D-CARE: The Dementia Care Study: Design of a Pragmatic Trial of the Effectiveness and Cost Effectiveness of Health System-Based Versus Community-Based Dementia Care Versus Usual Dementia Care.
David B Reuben, Thomas M Gill, Alan Stevens, Jeff Williamson, Elena Volpi, Maya Lichtenstein, Lee A Jennings, Zaldy Tan, Leslie Evertson, David Bass, Lisa Weitzman, Martie Carnie, Nancy Wilson, Katy Araujo, Peter Charpentier, Can Meng, Erich J Greene, James Dziura, Jodi Liu, Erin Unger, Mia Yang, Katherine Currie, Kristin M Lenoir, Aval-NaʼRee S Green, Sitara Abraham, Ashley Vernon, Rafael Samper-Ternent, Mukaila Raji, Roxana M Hirst, Rebecca Galloway, Glen R Finney, Ilene Ladd, Alanna Kulchak Rahm, Pamela Borek, Peter Peduzzi
Author Information
David B Reuben: Department of Medicine, Division of Geriatrics, David Geffen School of Medicine at UCLA, Los Angeles, California, USA. ORCID
Thomas M Gill: Department of Internal Medicine, Section of Geriatrics, Yale University, New Haven, Connecticut, USA. ORCID
Alan Stevens: Department of Medicine, Baylor Scott & White Health, Temple, Texas, USA.
Jeff Williamson: Department of Internal Medicine, Section on Gerontology and Geriatric Medicine, Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, USA.
Elena Volpi: Department of Internal Medicine, Division of Geriatrics, University of Texas, Medical Branch, Galveston, Texas, USA.
Maya Lichtenstein: Department of Neurology, Geisinger Health, Wilkes Barre, Pennsylvania, USA. ORCID
Lee A Jennings: Department of Medicien, Reynolds Section of Geriatrics, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA. ORCID
Zaldy Tan: Department of Medicine, Division of Geriatrics, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.
Leslie Evertson: Department of Medicine, Division of Geriatrics, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.
David Bass: Center for Research and Education, Benjamin Rose Institute on Aging, Cleveland, Ohio, USA.
Lisa Weitzman: Center for Research and Education, Benjamin Rose Institute on Aging, Cleveland, Ohio, USA.
Martie Carnie: Center for Patients and Families, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Nancy Wilson: Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.
Katy Araujo: Department of Internal Medicine, Section of Geriatrics, Yale University, New Haven, Connecticut, USA.
Peter Charpentier: Department of Internal Medicine, Section of Geriatrics, Yale University, New Haven, Connecticut, USA.
Can Meng: Department of Internal Medicine, Section of Geriatrics, Yale University, New Haven, Connecticut, USA.
Erich J Greene: Department of Internal Medicine, Section of Geriatrics, Yale University, New Haven, Connecticut, USA. ORCID
James Dziura: Department of Internal Medicine, Section of Geriatrics, Yale University, New Haven, Connecticut, USA.
Jodi Liu: Pardee RAND Graduate School, Santa Monica, California, USA.
Erin Unger: Department of Medicine, Division of Geriatrics, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.
Mia Yang: Department of Internal Medicine, Section on Gerontology and Geriatric Medicine, Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, USA. ORCID
Katherine Currie: Department of Internal Medicine, Section on Gerontology and Geriatric Medicine, Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, USA.
Kristin M Lenoir: Department of Internal Medicine, Section on Gerontology and Geriatric Medicine, Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, USA.
Aval-NaʼRee S Green: Department of Medicine, Baylor Scott & White Health, Temple, Texas, USA.
Sitara Abraham: Department of Medicine, Baylor Scott & White Health, Temple, Texas, USA.
Ashley Vernon: Department of Medicine, Baylor Scott & White Health, Temple, Texas, USA.
Rafael Samper-Ternent: Department of Internal Medicine, Division of Geriatrics, University of Texas, Medical Branch, Galveston, Texas, USA.
Mukaila Raji: Department of Internal Medicine, Division of Geriatrics, University of Texas, Medical Branch, Galveston, Texas, USA.
Roxana M Hirst: Department of Internal Medicine, Division of Geriatrics, University of Texas, Medical Branch, Galveston, Texas, USA.
Rebecca Galloway: Department of Internal Medicine, Division of Geriatrics, University of Texas, Medical Branch, Galveston, Texas, USA.
Glen R Finney: Department of Neurology, Geisinger Health, Wilkes Barre, Pennsylvania, USA.
Ilene Ladd: Department of Neurology, Geisinger Health, Wilkes Barre, Pennsylvania, USA.
Alanna Kulchak Rahm: Department of Neurology, Geisinger Health, Wilkes Barre, Pennsylvania, USA.
Pamela Borek: Department of Neurology, Geisinger Health, Wilkes Barre, Pennsylvania, USA.
Peter Peduzzi: Department of Internal Medicine, Section of Geriatrics, Yale University, New Haven, Connecticut, USA.
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 dementia care (CBDC) versus health system-based dementia care (CBDC) and the effectiveness of both approaches compared with usual care (UC) are unknown. DESIGN: Pragmatic randomized three-arm superiority trial. The unit of randomization is the PWD/caregiver dyad. SETTING: Four clinical trial sites (CTSs) based in academic and clinical health systems. PARTICIPANTS: A total of 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) HSDC provided by a nurse practitioner or physician's assistant dementia care specialist who works within the health system, or (2) CBDC provided by a social worker or nurse care consultant who works at a community-based organization, or (3) UC 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: The results will be reported in the spring of 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 with UC and will evaluate the cost effectiveness of each intervention.
