Department of General Internal Medicine, St Marianna University School of Medicine, Kanagawa, Japan.
Department of General Internal Medicine, Kawasaki Municipal Tama Hospital, Kanagawa, Japan.
JAMA Netw Open. 2024 Jul 1;7(7):e2423544. doi: 10.1001/jamanetworkopen.2024.23544.
There is currently no consensus on clinically effective interventions for polypharmacy among older inpatients.
To evaluate the effect of multidisciplinary team-based medication optimization on survival, unscheduled hospital visits, and rehospitalization in older inpatients with polypharmacy.
DESIGN, SETTING, AND PARTICIPANTS: This open-label randomized clinical trial was conducted at 8 internal medicine inpatient wards within a community hospital in Japan. Participants included medical inpatients 65 years or older who were receiving 5 or more regular medications. Enrollment took place between May 21, 2019, and March 14, 2022. Statistical analysis was performed from September 2023 to May 2024.
The participants were randomly assigned to receive either an intervention for medication optimization or usual care including medication reconciliation. The intervention consisted of a medication review using the STOPP (Screening Tool of Older Persons' Prescriptions)/START (Screening Tool to Alert to Right Treatment) criteria, followed by a medication optimization proposal for participants and their attending physicians developed by a multidisciplinary team. On discharge, the medication optimization summary was sent to patients' primary care physicians and community pharmacists.
The primary outcome was a composite of death, unscheduled hospital visits, and rehospitalization within 12 months. Secondary outcomes included the number of prescribed medications, falls, and adverse events.
Between May 21, 2019, and March 14, 2022, 442 participants (mean [SD] age, 81.8 [7.1] years; 223 [50.5%] women) were randomly assigned to the intervention (n = 215) and usual care (n = 227). The intervention group had a significantly lower percentage of patients with 1 or more potentially inappropriate medications than the usual care group at discharge (26.2% vs 33.0%; adjusted odds ratio [OR], 0.56 [95% CI, 0.33-0.94]; P = .03), at 6 months (27.7% vs 37.5%; adjusted OR, 0.50 [95% CI, 0.29-0.86]; P = .01), and at 12 months (26.7% vs 37.4%; adjusted OR, 0.45 [95% CI, 0.25-0.80]; P = .007). The primary composite outcome occurred in 106 participants (49.3%) in the intervention group and 117 (51.5%) in the usual care group (stratified hazard ratio, 0.98 [95% CI, 0.75-1.27]). Adverse events were similar between each group (123 [57.2%] in the intervention group and 135 [59.5%] in the usual care group).
In this randomized clinical trial of older inpatients with polypharmacy, the multidisciplinary deprescribing intervention did not reduce death, unscheduled hospital visits, or rehospitalization within 12 months. The intervention was effective in reducing the number of medications with no significant adverse effects on clinical outcomes, even among older inpatients with polypharmacy.
UMIN Clinical Trials Registry: UMIN000035265.
目前对于老年住院患者的多重用药问题，临床上尚无有效的干预措施。
评估多学科团队为药物优化对老年多重用药住院患者的生存、非计划性就诊和再住院的影响。
设计、地点和参与者：这是一项在日本一家社区医院的 8 个内科住院病房开展的开放性标签随机临床试验。参与者包括年龄在 65 岁及以上、正在服用 5 种或以上常规药物的住院患者。研究于 2019 年 5 月 21 日至 2022 年 3 月 14 日期间进行。从 2023 年 9 月至 2024 年 5 月进行统计分析。
参与者被随机分配接受药物优化干预或包括药物重整在内的常规护理。干预措施包括使用 STOPP（老年人用药筛查工具）/START（用药适宜性筛查工具）标准进行药物审查，然后由多学科团队为参与者及其主治医生制定药物优化建议。出院时，将药物优化摘要发送给患者的初级保健医生和社区药剂师。
主要结局为 12 个月内死亡、非计划性就诊和再住院的复合结局。次要结局包括用药数量、跌倒和不良事件。
2019 年 5 月 21 日至 2022 年 3 月 14 日期间，共有 442 名参与者（平均[标准差]年龄 81.8[7.1]岁；223[50.5%]名女性）被随机分配到干预组（n = 215）和常规护理组（n = 227）。与常规护理组相比，干预组在出院时（26.2%比 33.0%；调整后的优势比[OR]，0.56[95%置信区间，0.33-0.94]；P = .03）、6 个月时（27.7%比 37.5%；调整后的 OR，0.50[95% CI，0.29-0.86]；P = .01）和 12 个月时（26.7%比 37.4%；调整后的 OR，0.45[95% CI，0.25-0.80]；P = .007）有更少的患者使用 1 种或多种潜在不适当药物。干预组的主要复合结局发生率为 106 名患者（49.3%），常规护理组为 117 名患者（51.5%）（分层风险比，0.98[95% CI，0.75-1.27]）。两组的不良事件相似（干预组 123 例[57.2%]，常规护理组 135 例[59.5%]）。
在这项针对老年多重用药住院患者的随机临床试验中，多学科药物减少干预措施并未降低 12 个月内的死亡、非计划性就诊或再住院率。该干预措施在减少用药数量方面是有效的，且对临床结局没有显著的不良影响，即使是在老年多重用药住院患者中也是如此。
UMIN 临床试验注册：UMIN000035265。
