Discussion
dementia
This pilot study demonstrated the feasibility of implementing a pragmatic randomized clinical trial among participants with self- or proxy-reported dementia on waiting lists at MOW programs. We also showed the ability to link participants with their CMS data, monitor fidelity, and measure the time to nursing home placement. We observed that participants who received daily-delivered meals had lower rates of nursing home placement within 6 months compared with participants who received drop-shipped frozen meals, although these differences were not statistically significant. While this pilot trial was not adequately powered to detect effects that were as large as the observed differences at a 5% nominal level, the results suggest that there may be lower nursing home placement among individuals with self- or proxy-reported dementia who received daily-delivered meals with socialization and a safety check compared with individuals who received drop-shipped frozen meals.We enrolled 243 of 325 individuals with self- or proxy-reported dementia on waiting lists for MOW. The 243 participants differed by race and ethnicity and program from those not enrolled, suggesting that future work using this approach may need to consider the generalizability of enrollees compared with the eligible population. These findings provide useful estimates for the number of people who meet eligibility criteria we would need to identify on waiting lists at local MOW programs to enroll the required number of participants in a well-powered trial. In addition, the variation by program addressed the importance of understanding practices at each site, which relates to different methods of using waiting lists and contacting people to initiate service. We also found that we were able to link all but 16 participants with their CMS data using the information routinely collected by MOW programs. This information and our approach to linking the unlinked individuals may be helpful to other pragmatic trialists who are collecting identifiable information to link with administrative data.The results from this pilot study, which took place during 2021, must be interpreted considering the COVID-19 pandemic and implications it had on our study. First, MOW programs implemented procedures in response to the pandemic that reduced the frequency and kind of interactions that drivers had with clients, 1 of the key differentiators between the 2 study arms. For example, 1 program implemented social distancing requirements in which a driver could not enter a home but rather had to hang a bag with the food on the door, knock, and step away. Another program reduced delivery of daily-delivered meals to twice per week during the pandemic because of a decline in volunteer drivers. The reduction in the number of daily deliveries meant some meals were delivered chilled and may have needed preparation (eg, reheating). While reheating the chilled meals may have been simpler than preparing the frozen meals, the benefit of the ready-to-eat meal characterized by the daily meal delivery model may have been reduced for some. Given these COVID-19–related changes to the ways in which meals were delivered for the daily-delivered meals arm, it is likely that the effect of daily-delivered meals was attenuated in this pilot study. In addition, our measure of participant fidelity (ie, receiving meals for the full 6-month study period) could have been impacted by the pandemic and may have been specific to the population with self-reported dementia. Based on the National Survey of Older Americans Act Participants, more than 80% of its respondents received meals for 6 or more months.