Vasilevskis Eduard E, Shah Avantika S, Hollingsworth Emily K, Shotwell Matthew S, Mixon Amanda S, Bell Susan P, Kripalani Sunil, Schnelle John F, Simmons Sandra F
Vanderbilt University Medical Center, Center for Quality Aging, Nashville, TN, USA.
VA Tennessee Valley Healthcare System, Geriatric Research Education and Clinical Center, Nashville, TN, USA.
BMC Health Serv Res. 2019 Mar 14;19(1):165. doi: 10.1186/s12913-019-3995-3.
Polypharmacy is prevalent among hospitalized older adults, particularly those being discharged to a post-care care facility (PAC). The aim of this randomized controlled trial is to determine if a patient-centered deprescribing intervention initiated in the hospital and continued in the PAC setting reduces the total number of medications among older patients.
The Shed-MEDS study is a 5-year, randomized controlled clinical intervention trial comparing a patient-centered describing intervention with usual care among older (≥50 years) hospitalized patients discharged to PAC, either a skilled nursing facility (SNF) or an inpatient rehabilitation facility (IPR). Patient measurements occur at hospital enrollment, hospital discharge, within 7 days of PAC discharge, and at 60 and 90 days following PAC discharge. Patients are randomized in a permuted block fashion, with block sizes of two to four. The overall effectiveness of the intervention will be evaluated using total medication count as the primary outcome measure. We estimate that 576 patients will enroll in the study. Following attrition due to death or loss to follow-up, 420 patients will contribute measurements at 90 days, which provides 90% power to detect a 30% versus 25% reduction in total medications with an alpha error of 0.05. Secondary outcomes include the number of medications associated with geriatric syndromes, drug burden index, medication adherence, the prevalence and severity of geriatric syndromes and functional health status.
The Shed-MEDS trial aims to test the hypothesis that a patient-centered deprescribing intervention initiated in the hospital and continuing through the PAC stay will reduce the total number of medications 90 days following PAC discharge and result in improvements in geriatric syndromes and functional health status. The results of this trial will quantify the health outcomes associated with reducing medications for hospitalized older adults with polypharmacy who are discharged to post-acute care facilities.
This trial was prospectively registered at clinicaltrials.gov ( NCT02979353 ). The trial was first registered on 12/1/2016, with an update on 09/28/17 and 10/12/2018.
多重用药在住院老年人中很普遍，尤其是那些出院后前往后期护理机构（PAC）的患者。这项随机对照试验的目的是确定在医院启动并在PAC环境中持续进行的以患者为中心的减药干预措施是否能减少老年患者的药物总数。
Shed-MEDS研究是一项为期5年的随机对照临床干预试验，在出院后前往PAC（熟练护理机构[SNF]或住院康复机构[IPR]）的老年（≥50岁）住院患者中，比较以患者为中心的减药干预措施与常规护理。患者测量在医院入院时、出院时、PAC出院后7天内以及PAC出院后60天和90天进行。患者以置换区组方式随机分组，区组大小为2至4。干预措施的总体有效性将以药物总数作为主要结局指标进行评估。我们估计有576名患者将参与该研究。在因死亡或失访导致损耗后，420名患者将在90天时提供测量数据，这为检测药物总数减少30%与25%提供了90%的检验效能，α错误为0.05。次要结局包括与老年综合征相关的药物数量、药物负担指数、用药依从性、老年综合征的患病率和严重程度以及功能健康状况。
Shed-MEDS试验旨在检验以下假设：在医院启动并在PAC住院期间持续进行的以患者为中心的减药干预措施，将减少PAC出院后90天的药物总数，并改善老年综合征和功能健康状况。该试验的结果将量化与减少多重用药的住院老年患者出院后前往急性后期护理机构的药物使用相关的健康结局。
该试验已在clinicaltrials.gov上进行前瞻性注册（NCT02979353）。该试验于2016年12月1日首次注册，2017年9月28日和2018年10月12日进行了更新。
