the effectiveness and cost-effectiveness of shared care: protocol for a realist review

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The effectiveness and cost-effectiveness of sharedcare: protocol for a realist reviewRebecca Hardwick1*, Mark Pearson1, Richard Byng2 and Rob Anderson1

Abstract

Background: Shared care (an enhanced information exchange over and above routine outpatient letters) iscommonly used to improve care coordination and communication between a specialist and primary care servicesfor people with long-term conditions. Evidence of the effectiveness and cost-effectiveness of shared care is mixed.Informed decision-making for targeting shared care requires a greater understanding of how it works, for whom itworks, in what contexts and why. This protocol outlines how realist review methods can be used to synthesiseevidence on shared care for long-term conditions.A further aim of the review is to explore economic evaluations of shared care. Economic evaluations are difficult tosynthesise due to problems in accounting for contextual differences that impact on resource use and opportunitycosts. Realist review methods have been suggested as a way to overcome some of these issues, so this review willalso assess whether realist review methods are amenable to synthesising economic evidence.

Methods/Design: Database and web searching will be carried out in order to find relevant evidence to developand test programme theories about how shared care works. The review will have two phases. Phase 1 willconcentrate on the contextual conditions and mechanisms that influence how shared care works, in order todevelop programme theories, which partially explain how it works. Phase 2 will focus on testing these programmetheories. A Project Reference Group made up of health service professionals and people with actual experience oflong-term conditions will be used to ground the study in real-life experience. Review findings will be disseminatedthrough local and sub-national networks for integrated care and long-term conditions.

Discussion: This realist review will explore why and for whom shared care works, in order to support decision-makers working to improve the effectiveness of care for people outside hospital. The development of realist reviewmethods to take into account cost and cost-effectiveness evidence is particularly innovative and challenging, and ifsuccessful will offer a new approach to synthesising economic evidence. This systematic review protocol isregistered on the PROSPERO database (registration number: CRD42012002842).

Keywords: Shared care, Long-term conditions, Cost-effectiveness, Economic evaluation, Realist review, Integratedcare, Primary care

BackgroundOver 15 million people are estimated to have a long-term condition in the UK [1]. Despite only making up athird of the population, people with long-term conditionsaccount for between 50% and 80% of GP appointmentsand 64% of outpatient appointments [1]. The estimatedcosts of providing care, as it is currently delivered to

people with long-term conditions, is approximately £70million per year , making up 70% of the total budget forhealth care. It is predicted that the number of peoplewith more than one long-term condition will rise by athird in the current decade [1], and so the need to findcost-effective ways of managing long-term conditions isa priority for the National Health Service (NHS). TheQuality, Innovation, Productivity and Prevention (QIPP)challenge sees long-term conditions as a prime area inwhich productivity and innovation will improve patientcare and ensure that health service resources are usedin the most appropriate way [1].

* Correspondence: [email protected], Institute of Health Services Research, University of Exeter MedicalSchool, University of Exeter, Veysey Building, Salmon Pool Lane, Exeter EX24SG, UKFull list of author information is available at the end of the article

© 2013 Hardwick et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the CreativeCommons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, andreproduction in any medium, provided the original work is properly cited.

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A key issue that prevents better management of peoplewith long-term conditions is the lack of communicationand care coordination between different professionals andservices involved in an individual’s care. Health servicesare often fragmented, which can lead to poor communica-tion between professionals and the services with whichthey work [2]. This can result in poor quality care andpoor cost outcomes in a range of ways, such as medicinemanagement (unsafe or costly) or inefficient use of NHSstaff time. Finding ways to improve the communicationinterfaces between services and between professionals isan important part of developing better care managementof people with long-term conditions.One of the ways to deliver better quality and more

cost-effective services is to use models of care that pur-posefully seek to bridge the gaps between services. Sinceat least the 1970s shared care has been implemented asa way of achieving this outcome [3]. It was developed asa process or model to manage referral issues, poor com-munication and care fragmentation, as well as to releasecapacity in hospital outpatient clinics. It is commonlydefined as the planned delivery of care with an enhancedinformation exchange over and above routine clinic let-ters [3].Shared care often entails a shift away from hospital care

