from enrolment1 month

 
n.s.b

SAUC intervention -8.9 vs. SAUC control -6.4

P value = 0.42
Intervention: M 47

Control: M 49

2 months

 
Intervention: M 51

Control: M 52

4 months

 
Intervention: M 49

Control: M 54

6 monthsDifferences and statistically significance not statedIntervention: M 53

Control: M 56

McKegney 1981

US

(high quality)
Karnofsky Performance Status (KPS)

score: from 0 to 100; higher scores equal better performance status; patient report
Backwards

from death
180 to 150 daysAuthors stated there were no differences but statistical significance was not stated

 
"It should be briefly noted that the intensive and non-intensive patients did not differ in (...) overall health status as defined by the KPS" (McKegney 1981); no data provided to support this statement

150 to 120 days

120 to 90 days

90 to 60 days

60 to 30 days

30 to 0 days

Aiken 2006

US
SF-36 2subscales: physical functioning and role-physical

transformed score: from 0 to 100; lower scores equal lower physical functioning; negative slope equal reduction; patient report
Forwards from enrolment3 monthsPhysical functioning

Favours intervention

slope:

z 2.50; P value < 0.05

Intercept at 9 months:

z 2.16; P value < 0.05; g 0.41

Role-physical

n.s.
Growth modelling analysis (separate for COPD and CHF patients)

Physical functioning

COPD slope: intervention: 1.00 vs. control: -0.95

CHF slope: intervention: 0.18 vs. control: -1.39

Control slope declined while intervention slope rose

Role-physical

COPD slope: intervention: 0.57 vs. control: -0.14

CHF slope: intervention: -0.51 vs. control: 1.60

6 months

9 months

Hughes 1992

US
Barthels Self Care Index

score: range not stated; higher scores equal greater dependency; patient report  
Forwards from enrolment1 month

 
n.s.

Beta -0.58

t -0.11

P value = 0.92
ANCOVA (age, education, race, marital status, retirement due to health, prior private sector hospital use, living arrangement, and baseline care satisfaction scores – none of these factors were predictive of outcomes); descriptive data not provided

6 monthsn.s.

t < 1
Intervention (n = 18): M 72.00

Control (n = 16): M 69.31

Data were analysed using t-tests because the sample did not support regression models

McCorkle 1989

US
Enforced Social Dependency Scale (10 items)

score: from 10 to 54; higher scores equal greater functional dependency on others; patient report
Forwards

from enrolment
6 weeksFavours interventionc

 F = 5.72; P value = 0.02

Graphs showed that social dependency worsens in the control2 group (i.e. those receiving usual outpatient care) 6 weeks earlier than in the 2 treatment groups
Adjusted estimates

Intervention: M 22.33

Control1 (home cancer care): M 21.68

Control2 (usual outpatient care): M 21.74

12 weeksAdjusted estimates

Intervention: M 22.67

Control1 (home cancer care): M 20.97

Control2 (usual outpatient care): M 24.85

18 weeksAdjusted estimates

Intervention: M 24.57

Control1 (home cancer care): M 24.90

Control2 (usual outpatient care): M 25.17

Greer 1986

(CBA)
Karnofsky Performance Status (KPS)

score: from 0 to 100; higher scores equal better performance status; caregiver report
Backwards from death3 weeksAuthors stated there were no differences but statistical significance was not stated

"the three samples exhibited similar decreases in functional performance as measured by the Karnofsky Performance Status" (Greer 1986)
Adjusted estimates

Community-based intervention: M 29.52 (SE 0.64)

Hospital-based intervention: M 31.05 (SE 0.79), Control (conventional care): M 28.84 (SE 1.06)

1 weekAdjusted estimates

Community-based intervention: M 23.72 (SE 0.54)

Hospital-based intervention: M 25.39 (SE 0.57)

Control (conventional care): M 23.83 (SE 0.84)

 ANCOVA: analysis of covariance; CHF: congestive heart failure; CI: confidence interval; COPD: chronic obstructive pulmonary disease; ES: estimated effect size; M: mean; n.s.: not significant; SAUC: standardised area under the curve; SD: standard deviation; SE: standard error.
aResults from F-tests of non-imputed data; authors stated that imputed data gave similar results
bThe authors calculated mean changes from baseline at one to four months after enrolment by dividing the area under the curve scores by time; differences between groups were tested by bootstrap estimation to fit regression models allowing for clustering and predictive factors.
cThe authors used repeated measures analysis and analysis of variance; analysis included 78 patients who completed the three follow-up interviews (i.e. up to 18 weeks after enrolment); adjusted means were used due to baseline differences despite randomisation. 
 
Table 22. Psychological well-being: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Bakitas 2009

US

(high quality)
Center for Epidemiological Studies Depression (CES-D) Scale (20 items)

score: from 0 to 60; higher scores equal greater depressive symptoms (cut-off score of ≥ 16 for depression case); patient report
Forwards from enrolment1 monthFavours interventiona

M treatment effect (intervention-control) -1.8 (SE 0.81)

P value = 0.02
Intervention (n = 102): LSM 10.66 (95% CI 9.26 to 12.06)

Control (n = 98): LSM 11.87 (95% CI 10.43 to 13.30)

4 monthsIntervention (n = 72): LSM 10.67 (95% CI 9.03 to 12.32)

Control (n = 76): LSM 13.55 (95% CI 11.71 to 15.38)

7 monthsIntervention (n = 60): LSM 10.75 (95% CI 8.98 to 12.53)

Control (n = 54): LSM 13.55 (95% CI 11.71 to 15.38)

10 monthsIntervention (n = 47): LSM 12.65 (95% CI 10.67 to 14.62)

Control (n = 44): LSM 11.68 (95% CI 9.38 to 13.98)

13 monthsIntervention (n = 26): LSM 12.89 (95% CI 10.32 to 15.45)

Control (n = 31): LSM 11.68 (95% CI 9.38 to 13.98)

Backwards from deaththird last assessmentFavours interventiona

M treatment effect (intervention-control) -2.7 (SE 1.23)

P value = 0.03
Intervention (n = 49): LSM 10.71 (95% CI 8.43 to 12.98)

Control (n = 49): LSM 12.44 (95% CI 10.13 to 14.74)

second last assessmentIntervention (n = 79): LSM 11.86 (95% CI 9.90 to 13.81)

Control (n = 72): LSM 13.24 (95% CI 11.19 to 15.28)

last assessmentIntervention (n = 78): LSM 12.88 (95% CI 10.92 to 19.52)

Control (n = 73): LSM 17.49 (95% CI 15.46 to 19.52)

Rabow 2004

US

(high quality)
1) Profile of Mood States (POMS) Anxiety Scale (6 items)

score: from 0 to 24; higher scores equal greater anxiety; patient report

 

2) Center for Epidemiological Studies Depression (CES-D) Scale (20 items)

score: from 0 to 60; higher scores equal greater depressive symptoms (cut-off score of ≥ 16 for depression case); patient report
Forwards from enrolment6 monthsAnxiety

ANCOVA group main effect: n.s. F = 0.17

P value = 0.68

ANCOVA group by time interaction: favours intervention

F = 4.09

P value = 0.05

 

Depression

ANCOVA group main effect: n.s.

F = 1.19

P value = 0.28

ANCOVA group by time interaction: n.s.

F = 0.71

P value = 0.40
Adjusted estimates

Anxiety

Intervention (n = 50): M 6.8

Control (n = 40): M 5.5

Depression

Intervention (n = 50): M 16.5

Control (n = 40): M 17.5

12 monthsAdjusted estimates

Anxiety

Intervention (n = 50): M 5.3

Control (n = 40): M 5.9

Depression

Intervention (n = 50): M 12.4

Control (n = 40): M 15.3

Higginson 2009

UK

(high quality)
MS Impact Scale (MSIS) Psychological subscale

score: range not stated; higher scores equal greater psychological impact; patient report
Forwards from enrolment6 weeksn.s.b

ES -0.6

F = 2.11

P value = 0.16
M change from baseline

Intervention (n = 19): M 1.3 (SD 5.9; 95% CI -1.6 to 4.1)

Control (n = 16): M -2.3 (SD 5.1; 95% CI -5.0 to 0.5)

12 weeks

 
n.s.b

ES -0.1

F = 0.01

P value = 0.91
M change from baseline

Intervention (n = 21): M 0.1 (SD 6.5; 95% CI -2.9 to 3.1)

Control (n = 17): M -0.8 (SD 6.1; 95% CI -3.9 to 2.4)

Jordhøy 2000

Norway

(high quality)

 
1) EORCT-QLQ-C30 emotional functioning scale (4 items)

transformed score: from 0 to 100; higher scores equal better functioning; patient report

 

2) Impact of Event Scale (IES, 15 items) 2subscales: intrusion and avoidance

scores: intrusion subscale (from 0 to 35), avoidance subscale (from 0 to 40); higher scores equal more distress; patient report
Forwards from enrolment1 month

 
n.s.c

 

Emotional functioning

SAUC intervention -1.5 vs. SAUC control 1.7

P value = 0.94

 

IES intrusion

SAUC intervention -1.5 vs. SAUC control -2.6

P value = 0.29

 

IES avoidance

SAUC intervention -1.5 vs. SAUC control -2.0

P value = 0.88
Emotional functioning

Intervention: M 73 vs. control: M 73

IES intrusion

Intervention: M 11 vs. control: M 12

IES avoidance

Intervention: M 13 vs. control: M 14

2 months

 
Emotional functioning

Intervention: M 71 vs. control: M 72

IES intrusion

Intervention: M 12 vs. control: M 11

IES avoidance

Intervention: M 14 vs. control: M 14

4 months

 
Emotional functioning

Intervention: M 71 vs. control: M 75

IES intrusion

Intervention: M 9 vs. control: M 9

IES avoidance

Intervention: M 13 vs. control: M 13

6 monthsDifferences and statistical significance not statedEmotional functioning

Intervention: M 71 vs. control: M 76

IES intrusion

Intervention: M 11 vs. control: M 9

IES avoidance

Intervention: M 12 vs. control: M 14

McKegney 1981

US

(high quality)
Cornell Medical Index (CMI) (51 items)

score: range not stated; higher scores equal greater emotional disturbance; patient report
Backwards from death180 to 150 daysAuthors stated there were no differences but statistical significance was not stated

 
"It should be briefly noted that the intensive and non-intensive patients did not differ in terms of length of survival, nor did these two groups differ in several other quality of life outcomes such as (...) optimism" (McKegney 1981); no data provided to support this statement

150 to 120 days

120 to 90 days

90 to 60 days

60 to 30 days

30 to 0 days

Grande 1999

UK
2 items on anxiety and depression from Cartwright/Addington Hall studies

4-point items, range not stated; higher scores equal greater distress; caregiver report 6 weeks after death
Backwards from deathlast 2 weeksn.s.

P value ≥ 0.05

 

 

n.s.

P value ≥ 0.05

 
Anxiety

Intervention (n = 104): M 2.58 (SD 1.07)

Control (n = 21): M 2.62 (SD 1.02)

Depression

Intervention (n = 103): M 2.23 (SD 1.05)

Control (n = 19): M 2.16 (SD 1.07)

 

Although analysis used Mann–Whitney U-tests, authors reported Ms and SDs for clarity

McCorkle 1989

US
1) Profile of Mood States (POMS, 65 items)

score: range not stated; higher scores equal greater distress; patient report

 

2) Inventory of Current Concerns (ICC, 72 items)

score: range not stated; higher scores equal greater concerns; patient report 
Forwards from enrolment6 weeksn.s.

 

 
"The three groups did not differ significantly with respect to (...) ICC, and POMS scores" (McCorkle 1989); no data provided to support this statement

12 weeks

18 weeks

Aiken 2006

US
SF-36 2subscales: mental health and role-emotional

transformed score: from 0 to 100; lower scores equal lower functioning; negative slope equal reduction; patient report
Forwards from enrolment3 monthsn.s.Growth modelling analysis (separate for COPD and CHF patients)

Mental health

COPD slope: intervention: -0.37 vs. control: -0.10

CHF slope: intervention: -0.69 vs. control: -1.77

Role-emotional

COPD slope: intervention: 1.77 vs. control: 3.08

CHF slope: intervention: 0.00 vs. control: -0.24

6 months

9 months

Hughes 1992

US
Philadelphia Geriatric Center Morale Scale (short-version)

score: range not stated; higher scores equal lower morale; patient report

 

 

 
Forwards from enrolment1 monthn.s.

Beta 0.02

t 0.35

P value = 0.73
ANCOVA (age, education, race, marital status, retirement due to health, prior private sector hospital use, living arrangement, and baseline care satisfaction scores; none of these factors were predictive of outcomes); descriptive data not provided

6 monthsn.s.

t < 1
Intervention (n = 17): M 1.54

Control (n = 14): M 1.57

 

Data were analysed using t-tests because the sample did not support regression models

Buckingham 1978

US
1) Symptom checklist-90 (SCL-90) measure psychological problems; scoring not stated; patient report

 

2) Zuckerman and Lubin adjective checklist to measure depression; scoring not stated; patient report
Not statedNot statedAuthors stated there were differences but statistical significance was not stated

 
"Hospice patients (...) exhibited (...) lower levels of anxiety and depression than nonhospice patients" (Buckingham 1978); no data provided to support this statement

Greer 1986

 (CBA)
Emotional quality of life score from modified Spitzer quality of life index

score: from 0 to 14; higher scores equal better emotional quality of life; caregiver report
Backwards from death3 weeksAuthors stated there were no differences but  statistical significance was not stated

"Other measures, such as (...) Emotional Quality of Life (...) were comparable in the three systems of care" (Greer 1986)
Adjusted estimatesd

Community-based intervention: M 6.61 (SE 0.31)

Hospital-based intervention: M 7.02 (SE 0.34)

Control (conventional care): M 6.47 (SE 0.55)

1 weekAdjusted estimatesd

Community-based intervention: M 5.63 (SE 0.24)

Hospital-based intervention: M 6.12 (SE 0.25)

Control (conventional care): M 6.00 (SE 0.43)

 ANCOVA: analysis of covariance; CBA: controlled before and after study; CHF: congestive health failure; CI: confidence interval; COPD: chronic obstructive pulmonary disease; EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life questionnaire; ES: estimated effect size; IES: Impact of Event Scale; LSM: estimated least mean square; M: mean; n.s.: not significant; SAUC: standardised area under the curve; SD: standard deviation; SE: standard error.

aResults from repeated measures analysis of covariance (mixed-effects model applied to longitudinal data using random-subject effects to account for correlation between repeated outcome measurements on same individual).
bResults from F-tests of non-imputed data; authors stated that imputed data gave similar results. 
cThe authors calculated mean changes from baseline at one to four months after enrolment by dividing the area under the curve scores by time; differences between groups were tested by bootstrap estimation to fit regression models allowing for clustering and predictive factors.

dEstimates adjusted for sample differences; standard errors based on the linear regression equation.
 
Table 23. Social well-being: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Jordhøy 2000

Norway

(high quality)

 
EORTC QLQ-C30 social functioning scale (2 items)

score: from 0 to 100, higher scores equal better functioning; patient report
Forwards

from

enrolment
1 monthn.s.a

SAUC intervention -8.8 vs. SAUC control -0.4

P value = 0.10

 
Intervention (n = 153): M 52

Control (n = 116): M 54

2 monthsIntervention (n = 108): M 53

Control (n = 93): M 52

4 monthsIntervention (n = 71): M 61

Control (n = 65): M 58

6 monthsDifferences and statistical significance not statedIntervention (n = 56): M 67

Control (n = 52): M 58

Aiken 2006

US
SF-36 social functioning subscale

transformed score: from 0 to 100; higher scores equal better social functioning; negative slope equal reduction; patient report
Forwards

from enrolment

 
3 monthsn.s.b

 

 

 
Growth modelling analysis (separate for COPD and CHF patients)

COPD slope: intervention: 1.09 vs. control: 3.72

CHF slope: intervention: -0.80 vs. control: -2.15

6 months

9 months

Buckingham 1978

US
Social Adjustment Self Report Questionnaire

score: range and interpretation not stated; patient report
Not statedNot clearAuthors stated differences favouring the intervention but statistical significance was not stated"Hospice patients and primary care persons exhibited higher levels of social adjustment than non-hospice patients and primary care persons" (Buckingham 1978); no data provided to support this statement

Greer 1986

(CBA)
Social quality of life measure modified from Spitzer quality of life index

score: from 1 to 7; higher scores equal better social quality of life; caregiver report
Backwards

 from death
3 weeksDifferences and statistical significance not statedAdjusted estimatesc

Community-based intervention: 5.09 (SE 0.11)

Hospital-based intervention: 5.26 (SE 0.14)

Control: 5.54 (SE 0.20)

1 weekFavours controls

"Although ratings were very high in all three samples, PCP judgment of patients' social quality of life at the measure closest to death was statistically higher among CC patients" (Greer 1986)
Adjusted estimatesc

Community-based intervention: M 5.03 (SE 0.09)

Hospital-based intervention: M 5.09 (SE 0.09)

Control: M 5.62 (SE 0.16)

Item on hours of social visiting from people other than the caregiver

score: from 0 to 4 (categorised); higher scores equal greater number of hours of social visiting; caregiver report
Backwards

from death
3 weeksFavours intervention

"Three weeks prior to death, HC patients received significantly more hours of social visiting than CC patients from persons other than their PCP: the difference between HC and HB patients was not statistically significant" (Greer 1986)
Adjusted estimatesc

Community-based intervention: M 2.56 (SE 0.09) Hospital-based intervention: M 2.40 (SE 0.11)

Control: M 2.16 (SE 0.18)

1 weekDifferences and statistical significance not statedAdjusted estimatesc

Community-based intervention: M 2.61 (SE 0.07) Hospital-based intervention: M 2.55 (SE 0.09)

Control: M 2.41 (SE 0.14)

Item on amount of chatting with household members

score: from 0 to 7 (categorised); higher scores equal more chatting with household members; caregiver report
backwards

 from death
3 weeksDifferences and statistical significance not statedAdjusted estimatesc

Community-based intervention: M 2.87 (SE 0.07) Hospital-based intervention: M 2.87 (SE 0.09)

Control: M 2.86 (SE 0.17)

1 weekAuthors stated difference favouring the community-based vs. hospital-based intervention but statistical significance not stated and no comparison was made with control group

"The level of chatting with household members was similar in all three patient samples except at the measure closest to death, when HB patients were more active than HC patients" (Greer 1986)
Adjusted estimatesc

Community-based intervention: M 2.53 (SE 0.05)

Hospital-based intervention: M 2.71 (SE 0.07)

Control: M 2.57 (SE 0.12)

 CBA: controlled before and after study; CC: control (conventional care); CHF: congestive heart failure; COPD: chronic obstructive pulmonary disease; HB: hospital-based (hospital-based intervention); HC: home care (community-based intervention); M: mean; n.s. non-significant; PCP: primary care person; SAUC: standardised area under the curve; SE: standard error.

aThe authors calculated mean changes from baseline at one to four months after enrolment by dividing the area under the curve scores by time; differences between groups were tested by bootstrap estimation to fit regression models allowing for clustering and predictive factors.
bThe authors used growth modelling analysis, calculated slopes of "average" linear trajectory within a group, averaged across slopes of individual linear trajectories of individual within the group and compared intercepts at each time point and slopes for COPD and CHF patients separately.
cEstimates adjusted for sample differences; standard errors based on the linear regression equation for continuous variables and on logistic regression equation for dichotomous variables.
 
Table 24. Spiritual well-being: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Rabow 2004

US

(high quality)
Spiritual well-being scale (20 items, 2 subscales)

score: overall (from 20 to 120), religious subscale (from 10 to 60); existential subscale (from 10 to 60), higher score equal greater spiritual well-being; patient report
Forwards

from enrolment
6 monthsOverall spirituality

ANCOVA group main effect: favours intervention

between groups

F = 8.21

P value = 0.007

ANCOVA group by time interaction: favours intervention

F = 4.24

P value = 0.05

 

Religious subscale

ANCOVA group main effect: favours intervention

F = 14.01

P value = 0.001

ANCOVA group by time interaction: n.s.

F = 3.12

P value = 0.09

 

Existential subscale

ANCOVA group main effect: n.s.

F = 2.08

P value = 0.16

ANCOVA group by time interaction: n.s.

