End-of-life care pathways for improving outcomes in caring for the dying

  • Review
  • Intervention

Authors


Abstract

Background

This is an updated version of a Cochrane review first published in Issue 1, 2010 of The Cochrane Library. In many clinical areas, integrated care pathways are utilised as structured multidisciplinary care plans that detail essential steps in caring for patients with specific clinical problems. In particular, care pathways for the dying have been developed as a model to improve care of patients who are in the last days of life. The care pathways were designed with an aim of ensuring that the most appropriate management occurs at the most appropriate time and that it is provided by the most appropriate health professional. There have been sustained concerns about the safety of implementing end-of-life care pathways, particularly in the UK. Therefore, there is a significant need for clinicians and policy makers to be informed about the effects of end-of-life care pathways with a systematic review.

Objectives

To assess the effects of end-of-life care pathways, compared with usual care (no pathway) or with care guided by another end-of-life care pathway across all healthcare settings (e.g. hospitals, residential aged care facilities, community).

In particular, we aimed to assess the effects on symptom severity and quality of life of people who are dying; those related to the care such as families, carers and health professionals; or a combination of these.

Search methods

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 6, 2013), MEDLINE, EMBASE, PsycINFO, CINAHL, review articles and reference lists of relevant articles. We conducted the original search in September 2009, and the updated search in June 2013.

Selection criteria

All randomised controlled trials (RCTs), quasi-randomised trial or high-quality controlled before-and-after studies comparing use versus non-use of an end-of-life care pathway in caring for the dying.

Data collection and analysis

Two review authors assessed the results of the searches against the predetermined criteria for inclusion.

Main results

The original review identified 920 titles. The updated search found 2042 potentially relevant titles (including the original 920), but no additional studies met criteria for inclusion in the review update.

Authors' conclusions

With sustained concerns about the safety of the pathway implementation and the lack of available evidence on important patient and relative outcomes, recommendations for the use of end-of-life pathways in caring for the dying cannot be made. Since the last version of this review, no new studies met criteria for inclusion in the review update. With recently documented concerns related to the potential adverse effects associated with Liverpool Care Pathway (the most commonly used end-of-life care pathway), we do not recommend decision making based on indirect or low-quality evidence. All health services using end-of-life care pathways are encouraged to have their use of the pathway, to date, independently audited. Any subsequent use should be based on carefully documented evaluations. Large RCTs or other well-designed controlled studies are urgently required for the evaluation of the use of end-of-life care pathways in caring for dying people in various clinical settings. In future studies, outcome measures should include benefits or harms concerning the outcomes of interest in this review in relation to patients, families, carers and health professionals.

Plain language summary

End-of-life care pathways for the dying

Background

End-of-life pathways are used for people who are in the last days of their life to guide care, aid decision making and provide efficient care. This review examined whether using end-of-life care pathways in caring for the dying was effective.

Study characteristics

We searched scientific databases for clinical trials in which the effect of the end-of-life care pathway was compared with a control group that received usual care or with trials comparing one end-of-life care pathway with another end-of-life care pathway. Participants were to be patients, carers and families who received care guided by an end-of-life care pathway. There were no restrictions on age of the patient, diagnosis or setting (hospital, home, nursing home).

Key results

We found no studies fitting our criteria.

Quality of evidence

We could not locate any high-quality controlled studies that could answer this important question; despite concerns about the Liverpool Care Pathway (the most commonly used end-of-life care pathway). It is important for health services to base their care on high-quality evidence. Until such evidence is available, the use of end-of-life care pathways should be avoided. Large randomised controlled trials (where patients are allocated to treatments or groups using a random method) or other well-designed controlled studies are required for evaluating the use of end-of-life care pathways in caring for dying people in various clinical settings. Future studies should measure positive as well as negative outcomes for patients, families, carers and health professionals.

Background

This is an updated version of a Cochrane review first published in Issue 1, 2010 of The Cochrane Library (Chan 2010).

Description of the condition

It is well recognised that populations in developed countries are ageing (United Nations 2002). As populations age, the pattern of diseases from which people die also changes (WHO 2004). With advanced ageing, there is an increased risk of death from chronic diseases such as cancer and heart failure. For example, cancer was estimated to account for 7.6 million deaths (12% of all deaths) worldwide in 2008 (WHO and Cancer Research UK 2012). Therefore, palliative care has been identified as one of the worldwide public health priorities due to the ageing population (WHO 2004). While palliative care is concerned with "the quality of life of patients and families who face life-threatening illness, by providing pain and symptom relief, spiritual and psychosocial support from diagnosis to the end of life and bereavement" (WHO 2009), end-of-life care focuses on the last days and hours of life (Lunney 2003). The need to provide high-quality end-of-life care is essential. The needs of dying people may include, but are not limited to, knowing when death is coming, understanding what can be expected, being able to maintain a sense of control and having their wishes given preference, having access to information and excellent care, and having access to spiritual and emotional support as required (Steinhauser 2000; Steinhauser 2001). Quality end-of-life care may vary from person to person and may be difficult to define and measure accurately. However, such care should at least include the following domains: quality of life, physical symptoms, emotional and cognitive symptoms, advanced care planning, functional status, spirituality, grief and bereavement; satisfaction and quality of care, as well as carer's well-being (Mularski 2007).

