Clinical trial testing in-home multidisciplinary care management for older adults with cognitive vulnerability: Rationale and study design

Abstract

Care management approaches are being widely tested in the Medicare-eligible population to manage chronic conditions, but few have focused on cognitive vulnerability as the pathway to optimizing independence in the community-dwelling older population. Cognitive vulnerability refers to living with dementia, depression, and/or a history of delirium. Many studies have shown that cognitive vulnerability is associated with poor health-related outcomes in community-dwelling older adults, raising the health policy importance of finding evidence-based approaches to improve outcomes for this target population. Moreover, very little is known about effects of care management approaches in the rapidly growing Medicare Advantage population. In response to these knowledge gaps, we are testing the efficacy of an in-home, nurse practitioner-led care management team for adults age ≥ 65 with cognitive vulnerability in a Medicare Advantage population. Older adults and family caregivers randomized either to this multidisciplinary care management team, or to a telephonic care management program routinely offered by our Medicare Advantage partner. The intervention period is 12 months and the primary outcome is any emergency department visit or hospitalization over the 12-month period. In this paper, we report on the rationale for testing a multidisciplinary care management intervention for this target population, and explain how a university-based research team collaborated with a Medicare Advantage insurer to conceptualize and implement the clinical trial. We also provide details on study design, and on components of the in-home and telephonic care management interventions. We conclude with a synopsis of recruitment progress along with selected baseline characteristics of the study cohort.