F = 0.47

P value = 0.49
Adjusted estimates

Overall spirituality

Intervention (n = 50): M 98.0

Control (n = 40): M 91.2

Religious subscale

Intervention (n = 50): M 52.2

Control (n = 40): M 46.4

Existential subscale

Intervention (n = 50): M 44.4

Control (n = 40): M 42.5

12 monthsAdjusted estimates

Overall spirituality

Intervention (n = 50): M 105.5

Control (n = 40): M 92.4

Religious subscale

Intervention (n = 50): M 55.6

Control (n = 40): M 46.4

Existential subscale

Intervention (n = 50): M 48.2

Control (n = 40): M 44.9

Greer 1986

(CBA)
2items of Quality of Death measure (study-specific measure): patient felt at peace/ happy and felt at peace with God

score: yes/no; caregiver report from 90 to 100 days after death
Backwards

from death
3 daysNo tests performed (descriptive data only)Subsample analysis (n = 880)

Felt at peace

84% intervention vs. 79% control

Felt at peace with God

90% intervention vs. 93% control

 ANCOVA: analysis of covariance; CBA: controlled before and after study; M: mean; n.s.: non-significant.
 
Table 25. Nutrition: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

McKegney 1981

US

(high quality)
Nutritional status measure in research database assessed by structured interview 

score: range and interpretation not stated; patient report
Backwards from death180 to 150 daysAuthors stated there were no differences but statistical significance was not stated

 
"It should be briefly noted that the intensive and non-intensive patients did not differ in (...) nutrition" (McKegney 1981); no data provided to support this statement

150 to 120 days

120 to 90 days

90 to 60 days

60 to 30 days

30 to 0 days

 
Table 26. Cognitive status: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Hughes 1992

US
Short Portable Mental Status Questionnaire (10 items)

score: from 0 to 10; scale recoded so that higher score equal better cognitive functioning; patient report
Forwards from enrolment1 monthn.s.

Beta 0.12

t 0.32

P value = 0.75
ANCOVA (age, education, race, marital status, retirement due to health, prior private sector hospital use, living arrangement, and baseline care satisfaction scores; none of these factors were predictive of outcomes); descriptive data not provided

6 monthsn.s.

t < 1
Intervention (n = 17): M 8.33

Control (n = 14): M 8.86

 

Data were analysed using t-tests because the sample did not support regression models

Greer 1986

(CBA)
Item on patient awareness

score: from 1 to 4; higher scores equal greater awareness; caregiver report 

 
Backwards from death3 weeksAuthors stated there were no differences but statistical significance was not stated

"patient awareness was comparable in the three groups" (Greer 1986)
Adjusted estimatesa

Community-based intervention: M 1.88 (SE 0.05)

Hospital-based intervention: M 1.84 (SE 0.06)

Control: M 1.84 (SE 0.08)

1 weekAdjusted estimatesa

Community-based intervention: M 2.28 (SE 0.05)

Hospital-based intervention: M 2.18 (SE 0.05)

Control: M 2.23 (SE 0.09)

 ANCOVA: analysis of covariance; CBA: controlled before and after study; M: mean; n.s.: non-significant; SE: standard error.

aEstimates adjusted for sample differences; standard errors based on the linear regression equation.
 
Table 27. Caregiver pre-bereavement general health, pain and physical dimensions of quality of life: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Jordhøy 2000

Norway

(high quality)

 

and

 

Ahlner-Elmqvist 2008

Sweden
SF-36 5subscales: physical functioning (10items), role limitation due to physical problems (4items), bodily pain (2items), vitality (4items), and general health perception (5items).

transformed scores: from 0 to 100; higher scores equal better health; caregiver report 
Backwards from death44 to 13 monthsPhysical functioning subscale

 

Group main effect: favours intervention

b 5.47

SE 2.55;

P value < 0.05

 

Group by time interaction: marginally significant difference favouring intervention

P value < 0.10 and ≥ 0.05

 

Other 4 subscales

Group main effect and group by time interaction

n.s.

P value ≥ 0.10
Pooled analysis of data from the 2 studies (n = 517); longitudinal analysis of trajectories included pre- and post-bereavement measurements

Findings showed that intervention group scored 5 points higher than controls at the first time point (b 5.47); all other observed differences were not statistically significant

 

b values and SEs for each time interval (in group by time analysis) and graphs with descriptive data on trajectories in scores over time provided in Ringdal 2004 (Jordhøy 2000 and Ahlner-Elmqvist 2008)

12 to 6 months

5 to 0 months

Forwards from death1 to 2 months

3 to 5 months

6 to 12 months

13 to 17 months

 b: metric regression coefficient; n.s.: non-significant; SE: standard error.
 
Table 28. Caregiver pre-bereavement psychological well-being: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Jordhøy 2000

Norway

(high quality)

 

and

 

Ahlner-Elmqvist 2008

Sweden
SF-36 2subscales: role limitation due to emotional problems (3items) and mental health (5items)

transformed scores: from 0 to 100; higher scores equal better health; caregiver report 
Backwards from death44 to 13 monthsIncreased difference over time in scores for the 2 subscales favours intervention

 

Role limitation due to emotional problems

group effect: n.s.

b -6.67

SE 5.36

P value ≥ 0.10

 

Group by time interaction: favours intervention

P value < 0.05

 

Mental health

Group effect: n.s.

b -5.09

SE 3.02

P value ≥ 0.10

 

Group by time interaction: favours intervention

P value < 0.05
Pooled analysis of data from the 2 studies (n = 517); longitudinal analysis of trajectories included pre- and post-bereavement measurements

 

Findings showed a strong decline in scores before the death of the patient, and rising scores thereafter, especially for the intervention group

 

b values and SEs for each time interval (in group by time analysis) and graphs with descriptive data on trajectories in scores over time provided in Ringdal 2004 (Jordhøy 2000 and Ahlner-Elmqvist 2008)

 

 

12 to 6 months

5 to 0 months

Forwards from death1 to 2 months

3 to 5 months

6 to 12 months

13 to 17 months

McWhinney 1994

US
Center for Epidemiological

Studies Depression (CES-D) scale

score: range and interpretation not stated; caregiver report
Forwards from enrolment1 monthn.s."There were no clinically or statistically significant differences between the experimental and control groups on any of the measures at one month" (McWhinney 1994); no data provided

 

High attrition (53/146) mainly due to death; 2 month data not analysed due to further attrition

Hughes 1992

US
Philadelphia Geriatric Center Morale Scale (short-version)

score: range not stated; higher scores equal lower morale; caregiver report
Forwards from enrolment1 monthn.s.

Beta -0.02

t 0.57

P value = 0.57
ANCOVA (adjusted for age, race, education, relationship to patient and morale baseline score)

Intervention (n = 32): M 1.75 (SD 21)

Control (n = 27): M 1.58 (SD 0.32)

6 monthsFavours control

Beta -0.12

t -2.30

P value = 0.03
ANCOVA (adjusted for age, race, education, relationship to patient and morale baseline score); controlling for survival days did not alter findings

Intervention (n = 32): M 1.67 (SD 25)

Control (n = 27): M 1.62 (SD 0.34)

Buckingham 1978

US
1) Symptom checklist-90 (SCL-90)

measure of psychological problems; score range and interpretation not stated; caregiver report 

2) Zuckerman and Lubin adjective checklist for the measurement of depression

scores: range and interpretation not stated; caregiver report
Not statedNot statedAuthors stated differences favouring intervention but statistical significance not stated"Hospice patients and their primary care persons exhibited (…) lower levels of anxiety and depression than non-hospice patients and their primary care persons" (Buckingham 1978); no data provided to support this statement

Greer 1986

(CBA)
1) Profile of Mood States (POMS)

score: from 0 to 5; lower scores equal greater psychological distress; caregiver report

 

2) use of medication for anxiety or depression (yes/no; caregiver report)

 

3) report of increased drinking (yes/no; caregiver report)
Not statedNot statedPOMS

n.s.

 

Use of medication for anxiety or depression

n.s.

 

Increased drinking

n.s.

"There were no significant differences among the three PCP groups on a modified mood state scale measuring anxiety and depression. Similarly, no significant differences among the groups were observed in use of medications for anxiety or depression, and there was no reported increased use of alcohol" (Greer 1986)
Adjusted estimatesa

POMS

Community-based intervention: M 2.96 (SE 0.06)

Hospital-based intervention: M 2.98 (SE 0.08)

Control (conventional care): M 3.01 (SE 0.13)

Use of medication for anxiety or depression

Community-based intervention: 11% (SE 0.02)

Hospital-based intervention: 10% (SE 0.02)

Control (conventional care): 14% (SE 0.04)

Increased drinking

Community-based intervention: 4% (SE 0.01)

Hospital-based intervention: 5% (SE 0.01)

Control (conventional care): 6% (SE 0.02)

 ANCOVA: analysis of covariance; b: metric regression coefficient; CBA: controlled before and after study; M: mean; n.s.: non-significant; PCP: primary care person; SD: standard deviation; SE: standard error.

aEstimates adjusted for sample differences; standard errors based on the linear regression equation for continuous variables and on logistic regression equation for dichotomous variables.
 
Table 29. Caregiver pre-bereavement social well-being: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Jordhøy 2000

Norway

(high quality)

 

and

 

Ahlner-Elmqvist 2008

Sweden
SF-36 social functioning subscale (2 items)

transformed scores: from 0 to 100; higher scores equal better health; caregiver report 
Backwards from death44 to 13 monthsGroup main effect: n.s.

b -4.43

SE 3.85

P value ≥ 0.10

 

Group by time interaction: n.s.

P value ≥ 0.10
Pooled analysis of data from the 2 studies (n = 517); longitudinal analysis of trajectories included pre and post bereavement measurements

 

b values and SEs for each time interval (in group by time analysis) and graphs with descriptive data on trajectories in scores over time provided in Ringdal 2004 (Jordhøy 2000; Ahlner-Elmqvist 2008)

12 to 6 months

5 to 0 months

Forwards from death1 to 2 months

3 to 5 months

6 to 12 months

Buckingham 1978

US
Social Adjustment Self Report Questionnaire

score: range and interpretation not stated; caregiver report
Not statedNot statedAuthors stated differences favouring intervention but statistical significance was not stated"Hospice patients and primary care persons exhibited higher levels of social adjustment than non-hospice patients and primary care persons" (Buckingham 1978); no data provided to support this statement

 b: metric regression coefficient; n.s.: non-significant; SE: standard error.
 
Table 30. Caregiver burden: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Higginson 2009

UK

(high quality)
Zarit Burden Inventory (12 items)

score: from 0 to 48, higher scores equal greater burden); caregiver report
Forwards from enrolment6 weeksn.s.M change from baseline

Intervention (n = 24): 1.10 (95% CI -3.43 to 5.63)

Control (n = 20): -1.13 (95% CI -3.41 to 1.14)

12 weeksFavours intervention

F = 7.96

P value = 0.011
M change from baseline

Intervention (n = 25): -2.88 (95% CI -5.99 to 0.24)

Control (n = 23): 1.58 (95% CI -0.51 to 3.67)

Bakitas 2009

US

(high quality)
Montgomery Borgatta Caregiver Burden Scale (14 items, 3 subscales: objective burden, stress burden and demand burden)

scores: range not stated; caregiver report
Forwards from enrolment1 monthn.s.a

P value > 0.05
"There were no significant main effects or interactions for Time, Condition, or Patient Gender for any of the measures of caregiver burden (all P values > 0.05)" (O'Hara 2010, Bakitas 2009); no data provided to support this statement

4 months

7 months

10 months

Greer 1986 (CBA)Study-specific perceived caregiving burden measure

score: from 0 to 6; higher scores equal greater burden; caregiver report
Backwards from deathnot clear:

'last weeks of life'
Caregiver burden significantly higher in community-based interventionb

(not clear if against hospital-based intervention, control or both)
Adjusted estimatesb

Community-based intervention: M 3.32 (SE 0.07)

Hospital-based intervention: M 2.91 (SE 0.09)

Control (conventional care): M 3.13 (SE 0.16)

"Although one might expect the burden reported by HC PCPs to be much higher, given the greater level of instrumental care provided by HC PCPs in the last weeks of life, the differences observed were small, although statistically significant" (Greer 1986)

 CBA: controlled before and after study; CI: confidence interval; HC: home care (community-based intervention); M: mean; n.s.: not significant; PCP; primary care person; SE: standard error.

aThe authors used mixed effects modelling for repeated measures and adopted a factorial design of time, condition (intervention vs. control), and patient gender (male, female) with an unstructured covariance matrix. The contribution of each independent variable was tested as a main effect and in interaction with the other independent variables for each of the three caregiver burden subscales.
bThe authors undertook hypothesis testing on adjusted estimates of outcomes in each of the groups derived through linear regression. Although statistical significance was stated in the text, no details of the test results were given; estimates adjusted for sample differences; standard errors based on the linear regression equation.
 
Table 31. Caregiver mastery: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Higginson 2009

UK

(high quality)
Item on learning new caregiving skills from modified Lawton positivity questionnaire

"Have you learnt new skills while caring for your relative?" (Edmonds 2010, Higginson 2009); score: yes/no; caregiver report
Forwards from enrolment6 weeks

 

 
n.s.

Cochran-Mantel-Haenszel test for trend Chi2 2.56; P value = 0.11
Intervention: 12/16 (75%; 95% CI 48% to 93%)

Control: 12/17 (71%; 95% CI 44% to 90%)

12 weeksIntervention: 15/16 (94%; 95% CI 70% to 100%)

Control: 7/15 (47%; 95% CI 21% to 73%)

 CI: confidence interval; n.s.: non-significant.
 
Table 32. Positive aspects of caregiving: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Higginson 2009

UK

(high quality)
Modified Lawton positivity questionnaire (4 items)

score: range not stated; higher scores equal more positive views; caregiver report
Forwards from enrolment6 weeksn.s.

ES 0.49

F = 0.50

P value = 0.49
M change from baseline

Intervention (n = 9): M -0.3 (SD 1.7; 95% CI -1.7 to 1.0)

Control (n = 15): M -0.1 (SD -0.1; 95% CI -1.1 to 1.0)

12 weeksn.s.

ES -0.3

F = 0.10

P value = 0.75
M change from baseline

Intervention (n = 8): M -0.3 (SD 1.0; 95% CI -1.1 to 0.6)

Control (n = 12): M 0.3 (SD 2.0; 95% CI -1.0 to 1.5)

 CI: confidence interval; ES: effect size; M: mean; n.s.: non-significant; SD: standard deviation.
 
Table 33. Caregiver unmet needs: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Grande 1999

UK
Cartwright/Addington Hall surveys items on need for more support on 4areas: looking after patient, practical running of household, information, psychological support and transport

3-point items, range not stated; higher scores equal greater unmet needs; caregiver report 6 weeks after death
Backwards

 from death
last 2

weeks
n.s.

P value ≥ 0.05
Looking after patient

Intervention (n = 106): M 1.41 (SD 0.69)

Control (n = 21): M 1.52 (SD 0.75)

Practical running of household

Intervention (n = 107): M 1.24 (SD 0.56)

Control (n = 19): M 1.32 (SD 0.67)

Information

Intervention (n = 104): M 1.44 (SD 0.72)

Control (n = 21): M 1.52 (SD 0.81)

Psychological support

Intervention (n = 103): M 1.36 (SD 0.65)

Control (n = 19): M 1.37 (SD 0.76)

Transport

Intervention (n = 90): M 1.19 (SD 0.56)

Control (n = 18): M 1.11 (SD 0.47)

 

Although analysis used Mann–Whitney U-tests, authors reported Ms and SDs for clarity

 M: mean; n.s.: non-significant; SD: standard deviation
 
Table 34. Caregiver grief: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails






Bakitas 2009

US

(high quality)
Measure not stated

score: total score (sum G1-G15 items; from 0 to 60; higher scores equal greater grief); binary score for complicated grief (present if at least 3 items from G1 to G4 and G5 to G15 whose values were no less than 4 (often or always) separately); caregiver report
Forwards from deathApproximately 4 to 6 monthsGrief total score

n.s.

t-test P value = 0.56

Complicated grief

n.s.

P value = 1.0
Grief total score

Intervention (n = 50): M 22.24 (SD 11.22)

Control (n = 36): M 20.72 (SD 12.39)

Complicated grief

Intervention: 8/50 (16%)

Control: 6/36 (17%)






Jordhøy 2000

Norway

(high quality)
13-item scale developed from the 21-item Texas Revised Inventory of Grief (new scale called ‘TRIG100')

transformed scores: from 0 to 100; higher scores equal high grief reactions; caregiver report
Forwards from death1 monthn.s.a

group by time interaction

F = 0.348

P value = 0.790

(power 0.131)
n.s.

t-test -0.05

P value = 0.959
Intervention: M 70.86 (SD 2.76)

Control: M 71.11 (SD 4.41)

3 monthsn.s.

t-test 0.14

P value = 0.888
Intervention: M 71.71 (SD 2.76)

Control: M 71.06 (SD 3.89)

6 monthsn.s.

t-test -0.08

P value = 0.935
Intervention: M 67.23 (SD 3.08)

Control: M 67.64 (SD 3.98)

13 monthsn.s.

t-test 0.44

P value = 0.659
Intervention: M 67.20 (SD 2.95)

Control: M 64.97 (SD 4.28)

Grande 1999

UK
Texas Revised Inventory of Grief (TRIG): Scale 1 - grief at time of death (8 items) and Scale 2 - grief at time of scale completion (13 items)

scores: range not stated; higher scores equal worse outcome; caregiver report
Forwards from death6 months2 TRIG scales

n.s.
TRIG Scale 1 (at time of death)

Intervention (n = 74): M 19.1 (SD 6.9)

Control (n = 16): M 20.1 (SD 8.7)

TRIG Scale 2 (6 months after death)

Intervention (n = 70): M 46.5 (SD 12.9)

Control (n = 15): M 46.8 (SD 11.8)

 

Comparisons of scores of people who received and did not receive the intervention (27 people in intervention group did not receive the service) showed no differences






Greer 1986

(CBA)
Modified Grief Experience Inventory

score: from 0 to 10; higher scores equal greater grief; caregiver report
Forwards from death90 to 120 daysComparison between intervention and control not stated (authors only referred to significant differences between hospital-based vs. community-based intervention favouring the former)

"HC PCPs reported significantly greater emotional distress, as measured by a modified Grief Experience Inventory, than did HB PCPs" (Greer 1986)
Adjusted estimatesb

Community-based intervention: M 5.06 (SE 0.11)

Hospital-based intervention: M 4.49 (SE 0.13)

Control (conventional care): M 4.82 (SE 0.19)

 HC: home care; M: mean; n.s.: non-significant; PCP: primary care person; SD: standard deviation; SE: standard error.
aLongitudinal analysis of 92 caregivers who turned the four questionnaires (months since death of patient was the within subject factor in MANOVA and group was the between subject factor). MANOVA analysis also showed that grief reactions changed significantly over time (F = 8.145; P value < 0.001; power 0.997) but the pattern of change did not differ significantly between intervention and control groups.
bEstimates adjusted for sample differences; standard errors based on the linear regression equation.
 
Table 35. Caregiver post-bereavement general health, pain, social and physical dimensions of quality of life: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance

and direction
Details

Jordhøy 2000

Norway

(high quality)

 

and

 

Ahlner-Elmqvist 2008

Sweden
SF-36 6subscales: physical functioning (10items), social functioning (2items) role limitation due to physical problems (4items), bodily pain (2items), vitality (4items), and general health perception (5items)

transformed scores: from 0 to 100; higher scores equal better health; caregiver report 
Backwards from death44 to 13 monthsPhysical functioning subscale

group main effect: favours intervention

b 5.47

SE 2.55

P value < 0.05

group by time interaction: marginally significant difference favouring intervention

P value < 0.10 and ≥ 0.05

 

Other 5subscales

group effect and group by time interaction

n.s.

P value ≥ 0.10
Pooled analysis of data from the 2 studies (n = 517); longitudinal analysis of trajectories included pre- and post-bereavement measurements

 

b values and SEs for each time interval (in group by time analysis) and graphs with descriptive data on trajectories in scores over time provided in Ringdal 2004 (Jordhøy 2000; Ahlner-Elmqvist 2008)

12 to 6 months

5 to 0 months

Forwards from death1 to 2 months

3 to 5 months

6 to 12 months

13 to 17 months

Grande 1999

UK
SF-36

physical component summary scores

 

score: range not stated; higher scores equal better outcome; caregiver report
Forwards from death6 monthsn.s.Intervention (n = 73): M 45.5 (SD 13.4)

Control (n = 16): M 43.6 (SD 13.8)

 

Comparisons of scores of people who received and did not receive the intervention (27 people in intervention group did not receive the service) showed no differences

 b: metric regression coefficient; M: mean; n.s.: non-significant; SD: standard deviation; SE: standard error.
 
