Evaluating the Implementation Fidelity of a Pilot Pragmatic Randomized Clinical Trial Comparing Daily-Delivered Meals to Mailed Frozen Meals.

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.