Abstract

Background: IMP2ART is a UK-wide cluster randomised implementation trial which recruited 144 practices between January-2021 and April-2023.
Aim: To describe the baseline characteristics of 144 practices and learnings from the recruitment process.
Methods: Supported by Clinical Research Networks, researchers from Edinburgh, Sheffield and London recruited practices aiming to include UK-wide practices with a broad range of size, deprivation scores and training status. Recruited practices signed up to the Optimum Patient Care (OPC) quality improvement service; practices able to provide routine data extraction were subsequently randomised to implementation or control groups.
Results: We recruited 179 practices and were able to extract data from and randomise 144 practices from 15 areas of England and Scotland. Practice size ranged from 4,970 to 76,533 with a median of 10,648. 117/144 (81%) were training practices. In England the deprivation scores ranged from 6.1 to 50.4; 56/144 (39%) were above the average score of 21.4 (i.e. relatively deprived).
Although 55 (38%) were converted from ‘recruited’ to ‘randomised’ in less than 13-weeks, 43 (30%) took more than 6-months to gain approvals and establish data extraction, 9 (6%) were delayed by more than a year. 35/179 (20%) were not able to be randomised. Major challenges were:
• Multiplicity of local governance requirements. Local trusts required customised provision of information, often duplicating centrally provided documentation.
• Diverse interpretation of data protection implications. We provided approved Data Protection Impact Assessments, but Health Boards and Data Protection Officers raised queries and delayed (or blocked) practice participation.
• Technical problems. Despite extensive troubleshooting from OPC it was not possible to extract data from some practices, e.g. because of legacy systems.
Conclusions: Researchers recruiting practices to studies requiring routine data extraction should expect substantial delays and plan to over-recruit by approximately 20%.
Trial registration: ISRCTN15448074
Funding: National Institute for Health and Care Research