Table 36. Caregiver post-bereavement psychological well-being: home palliative care versus usual care

StudyMeasureAnalysisTime pointSignificance and directionDetails

Jordhøy 2000

Norway

(high quality)

 

and

 

Ahlner-Elmqvist 2008

Sweden
SF-36 2subscales: role limitation due to emotional problems (3items) and mental health (5items)

transformed scores: from 0 to 100; higher scores equal better health; caregiver report 
Backwards from death44 to 13 monthsIncreased difference over time in scores for the 2 subscales favours intervention

 

Role limitation due to emotional problems

group main effect: n.s.

b -6.67

SE 5.36

P value ≥ 0.10

group by time interaction: favours intervention

P value < 0.05

 

Mental health

group main effect: n.s.

b -5.09

SE 3.02

P value ≥ 0.10

group by time interaction: favours intervention

P value < 0.05
Pooled analysis of data from the 2 studies (n = 517); longitudinal analysis of trajectories included pre- and post-bereavement measurements

 

Findings showed rising scores after the patient died, especially for the intervention group

 

b values and SEs for each time interval (in group by time analysis) and graphs with descriptive data on trajectories in scores over time provided in Ringdal 2004 (Jordhøy 2000 and Ahlner-Elmqvist 2008)

12 to 6 months

5 to 0 months

Forwards from death1 to 2 months

3 to 5 months

6 to 12 months

13 to 17 months

Grande 1999

UK
SF-36 mental component summary scores

score: range not stated; higher scores equal better outcome; caregiver report
Forwards from death6 monthsn.s.Intervention (n = 73): M 48.8 (SD 11.0)

Control (n = 16): M 49.2 (SD 12.5)

 

Comparisons of scores of people who received and did not receive the intervention (27 people in intervention group did not receive the service) showed no differences

McCorkle 1989

US
Brief Symptom Inventory global severity index and 10subscales: somatisation, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism

scores: items rated from 0 to 4; range of global severity index and subscales not stated; higher scores equal greater distress; caregiver report
Forwards from death6 weeks

 
Global severity index

main group effect: n.s.

F = 2.56

P value = 0.089

group by time interaction: n.s.

F = 1.51

P value = 0.198

 

Subscales

(results with P value < 0.05 below, all described in McCorkle 1998, McCorkle 1989)

 

Depression

main group effect: favours intervention

F = 4.67

P value = 0.015

 

Paranoid ideation

main group effect: favours intervention

F = 3.66

P value = 0.034

group by time interaction: favours intervention

F = 3.83

P value = 0.003
Post-hoc t-tests (results with P value < 0.05)

Depression (intervention vs. control2): t 2.22; P value = 0.022

Psychoticism (intervention vs. control2): t 2.70; P value = 0.012

6 months

 
Post-hoc t-tests (results with P value < 0.05)

Hostility (intervention vs. control2): t 2.54; P value = 0.017

Paranoid ideation (intervention vs. control2): t 2.63; P value = 0.014

Psychoticism (intervention vs. control2): t 2.36; P value = 0.026

13 months

 
Post-hoc t-tests (results with P value < 0.05)

Global severity index (intervention vs. control2): t 2.39; P value = 0.024

Hostility (intervention vs. control2): t 3.18; P value = 0.004

Paranoid ideation (intervention vs. control2): t 3.57; P value = 0.001

25 monthsPost-hoc t-tests

all n.s.

 

Descriptive data (Ms and SDs) for global severity index and 10 subscales for each time point provided in McCorkle 1998, McCorkle 1989

Greer 1986

(CBA)
1) Use of medication for anxiety/depression (yes/no; caregiver report)

 

2) Increased drinking (yes/no; caregiver report)
Forwards from death90 to 120 daysAuthors stated no differences but statistical significance not stated

 

 "no difference in (…) use of medications for depression, or increased alcohol use during the bereavement period" (Greer 1986)
Adjusted estimatesa

Use of medication for anxiety or depression

Community-based intervention: 16% (SE 0.02)

Hospital-based intervention: 12% (SE 0.02)

Control (conventional care): 15% (SE 0.03)

Increased drinking

Community-based intervention: 4% (SE 0.01)

Hospital-based intervention: 5% (SE 0.01)

Control (conventional care): 6% (SE 0.02)

 b: metric regression coefficient; control2: usual outpatient care; n.s.: non-significant; SD: standard deviation; SE: standard error.

aEstimates adjusted for sample differences; standard errors based on the linear regression equation.
 
Table 37. Satisfaction with care: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Jordhøy 2000

Norway

(high quality)
FAMCARE (20 5-point items)

transformed score from 0 to 100; higher scores equal greater satisfaction; caregiver report

 

Note: item scores are presented in inverse scale, i.e. lower scores equal greater satisfaction
Backwards from death1 month after deathFavours intervention

F = 7.11

P value = 0.008

Eta2 0.040

b 7.68 (SE 3.15)

t 2.44

P value = 0.016

(adjusted for relationship to deceased, sex and age of caregiver, cancer, sex of patient, time since inclusion in the study, place of death)
Intervention (n = 112): M 71.68 (SD 20.03)

Control (n = 68): M 63.08 (SD 22.43)

 

Difference (intervention minus control) of 8.60 points reduced to 7.7 controlling for others variables

 

Item analyses using t-test showed 10 items with P value < 0.05; 3 items P value ≥ 0.05 and < 0.10; 7 items P value ≥ 0.01 (details in Ringdal 2002, Jordhøy 2000)

Rabow 2004

US

(high quality)
25 items (5-point Likert scale) from the Group Health Association of America Consumer Satisfaction Survey

score: from 20 to 100; higher scores equal greater satisfaction; patient report
Forwards from enrolment6 monthsANCOVA group main effect: n.s.

F = 1.31

P value = 0.26

ANCOVA group by time interaction: n.s.

F = 0.61

P value = 0.44
Adjusted estimates

Intervention (n = 50): M 69.6

Control (n = 40): M 74.5

12 monthsAdjusted estimates

Intervention (n = 50): M 70.1

Control (n = 40): M 72.4

Bakitas 2009

US

(high quality)
Revised version of Teno's After Death Bereaved Family Member Interview

overall rating item: range not stated; higher scores equal greater satisfaction; caregiver report
Backwards from deathApproximately 4-6 months after deathOverall rating

n.s.

P value = 0.91
Overall rating

Intervention (n = 50): M 41.08 (SD 12.26)

Control (n = 36): M 40.78 (SD 11.61)

Note: authors also measured a number of different dimensions of care satisfaction but found no statistically significant differences and only 1 marginally significant difference (P value = 0.06) in how the services responded to caregiver distress (rated better in the intervention group; M 4.5 score, SD 3.16 vs. M 3.28, SD 2.72 in the control group). Other dimensions of care examined included provision of family support, patient spiritual support, co-ordination of care, shared decision-making, information about symptoms and response to unmet needs and preferences, respect and individual-focused care and quality of pre-palliative cancer care

Brumley 2007

US

(high quality)

 
Reid-Gundlach Satisfaction

with Services instrument (12 items)

score: unknown to 48; higher scores equal greater satisfaction;  dichotomised for analysis ≥ 37 very satisfied)a; patient report (or caregiver if the patient was unable to take part in telephone interview)

 
Forwards from enrolment30 daysFavours intervention

logistic regression

OR 3.37 (95% CI 1.42 to 8.10); P value = 0.006
n = 216

Intervention: 93.1% very satisfied

Control: 80.0% very satisfied

60 daysn.s.

logistic regression

OR 1.79 (95% CI 0.65 to 4.96); P value = 0.26
n = 168

Intervention: 92.3% very satisfied

Control: 87.0% very satisfied

90 daysFavours interventionb

log regression

OR 3.37 (95% CI 0.65 to 4.96); P value = 0.03
n = 149

Intervention: 93.4% very satisfied

Control: 80.8% very satisfied

Hughes 1992

US
Adapted US hospice study scale (17 items)

score: from 1 to 3, higher scores equal greater satisfaction; patient report

 

 
Forwards from enrolment1 monthFavours intervention

Beta 0.13

t 2.15

P value = 0.04
ANCOVA (age, education, race, marital status, retirement due to health, prior private sector hospital use, living arrangement, and baseline care satisfaction scores – none of these factors were predictive of outcomes); descriptive data not provided

6 monthsMarginally significant difference favouring intervention

t -1.98

P value = 0.06
Intervention (n = 17): M 2.72

Control (n = 14): M 2.45

Data were analysed using t-tests because the sample did not support regression models

Adapted US hospice study scale (17 items)

score: from 1 to 3, higher scores equal greater satisfaction; caregiver report

 

 
1 monthFavours intervention

Beta 0.18

t 3.46

P value = 0.0007
ANCOVA (caregiver age, race, education, relationship to patient, care satisfaction baseline score); descriptive data not provided

6 monthsn.s.

Beta 0.12

t 1.59

P value = 0.12
ANCOVA (caregiver age, race, education, relationship to patient, care satisfaction baseline score); descriptive data not provided

Greer 1986 (CBA)Modified Medical Interview Satisfaction Scale

score: from 1 to 5; higher scores equal greater satisfaction; patient report
Forwards from enrolment3 weeksn.s.c

"No significant differences were observed in patient-reported levels of satisfaction, which were uniformly high in all settings" (Greer 1986)
Adjusted estimatesc

Community-based intervention: M 4.87 (SE 0.51)

Hospital-based intervention: M 3.76 (SE 0.98)

Control (conventional care): M 4.20 (SE 0.71)

1 weekAdjusted estimatesc

Community-based intervention: M 3.56 (SE 0.44)

Hospital-based intervention: M 4.60 (SE 0.72)

Control (conventional care): M 5.20 (SE 0.75)

1) Modified Medical Interview Satisfaction Scale

score: from 1 to 5; higher scores equal greater satisfaction; caregiver report pre and after death

2) Item on caregiver regret concerning the medical treatment the patient received (yes/no; caregiver report after death only)
Pre death

(time point not stated)
Adjusted estimatesc

Community-based intervention: M 4.39 (SE 0.04), Hospital-based intervention: M 4.54 (SE 0.05)

Control (conventional care): M 4.38 (SE 0.09)

Backwards from death90-120 days after deathModified Medical Interview Satisfaction Scale

favours hospital-based interventionc 

"HB [hospital-based] PCPs [primary care person], both before and after the patient's death, reported higher satisfaction with the patient's care than CC [conventional care] PCPs"; "small but significantly higher level of satisfaction reported by HB family members" (Greer 1986)

Regret concerning patient medical treatment

n.s.

"Few PCPs (...) reported increased (...) regret concerning the medical treatment the patient received (11%), with no statistically significant differences among settings" (Greer 1986)
Adjusted estimatesc

Modified Medical Interview Satisfaction Scale

Community-based intervention: M 4.36 (SE 0.04) Hospital-based intervention: M 4.48 (SE 0.05)

Control (conventional care): M 4.33 (SE 0.08)

Regret concerning patient medical treatment

Descriptive data by group not provided

 ANCOVA: analysis of covariance; b: metric regression coefficient; CI: confidence interval; M: mean; n.s.: non-significant; OR: odds ratio; SD: standard deviation; SE: standard error.

aThere were no differences in the dichotomised variable at baseline but there were statistically significant differences in the continuous variable favouring the intervention over control (M 39.3 (SD 6.2) vs. 40.8 (SD 5.2); P value = 0.03).
bLast point of analysis because reduction in sample size at 120 days (n = 136) resulted in the exclusion of this data in analyses.
cThe authors undertook hypothesis testing on adjusted estimates of outcomes in each of the groups derived through linear regression. Although statistical significance was stated in the text, no details of the test results were given; estimates adjusted for sample differences; standard errors based on the linear regression equation for continuous variables and on logistic regression equation for dichotomous variables.
 
Table 38. Overall palliative care outcomes: home palliative care versus usual care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Higginson 2009

UK

(high quality)
8items from Palliative care Outcome Scale (POS-8)

score: from 0 to 32; higher scores equal greater problems; negative change equal reduction; patient report
Forwards from enrolment6 weeksn.s.

 

 
M change from baseline

Intervention (n = 24): M -0.68 (95% CI -2.22 to 0.86)

Control (n = 20): M -0.55 (95% CI -2.42 to 1.33)

12 weeksn.s.M change from baseline

Intervention (n = 25): M -0.42 (95% CI -2.50 to 1.67) Control (n = 21): M -0.95 (95% CI -2.87 to 0.97)

Greer 1986 (CBA)

 
Quality of Death measure (study-specific measure with 13 items)

score: items scored yes/no were weighted according to importance for patients to generate final score; higher scores equal better quality of death; caregiver report 90-120 days after death
Backwards from death3 days (measured retrospectively, 90-120 days after death)Favours intervention

ANOVA

P value < 0.03

 

ANCOVA

F = 7.80

P value < 0.001

(adjusting for age, family income and extent of disease at diagnosis)

 

Newman-Keuls post-test on the adjusted mean scores

P value < 0.01
Subsample analysis (n = 880)

Community-based intervention: M 80.4

Hospital-based intervention: M 81.5

Control (conventional care): M 72.5

 

"Adjusted mean scores were not significantly difference from the unadjusted scores" (Wallston 1988, Greer 1986)

 

"Differences between the two types of hospice [i.e. the two intervention groups] were not significant"

(Wallston 1988, Greer 1986

 CI: confidence interval; M: mean; n.s.: non-significant.
 
Table 39. Symptom burden: reinforced versus standard home palliative care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

McMillan 2007

US
Revised version of Memorial Symptom Assessment Scale

24 symptoms (each rated from 0 to 4): lack of energy, pain, dry mouth, shortness of breath, lack of appetite, cough, feeling nervous, worrying, drowsy, feeling sad, feeling bloated, numbness or tingling, nausea, dizziness, difficulty sleeping, feeling irritable, difficulty concentrating, itching, sweats, difficulty swallowing, problems with urination, vomiting, diarrhoea, sexual problems; total score: from 0 to 96, greater scores equal greater symptom burden; patient report
Forwards from enrolment16 daysGroup main effecta: n.s.

estimate 0.409 (SE 0.875); P value = 0.641

Group by time interactiona: statistically significant differences between the 3 groups

estimate -0.101 (SE 0.038); P value = 0.009

Graph showed mean scores decreased from around 23 at baseline to 19 at 16 days and 17 at 30 days for the Cope intervention group, while in the standard care group they decreased from around 22 at baseline and at 16 days to around 21 at 30 days (in the supportive visits group they decreased from around 22 at baseline to 19.5 at 16 and 30 days)
Authors computed separate random-effects models comparing the standard home palliative care group with the standard plus supportive visits, and the standard plus the Cope intervention

Standard home palliative care vs. standard plus Cope intervention

group by time interaction: favours Cope intervention

estimate -0.101 (SE 0.039); P value = 0.013

Standard home palliative care vs. standard plus supportive visits

group by time interaction: n.s.

estimate -0.035 (SE 0.073); P value = 0.633

30 days

 n.s.: non-significant; SE: standard error.

aUnstandardised estimates from random-effects model.
 
Table 40. Pain: reinforced versus standard home palliative care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

McMillan 2007

US
Pain numeric rating scale

score: from 0 to 10, higher scores equal greater pain; patient report
Forwards from enrolment16 daysGroup main effecta: n.s.

estimate -0.039 (SE 0.197); P value = 0.836

Group by time interactiona: n.s.

estimate -0.012 (SE 0.011); P value = 0.268
No descriptive data provided

30 days

 n.s.: non-significant; SE: standard error.

aAuthors used a random-effects model. Non-significant group main effects or group by time interaction terms indicated no group differences in pain scores or trajectories of change.
 
Table 41. Breathlessness: reinforced versus standard home palliative care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

McMillan 2007

US
Dyspnoea intensity scale

score: from 0 to 10; higher scores equal worse dyspnoea; patient report
Forwards from enrolment16 daysGroup main effecta: n.s.

estimate 0.148 (SE 0.197); P value = 0.453

Group by time interactiona: n.s.

estimate -0.003 (SE 0.011); P value = 0.771
No descriptive data provided

30 days

 n.s.: non-significant; SE: standard error.

aAuthors used a random-effects model. Non-significant group main effects or group by time interaction terms indicated no group differences in pain scores or trajectories of change.
 
Table 42. Constipation: reinforced versus standard home palliative care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

McMillan 2007

US
Constipation assessment scale

score: from 0 to 16, higher scores equal worse constipation; patient report
Forwards from enrolment16 daysGroup main effecta: n.s.

estimate -0.170 (SE 0.208); P value = 0.416

Group by time interactiona: n.s.

estimate -0.001 (SE 0.012); P value = 0.973
No descriptive data provided

30 days

 n.s.; non-significant; SE: standard error.

aAuthors used a random-effects model. Non-significant group main effects or group by time interaction terms indicated no group differences in pain scores or trajectories of change.
 
Table 43. Quality of life: reinforced versus standard home palliative care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

McMillan 2007

US
Hospice Quality of Life Index (HQLI, 28 items)

score: range 0 to 280; higher scores equal greater quality of life; patient report
Forward from enrolment16 daysGroup main effecta: n.s.

estimate -2.994 (SE 2.562); P value = 0.246

Group by time interactiona: n.s.

estimate 0.132 (SE 0.113); P value = 0.246
No descriptive data provided

30 days

 n.s.: non-significant; SE: standard error.

aUnstandardised estimates from random-effects model.
 
Table 44. Physical function: reinforced versus standard home palliative care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Harding 2004

UK
ECOG Performance Scale

score: from 0 to 4, lower scores equal better performance status; caregiver report
Forwards from enrolment8 weeksn.s.a

b (effect) -0.24

P value = 0.14
Sample at 8 weeks (n = 46)

Intervention: M 2.0 (SD 1.3)

Control: M 2.1 (SD 1.2)

5 monthsn.s.a

b (effect) -0.34

P value = 0.08
Sample at 5 months (n = 26)

Intervention: M 1.7 (SD 1.2)

Control: M 2.3 (SD 1.3)

 n.s.: non-significant; SD: standard deviation.

aResults from multivariate regression on change scores from baseline.
 
Table 45. Survival: reinforced versus standard home palliative care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Walsh 2007

UK
Time from trial entry to deathNot statedNot statedAuthors reported there were no differences but statistical significance was not stated

"There was no difference between trial arms in (...) the patients' life expectancies; median survival time from trial entry was 12 weeks" (Walsh 2007)
Intervention (n = 118): median 13 weeks (interdecile range 2 to 41.1)

Control (n = 113): median 11 weeks (interdecile range 1 to 39.6)

 
Table 46. Caregiver general health: reinforced versus standard home palliative care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Walsh 2007

UK
General Heath Questionnaire (GHQ-28)

score: range not stated; higher scores equal more psychological distress; analysis used cut-off of 5/6; caregiver report
Forwards from enrolment4 weeksParticipants below GHQ-28 threshold (5/6) at any follow-up point with no relapse

n.s.

Intervention: 21/100 (21%) vs. control: 21/91 (23%)

Chi2 0.73

P value = 0.73

Participants below GHQ-28 threshold (5/6) at any follow-up point

n.s.

Intervention: 35/100 (35%) vs. control: 29/91 (32%)

Chi2 0.65

P value = 0.76
Intervention (n = 97): M 10.5 (SD 6.3)

Control (n = 85): M 11.9 (SD 6.4)

9 weeksIntervention (n = 70): M 9.3 (SD 6.5)

Control (n = 64): M 10.7 (SD 7.3)

12 weeksIntervention (n = 69): M 11.3 (SD 7.3)

Control (n = 54): M 11.7 (SD 7.8)

Harding 2004

UK
General Health Questionnaire (GHQ-12)

score: range not stated; higher scores equal higher levels of problems or difficulties; caregiver report
Forwards from enrolment8 weeksn.s.a

b (effect) -0.12

P value = 0.42
Sample at 8 weeks (n = 41):

Intervention: M 12.5 (SD 4.5)

Control: M 14.9 (SD 5.7)

5 monthsn.s.a

b (effect) -0.15

P value = 0.45
Sample at 5 months (n = 26):

Intervention: M 12.3 (SD 4.2)

Control: M 16.6 (SD 7.5)

 M: mean; n.s.: non-significant; SD: standard deviation.

aResults from multivariate regression on change scores from baseline.
 