and hospital-based specialists, so it may not necessarily bea way of improving the quality of care, but as a way of re-ducing the cost of care without any loss in care quality orsafety. Therefore, since some of the motivation or rationalefor introducing shared care relates to expected improve-ments in cost-effectiveness, any review of shared careshould try to accommodate such economic aspects.Models of shared care can be viewed as classic complex

interventions, being multi-component, highly dependenton the behaviours and choices of those delivering and re-ceiving the care, and having highly context-dependenteffectiveness. This creates challenges for conducting rigor-ous evaluations and also for synthesising research evidenceabout shared care, and for which we think more explana-tory and theory-driven methods (such as realist reviews)offer advantages over conventional review methods.Partly as a result of this complexity, the current evidence

base for shared care, as reviewed by conventional methodsfor the systematic review of effectiveness, is highly mixedand inconclusive [4]. Rather than seeking to assesswhether shared care is effective or cost-effective, it is bet-ter to use review methods that seek to explain how andwhy shared care and related models of care delivery aremore or less effective in different circumstances or for dif-ferent patient groups.

Shared care as a complex interventionComplex interventions have been defined as interven-tions that are multi-component, and where outcomes

are highly context dependent and also contingent on thebehaviours of participants and intervention providers[5]. At another level, complex interventions themselvescan often also be viewed as complex systems, interven-ing in the complex system of factors that cause and sus-tain the problems to be tackled or managed [6,7].Models of shared care are a good example of a complex

intervention, both in terms of being inherently multi-component, and because the outcomes and resourceimplications are likely to be modified in some way bythe context (patient group, location, organisational settingand so on) and the specific way in which schemes areimplemented. If they include a component of personalencouragement, training and resources (for example,manuals) to encourage greater self-care and monitoring,or if there is a designated care coordinator (for example,a practice nurse), then they also have important behav-ioural elements and associated cost implications.

The current mixed evidence about shared careThe most recent Cochrane systematic review of theevidence base for shared care concluded that there wasinsufficient good quality evidence to demonstrate sig-nificant benefits of shared care arrangements [4]. TheCochrane review also indicated that further work in thisarea would benefit from examining which ‘components’ ofshared care are effective in order to determine the settingsand patient groups in which shared care may be mosteffective. The review only reviewed economic studies ifthey were related to the included effectiveness studies,considerably limiting the scope of cost-effectivenessevidence reviewed.

Shared care remains a current and important idea in caredeliveryAlthough the Cochrane review authors suggested thatthere is ‘no evidence to support the widespread introduc-tion of shared care services at present’ [4], shared care orsimilar integrated/collaborative care arrangements con-tinue to be used. More generally, initiatives like the elec-tronic patient record and the national Connecting forHealth programme suggest that it is still important tohave effective ways to share care information betweendifferent organisations and sectors of health-care provision.Investigating who shared care works for, in what cir-cumstances and why will potentially support the follow-ing current NHS and social care policy goals:

a) Delivery of care closer to home.b)Quality, Innovation, Productivity and Preventionaspirations, which intend to achieve efficienciesthrough delivering the right health care service, inthe right place at the right time. QIPP focuses onbetter quality health care and increasing the

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throughput of patients, in ways which are innovativeand that look to add value by preventing further(more expensive) health and care serviceinterventions.

c) Personalisation. There is increasing emphasis on theimportance of tailoring health and care services tothe needs and aspirations of individual patients.Personalisation refers to a range of mechanisms thatare intended to put members of the public morefirmly in control of what care they receive, how it isdelivered, in what settings and what instances.Shared care can be viewed as a way to deliver morepersonalised care, as it can involve mutual decision-making with patients.

