Implementation

The previous sections have established that there has been substantial quantitative study of CIMT, but that there are aspects in both the development process and the evaluation of CIMT that may impact negatively on its implementation. These include: assumptions in the translation of evidence from deafferented, non-human primates to human stroke survivors; not being able to identify which stroke survivors are experiencing learned non-use; a lack of clarity about the components and dose of CIMT; and the limited qualitative study of the acceptability and feasibility of providing CIMT.

Previous study of implementation has found an innovation is more likely to be implemented if the relative advantage of the intervention and the guidelines and procedures are clear (Fleuren

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et al., 2004), and there is sufficient information about the use and the expected outcomes of the intervention (Greenhalgh et al., 2004). The previous sections have shown that, for CIMT, each of these may be an issue. Previous work (Dopson et al., 2002; Rycroft-Malone et al., 2004b) also indicates that the production of evidence, even if it is good evidence, is not enough to ensure diffusion to practice. If the evidence is not completely convincing, as is the case for CIMT, it opens up debate and negotiation (Dopson et al., 2002), where different pieces of evidence can be interpreted in different ways by stakeholders (Greenhalgh et al., 2004). Interpretations of

evidence and the involvement and views of others, particularly trusted colleagues, may impact on the implementation process (Dopson et al., 2002; Rycroft-Malone et al., 2004b), indicating a social element to the construction and use of evidence (Dopson et al., 2002; Rycroft-Malone et al., 2004b). Given the prolific reporting of CIMT studies, utilising a variety of protocols,

interpretation of the evidence must be a consideration for its implementation.

This chapter has shown that there are a number of potential challenges to the implementation of CIMT into practice. Implementation models or frameworks provide tools to organise the evidence to date, analyse the gaps and plan future work. As no previous systematic analysis of the

implementation of CIMT had been undertaken, conceptual frameworks were reviewed as a means of summarising the CIMT evidence to date and undertaking an analysis of its

implementation.

Over the past two decades a number of conceptual frameworks have been developed to assist in understanding the factors impacting on implementation of evidence into practice (Damschroder et al., 2009; Meyers et al., 2012; Rycroft-Malone, 2004). Conceptual implementation frameworks have been described as a collection of concepts drawn together into a structure with the aim of being able to communicate the concepts to others (Meyers et al., 2012). A framework should give

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an overview of the key elements or ideas and offer scaffolding for addressing implementation in a systematic manner (Meyers et al., 2012).

No framework addresses every aspect of implementation (Meyers et al., 2012); the choice of a framework should take into account how the framework will be used (Ilott et al., 2013), the focus of the work and the robustness of the framework. With this in mind a number of frameworks were reviewed for use in guiding further work on the implementation of CIMT.

The Consolidated Framework for Implementation Research (CFIR) was developed from a meta- synthesis of existing frameworks (Damschroder et al., 2009; Meyers et al., 2012). In developing the CFIR, Damschroder et al. (2009) attempted to standardise terminology and constructs, from which they developed a framework. The resultant framework consisted of five domains:

intervention characteristics; outer setting, which included the economic, political, and social context surrounding the organisation; inner setting, which included the structural, political and cultural context of the organisation in which the implementation will take place; characteristics of the individuals; and process of implementation (Damschroder et al., 2009). This framework offers a systematic approach to implementation, with domains that are routed in the literature. The CFIR was not the final choice of framework, as there was another framework with ‘domains’ that better described the current challenges to implementing CIMT into practice; however, an analysis was undertaken using the CFIR as part of the background work when planning this programme of work. This analysis summarises contextual aspects and offers additional insights for consideration in future studies; it is therefore presented in Appendix 2.

The Quality Implementation Framework (QIF) (Meyers et al., 2012), was also considered. This framework summarises 14 ‘critical steps’ organised into four phases: initial considerations, structure for implementation, on-going support strategies, and improving future applications.

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The issues raised in this chapter would all need to be addressed as part of the ‘initial

considerations’ phase. It was felt that whilst the QIF offered an evidence-based structure which promoted analysis of significant implementation issues, only the first phase of the QIF would currently be relevant to CIMT implementation.

The final framework that was considered was the Promoting Action on Research Implementation in Health Service (PARIHS) framework (Rycroft-Malone, 2004), a framework developed by a team with a strong nursing representation. Originally published by Kitson in 1998 (Kitson et al., 1998), it comprises three core elements: evidence, context and facilitation. The framework has

subsequently undergone a concept analysis of the core concepts (elements) and testing of the framework in practice (Rycroft-Malone, 2013, p. 133). The use of the core elements was supported and the testing provided additional information to augment the sub-elements contained within the framework (Rycroft-Malone, 2013, p.133). Although the PARIHS does not have the strong evidence base of the CFIR and QIF, it has been used to good effect in a number of studies (Rycroft-Malone, 2013; Rycroft-Malone et al., 2004a) indicating it has utility as a structure for implementing innovation. It was felt that a systematic and rigorous approach, recommended in the practice development literature (McCormack et al., 2004), to developing CIMT practice, would be best achieved through the elements of the PARIHS framework. The framework has a strong emphasis on research and recognises the importance of stakeholder experience in the ‘evidence’ element; it was anticipated that this would facilitate a means of articulating the challenges with the CIMT research to date, and assist in planning future work. Whilst the ‘Context’ element would enable an exploration of the services and settings in which CIMT might take place, ‘Facilitation’ recognises that it is likely that implementation will require an active process to enable change. For these reasons, PARIHS was selected as the underpinning

conceptual framework for this programme of work, and an analysis of the current CIMT evidence- base in the sub-acute population was undertaken using the framework. A summary is presented

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in Table 2.3. The ‘core elements’ of PARIHS are defined in the left hand column. The central column reports the PARIHS ‘sub-elements’ that, following the analysis, were considered most relevant to the implementation of CIMT. The final column reports a summary of the analysis. The aim of this analysis was to use the PARIHS framework to present the current CIMT evidence-base reported in the former part of this chapter, and to identify the gaps in knowledge that may impact on implementation of CIMT into practice. This structured approach provided a logical and coherent process to design and plan the studies reported within this thesis.