Table 47. Caregiver psychological well-being: reinforced versus standard home palliative care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Hudson 2005

Australia
Hospital Anxiety and Depression Scale (HADS, 14 items)

score: range not stated, analysis used cut-off of 11 points; lower scores equal possible case of anxiety/depression; caregiver report
Forwards from enrolment5 weeksn.s.

"There were no significant effects or trends found with the variables (...) 'anxiety' between the Time 1 [baseline] and Time 2 [5 weeks] assessments" (Hudson 2005)
n = 75

Intervention (n = 40): M 7.76 (SD 3.56)

Control (n = 35): M 8.06 (SD 3.95)

Forwards from death8 weeks after deathGroup main effect: n.s.

P value > 0.05
n = 45

Intervention (n = 20): M 6.96 (SD 4.02)

Control (n = 25): M 6.76 (SD 3.72)

"The main effect of the within-subjects factor 'time' indicated a trend for differences in overall mean scores between the two time points. Specifically, there was an overall decrease in mean anxiety scores between the pre-intervention and bereavement" (Hudson 2005) (F = 2.77; P value = 0.10)

Harding 2004

UK
State Anxiety Scale (SAI) short-version (6 items)

score: range not stated; higher scores equal higher levels of problems or difficulties; caregiver report
Forwards from enrolment8 weeksn.s.a

b (effect) -0.05

P value = 0.78
Sample at 8 weeks (n = 41):

Intervention: M 43.2 (SD 11.4)

Control: M 44.3 (SD 12.4)

5 monthsn.s.a

b (effect) -2.23

P value = 0.29
Sample at 5 months (n = 26):

Intervention: M 42.2 (SD 12.2)

Control: M 53.4 (SD 16.9)

 M: mean; n.s.: non-significant; SD: standard deviation

aResults from multivariate regression on change scores from baseline.
 
Table 48. Caregiver coping: reinforced versus standard home palliative care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

McMillan 2007

US
Brief COPE Scale (28 items)

measure of problem-focused and emotion-focused coping; 5-point items, subscale score range not stated; caregiver report
Forwards from enrolment16 daysProblem-focused coping

group main effect: n.s.a

estimate 0.05 (SE 0.03); P value = 0.867

group by time interaction: n.s.a

estimate 0.02 (SE 0.01); P value = 0.256

Emotion-focused coping

group main effect: n.s.a

estimate 0.14 (SE 0.36); P value = 0.694

group by time interaction: n.s.a

estimate -0.01 (SE 0.02); P value = 0.813
Descriptive data not provided

30 days

Harding 2004

UK
Coping Responses Inventory (CRI, 48 items)
measure of different types of coping responses to stressful life situations; scores range not stated; higher scores equal more reported use of coping strategies pertinent to that domain; caregiver report
Forwards from enrolment8 weeksn.s.b

CRI problem/approach focused

b (effect) 0.16

P value = 0.34

CRI cognitive problem/approach focused

b (effect) 0.19

P value = 0.28

CRI behavioural problem/approach focused

b (effect) 0.02

P value = 0.93

CRI emotion/avoidance focused

b (effect)=0.14; P=0.47

CRI cognitive emotion/avoidance focused

b (effect) 0.06

P value = 0.74

CRI behavioural emotion/avoidance focused

b (effect) 0.06

P value = 0.75
Sample at 8 weeks (n = 41):

CRI problem/approach focused Intervention: M 26.4 (SD 9.4)

Control: M 26.4 (SD 7.5)

CRI cognitive problem/approach focused Intervention: M 8.9 (SD 5.0)

Control: M 8.3 (SD 5.2)

CRI behavioural problem/approach focused

Intervention: M 17.5 (SD 6.9)

Control: M 18.1 (SD 5.8)

CRI emotion/avoidance focused Intervention: M 37.6 (SD 10.0)

Control: M 34.1 (SD 9.0)

CRI cognitive emotion/avoidance focused Intervention: M 19.5 (SD 5.5)

Control: M 18.5 (SD 6.8)

CRI behavioural emotion/avoidance focused

Intervention: M 18.1 (SD 6.2)

Control: M 15.5 (SD 5.4)

5 monthsn.s.b

CRI problem/approach focused

b (effect) 0.32

P value = 0.75

CRI cognitive problem/approach focused

b (effect) 0.17

P value = 0.42

CRI behavioural problem/approach focused

b (effect) 0.10

P value = 0.62

CRI emotion/avoidance focused

b (effect) 0.02

P value = 0.93

CRI cognitive emotion/avoidance focused

b (effect) 0.08

P value = 0.70

CRI behavioural emotion/avoidance focused

b (effect) -0.06

P value = 0.79
Sample at 5 months (n = 26):

CRI problem/approach focused

Intervention: M 27.0 (SD 7.1)

Control: M 24.1 (SD 10.1)

CRI cognitive problem/approach focused

Intervention: M 8.8 (SD 4.0)

Control: M 8.1 (SD 6.1)

CRI behavioural problem/approach focused

Intervention: M 18.1 (SD 5.8)

Control: M 16.0 (SD 6.9)

CRI emotion/avoidance focused

Intervention: M 40.0 (SD 13.6)

Control: M 32.1 (SD 10.8)

CRI cognitive emotion/avoidance focused

Intervention: M 19.4 (SD 7.8)

Control: M 17.0 (SD 5.8)

CRI behavioural emotion/avoidance focused

Intervention: M 20.6 (SD 7.8)

Control: M 15.1 (SD 5.9)

 M: mean; n.s.: non-significant; SD: standard deviation; SE: standard error.

aAuthors used a random-effects model. Non-significant group main effects or group by time interaction terms indicated no group differences in scores or trajectories of change.
bResults from multivariate regression on change scores from baseline.
 
Table 49. Caregiver mastery: reinforced versus standard home palliative care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

McMillan 2007

US
1) General Caregiver Mastery (6 items)

measure of caregiver feelings of control and confidence in caregiving; score range and interpretation not stated; caregiver report

2) Caregiver Demands Scale (46 items)

measure of burden and mastery specific to caregiving tasks including assistance with meals, intimate care, treatments, and supervision of the patient; caregivers rated both how stressful the task was (burden) and their confidence in their ability to manage their stress related to this task (mastery); score range and interpretation not stated; caregiver report
Forwards from enrolment16 daysGeneral mastery

group main effect:

n.s.a

estimate 0.33 (SE 0.20); P value = 0.089

group by time interaction: n.s.a

estimate 0.01 (SE 0.01); P value = 0.232

Caregiving task mastery

group main effect: n.s.a

estimate 0.03 (SE 0.05); P value = 0.514

group by time interaction: n.s.a

estimate 0.01 (SE 0.01); P value = 0.466
"The caregivers' feelings of mastery were not affected by the intervention. Mastery may be difficult to improve in hospice given the very demanding nature of the caregiving involved" (McMillan 2006, McMillan 2007); no descriptive data provided

30 days

Hudson 2005

Australia
1)Preparedness for Caregiving Scale (8 items)

measure of how ready caregivers perceive they are for their role; score range and interpretation not stated; caregiver report

2) Caregiver Competence Scale (4 items)

measure of the perceived adequacy of an individual's performance as a caregiver; score range and interpretation not stated; caregiver report

3) Zeiss Caregiving Self efficacy Scale

measure with 3 subscales: problem solving, respite and rewarding interaction; score range and interpretation not stated; caregiver report pre bereavement only
Forwards from enrolment5 weeksPreparedness for caregiving

group main effect: n.s.

group by time interaction: n.s.

P value > 0.05

Caregiver competence and caregiving self efficacy

n.s.

"There were no significant effects or trends found with the variables ‘self efficacy', ‘competence' (...) between the Time 1 [baseline] and Time 2 [five weeks] assessments" (Hudson 2005)
n = 75 (35 intervention, 40 control)

Preparedness for caregiving

Intervention: M 2.76 (SD 0.81)

Control: M 2.67 (SD 0.81)

"There was a trend for the main effect of the within-subjects factor 'time' [F = 3.36; P value = 0.071]. This indicated that preparedness increased as caregiving duration increased" (Hudson 2005)

Caregiver competence

Intervention: M 2.37 (SD 0.63)

Control: M 2.40 (SD 0.54)

Caregiving self efficacy

- Problem solving

Intervention: M 6.96 (SD 4.02)

Control: M 6.76 (SD 3.72)

- Respite

Intervention: M 6.79 (SD 2.16)

Control: M 6.23 (SD 2.67)

- Rewarding interaction

Intervention: M 8.29 (SD 1.50)

Control: M 8.22 (SD 2.50)

Forwards from death8 weeks after deathPreparedness for caregiving

n.s.

"There were no significant effects found with ‘preparedness' between the Time 1 [baseline] and Time 3 [8 weeks after death] assessments" (Hudson 2005)

Caregiver competence

group main effect: n.s.

group by time interaction: n.s.

P value > 0.05
n = 45 (25 intervention, 20 control)

Preparedness for caregiving

Intervention: M 2.83 (SD 0.79)

Control: M 2.59 (SD 0.88)

"The main effect of the within-subjects factor ‘time' was significant [F = 4.94; P value = 0.032]. Examination of the mean competence scores indicated an overall increase in reported competence between Time 1 and Time 3, irrespective of group" (Hudson 2005)

Caregiver competence

Intervention: M 2.53 (SD 0.51)

Control: M 2.47 (SD 0.48)

 M: mean; n.s.: non-significant; SD: standard deviation; SE: standard error.

aAuthors used a random-effects model. Non-significant group main effects or group by time interaction terms indicated no group differences in scores or trajectories of change.
 
Table 50. Caregiver grief: reinforced versus standard home palliative care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Walsh 2007

UK
Core Bereavement Items (CBI)

score: range and interpretation not stated; caregiver report
Forwards from death4 months after deathn.s.

 t 0.91

P value = 0.37
Intervention (n = 84): M 46.3 (SD 11.4)

Control (n = 97): M 45.6 (SD 11.6)

 M: mean; n.s.: non-significant; SD: standard deviation.
 
Table 51. Positive aspects of caregiving: reinforced versus standard home palliative care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Hudson 2005

Australia
Rewards of Caregiving Scale

authors used 11 items instead of the original 15, removing 4 items related to caregivers of the aged and 1 item related to caregivers of nursing home residents; score range and interpretation not stated; caregiver report
Forwards from enrolment5 weeksgroup main effect: n.s.

P value > 0.05

group by time interaction: favours intervention

F = 8.44

P value = 0.005
n = 75

Intervention (n = 40): M 3.09 (SD 0.82)

Control (n = 35): M 2.82 (SD 0.99)

"The standard care participants showed an overall decrease in reported rewards of caregiving between the Time 1 [baseline] and Time 2 [5 weeks] assessments, while the reported rewards of caregiving for the intervention group increased slightly" (Hudson 2005)

"The main effect of the within-subjects factor ‘time' indicated a trend for differences in overall mean reward scores over time [F = 2.84; P = 0.096]. Namely, the mean reward score for the entire sample at Time 1 [baseline] was greater than the mean reward scores for the entire sample at Time 2 [5 weeks]" (Hudson 2005)

Forwards from death8 weeks after deathgroup main effect: n.s.

P value > 0.05

group by time interaction: favours intervention

F = 4.68

P value = 0.036
n = 45

Intervention (n = 20): M 3.50 (SD 0.70)

Control (n = 25): M 3.04 (SD 0.82)

"Examination of the means table demonstrated that there was a slight decrease in the average rewards scores of the standard care group between Time 1 [baseline] and Time 3 [8 weeks after death]. In contrast, there was an overall increase in the average reward scores of the intervention group between Time 1 and Time 3" (Hudson 2005)

"The main effect of the within-subjects factor ‘time' indicated a trend for differences in overall mean scores between the two time points [F = 3.22; P = 0.080]. The mean scores for the entire sample at the two assessment times indicated that reported rewards at bereavement were greater than reported rewards at the baseline assessment" (Hudson 2005)

 M: mean; n.s.: non-significant; SD: standard deviation.
 
Table 52. Caregiver distress with patient symptoms: reinforced versus standard home palliative care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

McMillan 2007

US
Symptom Assessment Scale (MSAS)

24 patient symptoms such as pain, lack of energy, diarrhoea, and shortness of breath; adapted by asking caregivers to rate how distressing patient symptoms were to them (caregivers); score range not stated; higher scores equal greater distress with symptom burden; caregiver report
Forwards from enrolment16 daysGroup main effect: n.s.a

estimate -1.27 (SE 0.95); P value = 0.180

Group by time interaction: favours Cope intervention vs. standard home palliative care onlya

estimate -0.14 (SE 0.04); P value = 0.001
Analysis of change over time within each group revealed improvements in the Cope intervention group (estimate -0.28; SE 0.07; P value < 0.001) but not in the control group receiving standard home palliative care only (estimate 0.01; SE 0.01; P value = 0.847). The Cope intervention group improved by 30% while the control group showed a slight increase in scores.

Comparisons of the control group (i.e. standard specialist home hospice care) with a second control group (receiving standard specialist home hospice care + supportive visits) found no significant group by time interaction (estimate 0.13, SE 0.08; P value = 0.118).

Graph of percentage changes provided in McMillan 2006 (McMillan 2007).

30 days

 n.s.: non-significant; SE: standard error.

aUnstandardised estimates from random-effects model.
 
Table 53. Caregiver burden: reinforced versus standard home palliative care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

McMillan 2007

US
Caregiver Demands Scale (CDS)

measure of burden and mastery specific to caregiving tasks including assistance with meals, intimate care, treatments, and supervision of the patient; caregivers rated both how stressful the task was (burden) and their confidence in their ability to manage their stress related to this task (mastery); score range and interpretation not stated; caregiver report
Forwards from enrolment16 daysCaregiving task burden

group main effect: marginally significant difference favouring Cope intervention vs. standard home palliative care onlya

estimate -0.10 (SE 0.05); P value = 0.060

group by time interaction: favours Cope intervention against standard home palliative care onlya

estimate -0.01 (SE 0.01); P value = 0.021
Comparisons of the control group (i.e. standard specialist home hospice care) with a second control group (receiving standard specialist home hospice care and supportive visits) found no significant group by time interaction (estimate 0.01, SE 0.01; P value = 0.542)

There was a main effect of time (P value = 0.014) with increases in burden scores over time

30 days

Walsh 2007

UK
Carer Strain Index

score range not stated; higher scores equal greater strain, caregiver report
Forwards from enrolment4 weeksn.s.

"There was no significant interaction between time and trial arm (...) on carer strain" (Walsh 2007)
Intervention (n = 99): M 27.7 (SD 11.6)

Control (n = 86): M 27.8  (SD 11.5)

9 weeksIntervention (n = 73): M 26.7 (SD 11.4)

Control (n = 63): M 25.1 (SD 10.1)

12 weeksIntervention (n = 69): M 27.2 (SD 11.7)

Control (n = 54): M 27.3 (SD 10.2)

Harding 2004

UK
Zarit Burden Inventory (ZBI, 22 items)

score range 0 to 88; higher scores equal greater burden; subscales for personal strain and role strain; caregiver report
Forwards from enrolment8 weeksn.s.b

Zarit total

b (effect) 0.06

P value = 0.73

Zarit burden item

b (effect) 0.16

P value = 0.31

Zarit personal strain

b (effect) 0.04

P value = 0.83

Zarit role strain

b (effect) 0.05

P value = 0.74
Sample at 8 weeks (n = 41):

Zarit total

Intervention: M 29.2 (SD 14.9)

Control: M 31.0 (SD 16.5)

Zarit burden item

Intervention: M 1.2 (SD 1.2)

Control: M 1.0 (SD 1.3)

Zarit personal strain

Intervention: M 13.4 (SD 7.8)

Control: M 15.0 (SD 8.7)

Zarit role strain

Intervention: M 8.5 (SD 5.6)

Control: M 9.0 (SD 5.2)

5 monthsn.s.b

Zarit total

b (effect) -0.02

P value = 0.94

Zarit burden item

b (effect) 0.33

P value = 0.11

Zarit personal strain

b (effect) 0.12

P value =

Zarit role strain

b (effect) -0.17

P value = 0.38
Sample at 5 months (n = 26):

Zarit total

Intervention: M 27.1 (SD 13.2)

Control: M 36.7 (SD 16.1)

Zarit burden item

Intervention: M 1.1 (SD 1.2)

Control: M 1.8 (SD 1.6)

Zarit personal strain

Intervention: M 14.1 (SD 6.9)

Control: M 17.1 (SD 7.5)

Zarit role strain

Intervention: M 6.7 (SD 4.4)

Control: M 10.7 (SD 4.8)

 M: mean; n.s.: non-significant; SD: standard deviation; SE: standard error.

aAuthors used a random-effects model. Non-significant group main effects or group by time interaction terms indicated no group differences in scores or trajectories of change.
bResults from multivariate regression on change scores from baseline.
 
Table 54. Caregiver quality of life: reinforced versus standard home palliative care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Walsh 2007

UK
Caregiver Quality of Life Index (Cancer)

score: range not stated; higher scores equal lower quality of life; caregiver report
Forwards from enrolment4 weeksn.s.

"Carer quality of life deteriorated over time, but there was no significant interaction between time and trial arm on this outcome" (Walsh 2007)
Intervention (n = 93): M 69.6 (SD 22.4)

Control (n = 82): M 63.9 (SD 19.3)

9 weeksIntervention (n = 71): M 69.3 (SD 22.7)

Control (n = 59): M 65.2 (SD 17.0)

12 weeksIntervention (n = 64): M 65.2 (SD 21.3)

Control (n = 52): M 62.2 (SD 19.8)

McMillan 2007

US
Caregiver Quality of Life Index Cancer (CQOL-C, 35 items)

5-point items, range of total score not stated; higher scores equal greater quality of life; caregiver report
Forwards from enrolment16 daysGroup main effect: n.s.a

estimate -2.03 (SE 1.45); P value = 0.161

Group by time interaction: marginally significant difference favouring Cope intervention vs. standard home palliative care onlya

estimate -0.09 (SE 0.05); P value = 0.054
Analysis of change over time within each group revealed caregiver quality of life improved in the Cope intervention group over time (estimate 0.16, SE 0.07; P value = 0.033) while it remained unchanged for caregivers in standard home palliative care (estimate 0.02, SE 0.06; P value = 0.718)

Comparisons of the control group (i.e. standard specialist home hospice care) with a second control group (receiving standard specialist home hospice care and supportive visits) found no significant group by time interaction (estimate -0.06, SE 0.09; P value = 0.512)

30 days

 M: mean; n.s.: non-significant; SD: standard deviation; SE: standard error.

aAuthors used a random-effects model. Non-significant group main effects or group by time interaction terms indicated no group differences in scores or trajectories of change.
 
Table 55. Satisfaction with care: reinforced versus standard home palliative care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Walsh 2007

UK
Care satisfaction tool not stated

caregivers asked if they considered that the care received was poor (yes/no); caregiver report  
Backwards from death4 months after deathn.s.

Chi2 0.96; P value = 0.81
Intervention: 16/83 considered care poor (18%)

Control: 21/95 considered care poor (22%)

 n.s.: non-significant.
 
Table 56. Overall palliative care outcomes: reinforced versus standard home palliative care

StudyMeasureAnalysisFollow-upSignificance and directionDetails

Harding 2004

UK

 
Palliative care Outcome Scale (POS, 12 items)

total scale score; range not stated; higher scores equal worse outcomes; caregiver report
Forwards from enrolment8 weeks

 

 
n.s.a

b (effect) 0.05

P value = 0.78
n = 41

Intervention: M 15.0 (SD 7.0)

Control: M 17.6 (SD 6.3)  

20 weeks

 
n.s.a

b (effect) 0.08

P value = 0.68
n = 26

Intervention: M 13.7 (SD 8.3)

Control: M 16.8 (SD 6.3)

 M: mean; n.s.: non-significant; SD: standard deviation.

aResults from multivariate regression on change scores from baseline.
 