The need to incorporate and synthesise economicevidenceSystematic reviews that assess the cost-effectiveness ofcomplex interventions are being encouraged to take a morecontextualised and explanatory focus. There are two cen-tral research needs in relation to the conduct of systematicreviews of economic studies:

1. to ‘look beyond the established methodologicalconventions of systematic reviewing . . . [to] focusless on producing a pooled estimate of outcomes andmore on explaining why certain programmes work(and conversely, why, sometimes, they don’t), or aremore or less costly or cost-effective; and to

2. develop review methods that recognise that healthand other outcomes are jointly produced by both theinterventions themselves and the multi-level contextsin which they are placed’ ([8,9])

Therefore a secondary, more methodological aim ofthis study is to extend and adapt the approach of realistreviews to provide evidence of cost-effectiveness and re-source use, as well as effectiveness. We think this will beparticularly useful in relation to shared care becausesome of the underlying programme theories may be in-herently economic; they may be as much about expectedresource use or cost savings as they are about intendedimprovements in care outcomes.This systematic review protocol is registered on the PROS-

PERO database (registration number: CRD42012002842).

Review aimThis study aims to explain the effectiveness and cost-effectiveness of shared care using realist review method-ology. The review will have two phases.Phase 1 will identify programme theories about how

shared care works, for whom it works, in what contextsand why (ideas about what enables or inhibits effective

care sharing between different services and/or profes-sionals) from a range of published and other sources.Phase 2 will test these programme theories, using pub-

lished and unpublished empirical evidence, through theprocess of reasoning detailed under ‘Data synthesis’.

Review objectives

1. Examine the evolution of the concept of shared care2. Develop a range of programme theories that describehow shared care works, who it works for, in whatcircumstances and why.

3. Identify and describe the most importantmechanisms by which shared care is thought toproduce better outcomes for patients, carers orhealth and other care services

4. Identify and describe the contextual factors whichaugment/activate or decrease/negate the impact ofthese mechanisms (by which shared care is thoughtto produce better outcomes for patients, carers orhealth and other care services)

5. Identify and describe the resource use and costrequirements or impacts of the different mechanismsand contextual factors

6. Investigate the effectiveness and cost-effectiveness ofshared care using realist review methodology inorder to explain better the circumstances in whichshared care is likely to be effective and cost-effective.

MethodsRealist reviews are systematic reviews, in the sense thatthey have explicit research questions and methods foridentifying, selecting, appraising relevant studies, papersor reports and also methods of evidence synthesis. Ac-cordingly realist reviews exhibit the standard phases ofsystematic review, and these are described below. A keyoutput from a realist synthesis is a programme theory ortheories of the intervention in question. This is achievedthrough specifying how and why the programme or ser-vice is thought to cause its intended outcomes (Phase 1:theory building) through close examination of the activemechanisms and contexts, and then testing the assump-tions of that theory against further evidence, in order tostrengthen and refine it (Phase 2: theory testing). Theprocess at this stage seeks out and incorporates or elimi-nates rival explanations for the observed outcome pat-tern. In contrast to conventional systematic reviews ofeffectiveness studies, there is likely to be greater overlapof these phases, as well as some iteration, as new evi-dence is sourced that has implications for earlier phasesof the review process.Programme theories are possible explanations for the

way in which particular interventions are thought towork; they describe the way in which change occurs


because of an intervention. Realist reviews are con-cerned with unearthing the underlying mechanisms ofaction that make interventions work, and through look-ing at the contexts they are in, and the outcomes gener-ated, the reviewer theorises on what is happening in theintervention and why. Mechanisms can be defined forhow a programme’s resources or opportunities interactwith the reasoning of individuals and lead to changes inbehaviour and other causal factors. Contexts are thewider configuration of factors, not necessarily connectedto a programme, which may enable or constrain the op-eration of specific mechanisms.Another important feature of our review method will be

the involvement of a Project Reference Group (PRG)made up of patients with experience of shared care andtheir carers, and a selection of people who manage or pro-vide shared care arrangements. The group serves two pur-poses. Firstly, it aids the process of theory developmentand refinement, and secondly it ensures that the researchfindings are clear and useful to those involved in managingor providing services for people with chronic diseases.

