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Research methods
Protocol
Improving Primary Care After Stroke (IPCAS) randomised controlled trial: protocol for a multidimensional process evaluation
  1. Maria Raisa Jessica (Ryc) Aquino1,2,
  2. Ricky Mullis1,
  3. Elizabeth Kreit1,
  4. Vicki Johnson3,
  5. Julie Grant1,
  6. Lisa Lim1,
  7. Stephen Sutton1,
  8. Jonathan Mant1
  1. 1Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK
  2. 2Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK
  3. 3Leicester Diabetes Centre, University Hospital Leicester NHS Trust, Leicester, UK
  1. Correspondence to Dr Maria Raisa Jessica (Ryc) Aquino; ra532{at}medschl.cam.ac.uk

Abstract

Introduction Primary care interventions are often multicomponent, with several targets (eg, patients and 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, enhanced communication between care services, and a directory of national and local community services, currently being evaluated in a cluster randomised controlled trial (RCT). Informed by Medical Research Council guidance for complex interventions and the Behaviour Change Consortium fidelity framework, this protocol outlines the process evaluation of IPCAS within this RCT. The process evaluation aimed 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 with ‘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 My Life After Stroke course (10% of reviews and sessions) will be coded separately; semistructured 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; semistructured 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. Semistructured 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 December 2017, 17/YH/0441). Study results will be published in a peer-reviewed journal and presented at relevant conferences.

Trial registration number NCT03353519; Pre-results.

  • process evaluation
  • protocol
  • intervention fidelity
  • randomised controlled trial
  • stroke
  • primary care
https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjopen-2020-036879

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    Footnotes

    • Contributors JM, RM and SS were responsible for obtaining the funding for this study. The design of the process evaluation was led by MRJA, with contributions from JM, RM, EK, VJ and LL. JM, RM, EK, VJ and LL contributed to developing intervention fidelity measures. EK, VJ, LL and JG contributed to piloting intervention fidelity materials, participant recruitment, data collection and analysis. MRJA wrote the first draft of the manuscript. All authors contributed to and approved the final version.

    • Funding This study is funded by the National Institute for Health Research’s (NIHR) 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. JM is an NIHR Senior Investigator.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.