Meyers Primary Care Institute, a Joint Endeavor of University of Massachusetts Medical School, Reliant Medical Group, and Fallon Health, Worcester, Massachusetts, USA.
Department of Medicine, University of Massachusetts Medical School, Worcester, Massachusetts, USA.
J Am Geriatr Soc. 2020 Nov;68(11):2558-2564. doi: 10.1111/jgs.16696. Epub 2020 Jul 25.
To assess factors associated with trial participation in the context of a low-risk intervention intended to reduce adverse drug events in recently hospitalized older adults.
Mixed methods: analysis of data collected during enrollment efforts and focus groups.
A large, multispecialty group practice.
Individuals 50 years and older, recently discharged from the hospital and prescribed at least one high-risk medication, were eligible for the trial. Enrollees, decliners, and their caregivers were eligible to participate in focus groups.
Reasons for declining to participate during the initial invitation as well as reasons for not providing consent were recorded. Focus groups were conducted with eligible individuals to explore reasons for enrolling or declining. We conducted multivariable logistic regression to compare characteristics (including sex, age, healthcare proxy, number and type of medications, visiting nurse services, reason for admission, and length of hospital stay) of those who enrolled with those who did not enroll.
Of 3,606 individuals determined eligible, 3,147 (87%) declined, 98 (3%) verbally consented to participate but did not complete written consent, and 361 (10%) provided written consent and were considered enrolled. Individuals 80 year and older (odds ratio (OR) = 0.44; 95% confidence interval (CI) = 0.30-0.65) and those with visiting nurse services (OR = 0.64; 95% CI = 0.48-0.85) were least likely to enroll. Among those who provided a reason for declining (2,473), the most common was the belief they did not need additional medication assistance (18%). Another 332 (11%) declined because they were receiving visiting nurse services.
Recruiting older adults recently discharged from the hospital to participate in trials of low-risk, system-level interventions is challenging and may underenroll the oldest individuals and those potentially at the highest risk for adverse events, limiting generalizability of study findings. Alternative study designs may be more effective than individually randomized trials in assessing low-risk, system-level interventions.
评估与一项旨在减少近期住院老年患者不良药物事件的低风险干预措施相关的参与试验的因素。
混合方法：对纳入过程中收集的数据进行分析，并进行焦点小组讨论。
一家大型多专科实践机构。
年龄在 50 岁及以上、最近出院并至少服用一种高风险药物的患者有资格参加试验。参加者、拒绝者及其护理人员有资格参加焦点小组。
记录最初邀请时拒绝参与的原因以及未同意的原因。对符合条件的个人进行焦点小组讨论，以探讨参加或拒绝的原因。我们进行了多变量逻辑回归，比较了参加者和未参加者的特征（包括性别、年龄、医疗保健代理人、药物数量和类型、上门护士服务、入院原因和住院时间）。
在确定符合条件的 3606 人中，3147 人（87%）拒绝，98 人（3%）口头同意参加但未完成书面同意，361 人（10%）书面同意并被认为已纳入。80 岁及以上的个体（比值比（OR）=0.44；95%置信区间（CI）=0.30-0.65）和接受上门护士服务的个体（OR=0.64；95%CI=0.48-0.85）最不可能参加。在那些提供拒绝原因的人中（2473 人），最常见的原因是他们认为自己不需要额外的药物辅助（18%）。另有 332 人（11%）因正在接受上门护士服务而拒绝。
招募最近出院的老年患者参加低风险、系统层面干预措施的试验具有挑战性，可能会使年龄最大和最有可能发生不良事件的个体失访，限制了研究结果的普遍性。与个体随机试验相比，替代研究设计可能更有效地评估低风险、系统层面的干预措施。
