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NCT Number: NCT05669365

The Care Ecosystem Consortium Effectiveness Study

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.

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Key information

Conditions

Dementia Alzheimer Disease Arterial Occlusive Diseases Arteriosclerosis Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Dementia Alzheimers Dementia With Lewy Bodies Dementia, Vascular Frontotemporal Dementia Frontotemporal Lobar Degeneration Intracranial Arterial Diseases Intracranial Arteriosclerosis Leukoencephalopathies Lewy Body Disease Mental Disorders Metabolic Diseases Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Nutritional and Metabolic Diseases Parkinsonian Disorders Proteostasis Deficiencies Synucleinopathies TDP-43 Proteinopathies Tauopathies Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

, PWD participant

  • 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

Inclusion criteria

, Caregiver participant

  • 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

Exclusion criteria

, PWD participant

  • 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).

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

Treatment and study plan

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.

Primary outcomes

  1. Dementia Management Quality Measurement Set

    Time frame: 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).

  2. Change in emergency department (ED) visits

    Time frame: Baseline to 12 months

    Number of PWD ED visits, using claims and EHRs.

  3. Change in potentially inappropriate medications for dementia or cognitive impairment

    Time frame: Baseline to 12 months

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

  4. Change in caregiver depression

    Time frame: 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.

Secondary outcomes

  1. Change in PWD hospitalizations

    Time frame: Baseline to 12 months

    Number of PWD hospitalizations, using claims and EHRs.

  2. Change in PWD annual bed days

    Time frame: Baseline to 12 months

    Number of PWD inpatient bed days, using claims and EHRs.

  3. Change in central nervous system (CNS) acting medications

    Time frame: 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.

  4. Change in caregiver burden

    Time frame: 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).

  5. Change in caregiver self-efficacy

    Time frame: 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).

  6. Change in caregiver anxiety

    Time frame: 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.

Other outcomes

  1. Modifications of anti-dementia medications

    Time frame: Baseline to 12 months

    Binary indicator of whether or not a participant's use of anti-dementia medications changed (i.e., started, stopped, or changed treatment with an acetylcholinesterase inhibitor, donepezil, galantamine, rivastigmine, and/or N-methyl-D-aspartate (NMDA) receptor antagonist, memantine).

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

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

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 30, 2022
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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