Health System, Community-Based, or Usual Dementia Care for Persons With Dementia and Caregivers
David B. Reuben, Thomas M. Gill, Alan Stevens, Jeff D. Williamson, Elena Volpi, Maya Lichtenstein, Lee A. Jennings, Rebecca Galloway, Jenny Summapund, Katy Araujo, David M. Bass, Lisa Weitzman, Zaldy S. Tan, Leslie Chang Evertson, Mia Yang, Katherine Currie, Aval‐NaʼRee S. Green, Sergio Alfonso Sandoval Godoy, Sitara Abraham, Jordan Reese, Rafael Samper‐Ternent, Roxana M. Hirst, Pamela Borek, Peter Charpentier, Can Meng, James Dziura, Yunshan Xu, Eleni A. Skokos, Zili He, Sherry Aiudi, Peter Peduzzi, Erich J. Greene, D-CARE Study, Katherine Serrano, Erin Unger, Lucio E. Arruda, Lynn Bautista, Christopher M. Callahan, Katie Maslow, Shari M. Ling, Alice Bonner, Douglas Pace, Debra Cherry, Ian N. Kremer, Brenda P. Nicholson, Caroline Q. Stephens, Ron Hendler, Martha B. Carnie, Amy Shelton, Bridget M Mignosa, Brian Funaro, Kraig Eisenmann, Charles Lu, Sumon Chattopadhyay, Delaney Rhoades, Alicia Lakomski, Dori Maher, Darcy McCurry, Samuel E. Williamson, Sarah Moyer, Linda Robertson, Anna Tilles, Linda Battle, William C. Walker, Sophia Levine, Grace Knight, Abbie C. Eaton, Tiffany H. Rose, Eileen M. Weston, Brittney S. Orr, Scott A. Lang, Sandra Rinaldi, Jennifer Shore, Linda J. Garboczi, Karen Phoenix, Mary Niall Mitchell, Lisa Levan, Michael Layza, Dana M. Musgrave, Julie Silverman, A. D. Martin, Joseph Nienstedt, Ricky Handoo, Nancy Woolard, Deb Burcombe, Cara Hutchens, Sandhya Sanghi, Amarine K. Ocloo, Sophia Essiet, M.V. Shah, Hannah Bartosh, Joseph Banda, Thomas Birchfield, Taylor Roznos, Breann Collins, Donna R. Parker, Michelle Matlock, Leslie R.H. Drew, Tametra Jones, Brandy Hill
Abstract
Importance: The effectiveness of different approaches to dementia care is unknown. Objective: To determine the effectiveness of health system-based, community-based dementia care, and usual care for persons with dementia and for caregiver outcomes. Design, Setting, and Participants: Randomized clinical trial of community-dwelling persons living with dementia and their caregivers conducted at 4 sites in the US (enrollment June 2019-January 2023; final follow-up, August 2023). Interventions: Participants were randomized 7:7:1 to health system-based care provided by an advanced practice dementia care specialist (n = 1016); community-based care provided by a social worker, nurse, or licensed therapist care consultant (n = 1016); or usual care (n = 144). Main Outcomes and Measures: Primary outcomes were caregiver-reported Neuropsychiatric Inventory Questionnaire (NPI-Q) severity score for persons living with dementia (range, 0-36; higher scores, greater behavioral symptoms severity; minimal clinically important difference [MCID], 2.8-3.2) and Modified Caregiver Strain Index for caregivers (range, 0-26; higher scores, greater strain; MCID, 1.5-2.3). Three secondary outcomes included caregiver self-efficacy (range, 4-20; higher scores, more self-efficacy). Results: Among 2176 dyads (individuals with dementia, mean age, 80.6 years; 58.4%, female; and 20.6%, Black or Hispanic; caregivers, mean age, 65.2 years; 75.8%, female; and 20.8% Black or Hispanic), primary outcomes were assessed for more than 99% of participants, and 1343 participants (62% of those enrolled and 91% still alive and had not withdrawn) completed the study through 18 months. No significant differences existed between the 2 treatments or between treatments vs usual care for the primary outcomes. Overall, the least squares means (LSMs) for NPI-Q scores were 9.8 for health system, 9.5 for community-based, and 10.1 for usual care. The difference between health system vs community-based care was 0.30 (97.5% CI, -0.18 to 0.78); health system vs usual care, -0.33 (97.5% CI, -1.32 to 0.67); and community-based vs usual care, -0.62 (97.5% CI, -1.61 to 0.37). The LSMs for the Modified Caregiver Strain Index were 10.7 for health system, 10.5 for community-based, and 10.6 for usual care. The difference between health system vs community-based care was 0.25 (97.5% CI, -0.16 to 0.66); health system vs usual care, 0.14 (97.5% CI, -0.70 to 0.99); and community-based vs usual care, -0.10 (97.5% CI, -0.94 to 0.74). Only the secondary outcome of caregiver self-efficacy was significantly higher for both treatments vs usual care but not between treatments: LSMs were 15.1 for health system, 15.2 for community-based, and 14.4 for usual care. The difference between health system vs community-based care was -0.16 (95% CI, -0.37 to 0.06); health system vs usual care, 0.70 (95% CI, 0.26-1.14); and community-based vs usual care, 0.85 (95% CI, 0.42 to 1.29). Conclusions and Relevance: In this randomized trial of dementia care programs, no significant differences existed between health system-based and community-based care interventions nor between either active intervention or usual care regarding patient behavioral symptoms and caregiver strain. Trial Registration: ClinicalTrials.gov Identifier: NCT03786471.