Personalised care planning for adults with chronic or long-term health conditions

  • Protocol
  • Intervention

Authors


Abstract

This is the protocol for a review and there is no abstract. The objectives are as follows:

To assess the effects of personalised care planning for patients with long-term health conditions, as compared to forms of care in which active involvement of patients in treatment and management decisions (at least in goal setting and action planning) is not explicitly attempted or achieved.

We will address the following primary research questions:

  • Is personalised care planning effective for improving physical health (e.g. lipid measurements)?

  • Is personalised care planning effective for improving psychological health (e.g. anxiety and depression)?

  • Is personalised care planning effective for improving psychosocial health (e.g. quality of life)?

  • Is personalised care planning effective for improving patients' capabilities for self-managing their condition?

We will also look for evidence to address the following secondary research questions:

  • Is personalised care planning effective for improving patients' health-related behaviours?

  • How does personalised care planning impact on rates of use and costs of formal health services?

  • What is the relative effectiveness of different types of intervention used to promote personalised care planning?

Background

Description of the condition

The treatment and management of long-term health conditions (including those associated with physical, psychological, sensory, or cognitive problems) is the greatest challenge facing health systems around the world today (UN Secretary General 2011). Strategies used by health professionals to engage, support and empower people with long-term conditions have an important role in improving health outcomes (Wanless 2002; George Institute 2011). Patients who are better informed, more involved in decisions about their care and more 'activated' (i.e. recognise that they have an important role in self-managing their condition(s) and have the skills and confidence to do so) (Hibbard 2004) will experience improved health and better quality of life (Michie 2003; Schmittdiel 2008). Strengthening patients' autonomy and capacity to self-manage their health is pivotal to policymakers' attempts to control healthcare costs, particularly in times of economic recession. Some policymakers hope that this may also help to tackle unacceptable health inequalities between socioeconomic groups (Department of Health 2009).

The Chronic Care Model, which has been highly influential internationally, stresses the need to transform health care for people with long-term health conditions from a system that is largely reactive, responding mainly when a person is sick, to one that is much more proactive, focused on supporting patients' ability to self-manage their health (Wagner 1998; Epping-Jordan 2004; Nolte 2008). The model advocates an active role for patients, who are encouraged to become both more knowledgeable about factors affecting their condition(s) (including strategies for preventing exacerbations or ameliorating symptoms), and more actively involved in decisions about their care. The clinician's responsibility is to gauge the extent of the patient's knowledge, skills and confidence to self-manage his or her health, to strengthen this where necessary, and to ensure that relevant interventions and support services are available (Von Korff 1997; Department of Health 2011; Year of Care 2011). At the heart of the model is an informed, activated patient, supported by a well-prepared, proactive primary care team, working together to develop and implement a personalised care plan.

The rising prevalence of multi-morbidity makes the search for effective ways of developing personalised approaches even more important. Demographic change and longer life expectancy means that increasing numbers of people have more than one chronic condition, requiring specially tailored approaches to the management of complex combinations of conditions and treatment strategies (Barnett 2012). The specialty-led, single disease framework that characterises the organisation of most medical care is outdated. Ideally, care for people with multiple chronic conditions should be holistic: person-focused rather than disease-focused, and responsive to individuals' experiences of illness and treatment effects and their personal priorities (Mangin 2012). 

In managing long-term health conditions, the aims are: to minimise the negative impacts and maximise the potential for improved functioning and well-being; to strengthen people's capabilities for self-managing their condition; to reduce health risks by improving health-related behaviours; and to minimise dependence on resource-intensive, costly health services. Personalised care planning is seen as a promising way to achieve these goals.

Description of the intervention

Personalised (or collaborative) care planning aims to ensure that patients' values and concerns shape the way chronic conditions are managed. Instead of focusing on a standard set of disease management processes determined by clinicians, this approach encourages patients to select treatment goals and to work with clinicians to determine their specific needs for treatment and support (Reuben 2012). The process involves a shift from reactive care (waiting for patients to consult with symptoms) to a proactive approach in which patients are invited to attend specially scheduled care planning consultations. For the purpose of this review, we define personalised care planning as: an anticipatory (forward-looking), negotiated discussion or series of discussions between a patient and a health professional (perhaps with other professional or family members present) to clarify goals, options and preferences and develop an agreed plan of action based on this mutual understanding. 

In personalised care planning, patients and clinicians identify and discuss problems caused by or related to the patient’s condition(s), giving due consideration to both clinical tests and treatments and patients' accounts of the practical, social, and emotional effects of their condition(s) and treatment(s) on their daily lives. They then engage in a shared decision-making process involving goal setting and action planning, focused on determining priorities, agreeing realistic objectives, solving specific problems, and identifying relevant sources of support. In some cases a family member, carer/caregiver, or friend may also be included in the discussion. Management options and support needs under discussion might include any or all of the following:

  • clinical tests and treatments,

  • self-management information,

  • education or support,

  • strategies for modifying health-related behaviours, managing stress, or solving practical problems.

A collaborative process in which patient and clinician discuss treatment or management goals (goal setting- see B below) and agree a plan for tackling these (action planning - see C below) are the essential features, but the full process may involve any of the following steps (see Figure 1):

Figure 1.

Conceptual model

  • A. Preparation: The patient may be invited to a preliminary appointment to check their progress and undergo relevant clinical tests. Information (printed, electronic, written, or verbal) may be provided before or during the care planning appointment, to encourage the patient to reflect on his or her condition. This might include test results, and information about treatment options, or about health-related behaviours such as diet, exercise or smoking.

