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Improving the Safety and Continuity Of Medicines management at Transitions of care (ISCOMAT): protocol for a process evaluation of a cluster randomised control trial
    1. 1School of Pharmacy and Medical Sciences, Faculty of Life Sciences, University of Bradford, Bradford, UK
    2. 2Wolfson Centre for Applied Health Research, Bradford, UK
    3. 3Bradford Institute for Health Research, NIHR Yorkshire and Humber Patient Safety Translational Research Centre, Bradford, UK
    4. 4Leeds Institute of Health Sciences, University of Leeds, Leeds, UK
    5. 5Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK
    6. 6Leeds Institute for Data Analytics, University of Leeds, Leeds, UK
    7. 7Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK
    8. 8Clinical Trials Research Unit, University of Leeds, Leeds, UK
    9. 9School of Healthcare, University of Leeds, Leeds, UK
    1. Correspondence to Dr Catherine Powell; C.Powell2{at}


    Introduction A key priority for the UK National Health Service and patients is to ensure that medicines are used safely and effectively. However, medication changes are not always optimally communicated and implemented when patients transfer from hospital into community settings. Heart failure is a common reason for admission to hospital. Patients with heart failure have a high burden of morbidity, mortality and complex pharmacotherapeutic regimens. The Improving the Safety and Continuity Of Medicines management at Transitions of care programme comprises a cluster randomised controlled trial which will test the effectiveness of a complex behavioural intervention aimed at improving medications management at the interface between hospitals discharge and community care. We will conduct a rigorous process evaluation to inform interpretation of the trial findings, inform implementation of the intervention on a wider scale and aid dissemination of the intervention.

    Methods and analysis The process evaluation will be conducted in six purposively selected intervention sites (ie, hospital trusts and associated community pharmacies) using a mixed-methods design. Fidelity and barriers/enablers of implementation of the Medicines at Transitions Intervention (MaTI) will be explored using observation, interviews (20 patients, 40 healthcare professionals), surveys and routine trial data collection on adherence to MaTI. A parallel mixed analysis will be applied. Qualitative data will be thematically analysed using Framework analysis and survey data will be analysed descriptively. Data will be synthesised, triangulated and mapped to the Consolidated Framework for Implementation Research where appropriate. The process evaluation commenced on June 2018 and is due to end on February 2021.

    Ethics and dissemination Approved by Research Ethics Committee and the UK Health Research Authority REC: 18/YH/0017/IRAS: 231 431. Findings will be disseminated via academic and policy conferences, peer-reviewed publications and social media.

    Trial registration number ISRCTN66212970.

    • heart failure
    • cardiology
    • clinical trials
    • statistics & research methods

    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:

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    • Twitter @CathPowell5, @@cpgale3, @MedicinesDavid

    • Collaborators Our collaborators include members of the wider ISCOMAT Programme Management Team who contributed to previous work packages and the ongoing programme including: Jon Silcock, David K. Raynor, Robert Turner, John Wright, Ian Kellar, Roberta Longo, Ivana Holloway, Chris Bojke, Leeds Clinical Trials Research Unit.

    • Contributors CP, LB, BF, HI, SA, CG, PG, AF and DPA developed the detail of the process evaluation protocol. CP drafted the manuscript and all authors reviewed it critically for intellectual content and approved the final version submitted for publication.

    • Funding This study is funded by the National Institute for Health Research (NIHR) (Programme Grants for Applied Research (Grant Reference Number RP-PG-0514-20009)). This research was supported by the National Institute for Health Research (NIHR) Yorkshire and Humber Patient Safety Translational Research Centre (NIHR Yorkshire and Humber PSTRC).

    • Disclaimer The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Patient consent for publication Not required.

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

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