Johns Hopkins University, Baltimore, MD, USA.
Tuscaloosa VA Medical Center, Tuscaloosa, AL, USA.
J Appl Gerontol. 2024 Nov;43(11):1605-1610. doi: 10.1177/07334648241248269. Epub 2024 Apr 30.
In pragmatic clinical trials (PCTs), the intervention is carried out by participating sites instead of research staff. In this paper, we evaluate study sites' implementation adherence during a pilot PCT of home-delivered meals for older adults with dementia. Participants at three home-delivered meal programs were randomized to receive either (1) meals delivered daily or (2) frozen meals mailed every two weeks; participants' outcomes were tracked for six months. Using the adherence domains from the Framework for Implementation Fidelity, we identified six metrics to assess adherence, with a total possible adherence score ranging from 6 (low adherence) to 18 (high adherence); all three sites scored within the top quartile of adherence. Despite challenges to meal delivery during the COVID-19 pandemic, sites successfully implemented the intervention, justifying a follow-on PCT to test the comparative effectiveness of models of meal delivery on the time to nursing home placement for people living with dementia.
在实用临床试验 (PCT) 中，干预措施由参与的站点而不是研究人员实施。在本文中，我们评估了在一项针对痴呆老年人家庭送餐的试点 PCT 中，研究站点的实施依从性。三个家庭送餐计划的参与者被随机分配接受以下两种方案之一：(1)每天送餐或 (2)每两周邮寄冷冻餐；参与者的结果被跟踪了六个月。使用实施保真度框架中的依从性领域，我们确定了六个评估依从性的指标，总依从性得分范围从 6（低依从性）到 18（高依从性）；所有三个站点的得分都在前四分之一。尽管在 COVID-19 大流行期间送餐面临挑战，但站点成功地实施了干预措施，这证明了进行后续 PCT 以测试送餐模式对痴呆症患者入住养老院时间的比较效果是合理的。