  • B. Goal setting: Aimed at agreeing treatment or management goals, the goal setting process involves eliciting and clarifying patients' understanding of their condition, their values, outcome preferences and priorities. Patients may be encouraged to talk about their experience of living with the condition, their beliefs and concerns, and their comprehension of, and reactions to the information provided.The discussion of what matters to them may cover treatment or management options, desired outcomes, lifestyle or behaviour changes, practical, social and emotional challenges, and problem solving strategies. In personalised care planning, patients have scope to influence the agenda for discussion, and the choice of goals and priorities is not restricted to a pre-specified list of professionally-determined options.

  • C. Action planning: A plan is jointly developed for working towards agreed goals. This may include identifying practical ways in which the patient can achieve their behavioural goals (for example, how and when to take more exercise), referring the patient to external sources of support, either within formal health services (for example, health coaching or rehabilitation services), or in the community (for example, exercise or cookery classes), or peer support. The plan may also include clinician-ordered tests or treatments, referral to other clinical specialists or professionals, educational materials or courses, access to aids or appliances, care assistance or domestic help.

  • D. Documenting: The agreed actions are usually documented in a specially designed record (printed, electronic, or written) for use by clinician(s) involved in the patient's care and/or for use by the patient as an aide-mémoire. These may be either a single shared record, or two separate records containing appropriate detail for clinician or patient.

  • E. Coordinating: The clinician ensures that all agreed tests, treatments, interventions, education or support packages agreed in the action plan are available to the patient and provided in a well-coordinated fashion. This may include input from multi-disciplinary team members, from hospital- or community-based specialists, from educationalists and other staff, or from community organisations or support groups.

  • F. Supporting: Patient and clinician agree a schedule for regular, systematic follow-up that may involve a number of contacts (face-to-face, telephone, or electronic) to provide appropriate support to help the patient solve problems and achieve his or her goals. This might take the form of health coaching, motivational support, problem solving, or simply checking and reinforcing progress in implementing the agreed plan.

  • G. Reviewing: A meeting (face-to-face or remote) during which patient and clinician jointly review progress and plan next steps.

How the intervention might work

Personalised care planning aims to ensure that patients receive appropriate support for self-managing their condition alongside any necessary clinical treatments from health professionals. The principles of self-management have been developed in a number of theoretical models, mostly from the fields of psychology and behavioural science. These focus on understanding the factors that shape behaviour and those that might help people make the necessary adaptations to improve their health and ability to cope with illness and disability. Of these, Bandura's Social Cognitive Theory (Bandura 1977), Prochaska and DiClemente's 'Stages of Change' trans-theoretical model (Prochaska 1992), and Leventhal's Self-Regulation Theory (Leventhal 1998) are most often referred to. Taken together, these point to the importance of a sense of control or empowerment that can give people the confidence and motivation to take on and persist with new and difficult tasks. Interventions focus on confidence-building and equipping patients with the knowledge and skills to set personal goals and develop effective problem-solving strategies.

A commitment by both clinician and patient to shared decision making is considered essential for personalised care planning. The process is unlikely to succeed if either party is reluctant to participate. In shared decision making, clinicians and patients work together to understand problems, preferred goals and outcomes, sharing information and identifying options with the aim of reaching mutual agreement on the best course of action for the individual patient (Charles 1999; Glasgow 2005; Elwyn 2012b; Entwistle 2012; Mulley 2012). This approach recognises explicitly that it is usually appropriate to enable patients to make decisions about their care, ensuring they are well-informed and well-supported in the process of deliberation and decision making. Shared decision making takes as its starting point the notion that two types of expertise should be involved in selecting treatment or management options. Clinicians' expertise is based primarily on knowledge of the diagnosis, likely prognosis, treatment and support options, and the range of possible outcomes based on research evidence and population data; while patients usually know more about the impact of the condition on their daily life, their personal attitude to risk, values and preferences, and the constraints they may face in implementing any recommended behaviour changes. Both types of knowledge are needed to manage illness successfully, so both parties should be prepared to share information and take decisions jointly.

This concept (shared decision making) has often been applied to ‘acute’ or ‘elective’ situations where there are choices between discrete interventions that are professionally controlled (for example, choice between a prescribed medicine or surgery, or choice about whether or not to have a ‘preference-sensitive’ screening test that only licensed professionals can administer), but it is also central to personalised care planning for chronic conditions when clinicians work with patients to determine goals and priorities (Bodenheimer 2003; Tsai 2005). Effective management of chronic conditions usually involves both tests and treatments prescribed by clinicians, and actions that patients must do for themselves, such as administering medication appropriately, or making lifestyle changes. In some cases, a patient may be better informed about their condition than the clinician, in which case the clinician should respect this expertise and take account of it in the planning process. Some patients may not need support for self-management or behaviour change, but, for those that do, collaboratively-set goals and self-selected behavioural targets are seen as more motivational than clinician-assigned goals (Michie 2003). The process involves both shared decisions about how best to manage the condition, and shared responsibilities for implementing mutually agreed actions.

