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

Abstract

Background: The 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).Methods: Twelve 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.Discussion: This 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 registration: ISRCTN, ISRCTN41009897. Registered 19 November 2019, https://doi.org/10.1186/ISRCTN41009897. Clinicaltrials.gov, NCT04181879. Registered 02 December 2019, https://clinicaltrials.gov/ct2/show/NCT04181879.

Protocol for a Process Evaluation of an External Pilot Cluster Randomised Controlled Trial of a Theory-Based Intervention to Improve Appropriate Polypharmacy in Older People in Primary Care: The PolyPrime Study

“…This will add to the data from the main external pilot cRCT of the PolyPrime intervention which aims to provide information about 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) [14].…”

“…These interviews aimed to identify potential barriers and facilitators to prescribing and dispensing appropriate polypharmacy, which were then mapped to four behaviour change techniques (BCTs) to form the "active components" of the intervention [11]. The intervention, which was then tested in a small-scale feasibility study [12], consists of two main components: an online video demonstrating how GPs can improve appropriate polypharmacy during typical consultations with older patients (BCT: 'Modelling or demonstrating of behaviour'; [13]) and a patient recall process, whereby patients are invited to medication review consultations with GPs (on two occasions; an initial medication review and a 6month follow-up appointment with the same GP) [12,14]. The video includes feedback from both a practising GP and a simulated patient emphasising the positive outcomes of the consultation (BCT: issues which GPs should consider when conducting the medication reviews, along with links to additional resources for GPs [14,15].…”

“…The intervention, which was then tested in a small-scale feasibility study [12], consists of two main components: an online video demonstrating how GPs can improve appropriate polypharmacy during typical consultations with older patients (BCT: 'Modelling or demonstrating of behaviour'; [13]) and a patient recall process, whereby patients are invited to medication review consultations with GPs (on two occasions; an initial medication review and a 6month follow-up appointment with the same GP) [12,14]. The video includes feedback from both a practising GP and a simulated patient emphasising the positive outcomes of the consultation (BCT: issues which GPs should consider when conducting the medication reviews, along with links to additional resources for GPs [14,15]. To facilitate the patient recall process, two complementary intervention components involve GPs making explicit plans at weekly practice staff meetings of when and how they would ensure that target patients are prescribed appropriate polypharmacy (BCT: 'Action planning'; [13]) and GPs receiving prompts from reception staff to carry out this plan when target patients attend their appointments (BCT: 'Prompts/cues'; [13]).…”

“…This external pilot cluster randomised controlled trial is ongoing and will be completed by August 2021. A protocol paper for the main study has been submitted to Pilot and Feasibility Studies [14].…”

“…A detailed overview of the sampling and recruitment procedures for GPs and patients has been described elsewhere [14]. Brie y, GP practice recruitment (now complete) took place in two stages.…”