Objective To estimate the effectiveness, cost effectiveness (to be reported elsewhere), and safety of pharmacy independent prescribers in care homes. Design Cluster randomised controlled trial, with clusters based on triads of a pharmacist independent prescriber, a general practice, and one to three associated care homes. Setting Care homes across England, Scotland, and Northern Ireland, their associated general practices, and pharmacy independent prescribers, formed into triads. Participants 49 triads and 882 residents were randomised. Participants were care home residents, aged ≥65 years, taking at least one prescribed drug, recruited to 20 residents/triad. Intervention Each pharmacy independent prescriber provided pharmaceutical care to approximately 20 residents across one to three care homes, with weekly visits over six months. Pharmacy independent prescribers developed a pharmaceutical care plan for each resident, did medicines reviews/reconciliation, trained staff, and supported with medicines related procedures, deprescribing, and authorisation of prescriptions. Participants in the control group received usual care. Main outcomes measures The primary outcome was fall rate/person at six months analysed by intention to treat, adjusted for prognostic variables. Secondary outcomes included quality of life (EQ-5D by proxy), Barthel score, Drug Burden Index, hospital admissions, and mortality. Assuming a 21% reduction in falls, 880 residents were needed, allowing for 20% attrition. Results The average age of participants at study entry was 85 years; 70% were female. 697 falls (1.55 per resident) were recorded in the intervention group and 538 falls (1.26 per resident) in the control group at six months. The fall rate risk ratio for the intervention group compared with the control group was not significant (0.91, 95% confidence interval 0.66 to 1.26) after adjustment for all model covariates. Secondary outcomes were not significantly different between groups, with exception of the Drug Burden Index, which significantly favoured the intervention. A third (185/566; 32.7%) of pharmacy independent prescriber interventions involved medicines associated with falls. No adverse events or safety concerns were identified. Conclusions Change in the primary outcome of falls was not significant. Limiting follow-up to six months combined with a small proportion of interventions predicted to affect falls may explain this. A significant reduction in the Drug Burden Index was realised and would be predicted to yield future clinical benefits for patients. This large trial of an intensive weekly pharmacist intervention with care home residents was also found to be safe and well received. Trial registration ISRCTN 17847169. De-identified participant data, including primary, secondary, and patient reported outcome data, interview transcripts, prescription data, protocol, and statistical analysis plan, are available on request from DW (d.j.wright@leicester.ac.uk), LS (l.shepstone@uea.ac.uk), and Norfolk and Waveney Integrated Care Board (NWICB) research office (nwicb.RandDoffice@nhs.net). Reuse of the CHIPPS dataset will be made available on reasonable request for the purpose of improving patient care in health and social care and will be subject to completion of a data sharing agreement between NWICB, the University of East Anglia, and the third-party organisation.

中文翻译：

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护理院药剂师独立处方者的有效性和安全性评估：整群随机对照试验

目的 评估疗养院中药房独立处方者的有效性、成本效益（将在别处报告）和安全性。设计集群随机对照试验，集群基于药剂师独立处方者、全科诊所和一到三个相关护理院的三合会。英格兰、苏格兰和北爱尔兰的养老院、相关的全科诊所和药房独立处方者组成了三合会。参与者 49 个三合会和 882 个居民被随机分配。参与者是养老院居民，年龄≥65 岁，服用至少一种处方药，招募到 20 名居民/三合会。干预 每个药房独立处方者为一到三个疗养院的大约 20 名居民提供药学服务，在六个月内每周拜访一次。药房独立处方者为每位居民制定药学保健计划，进行药物审查/核对，培训员工，并支持与药物相关的程序、取消处方和处方授权。对照组的参与者接受常规护理。主要结果测量 主要结果是六个月时跌倒率/人，按治疗意向分析，并根据预后变量进行调整。次要结果包括生活质量（EQ-5D 代理）、Barthel 评分、药物负担指数、住院率和死亡率。假设跌倒减少 21%，则需要 880 名居民，考虑到 20% 的人员流失。结果 参加研究的参与者平均年龄为 85 岁；70% 是女性。干预组记录了 697 次跌倒（每位居民 1.55 次），538 次跌倒（1.55 次）。六个月时，对照组中每个居民 26 人）。调整所有模型协变量后，干预组与对照组相比的跌倒率风险比不显着（0.91，95% 置信区间 0.66 至 1.26）。次要结果在各组之间没有显着差异，但药物负担指数除外，该指数显着支持干预。三分之一 (185/566; 32.7%) 的药房独立处方干预涉及与跌倒相关的药物。没有发现不良事件或安全问题。结论 跌倒主要结果的变化并不显着。将随访时间限制在六个月内，再加上一小部分预计会影响跌倒的干预措施，可以解释这一点。实现了药物负担指数的显着降低，预计将为患者带来未来的临床益处。这项每周对疗养院居民进行强化药剂师干预的大型试验也被发现是安全且广受好评的。试验注册 ISRCTN 17847169。可根据 DW (djwright@leicester.ac.uk) 的要求提供未识别的参与者数据，包括主要、次要和患者报告的结果数据、访谈记录、处方数据、协议和统计分析计划, LS (l.shepstone@uea.ac.uk), 以及诺福克和韦夫尼综合护理委员会 (NWICB) 研究办公室 (nwicb.RandDoffice@nhs.net)。