Why it is important to do this review

Despite widespread support for the principle of personalised care planning, the nature and extent of evidence in support of this approach is unclear. A systematic review is needed to assess its likely effects. The model has been promoted by the World Health Organization (WHO) and encouraged in a number of countries including Australia, the UK and USA (Singh 2008), but international surveys show that many people with long-term conditions do not receive sufficient support from health professionals to enable them to plan their care and self-manage their condition(s) effectively (Schoen 2011). For example, it has been government policy in England since 2010 to ensure that all patients with long-term conditions are involved in a care planning process (Department of Health 2009). This commitment has recently been strengthened by inclusion of an explicit promise in the National Health Service Mandate that "everyone with long term conditions, including people with mental health problems, will be offered a personalised care plan that reflects their preferences and agreed decisions" ( Department of Health 2012). In certain cases people with complex conditions or combinations of conditions may be offered a personal health budget to cover the costs of needs identified during the care planning process (Forder 2012). However, a coordinated, personalised approach is not yet the norm in everyday practice. While most patients with long-term conditions in England report having some sort of care planning discussions with clinicians in primary care, only a small proportion experience proactive, systematic support along the lines described above (Burt 2012; Newbould 2012).

Implementing care planning in primary care involves significant organisational and cultural change (Year of Care 2011). Health professionals may be reluctant to embark on this if they do not believe it is warranted by the evidence (Blakeman 2006). They may also be unwilling to adopt this approach if they feel it will be too time-consuming for them or too burdensome for their patients (Coulter 2011). There is a need for more information about which components of care planning are necessary and which may not be, and which types of tools or interventions are helpful. For example, when is it important to complete the cycle of support and review, and when might it be sufficient to engage patients in goal setting and action planning only? Interventions specially designed for patients, clinicians or both may help to overcome barriers to implementation (see Types of interventions below).

People with multiple co-morbidities or cognitive impairments may find participation in care planning and self-management especially difficult (May 2009).There are also concerns that this approach could exacerbate health inequalities if people with low levels of health literacy or communication difficulties are less able to participate or lack the capacity to self-manage their health (Coulter 2011).

Several systematic reviews have pointed to the importance of a patient-centred, personalised approach to care management. Patient-oriented interventions to support self-management (for example information provision or educational programmes) have led to improvements in health outcomes for people with diabetes (Renders 2000; Deakin 2005), asthma (Powell 2002) and a number of other chronic conditions (Murray 2005; Foster 2007). Various strategies for increasing patients' motivation to adopt healthy behaviours (for example, motivational interviewing or use of written contracts) have helped to improved health outcomes for some patients (Rubak 2005; Bosch-Capblanch 2007; Lai 2010; Smedslund 2011). Interventions designed to improve communications and encourage greater patient involvement in decision making have been shown to improve patients' knowledge of screening or treatment options and outcomes, and in some cases have been shown to engender a more collaborative approach, but effects on health outcomes have been mixed (Kinnersley 2007; Wetzels 2007; Stacey 2011; Dwamena 2012; Edwards 2013). There is some overlap of focus between this latter group of reviews and the review we are proposing, in that they both cover strategies for engaging patients in decisions about their care, but none of these previous reviews has looked specifically at the effects of personalised care planning for patients with long-term conditions.

Objectives

To assess the effects of personalised care planning for patients with long-term health conditions, as compared to forms of care in which active involvement of patients in treatment and management decisions (at least in goal setting and action planning) is not explicitly attempted or achieved.

We will address the following primary research questions:

  • Is personalised care planning effective for improving physical health (e.g. lipid measurements)?

  • Is personalised care planning effective for improving psychological health (e.g. anxiety and depression)?

  • Is personalised care planning effective for improving psychosocial health (e.g. quality of life)?

  • Is personalised care planning effective for improving patients' capabilities for self-managing their condition?

We will also look for evidence to address the following secondary research questions:

  • Is personalised care planning effective for improving patients' health-related behaviours?

  • How does personalised care planning impact on rates of use and costs of formal health services?

  • What is the relative effectiveness of different types of intervention used to promote personalised care planning?

Methods

Criteria for considering studies for this review

Types of studies

We will include randomised controlled trials and cluster randomised controlled trials.

Types of participants

We are interested in the ways that healthcare professionals and/or health services engage people in personalised care planning relating to chronic conditions. Chronic conditions are defined as "diseases of long duration and generally slow progression" ( World Health Organization 2012), for example, heart disease and stroke, cancers, respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD), diabetes, kidney or liver disease, chronic pain and arthritis, neurological conditions such as epilepsy and multiple sclerosis, HIV/AIDS, and psychiatric conditions such as bipolar, schizophrenia or chronic depression. We will include adults (aged 18 or over) with any long-term physical, psychological, sensory, or cognitive condition or combination of conditions affecting their health, treated in any setting (primary care, secondary care, community care or residential care). This could include people with long-term disabilities not necessarily caused by disease, such as blindness, deafness, mobility, communication problems or intellectual disabilities, if they are receiving treatment from health professionals.

We will exclude studies involving simulated patients, or patients requiring treatment for acute or self-limiting problems only.

Types of interventions

To be included in the review, trials must have evaluated interventions (including changes to practice) that explicitly engage patients in a shared decision-making process involving both goal setting and action planning as described in Description of the intervention above (B, C).

We will exclude studies in which the intervention did not explicitly engage patients actively in determining their goals or priorities and developing a treatment/care/support plan, and those in which patients were not encouraged to exert meaningful influence on goals and plans, or where their choices were unduly constrained. We will exclude studies in which the intervention focused solely on group programmes without one-to-one clinical engagement. We will also exclude trials of interventions designed primarily to engage patients in making plans for end-of-life care (advance directives).

We aim to compare simple or brief approaches to care planning, for example those that involve a single session of goal setting and action planning only, against those that involve the full planning cycle including follow-up and review.

