Care Ecosystem: Navigating Patients and Families Through Stages of Care
University of California, San Francisco (UCSF) and University of Nebraska Medical Center (UNMC) Care Ecosystem
3 other identifiers
interventional
1,560
1 country
2
Brief Summary
This is a randomized clinical trial evaluating the benefits of a program that supports model care for persons with dementia and their family caregivers. Subjects were recruited from California, Nebraska and Iowa. Subjects determined to be eligible were consented and randomized into one of two groups. Two thirds of patients were enrolled into Navigated Care that provided them with assistance in meeting important benchmarks in their care, for example completion of legal and financial planning and strategies for minimizing caregiver burden. One third of patients were enrolled to a control group, entitled Survey of Care. Outcomes include quality of life, health care utilization, caregiver burden, satisfaction with care, caregiver depression, and caregiver self-efficacy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2015
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2014
CompletedFirst Posted
Study publicly available on registry
August 11, 2014
CompletedStudy Start
First participant enrolled
March 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2018
CompletedResults Posted
Study results publicly available
September 9, 2021
CompletedFebruary 20, 2024
February 1, 2024
3 years
August 7, 2014
July 20, 2021
February 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of Life-Alzheimer's Disease, Change From Baseline to 1 Year
An established 13-item measure, with a 1-4 ordinal scale for each item, to obtain a rating of the patient's quality of life from the caregiver. Item scores are summed for a total score ranging from 13-52, with higher scores representing better quality of life
Baseline to one year
Secondary Outcomes (5)
Change in Caregiver Reported Rate of Emergency Department Utilization: Baseline to One Year
Baseline to one year
Change in Caregiver Burden, Baseline to One Year
Baseline to one year
Satisfaction With Dementia Care
One year
Change in Caregiver Depression, Baseline to One Year
Baseline to one year
Change in Caregiver Self-efficacy, Baseline to One Year
Baseline to one year
Study Arms (2)
Navigated Care
EXPERIMENTALComprehensive longitudinal continuing care program
Survey of Care
NO INTERVENTIONControl group that will undergo the same regular assessments as patients enrolled in Navigated Care
Interventions
Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a "dashboard" functions as a patient care management system used by Care Team Navigators (CTNs).
Eligibility Criteria
You may qualify if:
- Patient has a diagnosis of dementia with a progressive course
- Patient has a primary caregiver (identified as having primary responsibility for patient) that is eligible for and agrees to join the study
- Patient is covered by Medicare or Medi-caid or is Medi-pending
- Patient is expected to live at least 3 months based on assessment by the referring provider, the patient's primary care provider, or medical record review
- Patient speaks either English, Cantonese, Mandarin, or Spanish
- Patient lives in California or Nebraska or Iowa
- Patient is age 45 or older
- Caregiver has primary responsibility for dementia patient that is eligible for and agrees to join the study
- Caregiver speaks either English, Cantonese, Mandarin, or Spanish
- Caregiver is a legal adult
You may not qualify if:
- Patient resides in a nursing home or skilled nursing facility at time of enrollment
- Participant is enrolled in a similar clinical trial that precludes their participation in our trial
- Patient is pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Franciscolead
- University of Nebraskacollaborator
- Centers for Medicare and Medicaid Servicescollaborator
- National Institute on Aging (NIA)collaborator
Study Sites (2)
University of California, San Francisco
San Francisco, California, 94143, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Related Publications (3)
Guterman EL, Kiekhofer RE, Wood AJ, Allen IE, Kahn JG, Dulaney S, Merrilees JJ, Lee K, Chiong W, Bonasera SJ, Braley TL, Hunt LJ, Harrison KL, Miller BL, Possin KL. Care Ecosystem Collaborative Model and Health Care Costs in Medicare Beneficiaries With Dementia: A Secondary Analysis of a Randomized Clinical Trial. JAMA Intern Med. 2023 Nov 1;183(11):1222-1228. doi: 10.1001/jamainternmed.2023.4764.
PMID: 37721734RESULTLiu 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: 36331050RESULTPossin 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: 31566651RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The economic outcomes are not reported beyond 12-month follow-up and were based only on survey data. Our sample likely differs in important ways from samples from similar programs that do not have a randomized control condition. During our recruitment and consent process, the only potential benefit communicated to prospective enrollees was that participation might inform and advance the quality of care provided to patients with dementia (PWDs) and their caregivers in the future.
Results Point of Contact
- Title
- Dr. Katherine Possin
- Organization
- University of California, San Francisco
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine L Possin, PhD
University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2014
First Posted
August 11, 2014
Study Start
March 20, 2015
Primary Completion
March 8, 2018
Study Completion
March 8, 2018
Last Updated
February 20, 2024
Results First Posted
September 9, 2021
Record last verified: 2024-02