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Square pegs and round holes. Overcoming the governance challenges of conducting a cluster-randomised implementation trial in UK-wide general practice (ID 374)

Hammersley VS, McClatchey K, Delaney B, Barat A, Preston M, Taylor S, Pinnock H

The University of Edinburgh

Funding: National Institute for Health and Care Research

Abstract

IMP2ART is a cluster-randomised implementation trial which has ethical and national level governance approval. Recruitment of 144 practices re-started post-pandemic in January 2021.
Aim: To describe the challenges of delivering a cluster-randomised implementation trial in which general practices are the participants including ethics, research governance, practice recruitment, routine data access, timely uptake of implementation.
Methods: Detailed research records of the challenges and how we are addressing them.
Progress made: We have recruited 129 practices and randomised 81. Key challenges are:
• No facility to classify practices as participants. Ethics approval was timely, but national governance (NRS/HRA) classified practices as sites not participants. The local information pack required by Trusts to assess ‘capacity and capability’ of sites was not appropriate necessitating repeated explanations.
• Multiplicity of local governance requirements. Each local trust had their own, different requirements requiring customised provision of information, often duplicating centrally provided documentation which they seemed unable to access.
• Diverse interpretation of data protection implications. Optimum Patient Care prepared detailed, approved, Data Protection Impact Assessments for all secure anonymised data transfers, but local Health Boards and Data Protection Officer scrutiny raised queries, required individual edits and delayed (or blocked) practice participation.
• Barriers to implementing IT. Scottish Health Boards manage IT centrally, delaying scheduling set-up until two practices are recruited in their area.
• Delays risk practice withdrawal. Practices have multiple challenges (COVID-19 burden, staff turnover, competing demands), but, even with regular communication, these research-related delays add to the challenge of retaining practices’ interest in IMP2ART.
Points for discussion: There is a need to recognise research methodologies that do not fit established processes, and develop streamlined, nationally-agreed processes (including UK- wide DPIA approval) to reduce the current delays and substantial burden in terms of senior researcher time conducting implementation research.

Conflicts of interest: None

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