Various interventions or practices have been developed to encourage or support personalised care planning. These may be targeted at patients, clinicians or both, and may be used singly or in combination. Examples of interventions that might contribute to personalised care planning, if they explicitly engage patients in a collaborative shared decision-making process involving goal setting and action planning, include the following:

Patient-focused interventions:
  • Information materials, decision aids or values clarification tools for patients (Protheroe 2010)

  • Computer-based interventions to help patients identify and achieve behavioural goals (Glasgow 2004)

  • Suggested lists of questions the patient can ask to prompt the clinician to involve them more actively in decisions about their care (Shepherd 2011)

  • Health coaching and motivational support to help patients clarify objectives, solve problems and achieve behavioural goals (Frosch 2011)

  • Patient-held records for summarising personal goals and test results (Dijkstra 2005)

Clinician-focused interventions:
  • Specific training programmes in shared decision making, care planning and/or motivational interviewing (Kennedy 2005)

  • Guidelines and feedback emphasising the need to elicit patients' preferences during care planning consultations (Wensing 2003)

  • Algorithms embedded in clinical record systems to guide the care planning process (Ell 2010)

Interventions designed to influence the behaviour of both clinicians and patients:
  • Brief tools for use within care planning consultations to guide the discussion about options and agreed actions (Elwyn 2012a)

  • An electronic or printed template for documenting jointly-agreed actions for use in monitoring and follow-up (Ross 2004).

We will compare the effects of the three broad types of intervention noted above, that is:

  • those that are primarily patient-focused,

  • those where the clinician is the primary focus, and

  • those designed to influence the behaviour of both clinicians and patients.

Not all examples of these kinds of interventions will meet the review's inclusion criteria, and we stress that we are primarily interested in the care planning process itself, during which patients' support needs may be identified and appropriate support interventions selected and used. The process might include any of the above-listed interventions, or others not described above. The point is that a personalised care planning process should provide what is required to help individual patients identify and then achieve their own condition-related goals. In some cases both parties may conclude that the patient is managing well and that no additional medical intervention or support is needed.

Our focus is on patient engagement to support and enhance self-management of long-term conditions in clinical settings. We anticipate that some trials will have evaluated personalised care planning as a minor part of a multi-component intervention including any of the examples listed above. We will exclude studies in which personalised care planning was not a major focus of the evaluation, or where it is not possible to isolate the specific effects of the personalised care planning process.

In summary, we aim to compare the following types of intervention:

  • Personalised care planning (as defined above) compared to forms of care where patient involvement in treatment or management decisions is not explicitly encouraged,

  • Brief approaches versus those involving preparation, follow-up support and review, and

  • Patient-focused interventions versus clinician-focused ones versus those aimed at both parties.

Types of outcome measures

See Figure 1 for an outline of the conceptual model used in the review showing primary and secondary outcomes and subgroups.

Primary outcomes
  1. Changes in health and well-being, including each of the following three dimensions measured separately:

    1. physical health - measured instrumentally (for example. blood pressure, blood lipids, body mass index, HbA1c, urinary albumin, etc.) or by observation or self-report (including symptom scales, pain scores)

    2. psychological health: observation or self-report scales (e.g. depression or anxiety scores)

    3. psychosocial health: patient-reported quality-of-life scales (including fatigue, self-esteem, coping, activities of daily living, etc.) or proxy reports (clinicians' observations or family member/carer reports)

  2. Changes in patients' self-management capabilities: measured by self-reports or observations (knowledge of condition and/or treatment or management options, self-efficacy, self-management behaviours, activation, confidence or perceived competence, and ability to access relevant support).

We will focus on validated measures where possible. Non-validated measures will be recorded but excluded from any meta-analysis.

Secondary outcomes
  1. Changes in health-related behaviours: diet, exercise, smoking, use of relaxation techniques, condition-relevant self-monitoring, adherence to treatment recommendations, attainment of personal goals

  2. Changes in use of formal health services: numbers and length of hospital admissions, numbers of outpatient, emergency department, or primary care visits, and, where recorded, effects on the costs of care.

We will record any harms associated with personalised care planning and include them in the analysis.

Timing of outcome assessment

Outcomes will be grouped into short-term (3 months or less), medium-term (6 to 12 months) and long-term (more than 1 year).

Selecting outcome measures for use in the analysis

The outcomes listed above are broad categories and it is possible that included studies might report more than one outcome within each of these groupings. In this case we will adopt the following process: outcomes reported in each trial will be listed independently by two review authors (AC, AE or SR) (without considering either the size of the effect or its statistical significance) and a decision will be made about which is most 'clinically' important. In cases of doubt, the decision will be referred to the other co-authors and the patient advisory group members (see 'Consumer participation' at Data collection and analysis below).

Search methods for identification of studies

Electronic searches

We will search the following databases for all years (start to present):

  • Cochrane Central Register of Controlled Trials (CENTRAL,The Cochrane Library, latest issue)

  • MEDLINE (OvidSP) 

  • EMBASE (OvidSP)

  • PsycINFO (OvidSP)

  • ProQuest Theses

  • ClinicalTrials.gov

  • WHO International Clinical Trials Registry

The search strategy will be tailored to each of these databases and reported in the review. It will include a list of terms developed by the Cochrane Consumers and Communication Review Group that covers most chronic conditions. There will be no language or date restrictions.

See Appendix 1 for MEDLINE search strategy.