Obstacles to quality end-of-life care have also been identified and may include failure to recognise treatment futility, lack of communication among decision makers, no agreement on a course of end-of-life care and failure to implement a timely end-of-life plan of care (Travis 2002). In recent years, there has been a variety of initiatives developed worldwide to target such issues by developing systemic approaches towards end-of-life care. These initiatives include programmes such as the National End of Life Care Programme (Department of Health 2008), Gold Standards Framework in Care Homes (Badger 2007), and the Liverpool Care Pathway (Ellershaw 1997; Ellershaw 2003a).

Description of the intervention

Integrated care pathways are documents that outline the essential steps of multidisciplinary care in addressing a specific clinical problem. They can be used to introduce clinical guidelines and systematic audits of clinical practice (Hockley 2005). The Liverpool Care Pathway is an example of an integrated care pathway specifically for the dying phase of palliation.

Historically, dying patients receiving general hospital care tended to lack adequate attention from senior medical staff and nursing staff (Mills 1994). The quality of symptom control and basic nursing care were considered to be inadequate (Mills 1994). It was thought that much could be learned from the way patients were cared for in the hospice movement (Mills 1994). The Liverpool Care Pathway was an example of strategies developed by the Royal Liverpool University Trust UK) and the Marie Curie Centre Liverpool (UK) (Ellershaw 1997; Ellershaw 2003a) based on the care received by people in the hospice setting. Other objectives of the pathway were to promote cost-effective health care by appropriate prescribing, and avoiding crisis interventions and inappropriate hospital admissions. The document is patient-centred and focuses on the holistic needs of people who are dying. It incorporates the physical, psychological, social, spiritual and religious aspects of care (Ellershaw 2007). The Liverpool Care Pathway defines 19 goals considered essential in the management of dying patients and for the care of their relatives/carers after death (Ellershaw 1997; Ellershaw 2003a). These goals were established with the issues identified from surveys, focus groups, expert opinion and consensus best practice.

Later, several other groups developed care pathways for dying people based on the concept of Ellershaw and colleagues (Bookbinder 2005; Fowell 2002; Pooler 2003). While the professional conjecture is that end-of-life care pathways promote best possible patient outcomes (Ellershaw 2007), speculation has suggested possible adverse effects. These controversies included premature use of the pathway leading to death due to the premature diagnosis of imminent death, the care pathway masking the signs in improvement in patients and causing carers' dissatisfaction (Delvin 2009; Smith 2009). There have been substantial concerns raised by the public and by health professionals that have been documented in the UK Government-commissioned, independent review of the Liverpool Care Pathway led by Baroness Julia Neuberger (Neuberger 2013). The panel reviewed multiple sources including: written submissions from the public and health professionals with experience of the Liverpool Care Pathway, the academic literature and hospital complaints. The panel concluded that the Liverpool Care Pathway, used generically for all patients in the last hours or days of life, was the wrong approach (Neuberger 2013). The report also highlighted the complexity around the use of the pathway, specifically highlighting a number of ethical, safety, clinical practice and negligence issues and how inadequately dying is diagnosed in clinical care (Neuberger 2013). As a result of the review in July 2013, the UK government made a decision to phase out the pathway nationally over the next six to 12 months after the release date of the Neuberger 2013 review.

It is particularly important to recognise that an end-of-life care pathway is a complex intervention (McConnell 2013; Medical Research Council 2000). Although there are methodological considerations and challenges, it is still important to conduct as rigorous evaluation as possible to determine the effects (benefits or harms) of the end-of-life care pathways (Currow 2011; Medical Research Council 2000). Therefore, a systematic review is warranted to substantiate claims as to whether the end-of-life care pathways are beneficial or harmful for dying patients and their carers.

How the intervention might work

In many clinical areas, integrated care pathways are utilised as structured multidisciplinary care plans that detail essential steps in caring for patients with specific clinical problems (Campbell 1998). Care pathways for the dying have been developed as a model to improve the end-of-life care of all patients. They ensure that the most appropriate management occurs at the most appropriate time and that it is provided by the most appropriate health professional.

Why it is important to do this review

Two systematic reviews reported that clinical pathways enhance efficiency of care without adverse effects on outcomes among patients who undergo gastrointestinal surgery (Lemmens 2008) and show a significant length of stay reduction in patients who undergo invasive procedures (Rotter 2008). Both of these systematic reviews included evidence involving designs such as randomised controlled trials (RCTs) and other types of controlled studies.

In contrast, one Cochrane systematic review reported that there was no significant benefit in functional outcome and patient satisfaction, and that quality of life might actually be made worse for patients following stroke care pathways (Kawn 2004). Therefore, clinical pathways seem to be beneficial for managing certain clinical problems, but not all.

Clinical pathways for end-of-life care management are used widely around the world and have been set as a part of the end-of-life care policies or strategies in some countries (Department of Health 2008; Department of Health and Ageing 2011; Ministry of Health NZ 2013; National Health Service 2005) There is a significant need for clinicians to be informed about the utilisation of end-of-life care pathways with a systematic review.

