Rankin Audrey, Cadogan Cathal A, Barry Heather E, Gardner Evie, Agus Ashley, Molloy Gerard J, Gorman Ashleigh, Ryan Cristín, Leathem Claire, Maxwell Marina, Gormley Gerard J, Ferrett Alan, McCarthy Pat, Fahey Tom, Hughes Carmel M
School of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast, BT9 7BL, UK.
School of Pharmacy and Biomolecular Sciences, Royal College of Surgeons in Ireland, Dublin, Ireland.
Pilot Feasibility Stud. 2021 Mar 19;7(1):77. doi: 10.1186/s40814-021-00822-2.
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).
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.
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.
ISRCTN, ISRCTN41009897 . Registered 19 November 2019. ClinicalTrials.gov, NCT04181879 . Registered 02 December 2019.
多种药物联合使用（多重用药）是老年人（≥65岁）面临的一个问题，且与不良健康结果相关。对于患有多种疾病的老年人群体而言，多重用药是现实情况，关键挑战在于确保合理的多重用药（与不合理的多重用药相对）。这项外部试点整群随机对照试验（cRCT）旨在进一步测试一种基于理论的干预措施，以改善北爱尔兰（NI）和爱尔兰共和国（ROI）两个司法管辖区基层医疗中老年人的合理多重用药情况。
北爱尔兰的12家全科医生诊所（n = 6）以及与北爱尔兰接壤的爱尔兰共和国的6个郡的诊所将被随机分为干预组或常规护理组。研究团队成员利用行为改变的理论领域框架，开发了一种干预措施来改善基层医疗中老年人的合理多重用药情况。该干预措施包括两个部分：（1）一个在线视频，展示全科医生在与老年患者会诊期间如何开具合理的多重用药处方；（2）一个患者召回流程，即邀请患者与全科医生进行预定的用药复查会诊。每个全科医生诊所将招募10名接受多重用药（≥4种药物）的老年患者（n = 120）。分配到干预组的全科医生诊所将被要求观看在线视频，并安排两次与患者的用药复查会诊；一次初始会诊和一次6个月的随访会诊。分配到对照组的全科医生诊所将继续为患者提供常规护理。该研究将评估招募、留存和研究程序的可行性，包括收集用药合理性（来自全科医生记录）、生活质量和卫生服务利用情况（即住院情况）的数据。一项嵌入式过程评估将评估干预的保真度（即干预是否按预期实施）、干预的可接受性以及潜在的作用机制。
这项试点cRCT将提供一系列研究参数可行性的证据，如招募和留存、数据收集程序以及干预的可接受性。预先设定的进展标准也将用于确定是否继续进行确定性的cRCT。
国际标准随机对照试验编号（ISRCTN），ISRCTN41009897。于2019年11月19日注册。美国国立医学图书馆临床试验注册库（ClinicalTrials.gov），NCT04181879。于2019年12月2日注册。
