The Care Ecosystem Consortium Effectiveness Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1227 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-17

Study Completion Date

2025-08-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Implementation of the Care Ecosystem Training Model for Individuals With Dementia in a High-risk, Integrated Care Management

NCT04556097

Dementia Alzheimer Disease

COMPLETED NA

Care Ecosystem: Navigating Patients and Families Through Stages of Care

NCT02213458

Dementia Alzheimer Disease Dementia, Vascular +3 more

COMPLETED NA

Care Ecosystem: Navigating Patients and Families Through Stages of Care, Extension Trial

NCT04287738

Dementia Alzheimer Disease Dementia, Vascular +3 more

COMPLETED NA

Care EcoSystem: Ochsner Health System

NCT03916718

Dementia

COMPLETED

Improving How People Living With Dementia Are Selected for Care Coordination

NCT05651308

Dementia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Care Ecosystem

Patient and caregiver dyads receive the Care Ecosystem intervention

Group Type EXPERIMENTAL

Care Ecosystem

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Care Ecosystem

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

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

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).

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No