Objectives

To assess the effects of end-of-life care pathways, compared with usual care (no pathway) or with care guided by another end-of-life care pathway across all healthcare settings (e.g. hospitals, residential aged care facilities, community).

In particular, we aimed to assess the effects on symptom severity and quality of life of people who are dying; those related to the care such as families, carers and health professionals; or a combination of these.

Methods

Criteria for considering studies for this review

Types of studies

We aimed to include clinical trials in which the effect of the end-of-life care pathway could be compared with a control group that received usual care or with trials comparing one end-of-life care pathway with another end-of-life care pathway. We planned to include RCTs, cluster RCTs and quasi-RCTs.

If limited RCTs and quasi-RCTs were available, we planned to consider including controlled before-and-after studies. The review authors adopted the criteria for inclusion of controlled before-and-after studies from the Cochrane Effective Practice and Organisation of Care Review Group guidelines (EPOC 2002). These criteria include (1) contemporaneous data collection, (2) appropriate choice of control site and (3) a minimum of two intervention sites and two control sites. We did not plan to include any non-controlled studies (EPOC 2002). The analysis for randomised and non-randomised studies were to have been undertaken separately because non-randomised comparisons may overestimate treatment effects (Chalmers 1983; Sacks 1982), and the size and direction of the bias can be unpredictable (Deeks 2003).

Types of participants

We included patients and families who had received care guided by an end-of-life care pathway. We included participants with different diseases such as cancer or organ failure. However, participants who received interventions must have been receiving care guided by an end-of-life care pathway for their last days and hours of life. We applied no restrictions on age of the patient, diagnosis or setting (hospital, home, nursing home).

Types of interventions

The planned comparisons were:

  • intervention (receiving care guided by an end-of-life care pathway) versus usual care;

  • intervention A (pathway A) versus intervention B (pathway B).

An end-of-life care pathway may have been part of a larger intervention; we only included these studies if the effect of the pathway could be isolated.

Types of outcome measures

Primary outcomes
  • Physical symptom severity (measured by any instrument used by the study author such as Edmonton Symptom Assessment Scale (Bruera 1991)), Memorial Symptom Assessment Scale (Portenoy 1994).

  • Psychological symptom severity (measured by any instrument used by the study author. For example, Hospital Anxiety and Depression Scale (Zigmond 1983)).

  • Quality of life (measured by any instrument used by the study author such as McGill Quality of Life Questionnaire (Cohen 1995)).

  • Harms (any adverse effects as determined by the researchers, health professionals or carers/families).

Secondary outcomes
  • Advanced care planning (as measured by whether advanced care planning had happened or not).

  • Communication between healthcare teams and families (as measured by the occurrence of any family meetings).

  • Carer's well-being.

  • Grief and bereavement.

  • Patient/staff/carer's satisfaction.

  • Staff confidence.

  • Cost of intervention.

  • Cost of care.

  • Medication/treatment use.

  • Spiritual needs.

We planned to include any tools used by the study authors of the included studies. We would have discussed the validity and reliability of the tools used in the appraisal of studies.

Search methods for identification of studies

The search was run for the original review in September 2009 and the subsequent search was run in June 2013.

Electronic searches

We searched:

  • the Cochrane Central Register of Controlled Trials (CENTRAL) up to Issue 6, 2013;

  • MEDLINE (1950 to 18 June 2013);

  • EMBASE (1980 to 18 June 2013);

  • PsycINFO (1980 to 18 June 2013);

  • CINAHL (1982 to 18 June 2013).

We developed the search strategy to comprise searches for both keywords and medical subject headings under existing database organisational schemes. The strategies for each database are presented in Appendix 1, Appendix 2, Appendix 3, Appendix 4 and Appendix 5. We applied no restrictions by language. We translated foreign language abstracts for the application of the inclusion and exclusion criteria, and, where necessary, we planned to translate the methods, results and discussion sections for inclusion in the review.

Searching other resources

We searched the reference lists of any relevant reviews or other studies, scanning paper issues of journals relevant to interventions of end-of-life care pathway and scanning abstracts from relevant conference proceedings. We also contacted experts in the field and would have contacted authors of included studies for advice as to other relevant studies. We also used Google to search the World Wide Web, Caresearch (www.caresearch.com.au), the ProQuest Dissertations and Theses database for grey literature and conference abstracts. We searched databases in TrialsCentral (www.trialscentral.org), the World Health Organization's (WHO) Clinical Trial Search Portal (www.who.int/trealsearch), and Current Controlled Trials (www.controlled-trials.com) to identify ongoing or recently completed studies. We planned, if applicable, to present relevant ongoing studies in a table in the review.

Data collection and analysis

Selection of studies

Two review authors pre-screened all search results (titles and abstracts) for possible inclusion, and those selected by either or both review authors were subject to full-text assessment. Two review authors independently assessed the selected articles for inclusion. We had planned to resolve any discrepancies by consensus, overseen by a third review author acting as arbiter, with approval by one review author and the arbiter being sufficient. We had also planned to list those studies excluded after full-text assessment in the table Characteristics of excluded studies, giving reasons for exclusion.