Table 57. Methods of collecting resource use information and calculating costs

StudyMethods of collecting resource use information and calculating costs

Rabow 2004

US
At study completion, a trained researcher assistant (blinded to group allocation) reviewed the medical center's computerised medical records (these contained information as entered in written medical records by treating physicians) for all patients during the study period. Charges were identified from the computerised billing record. The authors recognised that analysis of cost data would be preferable but they were able only to acquire data on charges. Costs were USD; currency date and year(s) to which resource use referred were not stated (study first published in 2003)

Grande 1999

UK
Information on home nursing and inpatient care in the last year of life was collated from electronic health service databases. Year(s) to which resource use referred were not stated (study first published in 1999)

Bakitas 2009

US
Data on resource use were collected by chart review until death or end of study (2003-2007)

Brumley 2007

US
Resource use data for each participant were collected retrospectively from the non-profit HMO mainframe database, from the time the patient enrolled in the study until the time of death or end of study (2002 to 2004). Costs were calculated using actual costs for contracted medical services (services provided by non-HMO contracted facilities in Colorado) and proxy cost estimates for all services provided within the HMO. The authors explained that because services provided within the HMO were not billed separately, it was necessary to use proxy costs. Hospitalisation and ED cost estimates were calculated using aggregated data from more than 500,000 HMO patient records and included ancillary services such as laboratory and radiology. Costs of physician office visits included nurse and clerk expenses. Home health and palliative care visits were calculated using "average time spent on each visit" multiplied by the cost for each discipline's reimbursement rate. The authors stated that proxy costs generated for hospital days and ED visits were significantly lower than the actual costs received from contracted providers. Costs were in 2002 USD

McCorkle 1989

US
A Medical Record Review Instrument was developed to collect systematic information about resource use from the patient's medical record. Participants were asked at each interview if they had been hospitalised, received medical treatment or visited their physician within the last 6 weeks. This information was used as a guide to identify the institutions in which medical records were to be reviewed. Trained research assistants audited the records from the time of diagnosis through the entire 24 weeks (6 months) of home care treatment (1983-1985)

Higginson 2009

UK
Research assistants (not blinded to group allocation) collected resource use data in the last 3 months from patients in face-to-face interview using an adapted version of the Client Service Receipt Inventory; data were collected at baseline (before randomisation) and at 6 and 12 weeks, at 18 weeks (the latter only for the control group, after receiving the service) and 24 weeks. Costs were assessed using a broad perspective including costs to health, social and voluntary services, and informal caregivers. Service costs were calculated by combining resource use data with nationally applicable unit costs. Informal care costs were estimated by assuming that in the absence of a caregiver, the help would need to be provided by a home care worker; the unit costs of the latter were, therefore, used as a "shadow price". Costs were in 2005 GBP

Aiken 2006

US
MCOs provided resource use data on each participant for the duration of his/her enrolment in the study (1999-2001), as well for the 6 months prior to enrolment (or all the time that the patient had been enrolled in the MCO prior to enrolment in the study). The authors had planned to measure hospital admissions as discrete events to compute length of stay for each admission as well as the cumulative number of inpatient days. However, they found that inadequately reported hospital claims data did not permit calculation of length of stay: "In a notable number of instances, admission date/discharge date pairs could not be unambiguously established from streams of MCO claims data; such pairs are required for each hospitalization episode for computation of the LOS of that hospitalization. Beyond this, an extensive line-by-line review of medical claims data by the PhoenixCare Medical Director and Project Director revealed that hospitalizations could not be sorted into those directly related to the PhoenixCare target diagnoses (CHF, COPD) versus those related to other ancillary conditions, because all hospitalizations were identified by the primary diagnosis regardless of the treatment provided" (Aiken 2006)

Zimmer 1985

US
Utilisation data were derived primarily from a health services utilisation diary. The diary was designed for the study and was a complete record of the patient's use of health services for as long as 6 months following study entry (1979-1982). It was kept on a daily basis by the patient, if able, or otherwise by the caregiver (family member or friend). The diaries were monitored and collected biweekly by study interviewers. The diary recording of hospitalisations was validated, and corrected where necessary, by comparison with billing forms for all hospitalisations during the 6-month period and also cross-checked against a sample of Visiting Nurse Service records and records of the intervention team (the latter for the intervention group only). Resource use data were weighted to estimate costs "using current average charges for services in the community at the main provider agencies" where rates were constant (e.g. visiting nurse service, health department, ED, nursing homes). The actual mean of hospital daily charges (USD300) was obtained from their billing forms and was used as the hospital per diem weight. The authors explained that since third-party reimbursements for physician house calls were well below actual costs, a more realistic physician home visit weighting factor was developed from estimates of total costs of a visit, including overhead and travel time, derived from a previous time-motion study of the intervention team. Costs were in USD (currency date not stated)

Jordhøy 2000

Norway
Limited description of data collection methods. The authors stated that sociodemographic and medical data were collected by research assistants from patients at baseline and that these data were recorded partly by interview and partly by consulting patients' medical recorded. Use of healthcare services by patients in both groups was recorded (study took place from 1995 to 1997)

Hughes 1992

US
Use of healthcare services within and outside the VA was monitored by participants. To improve recall, patients were provided with a healthcare diary and were asked to record services for the 6-month period of their participation in the study. They were contacted monthly by research staff to retrieve information and diaries were also examined by research staff in patients' homes during the 1 month and 6 month interviews. Self reported use of VA health care services was confirmed using VA records, files and computer databases. Self reported use of private sector health services was confirmed through letters or telephone calls to hospitals, doctors, clinic, nursing homes and home care agencies. Confirmation by a provider was obtained in 99% of cases and only confirmed utilisation data were included in the analysis. All VA hospital cost figures were derived from the hospital except VA ED and outpatient clinics (derived from national VA figures). Hospital costs were based on "average accounting costs per day in the hospital" (the authors believed that average cost data were the best available approximation of marginal costs referring to prior literature). Yearly "average per diem costs" for non-government not-for-profit hospitals in the respective state (Illinois) provided by the American Hospital Association were adjusted based on Medicare national data to include physician costs (an additional 33%), resulting in an adjusted private hospital per diem rate of USD 665.49. ED visit base costs for all private hospitals in Illinois was provided by the Illinois Cost Containment Council and the "average base cost" for hospitals located in the area where the patient sample resided was calculated from this list. Home health agency costs were obtained from the Federal Register's Medicare schedule of maximum limits on home health agency costs for metropolitan Chicago. Medicare nursing home reimbursement rate in Illinois (USD 54.41) were provided by a survey from the Illinois Health Care Association. Actual charges confirmed by providers were used to impute the cost of private ambulatory care and home care services. Costs were in 1985 USD as 40% of patients were enrolled during that year (study took place from 1984 to 1987)

McKegney 1981

US
Although group differences in hospital inpatient days and costs are stated, the methods of data collection were not described. year(s) which resource use referred to were not stated (study first published in 1977)

Tramarin 1992

Italy
Limited description of data collection methods. The authors stated this was conducted prospectively using all available clinical documentation; costs were calculated with a specially designed software using a dBIII Plus database with more than 500 items. The authors stated that a top-down approach was used to calculate costs because it was not possible to identify the separate use of the hospital facilities by each patient in the study (in contrast, the costs of the intervention were calculated for individual patients). The costing model was based on the analytical accounting system in use at the study hospital. Inpatient and outpatient clinical costs were estimated in 4 steps: 1) costs were obtained from the 1989 hospital general ledger (hospital overheads, ancillary services, direct inpatient services and non-inpatient services) were mapped into initial cost centres (costs of physically discrete patient or support services, e.g. laboratory, laundry ward, radiography unit costs, according to existing hospital accounting schemes); 2) costs from the overhead cost centres were allocated, on the basis of individual cost centre allocation statistics, to the final cost centres; 3) final cost centres were adjusted on the basis of the specific inpatient factions they contained to exclude any costs for outpatient treatment; 4) inpatient and outpatient costs within the final cost centres were allocated to individual patients on the basis of their relative consumption of each final cost centre service. To obtain cost per person-year, costs calculated during the 6 months following entry in the study (1990) were multiplied by 2. Costs were in 1990 ITL and in order to compare these costs with estimates from studies in other countries, the authors converted them to 1990 USD using health-care-specific purchasing power parities

Ahlner-Elmqvist 2008

Sweden
Limited description of data collection methods. The authors stated that a full-time employed research nurse collected medical baseline data; hospital stays were prospectively recorded for the entire study period (1995-1999)

Buckingham 1978

US
Data were obtained from existing records, self completed questionnaire items, hospice routine data retrieval system (for the intervention group only) and medical records kept by the primary physician (study took place from 1975 to 1977)

Axelsson 1998

Sweden
Intervention and control patients received upon discharge from hospital a folder with diary sheets for the registration of their use of different resources at home. At the same time their GP and district nurse were notified by separate letters that the patient was being included in the study and that they should record any contact with the patient in the folder. The time spent on home visits by different categories of staff for the care of these patients was continuously monitored on separate sheets. This included travelling time both ways and was registered in 15-minute units. In addition, medical records were examined to assess medical care utilisation. This was done prospectively for both groups. When a patient died, the data regarding their nursing requirements at home and in hospital were compiled. Intervention patients died between 1991 and 1993; control patients enrolled from 1992 to 1993

Greer 1986

(CBA)
Resource use data were obtained from caregivers (at each interview they presented a record of all services used by the patient); these data were checked with Medicare and other reimbursement records whenever feasible. Information on treatment prior to study enrolment was obtained from medical records (study took place between 1981 and 1983). Hospice inpatient and home care unit cost coefficients were developed using 1982 cost report data compiled either by the Health Care Financing Administration or evaluation staff accountants. Cost reports separately allocated all pertinent agency costs to a hospice cost centre. All inpatient costs were nationally adjusted based on Medicare hospital reporting data; hospice home care costs were not nationally adjusted since national standards did not exist. Total costs combine 'costs' and 'charges' since only charges were available for physician services, drugs, supplies, and equipment purchased at home. Costs include only direct health care costs. Costs were in 1982 USD

 ED: emergency department; CHF: congestive heart failure; COPD: chronic obstructive pulmonary disease; GBP: British pound; GP: general practitioner; HMO: Health Maintenance Organisation; ITL: Italian lira; MCO: Managed Care Organisations; USD: United States dollar; VA: Veteran Affairs.
 
Table 58. Emergency department use

StudyAnalysisTime horizonSignificance and directionDetails

Bakitas 2009

US

(high quality)
Forwards

from enrolment
During study periodn.s.

Wilcoxon rank sum test P value = 0.53
Intervention: 0.86 visits

Control: 0.63 visits

Note: not clear if the figures are means or medians

Brumley 2007

US

(high quality)
Forwards

from enrolment
During study period

 
Reduced ED use in intervention group

Cramer's V 0.15; P value = 0.01

linear regression adjusted for survival, age and severity of illness showed intervention reduced ED visits by 0.35 (P value = 0.02)
Intervention: 20% had ED visits

Control: 33% had ED visits

Rabow 2004

US

(high quality)
Forwards from enrolmentDuring study periodn.s.

t -0.24

P value = 0.81
Intervention (n = 50): M 1.6 visits (SD 2.2)

Control (n = 40): M 1.7 visits (SD 2.8)

Aiken 2006

US
Forwards

from enrolment
During study periodn.s.

overdispersed Poisson regression model predicted number of ED visits during enrolment from group, diagnosis and their interaction, controlling for total number of days in study and number of pre-enrolment ED visits; authors stated there was no significant intervention effect. Neither was there an effect on ED visits for a subgroup of participants identified as being at high risk for ED utilisation
Intervention: M visits/month 0.11 (SD 0.34)

Control: M visits/month 0.10 (SD 0.31)

 

Note: authors stated the number of ED visits per month remained "essentially unchanged" from 6 months prior to enrolment to period from then until the end of study

Hughes 1992

US
Forwards

from enrolment
6 months following enrolmentVA ED visits

"n.s."

t 1.14

Non-VA ED visits

"n.s"

t < 1
VA ED

Intervention (n = 86): M 0.57 visits (SD 0.8)

control (n = 85): M 0.72 visits (SD 0.9)

non-VA ED

Intervention (n = 86): M 0.10 visits (SD 0.3)

control (n = 85): M 0.08 visits (SD 0.3)

Zimmer 1985

US
Backwards from deathLast 2 weeks before deathNo differences (there were no ED visits in either group)Intervention (n = 21): 0 visits

Control (n = 12): 0 visits

 ED: emergency department; M: mean; n.s.: non-significant; SD: standard deviation; VA: Veteran Affairs.
 
Table 59. Intensive care unit use

StudyAnalysisTime horizonSignificance and directionDetails

Bakitas 2009

US

(high quality)
Forwards from enrolmentDuring study periodn.s.

Wilcoxon rank sum test P value > 0.99
Intervention: 0.06 days

Control: 0.06 days

Note: not clear if the figures are means or medians

Hughes 1992

US
Forwards from enrolment6 months following enrolment"n.s."

t < 1
Intervention (n = 86): M 0.13 days (SD 0.80)

Control (n = 85): M 0.45 days (SD 3.8)

 M:mean; n.s.: non-significant; SD: standard deviation.
 
Table 60. Nursing home admission

StudyAnalysisTime horizonSignificance and directionDetails

Jordhøy 2000

Norway

(high quality)
Forwards from enrolmentDuring study periodDifferences and significance not statedIntervention: 38/235 (16%) were admitted; M 0.2 admissions (SD 0.6)

Control: 46/199 (23%) were admitted; M 0.4 admissions (SD 0.9)

Backwards from deathLast month before deathReduced nursing home admission in intervention

P value < 0.01

However, multivariate regression showed no statistically significant group effect (P value = 0.08) when adjusted for age (OR 1.07; P value < 0.01), having home care at trial entry (OR 2.41; P value < 0.01), living with a spouse (OR 0.39; P value < 0.01) and having gastrointestinal or lung cancer diagnosis (OR 0.46; P value < 0.01)
Intervention: 28/219 (13%) were admitted

Control: 42/176 (24%) were admitted

 M: mean; OR: odds ratio; SD: standard deviation.
 
Table 61. Time patient spent in nursing home

StudyAnalysisTime horizonSignificance and directionDetails

Jordhøy 2000

Norway

(high quality)
Forwards from enrolmentDuring study periodLower proportion of time spent in nursing homes in intervention group

P value < 0.05

 

"The proportion of time spent in nursing homes was higher for the control group for the entire observation period and in the last month before death. Adjusted for baseline imbalances and prognostic factors as described, the differences were significant (p < 0.05). The factors that were predictive of proportion of readmission time in the last month of life were identical to those predictive of nursing-home admission" (Jordhøy 2000)
Proportion of days under observation in nursing homes

Intervention (n = 235): M 3.0% (SD 10.7), median 0% (range 0% to 87%)

Control (n = 199): M 7.4% (SD 18.6), median 0% (range 0% to 94%)

Backwards from deathLast month before deathProportion of days under observation in nursing homes  

Intervention (n = 219): M 7.2% (SD 22.0), median 0% (range 0% to 100%)

Control (n = 176): M 14.6% (SD 30.5), median 0% (range 0% to 100%)

 M: mean; SD: standard deviation.
 
Table 62. Nursing home days

StudyAnalysisTime horizonSignificance and directionDetails

Jordhøy 2000

Norway

(high quality)
Forwards from enrolmentDuring study periodDifferences and statistical significance not statedIntervention (n = 235): M 5.0 days (SD 17.3); total 1176 days

Control (n = 199): M 9.3 days (SD 31.4); total 1855 days

Backwards from deathLast month before deathDifferences and statistical significance not statedIntervention (n = 219): M 2.2 days (SD 6.8); total 490 days

Control (n = 176): M 4.3 days (SD 9.3); total 764 days

Hughes 1992

US
Forwards from enrolment6 months following enrolment"n.s."

t < 1

 

"n.s."

t -1.00
VA nursing home days

Intervention (n = 86): M 0.84 (SD 5.6)

Control (n = 85): M 0.52 (SD 2.4)

Non-VA nursing home days

Intervention (n = 86): M 0.07 (SD 0.07)

Control (n = 85): M 0.00 (SD 0.0)

 M: mean; n.s.: non-significant; SD: standard deviation.
 
Table 63. Hospital admission

StudyAnalysisTime horizonSignificance and directionDetails

Rabow 2004

US

(high quality)
Forwards from enrolmentDuring study periodn.s.

t 1.26; P value = 0.21
Intervention (n = 50): M 1.2 admissions (SD 2.0)

Control (n = 40): M 0.8 admissions (SD 1.0)

Jordhøy 2000

Norway

(high quality)
Forwards from enrolmentDuring study periodDifferences and statistical significance not statedIntervention (n = 235): 93% were admitted; M 2.6 admissions (SD 1.9); total 601 admissions

Control (n = 199): 94% were admitted; M 2.9 admissions (SD 2.7); total 570 admissions

Note: because of structure of hospital files, admissions counted to individual hospital departments

Backwards from deathLast month before deathDifferences and statistical significance not statedIntervention (n = 219): 83% were admitted

Control (n = 176): 87% were admitted

Brumley 2007

US

(high quality)
Forwards from enrolmentDuring study periodReduced hospitalisation in intervention group

Cramer's V 0.23; P value < 0.001
Intervention: 36% were admitted

Control: 59% were admitted

McCorkle 1989

US
Forwards from enrolment6 months following enrolmentn.s.

"The OHC group had fewer hospitalizations than the other two groups. (...) Differences were not significant"  (McCorkle 1989)
Intervention (n = 24): 14 (59%) were admitted; M 2.08 admissions (SD 2.23, range 0 to 9); total 50 admissions

Control1 (cancer home care; n = 27): 18 (67%) were admitted; M 2.82 admissions (SD 2.96, range 0 to 11); total 76 admissions

Control2 (conventional care; n = 26): 20 (74%) were admitted; M 2.62 admissions (SD 1.81, range 0 to 8); total 68 admissions

Note: excluded admissions for diagnosis and death; data limited to record audits completed at the participating institutions, numbers considered conservative

Zimmer 1985

US
Backwards from deathLast 2 weeks before deathDifferences and statistical significance not statedIntervention: 6/21 (29%) were admitted

Control: 7/12 (58%) were admitted

Hughes 1992

US
Forwards from enrolment6 months following enrolmentAuthors stated there was no difference but statistical significance not stated

"Percent of subjects readmitted to the hospital by group did not differ" (Hughes 1992)
Intervention (n = 86): 66% were admitted

Control (n = 85): 74% were admitted

Tramarin 1992

Italy
Forwards from enrolment6 months following enrolmentDifferences and statistical significance not statedIntervention: stage2: 1 admission by patient; stage3: 3 admissions by patient

Control: stage 2: 2.5 admissions by patient; stage 3: 3.5 admissions by patient

Note: not clear if the figures provided are means or medians

Ahlner-Elmqvist 2008

Sweden
Forwards from enrolmentDuring study periodDifferences and statistical significance not statedIntervention: 93/117 (79%) were admitted

Control: 161/163 (99%) were admitted

Buckingham 1978

US
Not statedNot statedAuthors stated there was no difference but statistical significance not stated"Nonhospice patients were channelled in and out of hospitals to a greater extent than were hospice patients" (Buckingham 1978); no data provided to support this statement

Axelsson 1998

Sweden
Backwards from deathLast 6 months before deathn.s.

P value ≥ 0.05
Intervention (n = 41): median 3 admissions (range 0 to 12)

Control (n = 15): median 3 admissions (range 0 to 8)

 M: mean; n.s.: non-significant; OHC: specialised Oncology Home Care (intervention group); SD: standard deviation.
 
Table 64. Length of hospital admissions

StudyAnalysisTime horizonSignificance and directionDetails

Jordhøy 2000

Norway

(high quality)
Forwards from enrolmentDuring study periodStatistical significance not statedLength of admission

Intervention (n = 235): M 10.5 days (SD 7)

Control (n = 199): M 11.5 days (SD 8.9)

Tramarin 1992

Italy

 
Forwards from enrolment6 months followingStatistical significance not stated" Average" duration of stay

Intervention: stage2: 6 days; stage3: 20 days

Control: stage2: 2.19 days; stage3: 37 days

Note: not clear if figures are means or medians

"The overall reductions in duration of stay for the intervention group were 68.5 and 46% at stages 2 and 3, respectively" (Tramarin 1992)

 M: mean; SD; standard deviation.
 
Table 65. Length of last hospital admission before death

StudyAnalysisTime horizonSignificance and directionDetails

Hughes 1992

US
Backwards from deathNALength of last hospital admission

authors stated reduced length of last hospital admission in intervention group but statistical significance was not stated
Length of last hospital admission

"HBHC patients spent 3.5 fewer days in the hospital prior to death than control group patients (mean 9.9 days versus 13.5 days, respectively)" (Hughes 1992)

Axelsson 1998
Sweden
Backwards from deathNALength of terminal hospitalisation

P value ≥ 0.05

"We found no significant differences in health care utilization when we compared the study group with the reference group" (Axelsson 1998)
Length of terminal hospitalisation

Intervention (n = 41): median 3 days (range 0 to 85)

Control (n = 15): median 12 days (range 0 to 47)

 HBHC: hospital-based home care (intervention); NA: not applicable.
 
