Care Ecosystem: Navigating Patients and Families Through Stages of Care

Alzheimer Disease Clinical Trial

Official title:

University of California, San Francisco (UCSF) and University of Nebraska Medical Center (UNMC) Care Ecosystem

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02213458
• Other study ID #: 1C12013003302
• Secondary ID: 5R01AG0567151C1C
• Status: Completed
• Phase: N/A
• Start date: March 20, 2015
• Est. completion date: March 8, 2018

Study information

• Verified date: February 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1560
• Est. completion date: March 8, 2018
• Est. primary completion date: March 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Dementia, Vascular
• Frontotemporal Lobar Degeneration
• Lewy Body Disease
• Memory Disorders

Intervention

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).

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	University of California, San Francisco	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	Centers for Medicare and Medicaid Services, National Institute on Aging (NIA), University of Nebraska

Country where clinical trial is conducted

United States, 

References & 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 De — View 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 inappropria — View 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 Co — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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