Data extraction and management

We developed a data extraction form based on the Cochrane Pain, Palliative and Supportive Care Review Group's template. We planned to extract the following main sets of data from each included study:

  • lead author;

  • date;

  • study participant inclusion criteria;

  • participants (participant diagnoses/condition(s) and demographics: race/ethnicity, gender, religion/culture, socioeconomic status, age);

  • study design and timetable, randomisation, allocation concealment;

  • interventions (end-of-life care pathway type);

  • intervention setting (hospital, home, residential aged care facilities);

  • numbers of participants in each trial arm, withdrawals and drop-outs;

  • outcome measures; time(s) at which outcomes were assessed.

At least two review authors were to have independently extracted data on to the data extraction form. Any discrepancies would have been referred to a third review author and any errors or inconsistencies resolved. The first review author was to have entered the data into Review Manager 5 (RevMan 2012), with another review author checking accuracy of the data entered.

Assessment of risk of bias in included studies

We intended to assess and report on the risk of bias of included studies in accordance with the guidelines in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011), which recommends the explicit reporting of the following individual domains:

The criteria for RCTs were:

  • sequence generation;

  • allocation concealment;

  • blinding of participants, personnel and outcome assessors (assessed for each main outcome or class of outcome);

  • incomplete outcome data (assessed for each main outcome or class of outcome);

  • selective outcome reporting;

  • other sources of bias.

The criteria for controlled before-and-after studies were:

  • baseline measurement of outcomes;

  • baseline characteristics of studies using second site as control;

  • protection against exclusion or selection bias;

  • protection against contamination;

  • reliable primary outcomes measures;

  • appropriate analysis of data.

We would have examined and reported the following:

  • validation and reliability of outcome measures;

  • whether the study obtained ethics committee approval and ensured informed consent for participation;

  • use of standardised protocols for information delivery. We were to have checked for consistency of the delivery of interventions where possible.

Two review authors would have independently assessed the risk of bias in included studies, with any disagreements resolved by discussion and consensus, and with a third review author acting as arbiter. We planned to present our assessment in 'Risk of bias' tables for each included study. We would have contacted study authors for additional information about the study methods as necessary. We would have incorporated the results of the risk of bias assessment into the review through narrative description and commentary about each of the items mentioned.

Measures of treatment effect

For individual studies, effect measures for categorical outcomes were to include risk ratio (RR) with their 95% confidence intervals (CI). For statistically significant effects, we would have calculated number needed to treat for an additional beneficial effect (NNTB). If possible, for continuous outcomes, the effect measure was to have been mean difference (MD) or, if the scale of measurement differed across trials, standardised mean difference (SMD), each with its 95% CI. For meta-analyses (see below), for categorical outcomes, we would have calculated typical estimates of RR with their 95% CI; and for continuous outcomes, we would have calculated the mean difference (MD) or a summary estimate for SMD, each with its 95% CI.

We would have analysed data using The Cochrane Collaboration's Review Manager 5 software (RevMan 2012).

Unit of analysis issues

We would have checked unit of analysis issues if we had found cluster randomised trials. We did not expect to find cross-over trials for this type of intervention due to the end-of-life pathway nature. If cluster randomised trials had been identified, we would have reported the intracluster correlation coefficient and adjusted for clustering if possible. Alternatively, we would have presented the cluster randomised studies as point estimates of the intervention effect without any statistical analysis or CIs.

Dealing with missing data

If some outcome data remained missing despite our attempts to obtain complete outcome data from authors, we would have performed an available-case analysis, based on the numbers of participants for whom outcome data were known. If standard deviations (SD) were missing, we would have imputed them from other studies, or where possible, computed them from standard errors (SE) using the formula SD = SE x √¯N, where these were available (Higgins 2011). We also planned to report on levels of drop-outs in the intervention and comparison groups as an indicator of 'acceptability' of the intervention, and the likelihood of bias.

Assessment of heterogeneity

We would have tested heterogeneity using the Chi2 statistics and any heterogeneity was to have been further quantified with the I2 statistic (which describes the percentage of the variability in effect estimates that is due to heterogeneity rather than sampling error). We would have considered a value greater than 50% as representing substantial heterogeneity (Higgins 2011).

Assessment of reporting biases

We would have assessed reporting bias using guidelines in Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). We did not expect to find a large number of studies, so we thought it was unlikely that publication or inclusion bias would be assessed. However, we planned to do a funnel plot if enough studies were available to do a meaningful assessment of publication bias.

Data synthesis

If studies had been sufficiently similar in terms of population, inclusion criteria, interventions, outcomes (including the time(s) at which these are assessed), or a combination of these, we would have considered pooling the data statistically using meta-analysis. We would have reported the results of the individual trials separately where the outcome data were unsuitable for meta-analysis. We planned to use fixed-effect models when population measures were similar and random-effects models where population parameters varied from study to study.

Subgroup analysis and investigation of heterogeneity

We would have conducted subgroup analyses if sufficient data could support the analyses. Subgroups may have included disease types and settings where care was received.

Sensitivity analysis

If there were other sources of heterogeneity, we planned to explore further by using sensitivity analysis to determine the effects of the end-of-life care pathways, overall methodological quality and use of intention-to-treat analysis. We would have removed studies with high attrition rates (over 50%) from the meta-analysis to determine whether the results would be significantly different without them.

