The Care Ecosystem Consortium Effectiveness Study

NCT05669365 | Completed DMC

• 1 other identifier: 1R01AG074710
• Study Type: interventional
• Target: 1,227
• Locations: 1 country
• Sites: 6

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.

Conditions

Dementia; Dementia, Vascular; Dementia With Lewy Bodies; Dementia Alzheimers; Frontotemporal Dementia

Outcome Measures

Primary Outcomes (4)

• Dementia Management Quality Measurement Set

  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).

  Baseline to 12 months

• Change in emergency department (ED) visits

  Number of PWD ED visits, using claims and EHRs.

  Baseline to 12 months

• Change in potentially inappropriate medications for dementia or cognitive impairment

  Number of high-risk medications used, operationalized using the 2019 Beers criteria, using medication lists from the EHR.

  Baseline to 12 months

• Change in caregiver depression

  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.

  Baseline to 12 months

Secondary Outcomes (6)

• Change in PWD hospitalizations

  Baseline to 12 months

• Change in PWD annual bed days

  Baseline to 12 months

• Change in central nervous system (CNS) acting medications

  Baseline to 12 months

• Change in caregiver burden

  Baseline to 12 months

• Change in caregiver self-efficacy

  Baseline to 12 months

Other Outcomes (1)

• Modifications of anti-dementia medications

  Baseline to 12 months

Study Arms (1)

Care Ecosystem

EXPERIMENTAL

Patient and caregiver dyads receive the Care Ecosystem intervention

Behavioral: Care Ecosystem

Interventions

Care Ecosystem BEHAVIORAL

Applying the principles of person-and-family centered and collaborative care to dementia, the Care Ecosystem (CE) offers proactive, protocol-guided phone- and web-based caregiver support, guidance, and care coordination that extends the reach of dementia primary and specialty care. Care is delivered primarily via the phone and web by unlicensed Care Team Navigators (CTNs), who are trained and supervised by a team of dementia specialists with nursing, social work, and pharmacy expertise. Care Protocols guide proactive, quality care that is documented in the electronic health record (EHR). The CTN is an unlicensed, trained dementia care guide who served as the PWD's and caregiver's primary point of contact to the program under nurse supervision. Care team navigators respond to caregivers' immediate needs first, then screen for common problems and provide personalized support and standardized education using the care plan protocols.

Care Ecosystem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)
• Is currently, or was ever enrolled, in the Care Ecosystem program.
• 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).
• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Ochsner Health System: collaborator
• Providence Health & Services: collaborator
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: collaborator
• HealthPartners Institute: collaborator
• University of Colorado, Denver: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (6)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

LA County Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

University of Colorado Health

Denver, Colorado, 80209, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

HealthPartners

Saint Paul, Minnesota, 55130, United States

Location

Providence Health

Portland, Oregon, 97213, United States

Location

Related Publications (4)

• 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.

  PMID: 30094817 BACKGROUND

• 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.

  PMID: 31566651 BACKGROUND

• 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.

  PMID: 30497302 BACKGROUND

• 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.

  PMID: 36331050 BACKGROUND

MeSH Terms

Conditions

Dementia; Dementia, Vascular; Lewy Body Disease; Alzheimer Disease; Frontotemporal Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Tauopathies; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Katherine L Possin, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: December 30, 2022
• Study Start: January 17, 2023
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data requests will be accepted starting 12 months after study close with no end date.
• Access Criteria: Access to trial individual participant data (IPD) can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Locations

US (6)