Improving Primary Care After Stroke (IPCAS) randomised controlled trial: protocol for a multidimensional process evaluation.
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Aquino, R., Mullis, R., Kreit, L., Johnson, V., Grant, J., Lim, L., Sutton, S., & et al. (2020). Improving Primary Care After Stroke (IPCAS) randomised controlled trial: protocol for a multidimensional process evaluation.. BMJ open, 10 (7), e036879. https://doi.org/10.1136/bmjopen-2020-036879
Introduction Primary care interventions are often multicomponent, with several targets (e.g. patients, healthcare professionals). Improving Primary Care After Stroke (IPCAS) is a novel primary care-based model of long-term stroke care involving a review of stroke-related needs, a self-management programme, a direct point of contact in General Practice (GP), enhanced communication between care services, and a directory of national and local community services, currently being evaluated in a cluster randomised controlled trial. Informed by Medical Research Council guidance for complex interventions and Behaviour Change Consortium fidelity framework, this protocol outlines the process evaluation of IPCAS within this RCT. The process evaluation aims to: explore how the intervention was delivered in context, and how participants engaged with the intervention. Methods and analysis Mixed-methods will be used. 1) Design: Intervention content will be compared to ‘usual care’. 2) Training: Intervention training sessions will be audio/video-recorded where feasible 3) Delivery: Healthcare professional self-reports, audio-recordings of intervention delivery and observations of MLAS course (10% of reviews and sessions) will be coded separately; semi-structured interviews will be conducted with a purposive sample of healthcare professionals. 4) Receipt and 5) Enactment: Where available, structured stroke review records will be analysed quantitatively; semi-structured interviews will be conducted with a purposive sample of study participants. Self-reports, observations and audio/video recordings will be coded and scored using specifically developed checklists. Semi-structured interviews will be analysed thematically. Data will be analysed iteratively, independent of primary endpoint analysis. Ethics and dissemination Favourable ethical opinion was gained from Yorkshire & The Humber - Bradford Leeds NHS Research Ethics Committee (19/12/2017; 17/YH/0441). Study results will be published in a peer-reviewed journal and presented at relevant conferences.
This study is funded by the National Institute for Health Research’s Programme Grant for Applied Research titled ‘Developing primary care services for stroke survivors’ reference PTC-RP-PG-0213-20001. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Jonathan Mant is an NIHR Senior Investigator.
National Institute for Health Research (NIHR) (via Cambridgeshire and Peterborough Clinical Commissioning Group (CCG)) (PTC-RP-PG-0213-20001)
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External DOI: https://doi.org/10.1136/bmjopen-2020-036879
This record's URL: https://www.repository.cam.ac.uk/handle/1810/310105
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