Results

Description of studies

See: 'Characteristics of included studies'; 'Characteristics of excluded studies'; 'Characteristics of ongoing studies'.

Results of the search

We found and assessed 2042 titles and abstracts in electronic format (including the 920 retrieved for the original review).

Included studies

We found no studies fulfilling the study eligibility criteria.

Excluded studies

We excluded 28 studies in the original review and 32 in the update because the study designs did not meet the criteria for included studies. We excluded three controlled before-and-after studies because they did not meet the minimum criteria to be included in this review. These criteria include (1) contemporaneous data collection, (2) appropriate choice of control site and (3) a minimum of two intervention sites and two control sites (EPOC 2002).

Risk of bias in included studies

We found no included studies, so could not evaluate bias.

Effects of interventions

We found no included studies.

Discussion

In this update, we identified no new RCTs, quasi-experimental studies or controlled before-and-after studies meeting our eligibility criteria for this review. Although the UK government has made a decision to phase out the Liverpool Care Pathway (the most commonly used end-of-life care pathway) in the UK, such decisions have not been made in other countries. With a number of safety concerns reported by Neuberger's report and the lack of evidence (Neuberger 2013), it is extremely difficult to determine whether the suggested negative consequences associated with the Liverpool Care Pathway are associated with the actual pathway-based care; poor implementation of pathway-based care; the emotional consequences of illness, death and bereavement; or a combination of these (Parry 2013). There is an urgent need for rigorous research to answer several key questions: do the adverse findings from Neuberger's report apply to countries other than the UK and, if so, to what extent? What are the differences in outcomes between the Liverpool Care Pathway and other end-of-life care pathways? Are the outcomes for dying patients who are placed on an end-of-life care pathway different to those receiving usual care? If the answers to these questions are 'yes': are the right people put on the end-of-life care pathway at the right time in their illness trajectory? In which settings should an end-of-life care pathway be used? How senior should the clinicians be and how much history of this patient should they have before an end-of-life care pathway is initiated?

The results of a number of case series and non-eligible controlled or non-controlled before-and-after studies indicated that end-of-life care pathways may have the potential to improve symptom management (Bailey 2005; Veerbeek 2008); clinical documentation and assessment (Bookbinder 2005; Luhrs 2005; Veerbeek 2008); knowledge of end-of-life care among internal medicine students (Okon 2004); prescription of medications for end-of-life (Bailey 2005; Mirando 2005); bereavement levels of relatives (Veerbeek 2008a); and outcomes in relation to respect, kindness, dignity, family emotional support, family self efficacy and co-ordination of care (Costantini 2013a). However, the effects of pathways are difficult to ascertain from these designs. Moreover, none of the excluded studies reported the adverse effects of any end-of-life care pathway.

It is well accepted that designing and conducting trials involving the dying is difficult and challenging due to methodological and ethical issues (Fowell 2004; Karlawish 2003). These issues may include difficult patient recruitment due to the patient being too ill to participate or unable to give informed consent, or the heterogeneous nature of palliative populations (Addington-Hall 2007). However, researchers should attempt to investigate end-of-life interventions with the most rigorous research methodology possible. For example, cluster randomised trials across multiple centres may be considered. One feasibility study revealed that cluster randomised trials are possible and may be more effective in recruiting patients in this population than randomised consent (Fowell 2006). Randomised consent requires informed consent after randomisation, but only if the patient is to receive the experimental treatment (Zelen 1990). Moreover, a range of other strategies can also be considered to make clinical trials possible. These include designing a shorter term study, limiting the number of outcomes, undertaking frequent follow-ups, advanced consent and proxy consent where appropriate for studies involving this population (Reyna 2008). Although the challenges in conducting clinical research for the dying are well recognised (Constantini 2011), one Italian research team acknowledges the importance of generating high-quality evidence to inform practice in this area and has completed a phase III cluster RCT to test the effectiveness of the Liverpool Care Pathway (Costantini 2013a). However, at the time of this update being finalised, the final report of the Costantini 2013a trial had not been published.

Authors' conclusions

Implications for practice

Although strong evidence supporting end-of-life care pathways is lacking, the principles underpinning such pathways remain relevant. Plans for end-of-life care should be developed in open consultation with the patient and significant others. All health services using an end-of-life care pathway are encouraged to have their use of the pathway, to date, independently audited, with particular emphasis on the Neuberger's findings (Neuberger 2013). Any subsequent use should be based on carefully documented prospective evaluations.

Implications for research

Although high-level evidence is currently unavailable, existing research may be used to inform the development of any future trials. There remains an urgent need for large RCTs or other well-designed controlled studies for the evaluation of the use of end-of-life care pathways in caring for dying people. Such evaluations might be difficult in countries where end-of-life care pathways are embedded in practice or are being withdrawn. However, it remains important to test the effectiveness of end-of-life care pathways where possible. To ensure generalisability, such trials should stratify participants according to different care settings including general acute care setting, emergency department, cancer care units, residential aged care facilities and specialist palliative care units. Additionally, if such studies demonstrate positive effects, it is imperative that there is careful ongoing evaluation of the implementation of any revised pathway as it is made available more broadly. In future studies, outcome measures should include the outcomes of interest in this review in relation to patients, families, carers and health professionals. These may include patients' symptom control, harms, communication between healthcare team and families, carer's well-being, grief and bereavement, staff and carers' satisfaction, staff confidence, cost of intervention, cost of care and medication use. Further, investigations of the effects of such pathways for specific populations are warranted. These specific populations may include, but are not limited to, children and patients with end-stage organ failure or dementia.