Phase 1: theory initiation and developmentPhase 1 aims to build a programme theory or theoriesof shared care, which explain how and why shared careis thought to lead to better outcomes for patients orothers (for example, service managers or the health sys-tem overall).For developing the programme theory we intend to

undertake an initial immersion in sources of informationabout the effectiveness and cost-effectiveness of sharedcare in the following ways.Through ongoing conversations with experts in the

field, a mind-map is being developed of ideas, views andopinions on why shared care works, who it works for, inwhat circumstances and why. This will be used to guidethe literature searches.The references and citations in the 2007 Cochrane Re-

view, the 1994 Hickman taxonomy paper and the 1994Report for the Royal College of General Practitioners onshared care in diabetes will be used for a literature search.A search will be made of past and current government

policy on shared care. The grey literature, includingwebsites and blogs, will also be searched.The following types of key word will be used to guide

the initial searches (likely to evolve as the search devel-ops). Population-specific key words include ‘long-termconditions’ and ‘diabetes’. Intervention-specific key wordsare ‘shared care’, ‘integrated care’ and ‘collaborative care’.Intervention-component-specific key words are ‘sharedcare records’, ‘e-health records’ and ‘referral management’.The exclusion/inclusion criteria are necessarily broad

in order to ensure the theory development phase is ableto take in the widest range of evidence of theories. We

will exclude studies on children and young people (up to18). We will also exclude studies with insufficient detailon why the intervention works, for whom, in whatrespects and why are excluded.We will include studies on adults and older adults (18+)

who have a long-term condition (chronic disease). We willinclude studies on interventions that involve professionalshaving shared responsibility or care planning for a definedgroup of patients (for example with a specific chronic dis-ease). We will also include studies that are likely to helpus answer the following question:

What are the theories or mechanisms by which sharedcare is thought to produce better outcomes for patients,carers or health and other care services?

Where helpful, this may include consideration of thefollowing more specific questions in order to adequatelymap the complexity of the intervention, its mechanismsand contexts.

1. How is the programme supposed to work?2. Are there differences in the understanding of whatthe programme is trying to do?

3. Is the programme theory applied consistently andcumulatively?

4. Does the programme theory tend to bend (evolve) inactual use?

5. Does the programme theory fare better withparticular individuals, interpersonal relations,institutions and infrastructures?

6. Does the policy apparatus surrounding the theoryadvance or impede it?

7. Is the theory self-affirming, self-defeating or self-neutralising (for example over time)? [6]

In addition to the above questions, because this review islooking at cost-effectiveness, we will also be looking at theevidence from the perspective of the following question,

What are the resource use and cost requirements orimpacts of the different mechanisms and contextualfactors (that are thought to explain the effectiveness ofshared care)?

Data extraction (Phase 1)For Phase 1 of the review, sources that contribute to the-ory development will be reviewed by the lead reviewerthrough a process of note-taking, annotation and concep-tualisation. At the same time we will refine our conceptu-alisation of shared care through building a programmetheory of shared care. Note-taking will be structured andtabulated in a way that best enables dialogue amongst


the review team and transparency about which sourcesinformed which strands of theoretical development.

Quality assessment (Phase 1)A formal quality assessment will not be undertaken aspart of Phase 1. Instead, the lead reviewer will makejudgments about the relevance of each source in con-tributing to theory development on a source-by-sourcebasis, providing explanation of why and to what extentthe source is thought to be relevant.

Formalising the programme theories (data synthesis)The final part of the first phase is to use our accumu-lated knowledge from the obtained sources to createeither some form of explanatory model and/or a short-list of candidate theoretical mechanisms and relatedcontexts. The origins of these ideas, and the specificsources on which they are grounded, will be documen-ted and justified. From this explanatory model, furtherquestions will be developed that will be used to guidethe next phase of the review and search. At this phase,the model needs a degree of middle-range abstractionand conceptualisation to ensure that it is identifiablein sources and therefore testable – there is no pointspecifying too closely at this phase as that would likelyclose off potentially useful avenues of sources.

