Clinical trial NCT05669365: The Care Ecosystem Consortium Effectiveness Study
Official title: The Care Ecosystem Consortium Effectiveness Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dementia
Dementia, Vascular
Dementia With Lewy Bodies
Dementia Alzheimers
Frontotemporal Dementia
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Ochsner Health System
name: Providence Health & Services
name: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
name: HealthPartners Institute
name: University of Colorado, Denver
name: National Institute on Aging (NIA)
First posted: 2022-12-30
Enrollment: 2550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion criteria, PWD participant

1. Age 18+
2. Provision of verbal consent (or surrogate consent), documented in REDCap, and assent
3. Willingness to enroll in the Care Ecosystem program
4. Lives in the community (i.e., not in an assisted living, board \& care, skilled nursing or memory care facility) at the time of enrollment
5. Have a dementia diagnosis documented in the EHR
6. Has had a visit with the referring provider in the last 12 months
7. Has a caregiver with a primary level of responsibility for the patient who is eligible and willing to participate

Inclusion Criteria, Caregiver participant

1. Age 18+
2. Provision of verbal consent, documented in REDCap
3. Has a primary level of responsibility for the care of a PWD-participant who is enrolling in the study
4. Willingness to enroll in the Care Ecosystem program and complete surveys

Exclusion Criteria, PWD participant

1. PWD-participants for whom a substantial amount of the patient's healthcare utilization records cannot be accessed for research purposes by the study team. (see Note)
2. Is currently, or was ever enrolled, in the Care Ecosystem program.
3. Medical documentation indicates that the patient's dementia is a non-progressive type (e.g., due to a head injury or stroke, and not expected to progress).

Note: This exclusion criteria will be operationalized differently at each site based on variations in data access options for their patient population; these options will include EHR and Medicare. A small percentage of participants may be enrolled from underrepresented populations for whom a substantial amount of utilization records cannot be accessed with written approval from the study PI. All participants must be affiliated with one of the 6 participating health systems:

Ochsner Health System Providence Health \& Services Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center HealthPartners Institute University of Colorado, Denver University of California, San Francisco

Primary outcomes:
measure: Dementia Management Quality Measurement Set
timeFrame: Baseline to 12 months
measure: Change in emergency department (ED) visits
timeFrame: Baseline to 12 months
measure: Change in potentially inappropriate medications for dementia or cognitive impairment
timeFrame: Baseline to 12 months
measure: Change in caregiver depression
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Change in PWD hospitalizations
timeFrame: Baseline to 12 months
measure: Change in PWD annual bed days
timeFrame: Baseline to 12 months
measure: Change in central nervous system (CNS) acting medications
timeFrame: Baseline to 12 months
measure: Change in caregiver burden
timeFrame: Baseline to 12 months
measure: Change in caregiver self-efficacy
timeFrame: Baseline to 12 months
measure: Change in caregiver anxiety
timeFrame: Baseline to 12 months
Other outcomes:
measure: Modifications of anti-dementia medications
timeFrame: Baseline to 12 months
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Torrance
country: United States
facility: LA County Harbor-UCLA Medical Center
state: California
city: Denver
country: United States
facility: University of Colorado Health
state: Colorado
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Saint Paul
country: United States
facility: HealthPartners
state: Minnesota
city: Portland
country: United States
facility: Providence Health
state: Oregon
Study officials:
affiliation: University of California, San Francisco
name: Katherine L Possin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peipert JD, Jennings LA, Hays RD, Wenger NS, Keeler E, Reuben DB. A Composite Measure of Caregiver Burden in Dementia: The Dementia Burden Scale-Caregiver. J Am Geriatr Soc. 2018 Sep;66(9):1785-1789. doi: 10.1111/jgs.15502. Epub 2018 Aug 10.
citation: Possin KL, Merrilees JJ, Dulaney S, Bonasera SJ, Chiong W, Lee K, Hooper SM, Allen IE, Braley T, Bernstein A, Rosa TD, Harrison K, Begert-Hellings H, Kornak J, Kahn JG, Naasan G, Lanata S, Clark AM, Chodos A, Gearhart R, Ritchie C, Miller BL. Effect of Collaborative Dementia Care via Telephone and Internet on Quality of Life, Caregiver Well-being, and Health Care Use: The Care Ecosystem Randomized Clinical Trial. JAMA Intern Med. 2019 Dec 1;179(12):1658-1667. doi: 10.1001/jamainternmed.2019.4101.
citation: Merrilees JJ, Bernstein A, Dulaney S, Heunis J, Walker R, Rah E, Choi J, Gawlas K, Carroll S, Ong P, Feuer J, Braley T, Clark AM, Lee K, Chiong W, Bonasera SJ, Miller BL, Possin KL. The Care Ecosystem: Promoting self-efficacy among dementia family caregivers. Dementia (London). 2020 Aug;19(6):1955-1973. doi: 10.1177/1471301218814121. Epub 2018 Nov 29.
citation: Liu AK, Possin KL, Cook KM, Lynch S, Dulaney S, Merrilees JJ, Braley T, Kiekhofer RE, Bonasera SJ, Allen IE, Chiong W, Clark AM, Feuer J, Ewalt J, Guterman EL, Gearhart R, Miller BL, Lee KP. Effect of collaborative dementia care on potentially inappropriate medication use: Outcomes from the Care Ecosystem randomized clinical trial. Alzheimers Dement. 2023 May;19(5):1865-1875. doi: 10.1002/alz.12808. Epub 2022 Nov 4.