Acknowledgements

The authors would like to acknowledge the contribution of the Cochrane Pain, Palliative and Supportive Care Review Group and the Cochrane Effective Practice and Organisation of Care Review Group. In particular, we would like to thank Phil Wiffen, Professor Christopher Eccleston, Jessica Thomas, Joanne Abbott, Laila Tyrrell, Caroline Struthers and all the referees for their valuable input (peer reviewers for the original review: Bridget Candy and Alain Mayhew; consumer referees: Kathy Smith and Clare Jeffrey).

Data and analyses

Download statistical data

This review has no analyses.

Appendices

Appendix 1. CENTRAL search strategy

#1 MeSH descriptor: [Palliative Care] this term only

#2 palliat*

#3 end-of-life

#4 terminally ill

#5 MeSH descriptor: [Terminally Ill] this term only

#6 dying

#7 hospice

#8 MeSH descriptor: [Hospices] explode all trees

#9 end-stage

#10 #1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9

#11 MeSH descriptor: [Critical Pathways] this term only

#12 ((clinical or critical or care) next path*)

#13 (care next (map* or plan*))

#14 MeSH descriptor: [Guideline] explode all trees

#15 MeSH descriptor: [Health Planning Guidelines] this term only

#16 MeSH descriptor: [Guideline Adherence] this term only

#17 (compliance next (protocol* or policy or guideline*))

#18 (guideline* near/2 (introduc* or issu* or impact or effect* or disseminat* or distribut* or implement*))

#19 "nursing protocol*"

#20 "professional standard*"

#21 (practice guidelin* or practice protocol* or clinical practice guidelin*)

#22 #11 or #12 or #13 or #14 or #15 or #16 or #17 or #18 or #19 or #20 or #21

#23 #10 and #22

Appendix 2. MEDLINE and MEDLINE In-progress (Ovid) search strategy

Database: Ovid MEDLINE(R)

1 Palliative Care/ or palliat$.mp.

2 end-of-life.mp.

3 terminally ill.mp. or Terminally Ill/

4 dying.mp.

5 hospice.mp. or Hospices/

6 end-stage.mp.

7 or/1-6

8 Critical Pathways/

9 ((clinical or critical or care) adj path$).mp.

10 (care adj (map$ or plan$)).mp.

11 exp Guideline/

12 Health Planning Guidelines/

13 Guideline Adherence/

14 (compliance adj (protocol? or policy or guideline?)).mp.

15 (guideline? adj2 (introduc$ or issu$ or impact or effect? or disseminat$ or distribut$ or implement$)).mp.

16 nursing protocol?.mp.

17 professional standard$.mp.

18 (practice guidelin$ or practice protocol$ or clinical practice guidelin$).mp.

19 or/8-18

20 Guideline.pt.

21 randomized controlled trial.pt.

22 controlled clinical trial.pt.

23 Intervention Studies/

24 experiment$.mp.

25 (time adj series).mp.

26 (pre test or pretest or post test or posttest).mp.

27 Random Allocation/

28 impact.mp.

29 intervention?.mp.

30 Evaluation Studies/

31 Comparative Study.pt.

32 Humans/

33 or/20-31

34 7 and 19 and 32 and 33 (1096)

Appendix 3. EMBASE (Ovid) search strategy

1 Palliative Care/ or palliat$.mp.

2 end-of-life.mp.

3 terminally ill.mp. or Terminally Ill/

4 dying.mp.

5 hospice.mp. or Hospices/

6 end-stage.mp.

7 or/1-6

8 Critical Pathways/

9 ((clinical or critical or care) adj path$).mp.

10 (care adj (map$ or plan$)).mp.

11 exp Practice Guideline/

12 Health Planning Guidelines/

13 Guideline Adherence/

14 (compliance adj (protocol? or policy or guideline?)).mp.

15 (guideline? adj2 (introduc$ or issu$ or impact or effect? or disseminat$ or distribut$ or implement$)).mp.

16 nursing protocol?.mp.

17 professional standard$.mp.

18 (practice guidelin$ or practice protocol$ or clinical practice guidelin$).mp.

19 or/8-18

20 randomized controlled trial/

21 controlled clinical trial/

22 Intervention Studies/

23 experiment$.mp.

24 (time adj series).mp.

25 (pre test or pretest or post test or posttest).mp.

26 Random Allocation/

27 impact.mp.

28 intervention?.mp.

29 Evaluation Studies/

30 comparative study/

31 Humans/

32 or/20-30

33 7 and 19 and 32 and 31

Appendix 4. PsycINFO (Ovid) search strategy

1 Palliative Care/ or palliat$.mp.

2 end-of-life.mp.

3 terminally ill.mp. or Terminally Ill/

4 dying.mp.

