Preventing cardiovascular disease in at-risk patients: Protocol for a feasibility study in general practice ('High-Risk Prevention Programme') - Extended Data

This webpage provides related study participant information leaflets/consent forms, study instruments, and completed CONSORT (2010 checklist of information to include when reporting a pilot or feasibility trial*) and STROBE (checklist of items that should be included in reports of observational studies) checklists. Abstract Background: Cardiovascular disease (CVD) is the number one cause of death globally. Whilst initiatives such as Ireland’s ‘Chronic Disease Management Programme’ have helped in the fight against CVD, a more intensive approach may be required to meet high-risk patients’ needs. The High-Risk Prevention Programme (HRPP), led by the Irish Heart Foundation, University College Dublin (UCD), and Ireland’s Health Service Executive (HSE) aims to design, deliver, and evaluate an intensive, six-week behaviour change programme among people at high risk of CVD living in Irish communities. In this paper, we aim to describe the HRPP intervention and the approach that will be used to evaluate it. Methods: The HRPP has been informed by an inclusive co-design process involving health provider and patient input, has been operating since February 2021 and will run until February 2023. Six general practices have agreed to take part in the project, and it is planned that 400 patients at high risk of CVD will participate. Participating patients attend either a practice nurse or health promotion coordinator-led six-week one-to-one consultation programme focusing on self-management of health issues. Feasibility, acceptability, and likely effectiveness will be assessed by means of a process evaluation involving a quantitative survey (patient health and health behaviours assessments) at baseline and 12 months, and in-depth qualitative interviews with patients, practice nurses and general practitioners. Conclusions: Project findings will inform whether a general practice-based intervention to prevent CVD among at-risk patients is feasible, acceptable in practice, has a positive impact, and what outcome measures might form the focus of future research.We would like to thank Ireland's Health Service Executive (HSE) for providing funding to the Irish Heart Foundation for leading the project. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript