Implementation of Dynamic Lycra^® Orthoses for Arm Rehabilitation in the Context of a Randomised Controlled Feasibility Trial in Stroke: A Qualitative study Using Normalisation Process Theory

Abstract

Objective: To explore how non-research funded rehabilitation practitioners implemented dynamic Lycra® orthoses for arm recovery after stroke into rehabilitation practice, as part of a feasibility randomised controlled trial. Design: Qualitative interview study. Setting: Two in-patient stroke units and associated rehabilitation units. Subjects: Fifteen purposefully selected stroke rehabilitation practitioners involved in delivery of dynamic Lycra® orthoses as part of a feasibility randomised controlled trial. Methods: Semi-structured interviews conducted at the end of the trial. Interviews examined their experiences of orthosis implementation. Normalisation Process Theory structured the interview guide and informed data analysis. NVivo software supported data analysis. Results: Practitioners intuitively made sense of the intervention in the face of uncertainty about its precise mechanisms of action (Normalisation Process Theory construct: coherence) and espoused commitment to the research, despite uncertainty about orthosis effectiveness (cognitive participation). They did however adapt the intervention based on perceived therapeutic need, their own skillsets and stroke survivor preference (collective action). They were uncertain about benefits (reflexive monitoring). Across the 4 theoretical constructs, ambivalence about the intervention was detected. Conclusions: Ambivalence interfered with implementation – but only to an extent. ‘Good-enough’ coherence, cognitive participation, collective action and reflexive monitoring were sufficient to initiate normalisation – as long as implementation did not undermine the relationship between practitioner and stroke survivor. Ambivalence stemmed from practitioners’ uncertainty about the intervention theory and mechanisms of action. Making intervention mechanisms of action more explicit to practitioners may influence how they implement and adapt a research intervention, and may determine whether those processes undermine or enhance outcomes.

Supporting translation of research evidence into practice—the use of Normalisation Process Theory to assess and inform implementation within randomised controlled trials: a systematic review

“…Darley et al [ 73 ] UK Mixed-methods process evaluation Stroke services Informal caregiver support Prospective 6. Delvaux et al [ 74 ] UK Qualitative Stroke services Arm recovery, rehabilitation after stroke Prospective 7. Evans et al [ 75 ] UK Qualitative Primary care Computer software prediction tool for emergency hospital admission risk Prospective 8.…”

“…Regarding the operationalisation of the sub-constructs, while just over half of the studies ( n = 22) [ 36 , 68 – 72 , 75 , 78 , 85 – 87 , 95 , 99 – 101 , 103 , 104 , 108 – 111 , 113 , 114 ] did not specify the use of any sub-constructs, nearly 30% of studies ( n = 12) [ 73 , 74 , 76 , 77 , 80 – 84 , 89 – 91 , 93 , 97 , 102 , 105 , 112 ] explicate their use of all 16 and use among the remaining studies (19%, n = 8) [ 79 , 88 , 92 , 94 , 96 , 98 , 106 , 107 ] varied. Figure 2 further illustrates the frequency of sub-construct use.…”

Study of Whole blood in Frontline Trauma (SWiFT): implementation study protocol

“…NPT will be used to examine, theorise and improve how prehospital WB should be embedded in routine delivery. We considered that NPT would be a useful analytical tool because NPT is a robust and highly cited theory of implementation that helps provide awareness of the work involved in embedding and sustaining practices associated with an intervention, and thus aids understanding of what becomes normalised into everyday settings 28 46 47. NPT is a sociological theory which explains the processes people adopt when implementing new interventions, to allow the intervention to become ‘normalised’ or embedded in routine practice.…”

“…NPT is widely used in IS , but its use in RCTs is still limited. Studies use NPT within RCTs largely prospectively, for example, to inform interview topic guides,47 53 54 though have also commonly been used as a framework for data analysis 55 56. NPT is beneficial to understanding the complex dynamics of implementation processes and identifying aspects of work that can be improved for sustainable integration into everyday practice 28 57 58.…”

“…NPT is beneficial to understanding the complex dynamics of implementation processes and identifying aspects of work that can be improved for sustainable integration into everyday practice 28 57 58. However, reported challenges of NPT use within RCTs appear to surface when mapping data onto the constructs, as overlap between them has been experienced 47 59. Introducing NPT from the outset of RCT planning can provide us with the opportunity to overcome these expected challenges.…”