Division of General Internal Medicine, Department of Internal Medicine, Kawasaki Municipal Tama Hospital, Kawasaki-shi, Kanagawa, Japan
Division of General Internal Medicine, Department of Internal Medicine, St Marianna University School of Medicine, Kawasaki-shi, Kanagawa, Japan.
BMJ Open. 2020 Oct 12;10(10):e041125. doi: 10.1136/bmjopen-2020-041125.
Whether medication optimisation improves clinical outcomes in elderly individuals remains unclear. The current study aims to evaluate the effect of multidisciplinary team-based medication optimisation on survival, rehospitalisation and unscheduled hospital visits in elderly patients.
We report the protocol of a single-centre, open-label, randomised controlled trial. The enrolled subjects will be medical inpatients, aged 65 years or older, admitted to a community hospital and receiving five or more regular medications. The participants will be randomly assigned to receive either an intervention for medication optimisation or the usual care. The intervention will consist of a multidisciplinary team-based medication review, followed by a medication optimisation proposal based on the Screening Tool of Older Persons' potentially inappropriate Prescriptions/Screening Tool to Alert doctors to the Right Treatment criteria and an implicit medication optimisation protocol. Medication optimisation summaries will be sent to primary care physicians and community pharmacists on discharge. The primary outcome will be a composite of death, unscheduled hospital visits and rehospitalisation until 48 weeks after randomisation. Secondary outcomes will include each of the primary endpoints, the number of prescribed medications, quality of life score, level of long-term care required, drug-related adverse events, death during hospitalisation and falls. Participants will be followed up for 48 weeks with bimonthly telephone interviews to assess the primary and secondary outcomes. A log-rank test stratified by randomisation factors will be used to compare the incidence of the composite endpoint. The study was initiated in 2019 and a minimum of 500 patients will be enrolled.
The study protocol has been approved by the Institutional Ethical Committee of St. Marianna University School of Medicine (No. 4129). The results of the current study will be submitted to a peer-reviewed journal.
UMIN000035265.
药物优化是否能改善老年人的临床结局仍不清楚。本研究旨在评估多学科团队为基础的药物优化对老年患者的生存、再住院和非计划性就诊的影响。
我们报告了一项单中心、开放标签、随机对照试验的方案。纳入的受试者为 65 岁或以上的住院患者，他们被收入社区医院，接受 5 种或更多的常规药物治疗。参与者将被随机分配接受药物优化干预或常规护理。干预措施将包括多学科团队的药物评估，然后根据老年人潜在不适当处方筛选工具/筛选工具以提醒医生正确治疗标准和一个隐含的药物优化方案提出药物优化建议。药物优化总结将在出院时发送给初级保健医生和社区药剂师。主要结局是随机分组后 48 周内死亡、非计划性就诊和再住院的复合结局。次要结局包括每个主要结局、规定药物的数量、生活质量评分、所需长期护理的水平、药物相关不良事件、住院期间死亡和跌倒。参与者将通过每两个月一次的电话随访进行 48 周的随访，以评估主要和次要结局。将采用按随机分组因素分层的对数秩检验比较复合结局的发生率。该研究于 2019 年启动，预计将纳入至少 500 名患者。
本研究方案已获得圣玛丽安娜大学医学院机构伦理委员会的批准（编号：4129）。本研究的结果将提交给同行评议的期刊。
UMIN000035265。