Searching other resources

We will scan reference lists of relevant retrieved articles and reviews on this topic to identify relevant studies not identified by the electronic searches. We will not systematically search grey literature or conduct handsearching. We will include relevant studies irrespective of publication status.

Data collection and analysis

Selection of studies

We will merge search results using EndNote software, and remove duplicates. Two of three review authors (AC, AE and SR) will screen titles and abstracts independently to exclude clearly irrelevant references. Full texts will be obtained where, in the opinion of at least one review author, the abstract indicates that the study may be eligible for inclusion, or where it is not clear that the study should be excluded. We will link multiple reports of the same study.

We will develop a standard form to record details of each study and reasons for inclusion or exclusion, based on the checklist below. All identified trial reports will be scrutinised by two authors independently (AC, AE or SR) to determine eligibility, and the reasons for including or excluding a study will be recorded, This will be documented in sufficient detail for inclusion in a PRISMA flow chart and a table showing the characteristics of the excluded studies. Once they have reviewed all relevant papers independently, the two authors will compare notes and discuss any discrepancies. In cases where there is disagreement about eligibility, papers will be referred to one of the authors not involved in the initial selection process (VE, SS or RP). If eligibility still cannot be determined, we will try to contact the original investigators for clarification.

We will use the following checklist to determine eligibility:

  1. Does the paper present primary data? EXCLUDE if review article, commentary, protocol, etc. but flag for later reference scan.

  2. Was this a randomised controlled trial or cluster randomised trial? EXCLUDE if not RCT or CRCT, but flag for later reference scan.

  3. Did the study include adults aged over 18? EXCLUDE if all participants were children or young people aged under 18. INCLUDE if age not stated or if participants included a majority of adults.

  4. Did participants have one or more chronic conditions? EXCLUDE if participants were healthy people or simulated patients or were consulting for acute (time-limited) conditions.

  5. Was the intervention concerned solely with planning for end-of-life care (advance directives)? If so, EXCLUDE.

  6. Was personalised care planning with active involvement of patients in a collaborative or shared decision-making process an explicit component of the intervention?

    1. Were patients actively involved in planning their treatment or care with clinician(s)? INCLUDE IF THIS AND OTHER INCLUSION CRITERIA LISTED BELOW ARE MET

    2. Did the intervention include both collaborative goal setting and collaborative action planning? INCLUDE.

    3. Did trial include patient-based outcomes? If not, EXCLUDE, for example if outcomes related to clinicians only. Trials of training programmes for clinicians that included measures of their effects on patients should be considered for inclusion in the review if the training covered personalised care planning.

    4. Were patients encouraged to set their own goals or priorities and/or were they offered a choice of treatment or support package? INCLUDE if the intention of the intervention was to enable patients to have meaningful influence on goal selection and/or choice of treatment or support package. EXCLUDE if choices were constrained to only a few pre-determined options, for example, only a choice between treatment A or treatment B.

    5. Was the care/action plan pre-prepared so patients had no opportunity to influence it? EXCLUDE.

    6. Was the care/action plan simply a pre-prepared list of instructions about what to do in particular circumstances? EXCLUDE.

    7. Is there any other evidence to suggest that the care planning process did not allow the patient to influence it? EXCLUDE

The checklist will be piloted in advance by all authors and, if necessary, modified to achieve greater clarity.

We will record reasons for inclusion/exclusion. If in any doubt, papers will be flagged for discussion and referred to the other authors (VE, SS, RP). All studies excluded for any of the reasons listed in 6 (a-g) above will be reported in the table 'Characteristics of Excluded Studies' (with reasons). In cases where relevant aspects of a study are unclear, these studies will be included for analysis until such time as they can be excluded, for example, following contact with the author. Those studies excluded for any of the reasons itemised in 1 to 5 above will not be recorded in the table 'Characteristics of Excluded Studies'.

We will collect and report in the review the details (citation details and any available information) of ongoing studies, as well as details of duplicate publications.

Data extraction and management

Two of three review authors (AC, AE and SR) will independently extract study characteristics and outcomes from reports. We will refer any discrepancies or disagreements to one of the other co-authors (VE, SS, RP) for resolution.

We will use a modified version of the template developed by the Cochrane Consumers and Communication Review Group to extract data from eligible studies.This will be piloted by review authors on a random sample of identified trials and, if necessary, modified.

We will record the following items for each included study:

  1. Identifier: study ID; paper ID; name of review author extracting data; date form completed; notes.

  2. Details of study: stated aim of intervention; stated aim of study; study design; methods of recruitment of participants; inclusion/exclusion criteria for participation in study; statistical methods; consumer involvement.

  3. Participants: description; geographic location; setting; number; age; sex; ethnic origin(s); principal health problem or diagnosis or co-morbidities if relevant to intervention; other health problems; stage of problem/illness; treatment received/receiving; literacy level, cognitive or communication difficulties; other relevant social/demographic details.

  4. Interventions: details of intervention, including theoretical basis, aim, content, format(s), media, source, setting for each arm of the study, and stages of the personalised care planning cycle completed (elements A to G in Figure 1); details of comparison intervention or usual care; details of co-interventions in all groups (i.e. in addition to, or instead of personalised care planning); delivery of intervention, e.g. stages, timing, frequency, duration, for each intervention included in the study; details of providers; intervention quality; fidelity/integrity.

  5. Outcomes: principal and secondary outcome measures; methods of assessing outcome measures; methods of follow-up for non-respondents; timing of outcome assessment; adverse events.