Table 66. Hospital inpatient days

StudyAnalysisTime horizonSignificance and directionDetails

Rabow 2004

US

(high quality)
Forwards from enrolmentDuring study periodn.s.

t 0.88

P value = 0.38
Intervention (n = 50): M 6.3 days (SD 12.4)

Control (n = 40): M 4.3 (SD 9.0)

Jordhøy 2000

Norway

(high quality)
Forwards from enrolmentDuring study periodDifferences and statistical significance not statedIntervention (n = 235): M 25.3 days (SD 22.4); total 5937 days

Control (n = 199): M 29.1 days (SD 29.3); total 5784 days

Backwards from deathLast month before deathDifferences and statistical significance not statedIntervention (n = 219): M 12.1 days (SD 10.0); total 2650 days

Control (n = 176): M 12.4 days (SD 9.4); total 2183 days

McKegney 1981

US

(high quality)
Not statedNot statedAuthors stated there were fewer hospital days in intervention group but statistical significance was not stated"Patients who were home visited by the nurses spent fewer days in the hospital than those not visited by the nurse" (Yates 1979, McKegney 1981); no data provided to support this statement

Bakitas 2009

US

(high quality)
Forwards from enrolmentDuring study periodn.s.

Wilcoxon rank sum test P value = 0.14
Intervention: M 6.6 days

Control: M 6.5 days

Brumley 2007

US

(high quality)
Forwards from enrolmentDuring study periodFewer hospital days in intervention group

Linear regression adjusted for survival, age and severity of illness showed intervention reduced hospital days by 4.36 (P value < 0.001)
No descriptive data provided

McCorkle 1989

US
Forwards from enrolment6 months following enrolmentn.s.

"Although not statistically significant, the total length of hospital stays was lower among subjects randomized to the specialized OHC program (OHC 258 days) compared with the SHC group (SHC 317 days) and the OC group (OC 272 days)" (McCorkle 1989)
Intervention: M 18.43 days (SD 19.71, range 4 to 80); total 258 days

Control1 (cancer home care): M 17.61 days (SD 17.72, range 3 to 77); total 317 days

Control2 (conventional care): M 13.60 days (SD 10.39, range 1 to 38); total 272 days

Note: excluded days in hospital for diagnosis and death; data limited to record audits completed at the participating institutions, numbers considered conservative

Zimmer 1985

US
Backwards from deathLast 2 weeks before deathAuthors stated reduced hospital days in intervention group but statistical significance was not stated

"Utilization of health care services during the terminal two weeks differed substantially between team and control patients (...). Team patients on the average had about half the number of hospital days" (Zimmer 1984, Zimmer 1985)
Intervention (n = 21): "average" 3.1; total 61 days

Control (n = 12): "average" 6.1; total 59 days

Hughes 1992

US
Forwards from enrolment6 months following enrolmentVA total hospital days

fewer hospital days in intervention group

t 2.27

P value = 0.03

VA hospital rehabilitation days "n.s."; t < 1

VA hospital intermediate bed days "n.s."; t -1.22

VA hospital general bed days: fewer hospital general bed days in intervention group; t 3.26; P value = 0.002

Non-VA private hospital days "n.s."; t < 1
VA total hospital days

Intervention (n = 86): M 9.94 days (SD 13.3)

Control (n = 85): M 15.86 days (SD 20.1)

VA hospital rehabilitation days:

Intervention (n = 86): M 0.00 (SD 0.0)

Control (n = 85): M 0.14 (SD 1.3)

VA hospital intermediate bed days:

Intervention (n = 86): M 4.00 (SD 8.0)

Control (n = 85): M 2.52 (SD 7.9)

VA hospital general bed days:

Intervention (n = 86): M 5.63 (SD 10.0)

Control (n = 85): M 12.06 (SD 15.2)

Non-VA private hospital days

Intervention (n = 86): M 0.69 days (SD 3.4)

Control (n = 85): M 0.43 days (SD 2.2)

Tramarin 1992

Italy
Forwards from enrolment6 months following enrolmentDifferences and statistical significance not statedIntervention: stage2: 6 days; stage3: 121 days

Control: stage2: 288 days; stage3: 467 days

Note: not clear if figures are totals, means or medians

 M: mean; n.s.: non-significant; OC: office care (control2); OHC: specialised oncology home care (intervention); SD: standard deviation; SHC: standard home care (control1); VA: Veteran Affairs.
 
Table 67. Time patient spent in hospital

StudyAnalysisTime horizonSignificance and directionDetails

Jordhøy 2000

Norway

(high quality)
Forwards from enrolmentDuring study periodn.s.

"Overall, the proportion of hospital readmission time did not differ for the entire follow-up or for the last month. Being female was the only factor predictive of time spent in hospital during the last month before death (p = 0.03)" (Jordhøy 2000)
Proportion of days under observation in hospital

Intervention (n = 235): M 32.2% (SD 31.8), median 20.9 (range 0 to 100)

Control (n = 199): M 29.8% (SD 29.3), median 20.8 (range 0 to 100)

"Because of bed shortages in Norwegian hospitals, the limited number of nursing-home beds are used for basic inpatient care whenever possible. By comparison, the inpatient capacity at the Palliative Medicine Unit was large, and we believe that, for the intervention group, hospital care (The Palliative Medicine Unit) was used instead of nursing-home care for some patients, whereas there was a shift from hospital to home care for other patients, resulting in the overall unchanged use of hospital" (Jordhøy 2000)

Backwards from deathLast month before deathProportion of days under observation in hospital

Intervention (n = 219): M 45.5% (SD 35.2), median 41.9 (range 0 to 100)

Control (n = 176): M 45.3% (SD 33.2), median 39.7 (range 0 to 100)

Ahlner-Elmqvist 2008

Sweden
Forwards from enrolmentDuring study periodLower proportion of time in hospital in intervention group

P value < 0.005
Proportion of time spent in hospital

18% for intervention and 31% for control

Backwards from deathLast month before deathProportion of time spent in hospital

lower proportion of time in hospital in intervention group

P value < 0.005

Proportion patients who spent all time in hospital

statistical significance not stated
Proportion of time spent in hospital

31% for intervention and 57% for control

Proportion patients who spent all time in hospital

Intervention: 13 (11%)

Control: 52 (32%)

 M: mean; n.s.: non-significant; SD: standard deviation.
 
Table 68. Institutional days

StudyAnalysisTime horizonSignificance and directionDetails

Higginson 2009

UK

(high quality)
Forwards from enrolment12 weeks following enrolmentAuthors stated increased institutional days in control group but statistical significance was not stated

"The control care patients were more likely to be (...) admitted to or seen in hospital" (Higginson 2009)
Intervention: 4/26 (17%) were institutionalised with M 19.0 days (SD 21.6)

Control: 6/28 (29%) were institutionalised with M 30.7 days (SD 32.1)

Grande 1999

UK
Backwards from deathLast year before deathMann Whitney U test n.s.

"None of the differences were statistically significant" (Grande 2004; Grande 1999)
Subanalysis of sample in bereavement follow-up (n = 96)

Intervention (n = 78): median 24.0 days (IQR 41.0)

Control (n = 18): median 14.5 days (IQR 29.6)

Note: institutional days included hospice, acute hospital, nursing home and continuing care beds

Axelsson 1998

Sweden
Backwards from deathDiagnosis to deathn.s.

P value ≥ 0.05
Intervention (n = 41): median 52.5 days (range 0 to 299)

Control (n = 15): median 53.5 days (range 8 to 107)

Last 6 months before deathn.s.

P value ≥ 0.05
Intervention (n = 41): median 31 days (range 0 to 94)

Control (n = 15): median 25 days (range 0 to 97)

Greer 1986

(CBA)
Forwards from enrolmentDuring study period (standardised to 50 days)Authors stated increased institutional days in control group but statistical significance was not stated

"CC patients spent more time in inpatient settings than either HB or HC patients" (Greer 1986)
Adjusted estimatesa

" Average" number of inpatient days per study day multiplied by "average" number of study days for hospice patients (50 days)

Community-based home hospice care: 8.0 days (SE 1.0)

Hospice-based home hospice care: 18.0 days (SE 1.5)

Conventional care: 23.0 days (SE 2.0)

Note: not clear if the figures are means or medians

 CC: conventional care (control group); HB: hospital-based (hospital-based intervention; HC: home-care based (community-based intervention); IQR: interquartile range; M: mean; SD: standard deviation; SE: standard error.

aStandard errors of estimates were based upon multiple regression analyses adjusted for sample differences. In calculating total per patient utilisation, the authors multiplied the utilisation per study day by the "average" number of study days (50) for hospice patients (intervention group).
 
Table 69. Outpatient clinic visits

StudyAnalysisTime horizonSignificance and directionDetails

Rabow 2004

US

(high quality)
Forwards from enrolmentDuring study periodUrgent care visits

fewer visits in intervention group

t -2.13

P value = 0.04

Specialist visits

n.s.

t -1.16

P value = 0.25
Urgent care visits

Intervention (n = 50): M 0.3 visits (SD 0.5)

Control (n = 40): M 0.6 visits (SD 0.9)

Specialist visits

Intervention (n = 50): M 4.9 visits (SD 8.1)

Control (n = 40): M 7.0 visits (SD 9.1)

Higginson 2009

UK

(high quality)
Forwards from enrolment12 weeks following enrolmentHospital specialist visits

differences and statistical significance not stated
Hospital specialist visits

Intervention: 8 (35%) received; M 1.0 contacts (SD 0.0)

Control: 16 (76%) received; M 1.3 contacts (SD 0.7)

Zimmer 1985

US
Backwards from deathLast 2 weeks before deathOut-of-home clinic visits per patient

differences and statistical significance not stated
Out-of-home clinic visits per patient  

Intervention (n = 21): 0 visits

Control (n = 12): 0.2 visits

Note: not clear if the figures are means or medians

Hughes 1992

US
Forwards from enrolment6 months following enrolmentVA outpatient clinic visits

fewer visits in intervention group

t 2.57

P value = 0.01

Non-VA ambulatory care visits

"n.s."

t 1.30
VA outpatient clinic visits

Intervention (n = 86): M 0.73 (SD 1.9)

Control (n = 85): M 2.59 (SD 6.1)

Non-VA ambulatory care visits

Intervention: M 0.00 (SD 0.0)

Control: M 0.16 (SD 1.2)

Tramarin 1992

Italy
Forwards from enrolment6 months following enrolmentOutpatient visits per patient

authors stated reduced use of outpatient clinics in intervention group for stage 3 patients only, but statistical significance was not stated

"The range of use of the outpatient clinic differed only for SCSAH stage 3 of the HC group, with a reduction in daily admission per patient of 31.9%" (Tramarin 1992)
Outpatient daily admissions by patient

Intervention: stage2: 25 daily admissions by patient; stage3: 7.5 daily admissions by patient

Control: stage2: 24.9 daily admissions by patient; stage3: 11 daily admissions by patient

Note: not clear if the figures are means or medians

Greer 1986 (CBA)Forwards from enrolmentDuring study period

(standardised to 50 days)
Physician and outpatient clinic visits

differences and statistical significance not stated
Adjusted estimatesa

Physician and outpatient clinic visits

Community-based intervention: 9.0 visits (SE 1.5)

Hospice-based intervention: 13.0 visits (SE 1.5)

Control (conventional care): 20.0 visits (SE 0.5)

Note: not clear if the figures are means or medians

 M: mean; n.s.: non-significant; SE: standard error; VA: Veteran Affairs.

aStandard errors of estimates were based upon multiple regression analyses adjusted for sample differences. In calculating total per patient utilisation, the authors multiplied the utilisation per study day by the "average" number of study days (50) for hospice patients (intervention group).
 
Table 70. Community care

StudyAnalysisTime horizonSignificance and directionDetails

Rabow 2004

US

(high quality)
Forwards from enrolmentDuring study periodPrimary care clinic visits

fewer visits in intervention group

t -2.20

P value = 0.03
Primary care clinic visits

Intervention (n = 50): M 7.5 (SD 4.9)

Control (n = 40): M 10.6 (SD 7.5)

Higginson 2009

UK

(high quality)
Forwards from enrolment12 weeks after enrolmentGeneral practice

authors stated less GP contact in intervention group but statistical significance was not stated

 

District/practice nurse

differences and statistical significance not stated

 

MS nurse

authors stated there were no differences but statistical significance was not stated

Social services 

differences and statistical significance not stated

Specialist home visit

differences and statistical significance not stated 
General practice

Intervention: 8 (35%) received; M 3.8 contacts (SD 0.5)

Control: 11 (52%) received; M 3.4 contacts (SD 1.2)

"Control care patients were more likely to be in contact with general practitioners" (Higginson 2009)

District/practice nurse

Intervention: 20 (87%) received; M 12.3 contacts (SD 19.7)

Control: 13 (62%) received; M 31.9 contacts (SD 50.7)

MS nurse

Intervention: 11 (48%) received; M 1.8 contacts (SD 1.8)

Control: 7 (33%) received; M 1.1 contacts (SD 0.2)

"Receipt of MS nurses was similar in the two groups"

Social services

Intervention: 10 (43%) received; M 6.4 contacts (SD 7.7)

Control: 8 (38%) received; M 4.1 contacts (SD 2.4)

Specialist home visit

Intervention: 5 (22%) received; M 5.2 contacts (SD 4.5)

Control: 0 received

Note: authors stated that specialist home visits were most likely to be from the intervention home palliative care team

Grande 1999

UK
Backwards from death

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
Penultimate week before deathGP visits

Daytime during week n.s.; P value ≥ 0.05

Daytime during weekend n.s.; P value ≥ 0.05

Fewer evening visits in intervention group; P value < 0.05

Fewer night visits in intervention group; P value < 0.001
GP visits

Daytime during week:

Intervention: M 2.18 (SD 1.73)

Control: M 2.32 (SD 2.42)

Daytime during weekend:

Intervention: M 0.35 (SD 0.81)

Control: M 0.39 (SD 0.68)

Evening:

Intervention: M 0.17 (SD 0.46)

Control: M 0.61 (SD 1.42)

Night:

Intervention: M 0.04 (SD 0.20)

Control: M 0.26 (SD 0.55)

Last week before death 

 

 

 

 

 

 

 

 
GP visits

Daytime during week n.s.; P value ≥ 0.05

Daytime during weekend n.s.; P value ≥ 0.05

Evening visits n.s.; P value ≥ 0.05

Night visits n.s.; P value ≥ 0.05
GP visits

Daytime during week:

Intervention: M 2.92 (SD 2.20)

Control: M 3.03 (SD 3.18)

Daytime during weekend:

Intervention: M 0.63 (SD 1.07)

Control: M 0.95 (SD 1.56)

Evening:

Intervention: M 0.59 (SD 0.91)

Control: M 1.11 (SD 1.56)

Night:

Intervention: M 0.47 (SD 0.82)

Control: M 0.63 (SD 1.10)

Last year before deathHours of home nursing care 

n.s.

"none of the differences were significant" (Grande 2004, Grande 1999)

Hours of HAH home nursing 

difference due to the intervention (control group received none)
Subanalysis of sample in bereavement follow-up (n = 96)

Hours of home nursing care

Intervention (n = 78): median 46.1 (IQR 83.8)

Control (n = 18): median 24.0 (IRQ 46.6)

Hours of HAH home nursing

Intervention (n = 78): median 18.0 (IRQ 107.0)

Control (n = 18): median 0.0 (IRQ 0.0)

Bakitas 2009

US

(high quality)
Forwards from enrolmentDuring study periodReferral to hospice care

n.s.

Fisher exact test P value = 0.75
Referral to hospice care

Intervention: 6/161 (3.7%)

Control: 4/161 (2.5%)

Brumley 2007

US

(high quality)
Forwards from enrolmentDuring study periodReferral to hospice care (1of 2sites only)

n.s.

Chi2 P value = 0.15

Days in hospice care (1of 2sites only) 

n.s.

t 0.52

P value = 0.60
Referral to hospice care (1of 2sites only)

Intervention: 25%

Control: 36%

Days in hospice care (1of 2sites only)

descriptive data not provided

Zimmer 1985

US
Backwards from deathLast 2 weeks before deathAuthors stated reduced use of "in-home" services in intervention group but statistical significance was not stated

"Team patients (...) received more in-home services" (Zimmer 1984, Zimmer 1985)

 

 

 

 
MD home visits

Intervention (n = 21): 0.8

Control (n = 12): 0.1

MD office visits

Intervention (n = 21): 0

Control (n = 12): 0

Nurse home visits

Intervention (n = 21): 1.7

Control (n = 12): 1.1

RN/LPN hours

Intervention (n = 21): 51.2

Control (n = 12): 42.0

Social worker home visits

Intervention (n = 21): 0

Control (n = 12): 0

Aide/homemaker visits

Intervention (n = 21): 21.1

Control (n = 12): 11.5

Laboratory technician home visits

Intervention (n = 21): 0.1

Control (n = 12): 0

Meals-on-wheels visits

Intervention (n = 21): 0.5

Control (n = 12): 0

Note: not clear if the figures are means or medians

Hughes 1992

US
Forwards from enrolment6 months following enrolmentNon-VA community nursing visits 

fewer visits in intervention

t 4.69

P value = 0.0001

 

Non-VA private home care visits

"n.s."

t -1.42

HBHC visits

difference due to the intervention (control group received none)
Non-VA community nursing visits

Intervention (n = 86): M 0.06 (SD 0.5)

Control (n = 85): M 7.06 (SD 13.7)

Non-VA private home care visits

Intervention (n = 86): M 2.00 (SD 12.8)

Control (n = 85): M 0.07 (SD 0.6)

HBHC visits

Intervention (n = 86): M 17.93 (SD 18.2)

Control (n = 85): 0 received

Buckingham 1978

US
Not statedNot statedAuthors stated reduced use of home care in control group but statistical significance was not stated"Few patients in the nonhospice study group received any form of home care service. A strong possibility exists therefore, that home care and not hospice service as such was the critical element in alleviating problems of terminal illness for hospice patients and their families. However, if this is true, the fact remains that Hospice, Inc., has presented itself as an effective vehicle for such home care assistance" (Buckingham 1978); no data provided to support this statement

Axelsson 1998

Sweden
Forwards from enrolmentDuring study period

 
All listed services: n.s.

