An external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (PolyPrime)

Talk Code: 
5D.4
Presenter: 
Carmel Hughes
Co-authors: 
Prof Carmel Hughes, Audrey Rankin, Ashleigh Gorman, Judith Cole, Cristín Ryan, Cathal A. Cadogan, Heather E. Barry, Ashley Agus, Danielle Logan, Cliona McDowell, Gerard J. Molloy, Claire Leathem, Marina Maxwell, Connie Brennan, Gerard J. Gormley, Alan Ferrett, Pat McCarthy, Tom Fahey, on behalf of the PolyPrime team
Author institutions: 
Queen’s University Belfast, Trinity College Dublin, Northern Ireland Clinical Trials Unit, National University of Ireland Galway, Northern Ireland Clinical Research Network (Primary Care), Public Involvement Enhancing Research, Donegal Volunteer Centre, Royal College of Surgeons in Ireland

Problem

For older populations with multimorbidity, polypharmacy (use of multiple medications) is standard practice. The key challenge is ensuring appropriate polypharmacy (as opposed to inappropriate polypharmacy). PolyPrime is a theory-based intervention that has been developed to enhance appropriate polypharmacy in older people in primary care. This pilot study aims to assess the feasibility of the PolyPrime intervention in primary care in Northern Ireland (NI) and the Republic of Ireland (ROI).

Approach

This external pilot cluster randomised controlled trial (cRCT) aimed to recruit 12 GP practices (six in NI and six in the ROI counties that border NI) and ten older patients receiving polypharmacy (≥4 medications) per GP practice (n=120). GP practices randomly allocated to the intervention arm watched an online video (which demonstrated how GPs could improve appropriate polypharmacy during consultations with older patients) and scheduled medication reviews with patients on two occasions: an initial review and a 6-month follow-up appointment. GP practices allocated to the control arm continued to provide usual care to patients without further input. The study assessed the feasibility of recruitment, retention and collecting GP record (medication appropriateness, health service use) and self-report patient (quality of life, health service use) data. Pre-specified progression criteria based on recruitment and retention of GPs and patients, and completeness of outcome data were used to determine whether to proceed to a definitive cRCT or if further modifications were warranted.

Findings

All progression criteria were met (two ‘Go’ and three ‘Amend’ criteria). Twelve GP practices were recruited (Go: ≥10 GP practices recruited to take part in ≤6-months) and randomised into intervention or control arms. Three practices subsequently withdrew from the study, stating pressures caused by the COVID-19 pandemic as the main reason (Amend: 6-9 GP practices retained for the required period). Sixty-eight patients were recruited (Amend: 60–95 patients recruited within 5-months), with 24 patients in intervention practices receiving both an initial and follow-up medication review. Forty-seven (69.1%) patients were retained (i.e. had GP record data available for primary outcome analysis at 9-months) until the end of the study (Amend: 50–79% of patients retained for the required period). GP record data were available for 56, 49 and 47 (all 100%) patients at baseline, 6-months and 9-months, respectively. All self-report patient data were available for 66 (97%), 47 (92%) and 47 (96%) patients at baseline, 6-months and 9-months, respectively (Go: ≥80% of each patient self-report and GP-reported outcome measure is complete).

Consequences

Despite challenges faced due to the COVID-19 pandemic, this study has demonstrated that it is feasible to conduct a theory-based intervention aimed at improving appropriate polypharmacy in older people in primary care across two healthcare jurisdictions. A future definitive cRCT will explore the effectiveness of the intervention.

Submitted by: 
AUDREY RANKIN
Funding acknowledgement: 
This study is funded by the HSC R&D Division Cross-border Healthcare 528 Intervention Trials in Ireland Network (CHITIN) programme, funded by the European Union’s INTERREG VA Programme, managed by the Special EU Programmes Body (SEUPB) project reference CHI/5431/2018. The views and opinions expressed in this document do not necessarily reflect those of the European Commission or the Special EU Programmes Body (SEUPB). The funding body (and study sponsor) were not involved in the design of the study or in the writing of this abstract.