Challenges and solutions of conducting dementia clinical trials: A palliative care at home pilot for persons with dementia

Recruitment and retention are common challenges in clinical trials, particularly with older adults and their caregivers who often benefit from palliative care but have significant strain from caregiving. In recent years, there has been an expansion in home-based palliative care programs, especially for patients with dementia. Because these programs often rely on physicians or advanced practice nurses, they are quite costly and may be difficult to staff due to workforce shortages. We created a novel program of home-based palliative care for patients with advanced dementia and their families, which centers around a community health worker, a social worker, and a nurse. We report on challenges our trial encountered and corresponding solutions. We enrolled 30 patients and their 30 caregivers in our pilot trial of home-based palliative care. We found two significant barriers to enrollment: (1) the electronic health record was insufficient to determine the severity of patients' dementia; and (2) rates of follow-up survey completion were low, with completion rates at 6 months between 14 and 44%. We created an iterative training process to determine dementia severity from electronic health records and applied person-centered approaches to improve survey completion. Electronic health records are not set up to include discrete fields for dementia severity, which makes enrollment of older adults with dementia in a clinical trial challenging. The strain of caring for a loved one with advanced dementia may also make participation in health-services research difficult for patients and their families. Novel approaches have the potential to counteract these challenges, improve recruitment and retention, and ultimately improve care for people with dementia and their caregivers.