"When comparing the study group with the reference group, there were no significant differences in the utilization of resources at home outside the PSS,
such as district nurses, the domiciliary service and so on" (Axelsson 1998)
Consultant nurse

Intervention: median 14.5 hours (range 2 to 157)

Control: 0 received

Surgeon

Intervention: median 2 hours (range 0 to 11)

Control: 0 received

District nurse

Intervention: median 2.25 hours (range 0 to 81)

Control:  median 4.5 hours (range 0 to 33.5)

Assistant nurse

Intervention: median 0 hours (range 0 to 79.5)

Control: median 0 hours (range 0 to 1.5)

GP

Intervention: median 0 hours (range 0 to 3)

Control: median 0 hours (range 0 to 3)

Home service

Intervention: median 0 hours (range 0 to 435)

Control: median 0 hours (range 0 to 12)

Night sitting

Intervention: median 0 hours (range 0 to 96)

Control: median 0 hours (range 0 to 0)

Greer 1986

(CBA)
Forwards from enrolment

 

 

 

 

 

 

 

  

 
During study period (standardised to 50 days) Home nursing visits

Differences and statistical significance not stated

Home health/homemaker visits

Differences and statistical significance not stated

Social service and other therapies visits

Differences and statistical significance not stated
Adjusted estimatesa

Home nursing visits

Community-based home hospice care: 15.5 (SE 1.5)

Hospice-based home hospice care: 11.0 (SE 1.5)

Conventional care: 3.5 (SE 0.5)

Home health/homemaker visits

Community-based home hospice care: 18.0 (SE 1.5)

Hospice-based home hospice care: 10.5 (SE 2.0)

Conventional care: 4.0 (SE 0.5)

Social service and other therapies visits

Community-based home hospice care: 2.5 (SE 0.3)

Hospice-based home hospice care: 1.0 (SE 0.3)

Conventional care: 0.2 (SE 0.1)

Note: not clear if the figures are means or medians

Backwards from deathLast week before deathAuthors stated increased use of social services in intervention group but statistical significance was not stated

"Hospice patients (...) are more likely to receive social service support than CC patients" (Greer 1986)
Adjusted estimatesb

Receipt of social services

(included general counselling, legal/financial counselling, paperwork assistance, help getting services, self care training)

Community-based home hospice care: 61% (SE 0.03)

Hospice-based home hospice care: 65% (SE 0.03)

Conventional care: 49% (SE 0.05)

Last 2 weeks before deathReceipt of social services

increased social care use in intervention groups

P value < 0.01

General counselling presented as n.s. by authors; P value ≥ 0.01

Legal/financial counselling presented as n.s. by authors; P value ≥ 0.01

Paperwork assistance increased paper work assistance in intervention groups; P value < 0.001

Help getting services presented as n.s. by authors; P value ≥ 0.01

Self care training presented as n.s. by authors; P value ≥ 0.01
Receipt of social services

(included general counselling, legal/financial counselling, paperwork assistance, help getting services, self care training)

Community-based home hospice care: 60.1%

Hospital-based home hospice care: 63.5%

Conventional care: 51.2%

General counselling:

Community-based home hospice care: 34.6%

Hospital-based home hospice care: 34.0%

Conventional care: 26.6%

Legal/financial counselling:

Community-based home hospice care: 8.0%

Hospital-based home hospice care: 8.0%

Conventional care: 7.6%

Paperwork assistance:

Community-based home hospice care: 29.3%

Hospital-based home hospice care: 35.1%

Conventional care: 20.8%

Help getting services:

Community-based home hospice care: 28.1%

Hospital-based home hospice care: 32.0%

Conventional care: 23.5%

Self care training:

Community-based home hospice care: 7.7%

Hospital-based home hospice care: 9.7%

Conventional care: 6.4%

Total study periodReceipt of social services

increased social care use in intervention group

P value < 0.01

General counselling: increased use of general counselling in intervention groups; P value < 0.01

Legal/financial counselling

presented as n.s. by authors; P value ≥ 0.01

Paperwork assistance: increased paper work assistance in intervention groups; P value < 0.001

Help getting services: increased help getting services in intervention groups; P value < 0.001

Self care training presented as n.s. by authors; P value ≥ 0.01
Receipt of social services

(included general counselling, legal/financial counselling, paperwork assistance, help getting services, self care training)

Community-based home hospice care: 77.3%

Hospital-based home hospice care: 77.3%

Conventional care: 67.8%

"Social service use was more prevalent among hospice patients throughout the course of the study, but this difference also existed prior to hospice admission and, at least partially, might have resulted from the use of social services in the process of transferring from conventional care to hospice" (Greer 1986)

General counselling:

Community-based home hospice care: 48.4%

Hospital-based home hospice care: 50.2%

Conventional care: 38.6%

Legal/financial counselling:

Community-based home hospice care: 13.4%

Hospital-based home hospice care: 13.6%

Conventional care: 13.4%

Paperwork assistance:

Community-based home hospice care: 43.3%

Hospital-based home hospice care: 44.3%

Conventional care: 30.7%

Help getting services:

Community-based home hospice care: 45.9%

Hospital-based home hospice care: 50.0%

Conventional care: 35.3%

Self care training:

Community-based home hospice care: 17.7%

Hospital-based home hospice care: 20.1%

Conventional care: 16.1%

 CBA: controlled before and after study; CC: conventional care (control); GP: general practitioner; HAH: hospital at home (intervention); HBHC: hospital-based team home care (intervention); IQR: interquartile range; LPN: licensed practical nurse; M: mean; MD: medical doctor; MS: multiple sclerosis; n.s.: non-significant; PSS: palliative support service (intervention); RN: registered nurse; SD: standard deviation; SE: standard error; VA: Veterans Affairs.

aStandard errors of estimates were based upon multiple regression analyses adjusted for sample differences. In calculating total per patient utilisation, the authors multiplied the utilisation per study day by the "average" number of study days (50) for hospice patients (intervention group).
bStandard errors of the estimates were based upon the logistic regression equation adjusted for sample differences.
 
Table 71. Informal care

StudyAnalysisTime horizonSignificance and directionDetails

Higginson 2009

UK

(high quality)
Forwards from enrolment12 weeks following enrolmentCare by informal caregiver

authors stated increased care by informal caregivers in control group but statistical significance was not stated

"The control care patients were more likely (...) to receive help from family/friends" (Higginson 2009)
Care by informal caregiver

Intervention: 15/23 (65%) received; M 152.5 contacts (SD 53.7)

Control: 16/21 (76%) received; M 151.1 contacts (SD 57.7)

Axelsson 1998

Sweden
Forwards from enrolmentDuring study periodNext of kin off work

authors stated there were no differences but statistical significance was not stated

"We found no differences between the study group and the reference group concerning the number of family members' days off work needed to support the cancer patient at home, the reason probably being that the majority of spouses were retired" (Axelsson 1998)
Next of kin off work

Intervention: median 0 days (range 0 to 12)

Control: 0 days (range 0 to 0)

Greer 1986

(CBA)
Backwards from deathNot statedHours of direct care help from primary care person

authors stated increased hours of direct care by primary care person in community-based intervention but statistical significance was not stated

"Hours of direct care provided the patient was significantly higher for HC patients than either HB or CC patients. (Greer 1986)
Adjusted estimatesa

Hours of direct care help from primary care person (categorised from 0 to 6; 0 = least)

measured at 3 weeks to death

Community-based home hospice care: M 4.01 (SE 0.19)

Hospital-based home hospice care: M 2.95 (SE 0.27)

Conventional care: M 2.27 (SE 0.34)

measured at 1 week to death

Community-based home hospice care: M 4.16 (SE 0.20)

Hospital-based home hospice care: M 3.02 (SE 0.25)

Conventional care: M 2.82 (SE 0.28)

 CC: conventional care (control); HB: hospital-based (hospital-based intervention); HC: home-based care (community-based intervention); M: mean; SD: standard deviation; SE: standard error.
aStandard errors of the estimates based on a multiple regression equation adjusted for sample differences.
 
Table 72. Caregiver post-bereavement healthcare use and absenteeism from work

StudyMeasureAnalysisTime horizonSignificance and directionDetails

Greer 1986

(CBA)
1) Physician visits after the patient died (score: from 0 to 4+, 0 = none; caregiver report)

 

2) Hospitalisation after the patient died (yes/no; caregiver report)

 

3) Absenteeism from work after the patient died (yes/no; caregiver report)

 
Forwards from deathFirst 90-120 days following deathPhysician visits and hospitalisation

Authors stated there were no differences but statistical significance was not stated

"no difference in morbidity, i.e. hospitalization, physician visits (…) during the bereavement period" (Greer 1986)

 

Absenteeism from work

n.s.

"Few PCPs (4%) reported increased absenteeism from work (…), with no statistically significant differences among settings" (Greer 1986)
Adjusted estimatesa

Physician visits

Community-based intervention: M 1.35 (SE 0.17)

Hospital-based intervention: M 1.25 (SE 0.22)

Control (conventional care): M 0.95 (SE 0.28)

Hospitalisation

Community-based intervention: 6% (SE 0.01)

Hospital-based intervention: 6% (SE -0.01)

Control (conventional care): 5% (SE 0.02)

Absenteeism from work

Descriptive data not provided

 CBA: controlled before and after study; M: mean; n.s.: non-significant; SE: standard error.
aStandard errors of the estimates based on a multiple regression equation for interval-scale variables and logistic regression equation for dichotomous variables adjusted for sample differences.
 
Table 73. Medication and other resources

StudyAnalysisTime horizonSignificance and directionDetails

Higginson 2009

UK

(high quality)
Forwards

 from enrolment
12 weeks after enrolmentDifferences and statistical significance not statedPalliative care nurse

Intervention: 9 (39%) received; M 3.0 (SD 1.5)

Control: 0 received

Other nurse

Intervention: 7 (30%) received; M 40.0 (SD 63.8)

Control: 7 (33%) received; M 95.0 (SD 79.6)

Specialist (ward)

Intervention: 5 (22%) received; M 1.0 (SD 0.0)

Control: 7 (33%) received; M 9.6 (SD 12.1)

Specialist (other)

Intervention: 4 (17%) received; M 1.1 (SD 0.3)

Control: 5 (24%) received; M 1.0 (SD 0.0)

Occupational therapist/physiotherapist

Intervention: 16 (70%) received; M 10.6 (SD 9.9)

Control: 14 (67%) received; M 22.5 (SD 47.7)

Dietician/chiropodist

Intervention: 12 (52%) received; M 3.5 (SD 2.5)

Control: 13 (62%) received; M 2.6 (SD 1.3)

Day centre

Intervention: 5 (22%) received; M 20.2 (SD 21.0)

Control: 5 (24%) received; M 20.4 (SD 15.9)

Respite care

Intervention: 2 (9%) received; M 9.5 (SD 0.7)  

Control: 5 (24%) received; M 10.0 (SD 5.9)  

Grande 1999

UK
Backwards

 from death
Last 2 weeks before deathOther primary and secondary care

authors stated no differences but statistical significance not stated
Other primary and secondary care

"Past analysis has also shown that the CHAH and control groups did not differ in the amount of input from any other primary or secondary care service in the final 2 weeks of life" (Grande 2000, Grande 1999)

Bakitas 2009

US

(high quality)
Forwards

from enrolment
During study periodReferral to palliative care

n.s.

P value = 0.34
Referral to palliative care

Intervention: 34/145 (23.4%)

Control: 39/134 (29.1%)

Aiken 2006

US
Forwards from enrolmentDuring study periodManaged Care Organization (MCO) case manager assigned

n.s.

Chi2 2.36

P value = 0.12
MCO case manager assigned

Intervention: 51%

Control: 62%

Zimmer 1985

US
Backwards

from death
Last 2 weeks before deathAmbulance/chairmobile rides

differences and statistical significance not stated
Ambulance/chairmobile rides

Intervention (n = 21): 0.1

Control (n = 12): 0.6

Note: not clear if the figures are means or medians

Hughes 1992

US
Forwards

from enrolment
6 months following enrolmentExtended care days

n.s.

t -1.0
Extended care days

Intervention (n = 86): M 0.38 (SD 3.6)

Control (n = 85): M 0.0 (SD 0.0)

Greer 1986

(CBA)

 

 

 

 

 

 

 
Backwards from death24-hour period at 3 weeks to deathAnalgesics

Prescribed and taken n.s.

"The direction of the relationship is similar [to measure taken at one week to death] but not statistically significant" (Goldberg 1986, Greer 1986)
Analgesics

Subsample of 181 patients: 59 patients in community-based intervention; 46 in hospital-based intervention and 76 in conventional care (control)

Prescribed and taken:

Community-based intervention: 76.7% prescribed; 69.4% took the analgesics prescribed

Hospital-based intervention: 85.3% prescribed; 76.5% took the analgesics prescribed

Conventional care (control): 75.5% prescribed; 68.3% took the analgesics prescribed

24-hour period at 1 week to deathAnalgesics

Prescribed and taken: increased analgesics prescription and uptake in hospital-based intervention than in community-based intervention and conventional care

P value < 0.01 (prescribed)

P value < 0.05 (taken)

Level of analgesic use n.s. (see details)

"Average" daily OME consumption 'n.s'

Increased oral route of analgesic consumption

in intervention groups; P value = 0.05

Reduced analgesic consumption on a pro order (i.e. as needed) in intervention groups; P value = 0.03
Analgesics

Subsample of 181 patients: 59 patients in community-based intervention; 46 in hospital-based intervention and 76 in conventional care (control)

Prescribed and taken:

Community-based intervention: 66.1% prescribed; 66.1% took the analgesics prescribed

Hospital-based intervention: 91.3% prescribed; 78.3% took the analgesics prescribed

Conventional care (control): 69.7% prescribed; 56.6% took the analgesics prescribed

Level of analgesic use:

"Of those who reported consuming analgesics at the last contact, 42.5% were classified as low, 51.3% consumed an intermediate amount, and only 6.2% were categorized in the high group. There were no statistically significant differences by setting for the level of analgesic consumed" (Goldberg 1986, Greer 1986)

"Average" daily OME consumption:

Community-based intervention: 117 mg/day

Hospital-based intervention: 137 mg/day

Conventional care (control): 146 mg/day

"These differences are not statistically significant due to high variability in the level of consumption among those studied" (Goldberg 1986, Greer 1986)

Oral route of analgesic consumption:

Community-based intervention: 90%

Hospital-based intervention: 85%

Conventional care (control): 55%

Analgesic consumption on a pro order (i.e. as needed):

Community-based intervention: 23%

Hospital-based intervention: 39%

Conventional care (control): 51%

Last 2 weeks before deathAggressive interventions

reduced use in intervention groups

P value < 0.01

Radiotherapy: reduced use in intervention groups; P value < 0.01

Surgery: reduced use in intervention groups; P value < 0.01

Chemo or hormonal therapy: reduced use in intervention groups; P value < 0.01

Thoracentesis: n.s.

"receipt of all services but thoracentesis (a procedure employed for draining air or fluid from the space around the lungs) was significantly more likely among conventional care than hospice patients" (Mor 1990, Greer 1986)
Aggressive interventions

Community-based intervention: 13.9%

Hospital-based intervention: 13.1%

Conventional care (control): 37.7%

Radiotherapy:

Community-based intervention: 3.8%

Hospital-based intervention: 5.6%

Conventional care (control): 13.5%

Surgery:

Community-based intervention: 0.6%

Hospital-based intervention: 1.9%

Conventional care (control): 6.8%

Chemo or hormonal therapy:

Community-based intervention: 7.2%

Hospital-based intervention: 5.4%

Conventional care (control): 24.2%

Thoracentesis:

Community-based intervention: 4.3%

Hospital-based intervention: 2.9%

Conventional care (control): 6.8%

Last 3 weeks before deathDiagnostic tests

(blood tests, x-rays, or scans)

reduced use in intervention groups

'hospice patients were also significantly less likely to have diagnostic blood tests or X-rays' (Mor 1990, Greer 1986)
Adjusted estimatesa

Diagnostic tests

(blood tests, x-rays, or scans)

Community-based intervention: 34% (SE 0.03)

Hospital-based intervention: 37% (SE 0.04)

Conventional care (control): 64% (SE 0.06)

Last week before deathCommunity-based intervention: 35% (SE 0.03)

Hospital-based intervention: 36% (SE 0.03)

Conventional care (control): 62% (SE 0.06)

Last 2 weeks before deathRespiratory support intervention

reduced use in intervention groups

P value < 0.001

Oxygen: reduced use in intervention groups; P value < 0.001

Respiratory therapy: reduced use in intervention groups; P value < 0.01
Respiratory support intervention

Community-based intervention: 32.2%

Hospital-based intervention: 27.2%

Conventional care (control): 44.0%

Oxygen:

Community-based intervention: 30.0%

Hospital-based intervention: 26.1%

Conventional care (control): 42.8%

Respiratory therapy:

Community-based intervention: 7.7%

Hospital-based intervention: 5.4%

Conventional care (control): 15.3%

Not statedPalliative radiotherapy

(sub-analysis of 2 clinical profiles)

Patients with primary brain cancer or brain metastases: reduced use in intervention groups; P value < 0.001

Patients with bone metastases with bone pain: n.s.
Palliative radiotherapy

(sub-analysis of 2 clinical profiles)

Patients with primary brain cancer or brain metastases (n = 311): 'Significantly higher proportion of nonhospice than hospice patients received radiation therapy (P < 0.001). This finding was obtained for both poorly and well-functioning patients. Among the 192 patients who were functioning poorly (largely bedbound), 30% of nonhospice patients received radiation therapy, as opposed to only 7% of hospice patients' (Mor 1990, Greer 1986)

Patients with bone metastases with bone pain (n = 314): 'Of the 314 patients with bone metastases who reported bone pain, there were no statistically significant differences in the proportions of those who received radiation therapy across the 3 groups. Although poorly functioning nonhospice patients were somewhat more likely to receive radiation than their hospice counterparts, this was not true of the best functioning patients. In neither of these cases, however, was the difference statistically significant' (Mor 1990, Greer 1986)

 CHAH: Cambridge hospital at home service; M: mean; n.s.: non-significant; OME: oral morphine equivalent; SD: standard deviation; SE: standard error.

aStandard errors of the estimates based on a logistic regression equation adjusted for sample differences.
 
Table 74. Cost-effectiveness analyses with total care costs

Study and sample analysedClinical effectivenessImpact on resource useImpact on total care costsCost-effectiveness

Brumley 2007

US

 

N intervention = 145

N control = 152

 

high quality economic evaluation

(mean score 0.7)
+ death at homea

+ death in hospitala

+ patient satisfaction with care at 30 days

+ patient satisfaction with care at 90 days

Ø patient satisfaction with care at 60 days

Ø death in nursing homea

Ø death in inpatient hospicea

Ø survivalb
[DOWNWARDS ARROW] ED visits

[DOWNWARDS ARROW] hospital admission

[DOWNWARDS ARROW] hospital inpatient days

Ø referral to hospice care

 

 

 

 
[DOWNWARDS ARROW] total adjusted mean costs per patientc USD7552 lower in intervention group (33% lower; 95% CI - USD12,411 to - USD780; P value = 0.03; R2 0.16)

unadjusted difference: t 3.63; P value < 0.001

time horizon: from enrolment to death, transfer to hospice care or study end (mean survival of 196 days in intervention group and 242 days in control group; 73% patients died)

currency: 2002 USD

 

Adjusted mean costs per patientc 

Intervention      USD2670 ± 12,523

Control             USD20,222 ± 30,026

 

Adjusted mean costs per patient per dayc

Intervention      USD95.30

Control             USD212.80

t - 2.417; P value = 0.02

 

Total costs included those associated with physician visits, ED visits, hospital days, skilled nursing facility days, and home health or palliative days
+ no summary measure, but the intervention was cost-effective as it resulted in statistically significant improved outcomes (no negative findings), reduced resource use (no negative findings) and a statistically significant reduction in total costs

Higginson 2009

UK

 

N intervention = 26

N control = 24

 

high quality economic evaluation (mean score 0.8)

 
+ symptom burden at 12 weeks

+ pain at 12 weeks

+ caregiver burden at 12 weeks

Ø palliative care outcomes (primary outcome; at 6 and 12 weeks)

Ø symptom burden 6 weeks

Ø pain at 6 weeks

Ø MS psychological impact at 6 and 12 weeks

Ø MS physical impact at 6 and 12 weeks

Ø caregiver burden 6 weeks

Ø caregiver mastery (learning new skills) at 6 and 12 weeks

Ø caregiver positivity at 6 and 12 weeks

 

 
? authors reported the use of a range of health, social and voluntary services but the statistical significance of differences was not statedØ total mean costs per patient GBP1789 lower in intervention group (29% lower; bootstrapped 95% CI - GBP5224 to GBP1902; n.s.); excluding inpatient care and informal care, mean service costs were GBP1195 lower in the intervention group (50% lower; bootstrapped 95% CI - GBP2916 to GBP178; n.s.)d

time horizon: 12 weeks from enrolment (only 4 deaths)

currency: 2005 GBP

 

Mean costs per patient  

Intervention       GBP4294

Control              GBP6084

 

Total costs included those associated with a range of health, social, and voluntary services (inpatient care, respite care, day centre, contacts with district/practice nurse, MS nurse, palliative care nurse, other nurse, general practice, specialist at home, in hospital, in a ward and in other places, occupational therapist, physiotherapist, dietician, chiropodist, dentist, speech  therapist, social services) and informal care
+ the intervention was cost-effective as it improved caregiver burden (ZBI) with no statistically significant differences in palliative care outcomes (POS-8) and total costs

 

The authors plotted cost-effectiveness planes for the two above-mentioned outcomes (ZBI and POS-8). These planes plot costs against outcomes forming four-quadrants to visualise if the intervention has better outcomes and higher costs, better outcomes at lower costs, worse outcomes at higher costs or worse outcomes but at lower costs. The authors accounted for uncertainty around the cost-effectiveness estimates by generating 1000 resamples using bootstrapping and computing cost and outcome differences for each, which were then plotted on the cost-effectiveness planes. The point estimates in cost-effectiveness planes suggest that the intervention was cost saving, with equivalent outcomes on overall palliative outcomes and improved outcomes for caregiver burden. The POS-8 plane showed 33.8% replications in the lower right quadrant, indicating that intervention patients had better outcomes and lower costs than controls, and 54.9% in the quadrant indicating worse outcomes but lower costs. By contrast, in the ZBI plane, 47.3% replications were in the quadrant showing lower costs and better outcomes and 48.0% in the quadrant showing higher costs and better outcomes

