ABSTRACT
Background/Objectives
Although several approaches have been developed to provide comprehensive care for persons living with dementia (PWD) and their family or friend caregivers, the relative effectiveness and cost‐effectiveness of community‐based versus health system‐based dementia care and the effectiveness of both approaches compared to usual care are unknown.
Design
Pragmatic randomized 3‐arm superiority trial. The unit of randomization is the PWD/caregiver dyad.
Setting
4 clinical trial sites (CTS) based in academic and clinical health systems.
Participants
2,150 English‐ or Spanish‐speaking PWD, who are not receiving hospice or residing in a nursing home, and their caregivers.
Interventions
Eighteen months of 1) Health systems‐based dementia care provided by a nurse practitioner or physician’s assistant Dementia Care Specialist who works within the health system, or 2) Community‐based dementia care provided by a social worker or nurse Care Consultant who works at a community‐based organization, or 3) Usual care with as‐needed referral to the Alzheimer’s Association Helpline.
Measurements
Primary outcomes: PWD behavioral symptoms and caregiver distress as measured by the Neuropsychiatric Inventory Questionnaire (NPI‐Q) Severity and Modified Caregiver Strain Index scales. Secondary outcomes: NPI‐Q Distress, caregiver unmet needs and confidence, and caregiver depressive symptoms. Tertiary outcomes: PWD long‐term nursing home placement rates, caregiver‐reported PWD functional status, cognition, goal attainment, “time spent at home”, Dementia Burden Scale‐Caregiver, a composite measure of clinical benefit, Quality of Life of persons with dementia, Positive Aspects of Caregiving, and cost‐effectiveness using intervention costs and Medicare claims.
Results
Will be reported in Spring 2024.
Conclusion
D‐CARE will address whether emphasis on clinical support and tighter integration with other medical services has greater benefit than emphasis on social support that is tied more closely to community resources. It will also assess the effectiveness of both interventions compared to usual care and will evaluate the cost effectiveness of each intervention.