Rankin Audrey, Gorman Ashleigh, Cole Judith, Cadogan Cathal A, Barry Heather E, Agus Ashley, Logan Danielle, McDowell Cliona, Molloy Gerard J, Ryan Cristín, Leathem Claire, Maxwell Marina, Brennan Connie, Gormley Gerard J, Ferrett Alan, McCarthy Pat, Fahey Tom, Hughes Carmel M
School of Pharmacy, Queen's University Belfast, Belfast, BT9 7BL, UK.
School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Dublin, Ireland.
Pilot Feasibility Stud. 2022 Sep 10;8(1):203. doi: 10.1186/s40814-022-01161-6.
For older populations with multimorbidity, polypharmacy (use of multiple medications) is a standard practice. PolyPrime is a theory-based intervention developed to improve 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).
This external pilot cluster randomised controlled trial (cRCT) aimed to recruit 12 general practitioner (GP) practices (six in NI; six in the ROI counties that border NI) and ten older patients receiving polypharmacy (≥ 4 medications) per GP practice (n = 120). Practices allocated to the intervention arm watched an online video and scheduled medication reviews with patients on two occasions. We assessed the feasibility of collecting GP record (medication appropriateness, health service use) and patient self-reported data [health-related quality of life (HRQoL), health service use)] at baseline, 6 and 9 months. HRQoL was measured using the EuroQol-5 dimension-5 level questionnaire (EQ-5D-5L) and medication-related burden quality-of-life (MRB-QoL) tool. An embedded process evaluation and health economics analysis were also undertaken. Pre-specified progression criteria were used to determine whether to proceed to a definitive cRCT.
Twelve GP practices were recruited and randomised. Three GP practices withdrew from the study due to COVID-related factors. Sixty-eight patients were recruited, with 47 (69.1%) being retained until the end of the study. GP record data were available for 47 patients for medication appropriateness analysis at 9 months. EQ-5D-5L and MRB-QoL data were available for 46 and 41 patients, respectively, at 9 months. GP record and patient self-reported health service use data were available for 47 patients at 9 months. Health service use was comparable in terms of overall cost estimated from GP record versus patient self-reported data. The intervention was successfully delivered as intended; it was acceptable to GPs, practice staff, and patients; and potential mechanisms of action have been identified. All five progression criteria were met (two 'Go', three 'Amend').
Despite challenges faced during the COVID-19 pandemic, this study has demonstrated that it may be feasible to conduct an intervention to improve appropriate polypharmacy in older people in primary care across two healthcare jurisdictions.
ISRCTN, ISRCTN41009897 . Registered 19 November 2019.
gov, NCT04181879 . Registered 02 December 2019.
对于患有多种疾病的老年人群，使用多种药物是一种标准做法。PolyPrime是一种基于理论的干预措施，旨在改善初级保健中老年人的合理用药。这项试点研究旨在评估PolyPrime干预措施在北爱尔兰（NI）和爱尔兰共和国（ROI）初级保健中的可行性。
这项外部试点整群随机对照试验（cRCT）旨在招募12家全科医生（GP）诊所（北爱尔兰6家；与北爱尔兰接壤的爱尔兰共和国6家），每家诊所招募10名接受多种药物治疗（≥4种药物）的老年患者（n = 120）。分配到干预组的诊所观看了在线视频，并分两次为患者安排用药审查。我们评估了在基线、6个月和9个月时收集全科医生记录（用药合理性、卫生服务使用情况）和患者自我报告数据[健康相关生活质量（HRQoL）、卫生服务使用情况]的可行性。使用欧洲五维度五水平问卷（EQ-5D-5L）和药物相关负担生活质量（MRB-QoL）工具测量HRQoL。还进行了嵌入式过程评估和卫生经济学分析。使用预先指定的进展标准来确定是否进行确定性cRCT。
招募并随机分配了12家全科医生诊所。由于与COVID相关的因素，3家全科医生诊所退出了研究。招募了68名患者，其中47名（69.1%）保留到研究结束。9个月时，有47名患者的全科医生记录数据可用于用药合理性分析。9个月时，分别有46名和41名患者的EQ-5D-5L和MRB-QoL数据可用。9个月时，有47名患者的全科医生记录和患者自我报告的卫生服务使用数据可用。根据全科医生记录估计的总体成本与患者自我报告的数据相比，卫生服务使用情况具有可比性。干预措施按预期成功实施；全科医生、诊所工作人员和患者都可以接受；并且已经确定了潜在的作用机制。所有五个进展标准均得到满足（两个“继续”，三个“修改”）。
尽管在COVID-19大流行期间面临挑战，但这项研究表明，在两个医疗管辖区对初级保健中的老年人进行干预以改善合理用药可能是可行的。
ISRCTN，ISRCTN41009897。2019年11月19日注册。
gov，NCT04181879。2019年12月2日注册。