  6. Notes: contact with author; power calculation; translation; duplicate publication.

  7. Results: dichotomous outcomes - outcome, timing of outcome assessment, observed n and total N for intervention and control group; continuous outcomes - outcome, timing of outcome assessment, mean/mean change, standard deviation (SD), N for intervention and control group.

  8. Relevance of outcomes to patients' personal goals, if recorded.

  9. Review author's comments on the study.

Assessment of risk of bias in included studies

We will assess and report on the methodological risk of bias of included studies in accordance with the Cochrane Handbook (Higgins 2011) and the guidelines of the Cochrane Consumers and Communication Review Group (Ryan 2011), which recommends the explicit reporting of the following individual elements for RCTs: random sequence generation; allocation concealment; blinding of participants and personnel; blinding of outcome assessment; completeness of outcome data, selective reporting; and any other obvious sources of bias, such as comparability between groups at baseline or the possibility of contamination between the groups.

If cluster RCTs are included in the review, we will also assess and report the risk of bias associated with an additional domain: selective recruitment of cluster participants (Ryan 2011).

In all cases, two authors will extract data and independently assess the risk of bias of included studies, with any disagreements resolved by discussion and consensus. We will contact study authors for additional information about the included studies, or for clarification of the study methods as required. All studies where risk of bias in respect of random sequence generation is rated as high will be excluded from the review. All other studies meeting the inclusion criteria will be included in the review regardless of the outcome of the assessment of risk of bias, but we will conduct a sensitivity analysis (by excluding the study) if either risk of bias due to method of randomisation or allocation concealment is unclear. We will incorporate the results of the risk of bias assessment into the review through standard tables and systematic narrative description and commentary about each of the elements, leading to an overall assessment of the risk of bias of included studies and a judgement about the internal validity of the review's results.

Measures of treatment effect

Given the range of possible ways the primary outcomes are likely to be reported, we expect to use a standardised mean difference (SMD) with 95% confidence interval (CI) to summarise the effect pooled for comparable outcomes. If enough studies report these as dichotomous outcomes we will use risk ratios (RR) and calculate 95% CIs to summarise the effect of personalised care. If only a small number report these outcomes as dichotomous, we will transform them and treat them as continuous and summarised using an SMD together with the rest of the studies found. We will aim to back transform to an appropriate scale for ease of interpretation (based on Hedges adjusted g) (Higgins 2011).

Unit of analysis issues

The inclusion of cluster randomised trials in this review raises the issue of potential unit of analysis problems. Whenever an adjusted (for clustering) effect is reported in the trial, we will extract this for inclusion in the review. For cluster randomised trials that only report analyses where clustering has not been adjusted for, we will carry out our own adjustment by calculating a design effect based on either published or imputed (from other studies) intra-class correlation coefficients (ICC). We will evaluate the impact of this on our findings through sensitivity analyses. If it is not possible to obtain sufficient information to re-analyse the data, we will report effect estimates and annotate 'unit of analysis error'.

Dealing with missing data

Whenever possible we will use intention-to-treat data in our analyses. Where data are insufficiently reported in the published paper, we will write to the original authors for clarification and further information. We will discuss the impact of the missing data on our findings and if we impute missing values, for example a missing standard deviation for a study reporting a continuous outcome, we will explore its impact on the results using sensitivity analyses.

Assessment of heterogeneity

Where studies are considered similar enough (based on consideration of diagnostic categories, type of intervention, or population subgroups) to allow pooling of data using meta-analysis, we will assess the degree of heterogeneity by visual inspection of forest plots and by examining the Chi2 test for heterogeneity. We will quantify heterogeneity using the I2 statistic. An I2 value of 70% or more will be considered to represent substantial levels of heterogeneity, but this value will be interpreted in light of the size and direction of effects and the strength of the evidence for heterogeneity, based on the P value from the Chi2 test (Higgins 2011).

Where we detect substantial clinical, methodological or statistical heterogeneity across included studies, we will not report pooled results from meta-analysis but will instead use a narrative approach to data synthesis. In this event we will assess possible clinical or methodological reasons for this variation by grouping studies that are similar in terms of diagnostic categories, intervention types or population subgroups to explore differences in intervention effects.

Assessment of reporting biases

We will assess publication bias by the use of funnel plots, if there is a sufficient number of trials. Reasons for asymmetry will be considered, if it is noted. We will address other potential reporting biases in the Discussion. In case of evidence of publication bias, we will use the fixed-effect model, which weights studies according to their precision, to avoid placing greater weight on small studies. The fixed-effect model is more robust in these cases because publication bias means that small studies with non-positive results are normally not reported, and the random-effects model (which gives larger weights to small studies) would be more affected by this situation.

If there are not enough trials to construct funnel plots, we will assess reporting bias qualitatively by looking at the properties of the included studies (for example, if only small studies with positive findings are identified for inclusion) and where author or expert contact indicates that there are relevant unpublished studies.

Data synthesis

We will pool data by using a random-effects meta-analysis unless we detect substantial heterogeneity (I2 > 70%). In this case we will look for the consistency in the direction of effect, check robustness of findings, and consider not presenting pooled estimates. If there is evidence of publication bias, and a risk that the results will be biased by a small study effect, we will use the fixed-effect model which weights studies according to their precision, to avoid placing greater weight on small studies. In the absence of unit of analysis errors, we will combine data from individual and cluster randomised controlled trials.

We will make a decision about whether to carry out a meta-analysis or not based on an assessment of whether participants, interventions, comparisons and outcomes are sufficiently similar to ensure a clinically meaningful result.

