Implementation of a self-management support approach (WISE) across a health system: a process evaluation explaining what did and did not work for organisations, clinicians and patients

Implementing self-management approaches have the potential to improve health outcomes and reduce the fiscal burden on health care systems [1]. Current adoption of self-management support (SMS) has been mainly directed at patient self-skills training and behaviour change with little consideration of the concurrent activities required of multiple partners in whole health system implementation to ensure adoption and integration into long-term condition management [2]. The disconnection of patient education skills training from chronic disease management located in primary care settings is likely to have contributed to a lack of reach to those most likely to benefit [3],[4]. Whilst primary care has been identified as a key provider of self-management education and support because of its reach and increasingly central role in chronic disease management [5],[6], general practitioners (GPs) have been reluctant to refer to external self-management education programmes because of a fear of fragmenting care and ambiguity over patient benefit [7]. Targeting and personalised management along with patient-mediated strategies are advocated components of future SMS interventions [8],[9].

Long-term condition management currently operates in UK primary care through an increasingly biomedical, bureaucratic, specialised and reductionist framework [10], reinforced by the Quality and Outcomes Framework (QOF) [11] and pay-for-performance schemes [12]. A counter trend is the advocation of empowering and engaging patients in their own care, a more patient-centred, social and psychological model of care. However, an implementation gap has been identified between these national policy aspirations and current means of delivery as patients are not being directed to local resources or engaged in behaviour change [13],[14]. The components of the Whole System Informing Self-management Engagement (WISE) approach to SMS had been firmly established but not implemented in a primary care context. Thus, there is a need to understand how a systemic patient-centred approach to SMS reconfigures existing relationships, communication and practices and how (and if) the principles of a whole systems approach can translate, embed and integrate into routine practice [15],[16]. The implementation literature states the importance of being clear about specifying the implementation strategy used [17]. The whole systems education strategy is outlined in Table 1.

The WISE approach [20] is an intervention with evidence-based components, designed to provide and encourage SMS uptake and delivery across a whole health system [21]. Informed by an understanding of how health care professionals and patients respond to long-term conditions, WISE aspired to engage patients, practitioners and the service organisation using a structured approach (Table 1) [22]. For this paper, we also considered the outer systems which influence implementation [23] and have added to the original model (see Figure 1) [22]. A large-scale randomised controlled trial (RCT) designed to test effectiveness and cost-effectiveness found that WISE had no effect whatsoever on 12-month patient outcomes [22],[24],[25]. The process evaluation explains why this evidence-based approach was not implementable in routine primary care.

The WISE intervention focussed on training primary care teams (GPs, nurses and administrative staff) over two half-day sessions and providing tools to support self-management. The exemplar conditions for the trial were diabetes, chronic obstructive pulmonary disease (COPD) and irritable bowel syndrome (IBS). A primary care trust (PCT)^a was the organisation supporting and investing in its implementation. The PCT employed two experienced lay trainers to deliver and support the training and practices. The PCT is in the North-West of England and serves a socio-economically deprived population. The training is described in detail elsewhere [25]. The tools included PRISMS [26], Guidebooks [18],[19] and an online directory (see Table 1).

Development and evaluation of the intervention followed the MRC framework for complex interventions. The pre-clinical and development phase was informed by theory and evidence set in the context of policy expectations and guidance. There was good evidence of effectiveness for the components of the intervention (patient-centred information, shared decision-making and training of health professional teams in secondary care) [26]-[39]. A formative evaluation was used to evaluate the feasibility of the intervention in a primary care setting and refine training prior to roll-out in an RCT [25]. The process evaluation was pre-specified to complement and provide additional evidence to the main trial [22],[40].

We viewed each level of implementation as part of a multilevel case study with an overarching analysis. NPT formed the bases of the process evaluation methodology and analysis; the survey questionnaire and the interview schedules were orientated around NPT constructs to gain a view on how WISE was being operationalised and actioned across settings. Responses to the WISE approach were determined at three levels (see the Additional file 1):

Interviews lasted between 40 to 90 min.

Table 2 summarises the findings across the three levels using NPT constructs to illuminate for whom which elements of WISE did or did not work in practice. This analysis explains why there were no effective changes in personal management arrangements, existing care "as usual" relationships or use of additional services and resources.

The process evaluation findings help explain why WISE implementation did not lead to SMS becoming embedded in primary care. NPT assisted understanding of what happened across the four levels of WISE: organisational, practice, health professional and patient. Whilst some aspects of implementation worked well (participating in training was a valued opportunity to bring the practice together), the explanations for WISE not embedding at any level were the lack of commitment and views that providing and enacting SMS within primary care practice was not a legitimate activity for patients or clinicians. In addition, during implementation, the PCT was disbanded as part of wider NHS changes so there was a considerable amount of organisational change, loss of staff and shifting priorities. This represented a significant 'outer context' change [23], which could not have been anticipated and had the most impact at the organisational level (where the research team had developed good relationships) but little at the professional or patient levels.