The authors also conducted a sensitivity analysis testing different imputation methods for dealing with missing data (last value carried, forward, next value carried backwards, and mean value), reporting similar results in nonimputed and imputed data, for all imputation methods

Zimmer 1985

US

 

N intervention = 21

N control = 12

 

high quality economic evaluation (mean score 0.7)

 
Ø death at homea

Ø survival
? authors reported the use of a range of out-of-home and in-home services but the statistical significance of differences was not stated

 
? total mean costs USD716 lower in intervention group (31% lower; statistical significance and/or uncertainty not reported)

time horizon: last 2 weeks before death (subanalysis of deaths within the study)

currency: USD, date not stated (study conducted in 1979-1982)

 

Mean costs of last 2weeks before death per patient

Intervention USD1577

Control USD2293

 

Total costs included out-of-home costs (hospital days, clinic visits, nursing home days, MD office or ED visits, ambulance or chairmobile rides) and in-home costs (MD visits, nurse visits, RN/LPN hours, aide/homemaker visits, social worker visits, laboratory technician visits, meals-on-wheels visits)
? no summary measure, and it is unclear if the intervention was cost-effective as there were no statistically significant differences in outcomes, and although total costs were lower in the intervention group, the statistical significance of this difference was not reported

Hughes 1992

US

 

N intervention = 85

N control = 86

 

high quality economic evaluation (mean score 0.7)

 
+ patient satisfaction with care at 1 month

+ caregiver satisfaction with care at 1 month

- caregiver morale at 6 months

Ø patient satisfaction with care at 6 monthse

Ø caregiver satisfaction with care at 6 months

Ø caregiver morale at 1 month

Ø morale

Ø cognitive functioning

Ø physical function

Ø survival 

 
[DOWNWARDS ARROW] hospital inpatient daysf

[DOWNWARDS ARROW] VA outpatient clinic visits

[DOWNWARDS ARROW] non-VA community nursing visits

Ø ED visits (VA and non-VA)

Ø ICU days

Ø nursing home days

Ø hospital admission

Ø non-VA community nursing visits

Ø non-VA private home care visits

Ø extended care days

? length of last hospital admission before death  
Ø total mean costs per patient USD769 lower in intervention group (18% lower; t 1.05; "n.s.")

time horizon: 6 months from enrolment (mean survival was 76.2 days in intervention group and 67.1 days in control group; 79% and 78% patients died within the study, respectively)

currency: 1985 USD

 

Mean costs of 6months following enrolment per patient

Intervention USD3479.36

Control USD4248.68

 

Total costs included those associated with institutional care (VA and private hospitals, nursing homes) and non-institutional (outpatient clinic visits, intervention team's visits, community nursing)

 
? no summary measure, and it is unclear if the intervention was cost-effective as there were positive and negative results in clinical outcomes and the difference in total costs was not statistically significant

Tramarin 1992

Italy

 

N intervention = 9

N control = 30

 

high quality economic evaluation (mean score 0.8)

 
? quality of life

 
? authors reported on hospital admission, length of hospital admission, hospital inpatient days and outpatient clinic visits but the statistical significance of differences was not stated? total '"average" costs per person-year USD7595 lower (35% lower; statistical significance or uncertainty, or both, not reported)

time horizon: costs per person-year (6 months from enrolment multiplied by 2; 22 deaths within the study)

currency: 1990 USD (converted from 1990 ITL using healthcare-specific purchasing power parities)

 

" Average" total costs per person-year

 

Intervention

     stage 2/3 patients USD 14, 259

     stage 2 patients only USD 11,321

     stage 3 patients only USD 17,237

 

Control

     stage 2/3 patients USD 21,854

     stage 2 patients only USD 15,944

     stage 3 patients only USD 27,764

 

Total costs included more than 500 items including inpatient, outpatient clinics and home care (including intervention service), hotel and general services, diagnostic examinations and therapy, treatment items, medication and personnel salaries
? cost-utility ratios calculated only for stage 3 patients ("average" cost-effectiveness ratio of USD482 per well-week in intervention group and USD791 in control group; statistical significance or uncertainty, or both, around estimates not reported) and more appropriate incremental ratios could not be calculated from the data; hence it is unclear if the intervention was cost-effective

Greer 1986 (CBA)

 

N intervention = 1457 (833 in community-based intervention, 624 in hospital-based intervention)

N control = 297

(conventional care)

 

high quality economic evaluation (mean score 0.7)

 

 

 
+ patient at home as long as wanted

(favours community-based intervention vs. other groups)

+ symptom severity at 3 weeks to death

(favours hospital-based intervention vs. other groups)

+ symptom severity at 1 week to death  

+ persistent pain at 3 and 1 week to death

(favours hospital-based intervention vs. other groups)

+ hours of social visiting at 3 weeks to death

+ caregiver satisfaction with care 90 to 120 after death

(favours hospital-based intervention vs. control)

+ quality of death referring to 3 days before death

- social quality of life at 1 week to death

- caregiver burden in last weeks before death

(higher in community-based intervention vs. other groups)

Ø patient report of pain at 1 and 5 weeks

Ø survival

Ø physical function at 3 and 1 week to death

Ø social quality of life at 3 weeks to death

Ø hours of social visiting at 1 week to death

Ø hours of chatting with household members at 3 weeks to death

Ø caregiver pre-bereavement psychological well-being (distress, use of medication for anxiety and depression, increased drinking)

Ø patient satisfaction with care at 3 and 1 week to death

Ø caregiver regret at 90 to 120 days after death concerning the medical care the patient received

? death at home

? caregiver satisfaction with place of death

? caregiver report of patient pain at 3 and 1 week to death (composite pain and pain-free)

? quality of life at 3 and 1 week to death

? emotional quality of life at 3 and 1 week to death

? hours of chatting with household members at 3 weeks to death

? spiritual well-being in the 3 days before death

? patient awareness at 3 and 1 week to death

? grief at 90 to 120 days after death

 

? caregiver post bereavement psychological well-being in first 90 to 120 days after death (use of medication for anxiety and depression, increased drinking)
[UPWARDS ARROW] receipt of social services

[UPWARDS ARROW] general counselling in study period

[UPWARDS ARROW] paperwork assistance

[UPWARDS ARROW] analgesics prescribed and taken at 1 week to death (increased in hospital-based intervention vs. other groups)

[UPWARDS ARROW] oral route of analgesics

[DOWNWARDS ARROW] analgesic consumption on a pro order

[DOWNWARDS ARROW] aggressive interventions (radiotherapy, surgery, chemo or hormonal therapy)

[DOWNWARDS ARROW] diagnostic tests (blood tests, x-rays, scans)

[DOWNWARDS ARROW] respiratory support interventions (oxygen, respiratory therapy)

[DOWNWARDS ARROW] radiotherapy for patients with primary brain cancer or brain metastases

0 general counselling in last 2 weeks before death

Ø legal/financial counselling

Ø help getting services

Ø self care training

Ø caregiver post-bereavement absenteeism from work in first 90-120 days after death

Ø analgesics prescribed and taken at 3 weeks to death

Ø level of analgesics used

Ø mean daily OME consumption

Ø thoracentesis

Ø palliative radiation therapy for patients with bone metastases with bone pain

? institutional days

? physician and outpatient visits

? home nursing visits

? home health/home worker visits

? hours of direct informal care caregiver post-bereavement healthcare use (physician visits, hospitalisation in first 90 to 120 days after death)
? total costs per study day USD48 lower in community-based intervention (32% lower) and USD3 lower in hospital-based intervention (2% lower) compared to the control group (conventional care); statistical significance not reported)

time horizon: from enrolment to death or study end (length of survival not stated; all patients died within the study)

currency: 1982 USD

 

Total costs per study day

Community-based intervention USD101 (SE 9.1)g

Hospital-based intervention USD146 (SE 10.0)g

Control (conventional care) USD149 (SE 11.7)g

Note: not clear if the figures are means or medians

 

Authors stated that total costs per study day were "substantially lower" in the community-based intervention group than in the hospital-based or control groups and that total costs were "comparable" for the first 2. Statistical significance was not stated

 

Total costs included those associated with inpatient and home care, physician visits, outpatient clinic visits, drugs, supplies and equipment expenditures. Total costs combine "costs" and "charges" since only charges were available for physician services, drugs, supplies, and equipment purchased at home

 

 
? no summary measure, and it is unclear if the intervention was cost-effective as there were positive and negative results in outcomes but also others where statistical significance was not reported; in addition, it is unclear if differences in costs were statistically significant between intervention groups and the control (conventional care)

 +: statistically significant positive effect (favouring intervention); -: statistically significant negative effect (favouring control); Ø: effect not statistically significant; ?: statistical significance of effect not stated; [UPWARDS ARROW]: statistically significant increase in intervention group; [DOWNWARDS ARROW]: statistically significant decreased in intervention group; CI: confidence interval; ED: emergency department; GBP: British pound; ICU: intensive care unit; ITL: Italian lira; LPN: licensed practical nurse; M: mean; MS: multiple sclerosis; MD: medical doctor; n.s.: non-significant; OME: oral morphine equivalent; RN: registered nurse;
SE: standard error; USD: United States dollar; VA: Veterans Affairs; ZBI: Zarit Burden Interview.
aResults as examined in meta-analysis.
bNo statistically significant difference in survival (log rank test P value = 0.08).
cAdjusted in linear regression for differences in age, survival, severity of illness and diagnosis; the authors stated they used ordinary least squares regression in the final analysis to account for the right-skewness in the cost data
dThe authors used bootstrapping to produce 95% CIs around the cost differences between the groups
eMarginally significant difference in t-test favouring intervention group (i.e. greater satisfaction with care in intervention group; P value = 0.06).
fStatistically significant differences for total VA hospital days and VA general hospital beds; not significant for inpatient days in VA hospital rehabilitation or intermediate beds or non-VA private hospitals
gStandard errors of estimates were based upon multiple regression equation.
 
Table 75. Disaggregated costs

StudyAnalysisTime horizon and currencySignificance and directionDetails

Rabow 2004

US
Forwards from enrolmentStudy period

currency: USD, date not stated (date when study was conducted also unknown)
All medical centre services charges

n.s.

t 0.25; P value = 0.80

Clinic visits n.s.; t -0.34; P value = 0.73

Urgent care visits n.s.; t -1.06; P value = 0.29

ED visits n.s.; t -1.01; P value = 0.32

Inpatient services n.s.; t 0.01; P value = 0.10

Other charges n.s.; t 0.13; P value = 0.89
All medical centre services charges

Intervention (n = 50): M USD47,211 (SD 73,009)

Control (n = 40): M USD43,338 (SD 69,647)

Clinic visits:

Intervention (n = 50): M USD7311 (SD 10,880)

Control (n = 40): M USD8068 (SD 9055)

Urgent care visits:

Intervention (n = 50): M USD749 (SD 2210)

Control (n = 40): M USD1342 (SD 2909)

ED visits:

Intervention (n = 50): M USD754 (SD 1138)

Control (n = 40): M USD1313 (SD 3281)

Inpatient services:

Intervention (n = 50): M USD31,294 (SD 54,285)

Control (n = 40): M USD31,225 (SD 66,611)

Other charges:

Intervention (n = 50): M USD1619 (SD 7973)

Control (n = 40): M USD1427 (SD 4714)

"Although analysis of cost data is preferable, we were able only to acquire data on charges using the medical center's computerized billing system" (Rabow 2004)

Higginson 2009

UK
Forwards from enrolment12 weeks following enrolment

Currency: 2005 GBP
Statistical significance not stated (descriptive data only)District/practice nurse

Intervention: M GBP224 (SD 420)

Control: M GBP398 (SD 922)

MS nurse

Intervention: M GBP33 (SD 62)

Control: M GBP13 (SD 22)

Palliative care nurse

Intervention: M GBP46 (SD 72)

Control: M GBP0 (SD 0)

Other nurse

Intervention: M GBP451 (SD 1573)

Control: M GBP922 (SD 2078)

General practice

Intervention: M GBP48 (SD 87)

Control: M GBP68 (SD 96)

Specialist (home)

Intervention: M GBP93 (SD 258)

Control: M GBP0 (SD 0)

Specialist (hospital)

Intervention: M GBP29 (SD 44)

Control: M GBP78 (SD 76)

Specialist (ward)

Intervention: M GBP18 (SD 37)

Control: M GBP260 (SD 707)

Specialist (other)

Intervention: M GBP16 (SD 39)

Control: M GBP19 (SD 39)

Occupational therapist/physiotherapist

Intervention: M GBP290 (SD 425)

Control: M GBP389 (SD 897)

Dietician/chiropodist/ dentist

Intervention: M GBP41 (SD 65)

Control: M GBP33 (SD 29)

Speech therapist

Intervention: M GBP16 (SD 58)

Control: M GBP25 (SD 122)

Social services

Intervention: M GBP69 (SD 152)

Control: M GBP46 (SD 89)

Informal caregivers

Intervention: M GBP2288 (SD 2254)

Control: M GBP2620 (SD 2247)

Day centre

Intervention: M GBP110 (SD 321)

Control: M GBP115 (SD 290)

Inpatient centre

Intervention: M GBP906 (SD 3173)

Control: M GBP2377 (SD 6265)

Respite care

Intervention: M GBP39 (SD 137)

Control: M GBP110 (SD 255)

Zimmer 1985

US

 
Backwards from deathLast 2 weeks before death

currency: USD, date not stated (study conducted in 1979-1982)
Statistical significance not stated (descriptive data only)

"although the standard costs 'weight' of $300 was used in this analysis for all hospital days, the actual charges per day, taken from the hospital bills of those who were hospitalized, was higher for control than for team patients" (Zimmer 1984, Zimmer 1985)
Mean costs per patient of last 2 weeks before death

Hospital costs

Intervention (n = 21): USD942

Control (n = 12): USD1824

Intervention as % of control: 52%

Mean actual hospital charges per day of patients hospitalised during the last 2 weeks before death

Intervention (n = 5): M USD282; median USD292

Control (n = 6): M USD347; median USD313

Total out-of-home costs

Intervention (n = 21): USD946

Control (n = 12): USD1847

Intervention as % of control: 51%

Total in-home costs

Intervention (n = 21): USD631

Control (n = 12): USD446

Intervention as % of control: 141%

Hughes 1992

US
Forwards from enrolment6 months following enrolment

currency: 1985 USD
Institutional

VA hospital

increased in control group; t 2.47; P value = 0.02

Private hospital

t < 1; "n.s."

Total hospital costs

increased in control group; t 2.09; P value = 0.04

Total institution costs

increased in control group; t 1.99; P value = 0.05

 

Non-institutional

Outpatient clinic

increased in control group; t 2.76; P value = 0.01

HBHC (intervention)

intervention difference (tests not performed)

Community nursing

increased in control group; t 4.86; P value < 0.01

Total home care costs

increased in intervention group; t -5.10; P value < 0.01

 

Total VA costs

t < 1; "n.s."

 

Total non-VA costs

t < 1; "n.s."
Institutional

VA hospital

Intervention (n = 86): M USD1795.07

Control (n = 85): M USD3434.38

Private hospital

Intervention (n = 86): M USD457.56

Control (n = 85): M USD289.68

Total hospital costs (VA and private)

Intervention (n = 86): M USD2251.25

Control (n = 85): M USD3724.06

Total institution costs (all hospital and nursing home)

Intervention (n = 86): M USD2341.79

Control (n = 85): M USD3757.37

Non-institutional

Outpatient clinic

Intervention (n = 86): M USD26.46

Control (n = 85): M USD100.42

HBHC (intervention)

Intervention (n = 86): M USD999.28

Control (n = 85): -

Community nursing

Intervention (n = 86): M USD1.97

Control (n = 85): M USD343.29

Total home care costs (HBHC plus community nurse)

Intervention (n = 86): M USD1001.24

Control (n = 85): M USD343.29

Total VA costs

Intervention (n = 86): M USD2934.52

Control (n = 85): M USD3602.37

 

Total non-VA costs

Intervention (n = 86): M USD544.84

Control (n = 85): M USD646.31

 

"The average general bed costs for HBHC was USD 1,310 as compared to USD 2,807 for controls (t=3.26, df=169, p<0.02)" (Hughes 1992)

Tramarin 1992

Italy
Forwards from enrolment1 year (calculated by multiplying resources used in the 6 months following enrolment by 2)

 

currency: 1990 ITL (million) and 1990 USD (converted from ITL using healthcare-specific purchasing power parities)

 
Statistical significance not stated (descriptive data onlyInpatient care

Intervention:

  • stage 2 patients: ITL5.826 million (95% CI 2.8 to 8.6; USD3795)


  • stage 3 patients: ITL19.744 million (95% CI 5.4 to 34; USD12,863)


Control:

  • stage 2 patients: ITL17.586 million (95% CI 14.2 to 21.4; USD11,457)
  • stage 3 patients: ITL39.578 million (95% CI 32 to 47; USD25,784)


 

Outpatient care

Intervention:

  • stage 2 patients: ITL9.184 million (95% CI 8.2 to 9.8; USD5983)
  • stage 3 patients: ITL2.106 million (95% CI 1.8 to 2.2; USD1372)


Control:

  • stage 2 patients: ITL6.888 million (95% CI 6.6 to 7; USD4487)
  • stage 3 patients: ITL3.040 million (95% CI 2.8 to 3.2; USD1980)


 

Home care (intervention)

Intervention:

  • stage 2 patients: ITL2.368 million (95% CI 2 to 2.4; USD1543)
  • stage 3 patients: ITL4.608 million (95% CI 3.8 to 5.4; USD3002)


Control:

  • stage 2 patients: -
  • stage 3 patients: -


 

"Analysis of cost distribution revealed that personnel salaries accounted for 71 and 19.9% of the total expenditure of the inpatient and outpatient clinics, respectively, for both groups. In the outpatient clinic, most expenses were associated with direct care of patients. Diagnostic examinations and therapy accounted for 48.5% and zidovudine for a further 29.5%" (Tramarin 1992)

Greer 1986

(CBA)
Forwards from enrolmentStudy period

currency: 1982 USD

 

 

 

 

 
Inpatient costs

reduced in intervention groups

"Inpatient and physician costs per study day were significantly higher in CC than in either HC or HB settings" (Greer 1986)

 

Home care costs

statistical significance not stated

 

Physician visit costs

reduced in intervention groups (see above)

 

Outpatient costs

statistical significance not stated

 

Drugs, supplies and equipment expenditures

statistical significance not stated
Inpatient costs

Community-based intervention: USD46 (SE 8.8)

Hospital-based intervention: USD99 (SE 9.6)

Control (conventional care): USD135 (SE 11.6)

 

Home care costs

Community-based intervention: USD54 (SE 4.5)

Hospital-based intervention: USD46 (SE 4.9)

Control (conventional care): USD6 (SE 1.1)

 

"Home care costs per study day in CC were approximately 10% of hospice costs"; "HC patients had more home visits than HB patients, but the difference in home care costs per day was not large enough to counterbalance the large inpatient cost difference" (Greer 1986)

 

Physician visit costs

Community-based intervention: USD9 (SE 1.7)

Hospital-based intervention: USD8 (SE 1.9)

Control (conventional care): USD18 (SE 1.6)

 

Outpatient costs

Community-based intervention: USD1.8 (SE 0.69)

Hospital-based intervention: USD1.2 (SE 0.75)

Control (conventional care): USD3.0 (SE 0.84)

 

Drug, supplies and equipment expenditures

Community-based intervention: USD1.8 (SE 0.51)

Hospital-based intervention: USD0.7 (SE 0.56)

Control (conventional care): USD0.1 (SE 0.60)

 

Note: not clear if the figures are means or medians

 

"Inpatient utilization increased as death approached in each of the systems of care [graphs provided]. Home service use increased dramatically in the last week of life only in the HC sample; during the last week of life, HC patients received an average of one home service visit per day in contrast to one per week for CC and 3.5 per week for HB patients" (Greer 1986)

 CBA: controlled before and after study; CC: conventional care (control); CI: confidence interval; ED: emergency department; GBP: British pound; HBHC = hospital-based home care (intervention); HC: home-based care (community-based intervention); HB: hospital-based (hospital-based intervention); ITL: Italian lira; M: mean; n.s.: non-significant; SD: standard deviation; SE = standard error; USD: United States dollar; VA: Veteran Affairs.