If we are unable to pool the data statistically using meta-analysis, we will group the data based on the category that best reflects the heterogeneity of studies and makes most sense to the reader (i.e. by interventions, populations or outcomes). Within each category we will present the data in tables and summarise the results narratively.

Subgroup analysis and investigation of heterogeneity

Where possible, we will analyse results for the following subgroups to examine factors that might modify any effects (see Figure 1):

  • Multi-morbidity: Patients with multiple chronic conditions or disabilities

  • Low health literacy: Patients who face communication or comprehension problems due to low educational level, minority language, cognitive impairment or intellectual disability.

Sensitivity analysis

We will use sensitivity analyses to determine the impact of our model choices and assumptions in the findings. We will explore the impact of our choice of ICC in the adjustment, the use of a random-effects model if publication bias is present, and the inclusion of high/low quality studies in the review by examining the methodological and clinical characteristics of the included trials (see Assessment of risk of bias in included studies above).

'Summary of findings' table

We will prepare a 'Summary of findings' table to present the results of meta-analysis, based on the methods described in chapter 11 of the Cochrane Handbook for Systematic Reviews of Interventions (Schünemann 2011). We will present the results of meta-analysis for the major comparisons of the review (personalised care planning versus usual care or other forms of self-management support) for each of the two primary outcomes (health and well-being, self-management capabilities), including potential harms, as outlined in the Types of outcome measures section. We will provide a source and rationale for each assumed risk cited in the tables, and will use the GRADE system to rank the quality of the evidence using the GRADEprofiler (GRADEpro) software (Schünemann 2011). If meta-analysis is not possible, we will present results in a narrative 'Summary of findings' table format.

The table will include results for the following variables:

  • Patients or population (diagnostic group(s), single versus multi-morbidity, socioeconomic variables, health literacy (eg cognitive or communication difficulties or intellectual disability)

  • Setting (country, care setting: primary, secondary, community)

  • Comparison group

  • Focus of intervention (patient, clinician, both)

  • Care planning approach (brief versus extended)

  • Perceived risks due to type of population subgroup (eg low health literacy or low motivation inhibiting participation)

  • Outcomes (physical, psychological and psychosocial, self-management capabilities) and time period

  • Adverse events resulting from the intervention

  • Relative effects

  • Number of participants (studies)

  • Quality of evidence (GRADE)

  • Comments.

Consumer participation

We have recruited an expert patient advisory group of six people with experience of living with long-term conditions. Between them they have experience of living with the following conditions: Alzheimer's disease (carer of family member), anxiety, asthma, bilateral above knee amputation, cataracts, depression, epilepsy, erythromelalgia, irritable bowel syndrome, labyrinthitis, migraine, multiple sclerosis, myeloproliferative disorder, over- and under-active thyroid, peripheral vascular disease, polycystic ovaries, poor circulation, Raynaud's syndrome, rheumatoid arthritis, and tendonitis. They have agreed to advise on various aspects of the review. They have provided feedback on the protocol, specifically the selection of outcome measures, and at a later stage will be asked for their feedback on emerging findings from the review. They are paid a fee for their time. We do not anticipate any face-to-face meetings, but if this turns out to be necessary we will pay any necessary travel or accommodation expenses.

Input and advice is sought from the expert patient advisory group via a secure dedicated website where they can record comments and queries.The website includes a short summary of the research plan as background information. Group members have been encouraged to submit questions about the study at any time via the website. During the development of this protocol we asked them to review the outcomes we had selected for the study. They were asked to indicate which of these they considered should have highest priority in the light of their own experience, to rank all other outcome measures in order of priority and to give reasons for their ranking. They were also asked to indicate any important outcomes that had not been included in the protocol. Participants provided detailed and helpful comments on their rankings. The results of this exercise supported the choice of outcomes listed above, and no outcomes of any significance were identified as missing from the review.

At a later stage in the review process, we will ask the group's members to give their reactions to the findings of the review and to provide comments on the plain language summary to ensure it is comprehensible, accessible and relevant.

The group will also be asked to help with disseminating the results of the completed review.

Acknowledgements

We are very grateful for useful advice from the following members of the expert patient advisory group: Carole Bennett, Graham Brown, Eleni Chambers, Lesley Cox, Linda Eccles, and Margo Milne. We also received helpful advice from Adrian Edwards, Sophie Hill, Bronwyn Hemsley, Joanne Protheroe and Anne Lyddiatt, who reviewed the draft protocol. We are also grateful to Nia Roberts of the Bodleian Health Care Libraries, University of Oxford, and John Kis-Rigo of the Cochrane Consumers and Communication Review Group for help in designing the search strategy.

Appendices

Appendix 1. MEDLINE search strategy

1. chronic*.mp.

2. ((persistent or long* term or ongoing or degenerative) adj3 (disease* or ill* or condition* or insufficienc* or disorder*)).tw.

3. long term care/

4. long* term care.tw.

5. exp cardiovascular diseases/

6. (heart disease* or heart failure or myocardial ischemia or coronary disease* or coronary artery disease* or myocardial infarction or hypertension or high blood pressure).tw.

7. sickle cell.mp.

8. exp lung diseases obstructive/

9. (obstructive lung disease* or obstructive pulmonary disease* or copd or asthma or bronchitis).tw.

10. exp emphysema/

11. exp pulmonary emphysema/

12. emphysema.tw.

13. (cystic fibrosis or respiratory distress).mp.