Use of NPT in implementation studies has highlighted similar problems with engaging practitioners in order to embed practice. Lloyd et al. [44] found that work was needed to ensure shared understanding within teams concerning the purpose of shared decision-making with patients. Other process evaluations of RCTs have used NPT to help explain lack of replication of single-centre trials; however, Clarke et al. found that contextual factors including organisational history and team relationships impinged on training implementation, and NPT had limitations in this area because of undue emphasis on individual and collective agency [54]; they also found that an NPT framework does not place 'sufficient emphasis on those who receive complex interventions, especially when the 'service user' is referred to as a 'partner in care.' We would concur with this. There is a need for greater consideration in implementation theory of the importance of the patient role and the implementation work they need to do. Consideration of the Consolidated Framework for implementation [23], in conjunction with NPT, helped in interpreting the wider context—the 'outer setting' in Damschroder's model—and the mismatch between policy and practice.

Why did WISE fail in implementation? The RCT itself was well-implemented, with good reach in terms of practices and patients recruited. How WISE was interpreted and made meaningful in a particular primary care context contributed to a failure to embed the intervention in everyday practice. This came from professional and, to an extent, patient views that self-management support was something that ultimately was not the core business of primary care, and these expectations shaped the fate of the intervention post-training. The challenge is to show how an intervention of greater intensity or duration could enhance effectiveness without compromising reach. The training intervention was well-attended by staff and apparently liked. The complex intervention had good evidence to support its effectiveness. The training was developed with Gask using her evidence-based principles [31],[55]-[57]. However, some of what was done was untested in an RCT, for example, training whole practice teams. Pragmatic changes were needed to roll out the training, namely flexibility, simplification of training and use of lay trainers rather than health professionals—so WISE may have lost potency as an intervention. Unpicking the components of the intervention and considering what was ineffective in the primary care context could enhance understanding. The evidence for training teams in SMS was derived from trials in secondary care. Quality improvement interventions with financial incentives can improve collaboration and patient outcomes in primary care [58],[59]. The training aimed from the outset to instil a learning organisational ethos and to actively engage a range of staff. This was successful as notes from the trainer indicated that in the first WISE sessions, an enjoyable collegial atmosphere was evident which seemingly underpinned the positive scores in the post-training satisfaction survey (Table 3). However, the clear engagement and satisfaction with training did not translate into the practices of everyday working and probably relates to primary care culture and drivers (QOF in the UK). Communication within practices was not changed, and role demarcation and silo working patterns persisted. The lack of didactic direction or direct monitoring may have contributed to lack of uptake together with the lack of identifiable champions in PCT management or in practices to drive the embedding of a culture of SMS [60]. Emerging evidence about implementation has found that audit and feedback are effective in improving quality of care, and such support might be important post-training [61]. The shared decision-making component, PRISMS, was ineffective. Whilst there is evidence that shared decision-making and patient reported outcomes are effective, the obstacle here is the difficulty both clinicians and patients had with integrating PRISMS into consultations.

This study contributes to a better understanding of why SMS is not routinely adopted and implemented in primary care, by illuminating how and why providing and enacting SMS was not viewed as a legitimate activity or priority by professionals and organisations. There was a failure to, in principle, engage with and identify patients' support needs. Thus, policy presumptions concerning SMS within primary care appear to be misplaced. Implementation failure brings with it potential to negatively impact on individuals' opportunities to maximise improvements they can make to quality of life in living with a long-term condition. There are also likely significant fiscal costs to the health system if robust SMS is not adopted in primary care given the expectations of decreased utilisation with increased SMS. Implementation of SMS within the health service is bound to fail if it does not account for and connect to patient circumstances and real-life priorities. Finally, self-management requires resources which extend beyond the immediacy of the practices implicating the need for links to broader networks of care and greater understanding of network mechanisms [62]. It is possible to extend systems of resources that involve other agents, but this requires programmatic change.

^aPCTs are now defunct, so the term is a historical reference.

^bOne of the senior managers interviewed was the executive responsible for WISE and a member of the steering committee.

AK, AR, CCG, TB and JP contributed to the early conception and theoretical framework for the study design. RB, CG, VL and RM collected data for the process evaluation. AK drafted the manuscript. All authors contributed to the design of instruments and schedules used to collect data and analysis and interpretation of the data, contributed to revising the drafts and gave approval to the final version.