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

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Alzheimer Disease; Lewy Body Disease; Dementia, Vascular; Frontotemporal Lobar Degeneration; Memory Disorders
• Intervention / Treatment: Behavioral: Navigated Care

• Study Type: Interventional
• Enrollment (Actual): 1560
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

This study will enroll patients as well as their primary caregivers as research participants.

Inclusion criteria for patient participants:

1. Patient has a diagnosis of dementia with a progressive course
2. Patient has a primary caregiver (identified as having primary responsibility for patient) that is eligible for and agrees to join the study
3. Patient is covered by Medicare or Medi-caid or is Medi-pending
4. 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
5. Patient speaks either English, Cantonese, Mandarin, or Spanish
6. Patient lives in California or Nebraska or Iowa
7. Patient is age 45 or older

Inclusion criteria for caregiver participants:

1. Caregiver has primary responsibility for dementia patient that is eligible for and agrees to join the study
2. Caregiver speaks either English, Cantonese, Mandarin, or Spanish
3. Caregiver is a legal adult

Exclusion Criteria:

1. Patient resides in a nursing home or skilled nursing facility at time of enrollment
2. Participant is enrolled in a similar clinical trial that precludes their participation in our trial
3. Patient is pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Navigated Care; Comprehensive longitudinal continuing care program	Behavioral: Navigated Care; 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).
No Intervention: Survey of Care; Control group that will undergo the same regular assessments as patients enrolled in Navigated Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Caregiver Reported Rate of Emergency Department Utilization: Baseline to One Year	Health care utilization based upon caregiver survey to assess emergency department, hospitalization, and ambulance use rates. To be confirmed using Medicare claims data.	Baseline to one year
Change in Caregiver Burden, Baseline to One Year	Zarit Burden Interview (short version). An established 12-item measure, with a 0-4 ordinal scale for each item, to measure caregiver burden. Item scores are summed for a total score ranging from 0-48, with higher scores representing higher levels of burden.	Baseline to one year
Satisfaction With Dementia Care	A novel 1-item measure, with a 1-5 ordinal scale, to measure caregiver satisfaction with dementia care provided by the patient's clinical team. Also, one question asking caregivers whether they would recommend the Care Ecosystem to another caregiver. Collected in the treatment group only.	One year
Change in Caregiver Depression, Baseline to One Year	Patient Health Questionnaire 9 (PHQ-9). Higher scores represent more severe depression. Scores range from 0-27.	Baseline to one year
Change in Caregiver Self-efficacy, Baseline to One Year	A novel 4-item measure on a 1-5 ordinal scale to measure self-efficacy around dementia caregiving. Higher scores represent greater self-efficacy. Scores range from 5-15.	Baseline to one year

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute on Aging (NIA); University of Nebraska; Centers for Medicare and Medicaid Services
• Investigators: Principal Investigator: Katherine L Possin, PhD, University of California, San Francisco

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2015
• Primary Completion (Actual): March 8, 2018
• Study Completion (Actual): March 8, 2018

Study Registration Dates

• First Submitted: August 7, 2014
• First Submitted That Met QC Criteria: August 7, 2014
• First Posted (Estimated): August 11, 2014

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Family Caregivers; Pragmatic Clinical Trial; Patient Care Management
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Tauopathies; Intracranial Arterial Diseases; Intracranial Arteriosclerosis; Leukoencephalopathies; Dementia; Alzheimer Disease; Lewy Body Disease; Dementia, Vascular; Memory Disorders; Frontotemporal Lobar Degeneration
• Other Study ID Numbers: 1C12013003302; 5R01AG056715 (U.S. NIH Grant/Contract); 1C1CMS331346 (Other Grant/Funding Number: Centers for Medicare and Medicaid Services)