The Care Ecosystem Consortium Effectiveness Study
- Conditions
- Frontotemporal DementiaDementia With Lewy BodiesDementia AlzheimersDementiaDementia, Vascular
- Interventions
- Behavioral: Care Ecosystem
- Registration Number
- NCT05669365
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
The Care Ecosystem is an accessible, remotely delivered team-based dementia care model, designed to add value for patients, providers and payers in complex organizational and reimbursement structures. Care is delivered via the phone and web by unlicensed Care Team Navigators, who are trained and supervised by a team of dementia specialists with nursing, social work, and pharmacy expertise. The evidence base to date suggests that the Care Ecosystem improves outcomes important to people with dementia, caregivers, and payers when delivered in a controlled research environment, including reduced emergency department visits, higher quality of life for patients, lower caregiver depression, and reduced potentially inappropriate medication use (Possin et al., 2019; Liu et al., 2022). The investigators propose a rapid pragmatic trial in 6 health systems currently offering the Care Ecosystem program in geographically and culturally diverse populations. The investigators will leverage technology, delivering care via the phone and web and using electronic health records to monitor quality improvements and evaluate outcomes while maximizing external validity. The investigators will evaluate the effectiveness of the Care Ecosystem on outcomes important to patients, caregivers, healthcare providers, and health systems during the pandemic. By evaluating the real-world effectiveness in diverse health systems that are already providing this model of care, this project will bridge the science-practice gap in dementia care during an unprecedented time of heightened strain on family caregivers, healthcare providers and health systems.
- Detailed Description
This study is a rapid, pragmatic, single-arm trial of 1,275 patients with dementia (PWD) and their caregivers (Total N = 2,550) at 6 US health systems currently offering the Care Ecosystem (CE) intervention to geographically and culturally diverse populations. The investigators will compare the effectiveness of 12-months of the CE intervention with a matched comparison group (N=1,275) identified from the EHR at each site. Patient health care utilization outcomes will be collected via patient insurance / Medicare claims and electronic health record data. Caregiver surveys completed via interview (phone, video or in-person) at baseline, 6-months and 12-months will serve the dual purpose of providing outcome data and supporting care.
This clinical trial is made up of four sub-studies on care quality, utilization, medications, and caregiver and patient experience. While all the sub-studies concern the same intervention group of dyads, each will use data from different sources, different analytic methods, and different controls. Care quality, utilization, and medication metrics will be compared to matched controls identified from the EHR. Caregiver and patient experience metrics will be compared pre/post and to controls from a prior Randomized Control Trial (RCT) (ClinicalTrials.gov NCT02213458). For these reasons, there are primary and secondary endpoints for each.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2550
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Care Ecosystem Care Ecosystem Patient and caregiver dyads receive the Care Ecosystem intervention
- Primary Outcome Measures
Name Time Method Dementia Management Quality Measurement Set Baseline to 12 months The rate of completion of a 10-item, adapted Dementia Management Quality Measurement Set. This count variable has a range of 0 (no dementia quality care elements completed) to 10 (all dementia quality care elements completed).
Change in caregiver depression Baseline to 12 months Caregiver depression will be measured by the 9-item Patient Health Questionnaire (PHQ-9), ranging from 0-27 points, with higher scores indicating more severe depression.
Change in emergency department (ED) visits Baseline to 12 months Number of PWD ED visits, using claims and EHRs.
Change in potentially inappropriate medications for dementia or cognitive impairment Baseline to 12 months Number of high-risk medications used, operationalized using the 2019 Beers criteria, using medication lists from the EHR.
- Secondary Outcome Measures
Name Time Method Change in PWD annual bed days Baseline to 12 months Number of PWD inpatient bed days, using claims and EHRs.
Change in caregiver anxiety Baseline to 12 months Caregiver anxiety score, as measured by the Generalized Anxiety Disorder 2-item questionnaire (GAD-2), with scores ranging from 0-6 and higher scores indicating higher anxiety.
Change in PWD hospitalizations Baseline to 12 months Number of PWD hospitalizations, using claims and EHRs.
Change in central nervous system (CNS) acting medications Baseline to 12 months Number of CNS acting medications to be avoided in persons with dementia, delirium, or a history of falls or fractures according to the 2019 Beers criteria, using medication lists from the EHR.
Change in caregiver burden Baseline to 12 months The Dementia Burden Scale-Caregiver (DBS-CG) is a composite of the Neuropsychiatric Inventory (NPI-Q) for Distress, the Modified Caregiver Strain Index (MCSI), and and 8-item Patient Health Questionnaire (PHQ-8) with items transformed linearly to be on a 0-100 possible range and then averaged with higher scores indicating higher caregiver burden (Peipert et al., 2018).
Change in caregiver self-efficacy Baseline to 12 months Caregiver self-efficacy score, as measured by a four-item survey with scores ranging from 5-20 points and higher scores indicating higher self-efficacy (Possin et al., 2019; Merrilees et al., 2018).
Trial Locations
- Locations (6)
University of California, San Francisco
🇺🇸San Francisco, California, United States
University of Colorado Health
🇺🇸Denver, Colorado, United States
Providence Health
🇺🇸Portland, Oregon, United States
LA County Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
HealthPartners
🇺🇸Saint Paul, Minnesota, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States