Protocol of a randomised controlled trial on the efficacy of medication optimisation in elderly inpatients: medication optimisation protocol efficacy for geriatric inpatients (MPEG) trial.
Protocol of a randomised controlled trial on the efficacy of medication optimisation in elderly inpatients: medication optimisation protocol efficacy for geriatric inpatients (MPEG) trial.
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DOI：
10.1136/bmjopen-2020-041125
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发表时间：
2020-10-12
期刊：
影响因子：
2.9
通讯作者：
Matsuda T
中科院分区：
文献类型：
--
作者：
Ie K;Hirose M;Sakai T;Motohashi I;Aihara M;Otsuki T;Tsuboya A;Matsumoto H;Hashi H;Inoue E;Takahashi M;Komiya E;Itoh Y;Tsuchida T;Kurosu E;Albert SM;Okuse C;Matsuda T
目前尚不清楚优化用药是否能改善老年人的临床结果。目前的研究旨在评估基于多学科团队的药物优化对老年患者的生存、再住院和非计划就诊的影响。我们报告了一项单中心、开放标签、随机对照试验的方案。登记的对象将是65岁或以上、住进社区医院并接受五次或五次以上常规药物治疗的内科住院患者。参与者将被随机分配接受药物优化干预或常规护理。干预措施将包括基于多学科团队的药物审查，然后是基于老年人可能不适当的处方/筛查工具的筛选工具的药物优化建议，以提醒医生正确的治疗标准，以及隐含的药物优化方案。出院时，将向初级保健医生和社区药剂师发送用药优化摘要。主要结果将是死亡、计划外就诊和再住院直到随机分组后48周的综合结果。次要结果将包括每个主要终点、处方药物的数量、生活质量评分、所需长期护理水平、与药物有关的不良事件、住院期间死亡和跌倒。参与者将接受为期48周的跟踪调查，每两个月进行一次电话访谈，以评估主要和次要结果。按随机化因素分层的对数等级检验将用于比较复合终点的发生率。这项研究于2019年启动，将招募至少500名患者。该研究方案已得到圣玛丽安娜大学医学院机构伦理委员会的批准(第4129号)。目前的研究结果将提交给同行评议的期刊。UMIN000035265
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
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