Phase 2: theory refinement/testingSearch strategyThe search strategy is as for Phase 1, but in particular it willseek evidence from empirical studies (qualitative or quanti-tative) of deviant or rival explanations to the theory devel-oped. In addition, we will identify and include quantitativecomparative studies in order to examine any associationsbetween effectiveness/lack of effectiveness and the presenceand strength of presence of the theories/mechanisms.For this part of the evidence synthesis we will include:randomised controlled trials, non-randomised controlledtrials, controlled before-and-after studies and uncontrolledbefore-and-after studies. The theory testing/refinementphase of the review may also make use of primary qualita-tive research studies or mixed-methods research whererelevant. The point throughout is to ensure that theprogramme theory that is being tested determines whatevidence is sought (that is, it is based on relevance), inorder to provide data that enables theory developmentand testing.

Data extraction (Phase 2)For phase 2, we expect a set of basic information will becollected from relevant groups of included studies. Thesetables and data fields will be developed from Phase 1,based on the formalised programme theories. Other lessstandard data of relevance to the specified programme

theories will also be extracted. This data will be extractedby one reviewer and a sample of forms checked by thesecond reviewer. Disagreements or discrepancies will beresolved through involvement of the third member ofthe review team.The data-extraction process itself will involve critical

discussion between reviewers and the wider team so thatdata are not simply classified but are used to begin todevelop a line of argument that feeds into the final syn-thesis phase.

Quality assessment (Phase 2)Realist reviews are mixed-methods reviews as they incorp-orate both quantitative and qualitative studies, as well asgrey literature. Therefore, different approaches to qualityassessment are necessary during the review. Overall, thequality of evidence will be judged by how well it meets theexplanatory need of the review at that time: it will bejudged on how relevant it is to theory building and refin-ing (during Phase 1) and how far it added rigour to(tested) the theory (during Phase 2).For particular study types, we intend to use a range of

quality assessment or critical appraisal tools as appropri-ate to the study design. For example, when we are asses-sing the internal validity of comparative effectivenessstudies, we intend to use a standard tool for assessingrisk of bias and for other study types, such as processevaluations, we intend to assess them using a modifiedversion of the Wallace et al. quality appraisal tool forqualitative studies [10]. For the purposes of transpar-ency, we shall document our decisions about rigour (asappraised by the tools) and relevance (the contributionthe piece makes to the review as a whole).

Data synthesis (Phase 2)For synthesis, a similar strategy will be used for bothPhase 1 (identification of programme theories) and Phase 2(testing of programme theories).Synthesis of the diverse sources of evidence included

in a realist review is conducted through a process ofreasoning that is structured around the followingactivities [6].

a) Juxtaposition of sources of evidence - for example,where evidence about implementation in one sourceenables insights into evidence about outcomes inanother source.

b)Reconciling of sources of evidence - where resultsdiffer in apparently similar circumstances, furtherinvestigation is appropriate in order to findexplanations for why these different resultsoccurred.

c) Adjudication of sources of evidence - on the basis ofmethodological strengths or weaknesses.


d)Consolidation of sources of evidence - whereevidence about mechanisms and outcomes iscomplementary and enables a multi-facetedexplanation to be built.

e) Situating sources of evidence - where outcomesdiffer in particular contexts, an explanation can beconstructed of how and why these outcomes occurdifferently.

The transparency of a synthesis in a realist review isachieved by documenting these reasoning processes, de-scribing how they are grounded in the empirical evidenceand justifying the inferential shifts that occur through thisengagement with the evidence.In addition, for Phase 2, we aim to code studies accord-

ing to both the presence or absence of selected theoreticalmechanisms and contexts, and the broad strength of thefindings in relation to shared care outcomes (for exampleas highly effective, effective or not effective). These combi-nations of mechanisms, contexts and measures of effect-iveness may be used to try to explain between-study (thatis between-programme) differences in programme effect-iveness. We hope that this might be achieved throughtabulating these data and findings, graphically exploringpotential associations or possibly more formal techniquessuch as qualitative comparative analysis.

