Clinical trial NCT02213458: Care Ecosystem: Navigating Patients and Families Through Stages of Care
Official title: University of California, San Francisco (UCSF) and University of Nebraska Medical Center (UNMC) Care Ecosystem
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Alzheimer Disease
Dementia, Vascular
Lewy Body Disease
Frontotemporal Lobar Degeneration
Memory Disorders
Keywords: Pragmatic Clinical Trial
Family Caregivers
Patient Care Management
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of Nebraska
name: Centers for Medicare and Medicaid Services
name: National Institute on Aging (NIA)
First posted: 2014-08-11
Enrollment: 1560
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Quality of Life-Alzheimer's Disease, Change From Baseline to 1 Year
timeFrame: Baseline to one year
Secondary outcomes:
measure: Change in Caregiver Reported Rate of Emergency Department Utilization: Baseline to One Year
timeFrame: Baseline to one year
measure: Change in Caregiver Burden, Baseline to One Year
timeFrame: Baseline to one year
measure: Satisfaction With Dementia Care
timeFrame: One year
measure: Change in Caregiver Depression, Baseline to One Year
timeFrame: Baseline to one year
measure: Change in Caregiver Self-efficacy, Baseline to One Year
timeFrame: Baseline to one year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of California, San Francisco
name: Katherine L Possin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.