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

Pilot and Feasibility Studies

Tom Fahey¹  Pat McCarthy²  Claire Leathem³  Marina Maxwell³  Evie Gardner⁴  Ashley Agus⁴  Alan Ferrett⁵  Gerard J. Gormley⁶  Cathal A. Cadogan⁷  Cristín Ryan⁸  Ashleigh Gorman⁸  Carmel M. Hughes⁹  Audrey Rankin⁹  Heather E. Barry⁹  Gerard J. Molloy^1,10 

[1] Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland;Donegal Volunteer Centre, Donegal, Ireland;Northern Ireland Clinical Research Network (Primary Care), Belfast, UK;Northern Ireland Clinical Trials Unit, Belfast, UK;Public Involvement Enhancing Research, Belfast, Northern Ireland, UK;School of Medicine, Dentistry and Biomedical Sciences, Queen’s University Belfast, Belfast, UK;School of Pharmacy and Biomolecular Sciences, Royal College of Surgeons in Ireland, Dublin, Ireland;School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Dublin, Ireland;School of Pharmacy, Queen’s University Belfast, 97 Lisburn Road, BT9 7BL, Belfast, UK;School of Psychology, National University of Ireland, Galway, Ireland;

关键词: Polypharmacy;    Behaviour change;    Primary care;    General practice;    Complex intervention;    Pilot study;    Process evaluation;    Older people;    Prescribing;   

DOI  :  10.1186/s40814-021-00822-2

来源: Springer

【 摘 要 】

BackgroundThe use of multiple medications (polypharmacy) is a concern in older people (≥65 years) and is associated with negative health outcomes. For older populations with multimorbidity, polypharmacy is the reality and the key challenge is ensuring appropriate polypharmacy (as opposed to inappropriate polypharmacy). This external pilot cluster randomised controlled trial (cRCT) aims to further test a theory-based intervention to improve appropriate polypharmacy in older people in primary care in two jurisdictions, Northern Ireland (NI) and the Republic of Ireland (ROI).MethodsTwelve GP practices across NI (n=6) and the six counties in the ROI that border NI will be randomised to either the intervention or usual care group. Members of the research team have developed an intervention to improve appropriate polypharmacy in older people in primary care using the Theoretical Domains Framework of behaviour change. The intervention consists of two components: (1) an online video which demonstrates how a GP may prescribe appropriate polypharmacy during a consultation with an older patient and (2) a patient recall process, whereby patients are invited to scheduled medication review consultations with GPs. Ten older patients receiving polypharmacy (≥4 medications) will be recruited per GP practice (n=120). GP practices allocated to the intervention arm will be asked to watch the online video and schedule medication reviews with patients on two occasions; an initial and a 6-month follow-up appointment. GP practices allocated to the control arm will continue to provide usual care to patients. The study will assess the feasibility of recruitment, retention and study procedures including collecting data on medication appropriateness (from GP records), quality of life and health service use (i.e. hospitalisations). An embedded process evaluation will assess intervention fidelity (i.e. was the intervention delivered as intended), acceptability of the intervention and potential mechanisms of action.DiscussionThis pilot cRCT will provide evidence of the feasibility of a range of study parameters such as recruitment and retention, data collection procedures and the acceptability of the intervention. Pre-specified progression criteria will also be used to determine whether or not to proceed to a definitive cRCT.Trial registrationISRCTN, ISRCTN41009897. Registered 19 November 2019. ClinicalTrials.gov, NCT04181879. Registered 02 December 2019.

【 授权许可】

CC BY