Study Information
Background and Significance
In the United States, an estimated 5.7 million persons are affected by Alzheimer’s disease, the most common type of dementia. The clinical manifestations of dementia are protean and devastating, including cognitive impairment, immobility and falls, swallowing disorders and aspiration pneumonia, and behavioral disturbances (e.g., agitation, aggression, disinhibition, depression, apathy, and hallucinations). These sequelae often lead to caregiver stress, burnout, and medical illnesses. Thus, dementia can be considered the prototype for a disorder with complex needs that span both the patient and caregiver, medical and social domains, and health system and community-based organizations. Although there is some evidence of effectiveness for dementia care programs based within health care systems and programs based in the community, the comparative effectiveness of these two approaches in improving quality and outcomes for patients with dementia and their caregivers is unknown.
Study Aims
The proposed pragmatic trial seeks to determine which of two approaches, health system-based (HSDC) versus community-based dementia care (CBDC), is more effective in achieving better self-reported patient and caregiver outcomes across 4 different clinical sites.
Both approaches will be compared to enhanced usual care that includes consistent referral to the Alzheimer’s Association hotline.
Study Description
Overall Study Design
4-site, pragmatic, randomized trial
Main components of the intervention and comparator(s)
The three comparator interventions will be
Health System-based Dementia Care (HSDC) based on the UCLA Alzheimer’s and Dementia Care program, which includes a nurse practitioner Dementia Care Manager, who works for the health system and has order writing capabilities and
Community-based Dementia Care (CBDC) using the Benjamin Rose Institute (BRI) Care Consultation model and
Enhanced usual care with consistent referral to Alzheimer’s Association Hotline (1-800-272-3800) to speak to master’s level consultants for decision-making support, crisis assistance, and caregiver education, and referral to local programs and services.. The HSDC program will be delivered through primary care clinics affiliated with a trial site health system; while the CBDC program will be delivered through a local community organization.
Study population
2150 (1000 in each active intervention arm and 150 in the enhanced usual care arm) participants will be recruited from primary care practices at 4 clinical trial sites.
Inclusion criteria are:
an established diagnosis of dementia
not residing in a nursing home at the time of recruitment
having caregivers who speak English or Spanish
having a primary care provider who would be willing to partner with the program.
Primary and secondary outcomes
Primary outcomes include
NPI-Q Severity (a measure of patient behavioral symptoms)
Modified Caregiver Strain Index (MCSI) scales (a measure of impact of dementia on caregivers)
Secondary outcomes include
NPI-Q Distress (a measure of caregiver distress due to patients’ behavioral symptoms)
Caregiver unmet needs and confidence, strain, and depressive symptoms
Analytic methods
Intent to treat analysis of the primary outcomes (NPI-Q Severity and MCSI scores), as well as continuous secondary outcomes (caregiver unmet needs, strain, and depression) will be done using a longitudinal repeated measures analysis.
The Cox model will be used to analyze differences in rates of long-term nursing home placement.
Heterogeneity of treatment effects for the co-primary outcomes will be assessed in six key subgroups of participants based on baseline characteristics:
Higher vs. lower patient function by FAQ
Independent vs. dependent function by Katz ADL
More vs. less NPI-Q Severity
More vs. less MCSI (caregiver strain)
Spouse caregiver vs. Other caregiver
White Non-Latino vs. Nonwhite or Latino