Comparator/controlFor the first phase of the review, which primarily concernsdevelopment of programme theory, there is no need to de-fine comparators or control groups. For the phase of thereview that aims to test/refine the programme theories inrelation to evidence about patient outcomes from effect-iveness studies, the comparators may be any pre-existingor co-existing forms of care in which the care was not for-mally shared between the relevant professionals or caresettings (for example the same types of patient might havebeen cared for predominantly via hospital specialist out-patient appointments, or in general practice but withoutplanned specialist input).

Project reference groupAs well as being based on documentary sources and theirsynthesis, as described in this protocol, the selection andprioritisation of programme theories will be informed bytwo or three meetings with a Project Reference Group.The PRG will be made up of people who have long-termconditions, and their carers, who have experienced sharedcare, as well as professionals who have experience of shar-ing care. The PRG will help identify and choose betweendifferent potential programme theories, and also provide areality check on the clarity and explanatory potential ofthe selected theories/mechanisms, which will become afocus of Phase 2 of the review.

DisseminationThe main results of the review will be published and disse-minated through the National Institute for Health Research(NIHR) Collaboration for Leadership in Applied HealthResearch & Care (CLAHRC) for the South West Peninsula.The review will be distributed to relevant teams at theDepartment of Health (for example the Long Term Con-ditions Quality, Innovation, Productivity and PreventionTeam), as well as to Clinical Commissioning Groupswithin the geographical area of the South West Peninsula.The review will also be distributed to NHS Commission-ing and Providing organisations, as well as appropriatenon-statutory health or care service providers. The workwill also be presented at a relevant national conference,and publications from the review will be written up andpublished in peer-reviewed academic journals.

DiscussionThis realist review will explore why and for whom sharedcare works, in order to support decision-makers workingto improve the effectiveness of care for people outside hos-pital. The development of realist review methods to takeinto account cost and cost-effectiveness evidence is par-ticularly innovative and challenging, and if successful willoffer a new approach to synthesising economic evidence.

AbbreviationsCLAHRC: Collaboration for Leadership in Applied Health Research and Care;NHS: National Health Service; NIHR: National Institute for Health Research;PRG: Project reference group; QIPP: Quality, innovation, productivity andprevention.

Competing interestsThe authors declare that they have no competing interests.

Authors’ contributionsRH led the design and drafting of the review protocol. MP contributed tothe design and drafting of the review protocol. RH scoped and designed thesearch strategy in collaboration with Chris Cooper, Information Specialist. RBprovided substantive topic-specific input that informed the revision andrefinement of the review protocol. RA conceived the review and oversawthe development and revision of the protocol, and MP provided substantivemethodological input. All authors read and approved the final manuscript.

AcknowledgementsThis protocol presents independent research funded by the NationalInstitute for Health Research (NIHR) Collaboration for Leadership in AppliedHealth Research and Care (CLAHRC) for the South West Peninsula. The viewsexpressed in this publication are those of the author(s) and not necessarilythose of the NHS, the NIHR or the Department of Health in England.

Author details1PenTAG, Institute of Health Services Research, University of Exeter MedicalSchool, University of Exeter, Veysey Building, Salmon Pool Lane, Exeter EX24SG, UK. 2Primary Care Group, National Institute for Health ResearchCollaborative for Leadership in Applied Health Research and Care for theSouth West Peninsula, Peninsula Medical and Dental School, PlymouthUniversity, Plymouth, UK.

Received: 13 December 2012 Accepted: 28 January 2013Published: 12 February 2013


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doi:10.1186/2046-4053-2-12Cite this article as: Hardwick et al.: The effectiveness and cost-effectiveness of shared care: protocol for a realist review. SystematicReviews 2013 2:12.

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the effectiveness and cost-effectiveness of shared care: protocol for a realist review

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