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Table 2.3 The current evidence-base of CIMT in sub-acute stroke analysed using the PARIHS

Core Element Sub-elements Summary of CIMT Implementation

Evidence Research

Clinical Experience Patient Experience Local

Data/Information

Analysis based on the evidence reviewed and evaluated in this chapter:

 There is a clear development process for CIMT, although some assumptions have been made during this process.

 There is evidence from systematic reviews that CIMT is effective in increasing UL function in stroke survivors. There are a variety of CIMT protocols in the published literature; it is not known which CIMT protocols are most effective. There needs to be a method of accurately and comprehensively recording UL therapeutic interventions to facilitate research and transfer of evidence to practice.

 Whilst therapists predominantly work with stroke survivors in the sub-acute phase of stroke; it is not clear whether CIMT is effective in sub-acute stroke. The role of the constraint in sub- acute stroke is not established. A systematic review of CIMT in the sub-acute phase of stroke is required.

 It is not clear whether stroke survivors experiencing sensory loss, unilateral spatial neglect, or other impairments benefit more than those who do not.

 There is a lack of qualitative study of CIMT and the patient’s (stroke survivor) and clinician’s experience of CIMT in the sub-acute phase of stroke has not been established through a systematic review process. This means that factors such as facilitators and barriers to implementing CIMT have not been summarised.

 There is a need to establish if there is good quality qualitative research relevant to the implementation of CIMT involving stroke survivors and therapists, to enable a greater understanding of factors that may impact implementation. Where there are gaps in this knowledge, well-designed qualitative research involving patients (stroke survivors) and clinicians (therapists) is required.

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 It is unclear how the evidence relates to UK stroke services and whether local

data/information has been a part of the implementation process in UK stroke services to date. Context Culture

Leadership Evaluation

Analysis based on the evidence reviewed and evaluated in this chapter:

 Evaluation of effectiveness of the intervention has taken place in a number of settings; however little CIMT research has taken place in the UK.

 The majority of stroke rehabilitation occurs in the sub-acute phase of stroke, there is a need to evaluate implementation of CIMT in this context.

As the ‘Evidence’ element above indicates, there is a need to establish factors that may impact implementation:

 The impact of culture and environment on stroke survivor and therapist beliefs about CIMT are unclear.

 It is not clear what type of leadership might be required and available to implement CIMT.  The aspects of teamwork required to implement CIMT have not been explored.

Further study is required to understand the impact of context on the implementation of CIMT Facilitation Purpose

Role

Skills and Attributes

Although two studies (Gillot et al., 2003; Page et al., 2002a) explored the perceptions of stroke survivors and therapists, the actual barriers to CIMT, that facilitation would need to overcome to implement the interventions, has not been fully explored:

 It is not known what form facilitation should take to further the implementation of CIMT into practice.

 The support therapists might need in order to gain the necessary knowledge and skills to implement CIM T is not known.

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To start to address the gaps identified in this analysis, two systematic reviews were planned. Firstly a systematic review of RCTs to explore the effectiveness of CIMT protocols in sub-acute phase of stroke. Secondly a systematic review of the qualitative evidence to explore what is known about the acceptability of CIMT and the feasibility of providing it as a therapeutic intervention. These systematic reviews were subsequently undertaken and are reported in Chapters 3 and 4.

2.5

Summary

The previous chapter established that UL function is important for many activities and loss of this function can impact on well-being; UL function should therefore be addressed as part of

rehabilitation following stroke. There is a need to establish which UL interventions are most likely to produce the best UL recovery in the first few months post-stroke.

This chapter has summarised the development and subsequent evaluation of CIMT using the development-evaluation-implementation process (Medical Research Council, 2008). CIMT developed from laboratory work and has a theoretical basis; however, assumptions have been made in transferring this evidence to stroke survivors. This may impact on the effectiveness of the intervention in stroke survivors and the implementation of CIMT into practice.

The components comprising CIMT have not been clearly described. This is particularly true of the training component; although shaping has been proposed as a key element of training in CIMT, it is unclear whether the training articulated in the CIMT should be defined as shaping, or whether it is the most effective means of training. The training component in future studies should be clearly articulated. This chapter discussed the importance of standardising and describing each component and the dose of an intervention. High quality studies must be replicable and

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therefore there needs to be a means of comprehensively and accurately documenting UL interventions and any comparison interventions.

The evaluation of CIMT has included a variety of CIMT protocols. This variety, along with the limited evidence about which are effective, acceptable and feasible may impact on

implementation. There remain some gaps in the development of CIMT and therefore further qualitative investigation of the feasibility of providing the intervention and the acceptability of the intervention to stroke survivors is required.

As the context is an important consideration in implementation, and the majority of

rehabilitation takes place in the sub-acute phase of stroke, this timeframe will be the focus of this thesis. Whilst a number of CIMT systematic reviews have been undertaken, these neither give a clear picture of the effectiveness of CIMT in sub-acute stroke, nor summarise what is known about the qualitative experience of CIMT. Systematic reviews are required to address these gaps and underpin future work.

An analysis using the PARIHS framework was undertaken and a predominantly qualitative programme of work was proposed to address some of the gaps established above. The next chapter will explore the theoretical perspectives that underpin this work

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