Pragmatic Trial of the Effectiveness and Cost-Effectiveness of Dementia Care.

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PROJECT SUMMARY In the United States, an estimated 5.5 million persons are affected by Alzheimer's disease, the most common type of dementia. The clinical manifestations of dementia are devastating and often lead to caregiver stress, burnout, and medical illnesses. Dementia is a prototype of a disorder with complex needs that span both the patient and caregiver, medical and social domains, and health system and community-based organizations. In response, several dementia care programs have been developed to more comprehensively meet the needs of patients and their caregivers, including those based within health care systems and those based in the community. These programs have been implemented at either single sites or on a relatively small scale; none has been replicated widely because of unanswered questions about effectiveness and cost-effectiveness. In November 2017, the Patient Centered Outcomes Research Institute (PCORI) approved a 4-site pragmatic clinical trial to compare the effectiveness of health-systems-based care (based on the UCLA Alzheimer's and Dementia Care program) with community-based care (based on the Benjamin Rose Institute Care Consultation program) on patient- and caregiver-reported outcome measures, including behavioral symptoms and caregiver distress (co-primary outcomes), and secondary outcomes of caregiver strain, unmet needs, and depression over 18-months. Because of PCORI's mandate, neither intervention will be compared to usual care (thus, only relative effectiveness can be determined). Nor will cost-effectiveness of either intervention be evaluated. The proposed research will add a third usual care (UC) arm and expand outcomes to include costs and health care utilization. This expansion will permit comparison of each of the intervention arms to current usual care, thereby providing multisite pragmatic randomized clinical trial evidence for effectiveness of the two active treatment arms. It will also allow evaluation of whether paying for such care will offset the costs and determination of which intervention is more cost effective. The study will also conduct exploratory analyses of tertiary outcomes of both interventions versus usual care including mortality, time spent at home, long-term nursing home placement, physician and patient/caregiver satisfaction and comparing all three groups on several types of utilization and out-of-pocket expenses. The study's questions are fundamental to planning for the clinical care of persons with dementia. They address both clinical effectiveness and cost-effectiveness. By answering these questions, clinicians, health systems, and insurers can make decisions about which programs to promote, scale and disseminate.