14. exp nervous system diseases/

15. (brain adj (disease* or damage* or injur*)).tw.

16. (cerebrovascular or brain ischemia or cerebral infarction or carotid artery disease* or stroke or epilep* or seizure*).tw.

17. (neurodegenerative or Huntington* or Parkinson* or amyotrophic lateral sclerosis or multiple sclerosis or motor neuron disease).tw.

18. (paralys* or quadriplegi* or tetraplegi* or paraplegi* or locked-in syndrome).tw.

19. ((communication or learning or consciousness or perceptual or speech or voice or vision or hearing or psychomotor) adj disorder*).tw.

20. (hearing loss or hearing aid* or deaf* or blind* or stutter*).tw.

21. down* syndrome.tw.

22. cerebral palsy.tw.

23. exp gastrointestinal diseases/

24. (gatroenter* or intestinal or bowel or colonic).tw.

25. renal insufficiency/

26. ((renal or kidney) adj (failure* or insufficienc*)).tw.

27. diabetes mellitus/

28. (diabetes or diabetic*).tw.

29. exp nutrition disorders/

30. (underweight or malnutrition or malnourished or overweight or obes*).tw.

31. exp arthritis/

32. exp rheumatic diseases/

33. (arthritis or osteoarthritis or rheumati* or fibromyalgia).tw.

34. ((back or neck) adj pain).tw.

35. exp thyroid diseases/

36. thyroid.tw.

37. exp hypersensitivity/

38. (hypersensitivit* or allerg* or intolerance or anaphyla*).mp.

39. exp neoplasms/

40. (cancer* or oncolog* or neoplasm* or carcinom* or tumo?r* or malignan* or leuk?emia).tw.

41. exp hiv infections/

42. (hiv infect* or hiv disease*).tw.

43. exp mental disorders/

44. exp behavioral symptoms/

45. ((mental* or psychiatr* or psychological*) adj (ill* or disorder* or disease* or distress* or disab* or problem* or health* or patient* or treatment)).tw.

46. ((personality or mood or dysthymic or cognit* or anxiety or stress or eating or adjustment or reactive or somatoform or conversion or behavior or perception or psycho* or impulse control or development* or attention deficit or hyperactivity or conduct or motor skills or movement or tic or substance related) adj disorder*).tw.

47. (psychos#s or psychotic* or paranoi* or schizo* or neuros#s or neurotic* or delusion* or depression or depressive or bipolar or mania or manic or obsessi* or compulsi* or panic or phobic or phobia or anorexia or bulimia or neurastheni* or dissociative or autis* or Asperger* or Tourette or dyslex* or affective or borderline or narcissis* or suicid* or self injur* or self harm or adhd).tw.

48. (((substance or drug or alcohol) adj abuse) or "substance use" or "illegal drug use" or addict* or alcoholism or (problem* adj1 drinking)).tw.

49. or/1-48

50. patient care planning/

51. ((care or action or treatment) adj plan*).tw.

52. decision making/

53. choice behavior/

54. (patient* adj7 (decision* or choice*)).tw.

55. patient preference/

56. (patient* adj3 (preference* or priorit* or value*)).tw.

57. (treatment adj (option* or choice*)).tw.

58. goals/

59. (goal* adj2 (set* or plan*)).tw.

60. patient centered care/

61. (patient adj (cent*red or focus*ed or oriented)).tw.

62. individualised medicine/

63. (individuali#e? or individuali#ing or personali#e? or personali#ing or tailor or tailored or tailoring).tw.

64. or/50-63

65. cooperative behavior/

66. (patient* adj3 (participat* or involv*)).tw.

67. (negotiat* or agreement or concordan* or cooperat* or co-operat* or collaborat* or partnership).tw.

68. or/65-67

69. 64 and 68

70. patient participation/

71. (patient* adj2 (empower* or activat*)).tw.

72. ((shared or joint or informed or collaborative) adj2 decision making).tw.

73. ((involv* or participat*) adj3 (choice* or decision*)).tw.

74. (decision adj (aid* or support or tool*)).tw.

75. patient provider agreement*.tw.

76. decisional self efficacy.tw.

77. (personal budget* or direct payment*).tw.

78. (record access or patient held record*).tw.

79. ((self management or self care) adj2 support*).tw.

80. or/69-79

81. 49 and 80

82. randomized controlled trial.pt.

83. controlled clinical trial.pt.

84. randomized.ab.

85. placebo.ab.

86. clinical trials as topic.sh.

87. randomly.ab.

88. trial.ti.

89. or/82-88

90. exp animals/ not humans.sh.

91. 89 not 90

92. 81 and 91

 

Contributions of authors

Angela Coulter conceived the review and drafted the protocol. Abi Eccles led the design of the search strategy and organised the consumer involvement. Rafael Perera wrote the data analysis section. Abi Eccles, Sasha Shepperd,Vikki Entwistle, Sara Ryan and Rafael Perera contributed to the study design and reviewed and edited the protocol.

Declarations of interest

In addition to her part-time post at the University of Oxford, Angela Coulter acts as a paid consultant for the Informed Medical Decisions Foundation, a not-for-profit organisation that develops content for patient decision aids that are distributed by Health Dialog, Bupa and other organisations. All other authors have no known conflicts of interest.

Sources of support

Internal sources

  • No sources of support supplied

External sources

  • Department of Health Policy Research Programme, UK.

    This is an independent report commissioned and funded by the Policy Research Programme in the Department of Health, England. The views expressed are not necessarily those of the Department.

Ancillary