5 hospice.mp. or Hospices/

6 end-stage.mp.

7 or/1-6

8 ((clinical or critical or care) adj path$).mp.

9 (care adj (map$ or plan$)).mp.

10 (compliance adj (protocol? or policy or guideline?)).mp.

11 (guideline? adj2 (introduc$ or issu$ or impact or effect? or disseminat$ or distribut$ or implement$)).mp.

12 nursing protocol?.mp.

13 professional standard$.mp.

14 (practice guidelin$ or practice protocol$ or clinical practice guidelin$).mp.

15 (or/8-9) or (or/10-14)

16 7 and 15

Appendix 5. CINAHL (EBSCO) search strategy

S38 S23 AND S36 AND S37 Search modes - Boolean/Phrase Interface - EBSCOhost

S37 S24 OR S25 OR S26 OR S27 OR S28 OR S29 OR S30 OR S31 OR S32 OR S33 OR S34 OR S35 Search modes - Boolean/Phrase Interface - EBSCOhost

S36 (MH "Human") Search modes - Boolean/Phrase Interface - EBSCOhost

S35 PT comparative study Search modes - Boolean/Phrase Interface - EBSCOhost

S34 (MH "Evaluation Research") Search modes - Boolean/Phrase Interface - EBSCOhost

S33 intervention* Search modes - SmartText Searching Interface - EBSCOhost

S32 intervention* Search modes - Boolean/Phrase Interface - EBSCOhost

S31 impact Search modes - Boolean/Phrase Interface - EBSCOhost

S30 (MH "Random Assignment") Search modes - Boolean/Phrase Interface - EBSCOhost

S29 (pre test or pretest or post test or posttest) Search modes - Boolean/Phrase Interface - EBSCOhost

S28 "time series" Search modes - Boolean/Phrase Interface - EBSCOhost

S27 experiment* Search modes - Boolean/Phrase Interface - EBSCOhost

S26 (MH "Experimental Studies") Search modes - Boolean/Phrase Interface - EBSCOhost

S25 PT randomized controlled trial Search modes - Boolean/Phrase Interface - EBSCOhost

S24 PT guideline Search modes - Boolean/Phrase Interface - EBSCOhost

S23 S22 Limiters - Published Date from: 20090801-20130131

Search modes - Boolean/Phrase Interface - EBSCOhost

S22 (S10 AND S21) Search modes - Boolean/Phrase Interface - EBSCOhost

S21 S11 OR S12 OR S13 OR S14 OR S15 OR S16 OR S17 OR S18 OR S19 OR S20 Search modes - Boolean/Phrase Interface - EBSCOhost

S20 ("practice guidelin*" or "practice protocol*" or "clinical practice guidelin*") Search modes - Boolean/Phrase Interface - EBSCOhost

S19 "professional standard$" Search modes - Boolean/Phrase Interface - EBSCOhost

S18 "nursing protocol?" Search modes - Boolean/Phrase Interface - EBSCOhost

S17 (guideline? N2 (introduc* or issu* or impact or effect? or disseminat* or distribut* or implement*)) Search modes - Boolean/Phrase Interface - EBSCOhost

S16 (compliance N1 (protocol? or policy or guideline?)) Search modes - Boolean/Phrase Interface - EBSCOhost

S15 (MH "Guideline Adherence") Search modes - Boolean/Phrase Interface - EBSCOhost

S14 (MH "Practice Guidelines") Search modes - Boolean/Phrase Interface - EBSCOhost

S13 "care map*" or "care plan*" Search modes - Boolean/Phrase Interface - EBSCOhost

S12 "clinical path*" or "critical path*" or "care path*" Search modes - Boolean/Phrase Interface - EBSCOhost

S11 (MH "Critical Path") Search modes - Boolean/Phrase Interface - EBSCOhost

S10 S1 OR S2 OR S3 OR S4 OR S5 OR S6 OR S7 OR S8 OR S9 Search modes - Boolean/Phrase Interface - EBSCOhost

S9 end-stage Search modes - Boolean/Phrase Interface - EBSCOhost

S8 (MH "Hospices") Search modes - Boolean/Phrase Interface - EBSCOhost

S7 hospice Search modes - Boolean/Phrase Interface - EBSCOhost

S6 dying Search modes - Boolean/Phrase Interface - EBSCOhost

S5 (MH "Terminally Ill Patients") Search modes - Boolean/Phrase Interface - EBSCOhost

S4 "terminally ill" Search modes - Boolean/Phrase Interface - EBSCOhost

S3 end-of-life Search modes - Boolean/Phrase Interface - EBSCOhost

S2 Palliative Care Search modes - Boolean/Phrase Interface - EBSCOhost

S1 (MH "Palliative Care") Search modes - Boolean/Phrase Interface - EBSCOhost

What's new

DateEventDescription
27 November 2013AmendedThis review will be updated in 2014. See Published notes.

