Understanding implementation of a complex intervention in a stroke rehabilitation research trial: A qualitative evaluation using Normalisation Process Theory

PLOS ONE RESEARCH ARTICLE Understanding implementation of a complex intervention in a stroke rehabilitation research trial: A qualitative evaluation using Normalisation Process Theory Louise Johnson ID1,2*, Julia Mardo3, Sara Demain2 a1111111111 a1111111111 a1111111111 a1111111111 a1111111111 1 University Hospitals Dorset NHS Foundation Trust, Castle Lane East, Bournemouth, Dorset, United Kingdom, 2 School of Health Sciences, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, United Kingdom, 3 Dorset Healthcare NHS Foundation Trust, Yeatman Hospital, Hospital Lane, Sherborne, Dorset, United Kingdom * Abstract OPEN ACCESS Citation: Johnson L, Mardo J, Demain S (2023) Understanding implementation of a complex intervention in a stroke rehabilitation research trial: A qualitative evaluation using Normalisation Process Theory. PLoS ONE 18(9): e0282612. https://doi.org/10.1371/journal.pone.0282612 Editor: Adetayo Olorunlana, Caleb University, NIGERIA Received: September 7, 2022 Accepted: February 18, 2023 Background The Implicit Learning in Stroke study was a pilot cluster randomised controlled trial, investigating the use of different motor learning strategies in acute stroke rehabilitation. Participating Stroke Units (n = 8) were from the South East/West regions of the UK, with the experimental intervention (implicit learning) being delivered by clinical teams. It required therapists to change how they gave instructions and feedback to patients during rehabilitation. This paper reports the processes underpinning implementation of the implicit learning intervention. The evaluation aimed to i) understand how therapists made sense of, engaged with and interpreted the effects of the intervention; ii) compare this to the experience reported by patients; iii) extrapolate learning of broader relevance to the design and conduct of research involving complex interventions in stroke rehabilitation. Published: September 8, 2023 Peer Review History: PLOS recognizes the benefits of transparency in the peer review process; therefore, we enable the publication of all of the content of peer review and author responses alongside final, published articles. The editorial history of this article is available here: https://doi.org/10.1371/journal.pone.0282612 Copyright: © 2023 Johnson et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data Availability Statement: All relevant data are within the paper and its Supporting information files. Methods Qualitative evaluation, with data collected through focus groups with clinical staff (n = 20) and semi structured interviews with people with stroke (n = 19). Mixed inductive and theory driven analysis, underpinned by Normalisation Process Theory. Results How therapists made sense of and experienced the intervention impacted how it was implemented. The intervention was delivered by individual therapists, and was influenced by their individual values, beliefs and concerns. However, how teams worked together to build a shared (team) understanding, also played a key role. Teams with a more “flexible” interpretation, reported the view that the intervention could have benefits in a wide range of scenarios. Those with a more fixed, “rule based” interpretation, found it harder to implement, and perceived the benefits to be more limited. Therapists’ concerns that the intervention may PLOS ONE | https://doi.org/10.1371/journal.pone.0282612 September 8, 2023 1 / 22 PLOS ONE Funding: This project is funded by the National Institute of Health Research (NIHR) [ICA-CL-201703-011]. Funding was awarded to LJ, as part of a Clinical Lectureship. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. www. nihr.ac.uk. Competing interests: The authors have declared that no competing interests exist. Abbreviations: IMPS, Implicit Learning in Stroke; NPT, Normalisation Process Theory. Implementation of a complex intervention in a stroke rehabilitation trial impair therapeutic relationships and patient learning were not reflected in how patients experienced it. Conclusions Changing practice, whether in a research study or in the “real world”, is complex. Understanding the process of implementation is crucial to effective research delivery. Implementation frameworks facilitate understanding, and subsequently the systematic and iterative development of strategies for this to be addressed. How teams (rather than individuals) work together is central to how complex interventions are understood and implemented. It is possible that new complex interventions work best in contexts where there are ‘flexible’ cultures. Researchers should consider, and potentially measure this, before they can effectively implement and evaluate an intervention. Trial registration Clinical Trials - NCT03792126. Introduction The Implicit Learning in Stroke Study (IMPS) was a mixed methods, pilot cluster-randomised controlled trial, investigating the impact of implicit learning principles on the recovery of lower limb motor function in sub-acute stroke rehabilitation [1]. Implicit learning targets the non-conscious attributes of the motor learning process, [2] leading to learning without awareness. This differs from “usual care” rehabilitation, which is known to be explicit in nature, i.e. therapists typically use frequent, detailed, body focussed instructions and feedback [3, 4]. The IMPS study involved eight acute stroke units (SU’s) in the UK, who were cluster randomised to either adopt principles of implicit learning during rehabilitation (n = 4), or continue with usual care (n = 4). Here we report findings from a nested qualitative study, which sought to understand therapist perceptions of implementing, and patient experiences of receiving, the implicit learning approach. The challenge of implementing research findings within stroke rehabilitation is well documented [5–8]. Reasons for this are multifaceted, and are influenced by the complex nature of most rehabilitation interventions–which typically involve various components, require expertise to deliver, and must be flexible enough to meet the specific needs of the individual [9]. Few stroke rehabilitation studies have used implementation science theories to comprehensively understand these factors during trial delivery, limiting the potential to support effective knowledge translation into practice. Improving understanding of the factors impacting implementation at this pilot stage will ensure the intervention is developed to be workable in practice, and enable robust design of a future definitive tr (...truncated)