Title: A randomised pilot study of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (PolyPrime)
Funder: Health and Social Care Research and Development Division (HSC R&D) of Public Health Agency, Northern Ireland

Abstract: Historically, polypharmacy was viewed negatively (too many medicines), but the advent of multimorbidity and the plethora of treatment guidelines have led to prescribing of multiple medicines, particularly in the older population. The challenge is to obtain a balance between many medicines (appropriate polypharmacy) and too many medicines (inappropriate polypharmacy). Members of the research team have developed a theory-based intervention, targeting prescribing of appropriate polypharmacy in primary care, which we have tested for feasibility in two general practices. We have also developed a Core Outcome Set (COS) for polypharmacy research. The proposed study will further refine and test the intervention in a randomised pilot study comprising three phases. Phase 1: The intervention package currently consists of two components: (a) a video incorporating behaviour change techniques (BCTs) demonstrating how general practitioners (GPs) can prescribe appropriate polypharmacy (primarily focusing on reducing unnecessary/inappropriate medicines) during a typical consultation with an older patient, and (b) a patient recall process (appointment with GP for a medication review). The intervention package was developed in Northern Ireland (NI), and although there are not marked differences in primary care across NI and the Republic of Ireland (ROI), we will undertake a refinement exercise to account for any subtle cross-border differences in context and practice. We will interview 24 general practitioners (GPs) across 12 practices in the six border counties in the ROI and use the findings to refine the intervention package, prior to pilot testing in the Defined Area. In Phase 2, we will undertake a randomised pilot study involving 12 practices: six practices in NI and six practices in the six border counties in the ROI; (10 patients per practice). Eligibility criteria for patients are: ≥70 years, prescribed four or more regular medicines, living at home and not cognitively impaired. Practices will be randomised to intervention or control groups, whereby the intervention package will be tested in the intervention practices and usual care will continue in the control practices. The video will be made available via a secure online platform, and GPs will be invited to view the video as often as they wish during the intervention period (12 months). Eligible patients will be invited to attend an appointment (baseline and six months) with their GP, during which their medication will be reviewed and polypharmacy addressed. The outcomes will be medication appropriateness (appropriate polypharmacy) as assessed by validated criteria and health-related quality of life. We will also undertake a cost analysis. In Phase 3, a mixed methods process evaluation will be conducted during and after the pilot study to assess fidelity of delivery, receipt, enactment and acceptability of the intervention, to inform interpretation of findings. Progression rules will be used to determine if we should proceed to a full-scale trial. The potential benefits from this study include a refined intervention suitable for cross-border research, an in-depth understanding regarding fidelity to and implementation of the intervention, and expanded capacity to undertake primary care research in the Defined Area through training and mentoring provided over the course of the study.


Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: GENERIC HEALTH RELEVANCE