History

Protocol first published: Issue 4, 2009
Review first published: Issue 1, 2010

DateEventDescription
23 August 2013New search has been performedA new search was run in June 2013 but no new studies met criteria for inclusion in the review update.
15 August 2013New citation required but conclusions have not changedNew Citation: Conclusion not changed

Contributions of authors

Writing the protocol: RC, JW.
Developing the search strategy: RC and Joanne Abbott, the Trials Search Co-ordinator, Cochrane Pain, Palliative and Supportive Care Group.
Searching for trials: RC, JW.
Selecting trials: RC, JW.
Data entry: RC, JW.
Analysis: RC, JW.
Interpreting analysis: RC, JW.
Drafting final review: RC, JW.
Updating the review: RC, JW.

Declarations of interest

None known.

Sources of support

Internal sources

  • Cancer Care Services, Royal Brisbane and Women's Hospital, Brisbane, Australia.

    For funding the salary and facilities for RC to conduct this systematic review

  • Centre for Clinical Nursing, Royal Brisbane and Women's Hospital, Brisbane, Australia.

    For funding the salary and facilities for JW to conduct this systematic review

External sources

  • No sources of support supplied

Notes

This updated review has been amended (November 2013) to align the 'Date of search' with the 'Date assessed as up to date'. In light of the recent publication of Costantini 2013, this review will be updated again in 2014 in order to include the results from this trial.

Characteristics of studies

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Bailey 2005Before and after study (without control)
Bookbinder 2005Controlled before-and-after study: non-contemporaneous data collection, non-comparable sampling
Chaplin 2009Non-experimental study: case report
Costantini 2013aBefore-and-after study (without control)
Di Leo 2013Non-experimental study: implementation phase 0-1 study (without control)
Ellershaw 1997Non-experimental study: case report
Ellershaw 2001Non-experimental study: audit
Ellershaw 2003Review
Ellershaw 2007Letter
Fowell 2002Non-experimental study: audit
Fowell 2003Non-experimental study: audit
Hardy 2007Non-experimental study: audit
Hockley 2005Non-experimental study: qualitative study
Horey 2012Non-experimental study
Jack 2003Non-experimental study: qualitative study/focus groups
Johnson 2004Non-experimental study: cross-sectional survey study
Luhrs 2005Controlled before-and-after study: non-contemporaneous data collection, non-comparable sampling and does not have at least 2 intervention and 2 control sites
Main 2006Non-experimental study: case report
Matthews 2006Non-experimental study: audit
Mellor 2004Qualitative study
Mirando 2005Non-experimental study: audit
Neo 2012Non-experimental study: retrospective audit
Okon 2004Controlled before-and-after study: does not have at least 2 intervention and 2 control sites
Osterlind 2008Non-experimental study: qualitative study
Peterson 2000Non-experimental study: case report
Pooler 2003Non-experimental study: audit
Rose 2006Non-experimental study: audit
Taylor 2007Before-and-after study (without control)
Thompson-Hill 2009Before-and-after study (without control)
Veerbeek 2006Non-experimental study: audit
Veerbeek 2008Before-and-after study (without control)
Veerbeek 2008aBefore-and-after study (without control)

Characteristics of studies awaiting assessment [ordered by study ID]

Costantini 2013

  1. a

    LCP-I: Liverpool Care Pathway - Italian; PCU: palliative care unit.

MethodsThis is a randomised cluster trial, stratified by regions and matched for assessment period. Pairs of eligible medical wards from different hospitals will be randomised to receive the LCP-I programme or no intervention until the end of the trial. The LCP-I programme will be implemented by a PCU
Participants

Participants are pairs of medical wards from different hospitals, that fulfil the eligibility criteria

Inclusion criteria:

  • classified in the regional records as 'Medical', 'General Medical' or 'Internal Medical'

  • at least 25 cancer deaths on the ward per year. The data can be estimated from a review of deaths occurring on the ward over a minimum 6-month period during the 2 years preceding the start of the trial

  • consent from the hospital management to participate to the trial

  • consent from the head of the medical ward to participate to the trial

  • consent from an expert and skills-trained PCU to implement the LCP-I programme

Exclusion criteria:

  • if in the same hospital another medical ward has already been randomly selected to participate in the research programme (regardless of which arm was randomised)

InterventionsThe LCP-I programme: a continuous quality improvement programme of end-of-life care implemented by a PCU in a hospital medical ward. The programme is a complex intervention involving implementation project on the ward, induction of the programme, intensive education programme, clinical implementation of the LCP-I documentation with intensive support to the ward staff, evaluation and further training and consolidation exercises
Outcomes

Primary outcomes:

The quality of end-of-life care:

  • the Global Scale of the "Toolkit After-death Bereaved Family Member Interview" (Teno 2001)

  • the Global Scale of the Toolkit is a combination of 6 items that are evaluated at the end of the interview on a 0-10 scale (see page 15 of the Toolkit). The scores of the 6 items are added up and linearised on a 0-100 scale where 0 = poor quality and 100 = high quality of care. Where answers are missing for 1 or more of the 6 items, the score is estimated for the item for which valid answers are available. To calculate the score on the Global Scale a minimum of 4 valid answers out of 6 are necessary

The quality of the end-of-life care provided to dying patients:

  • the Global Scale of the Toolkit, as expressed on a 0-100 scale where 0 = poor quality and 100 = excellent quality of care

NotesTrial registration: ClinicalTrials.gov Identifier: NCT01081899

Ancillary