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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04287738
• Other study ID #: 1R01AG056715-01
• Secondary ID: 1R01AG056715-01
• Status: Completed
• Phase: N/A
• Start date: March 20, 2015
• Est. completion date: May 20, 2022

Study information

• Verified date: November 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an extension trial of a prior trial (NCT02213458). Both persons with dementia (PWD) and their caregivers were enrolled as dyads. The purpose of this randomized clinical trial is to evaluate the benefits of a program that supports model care for PWD and their caregivers. Whereas the prior trial only delivered care and examined outcomes up to 12-months, this trial extends care and outcome measurement for 5 years or until death, and includes all dyads where the caregiver reported high caregiver burden (Zarit-12 greater than or equal to 17) at pre-randomization baseline for the original trial. Participants were recruited from California, Nebraska and Iowa. Participants determined to be eligible were consented and randomized into one of two groups. Two thirds of dyads were enrolled into Navigated Care that provided them with phone-based 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 dyads were enrolled to a control group, entitled Survey of Care. Outcomes were unchanged from the original trial except for the addition of time to long term care placement and are detailed below.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 912
• Est. completion date: May 20, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Inclusion criteria for patient participants:

• 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 English, Cantonese, or Spanish

• Patient lives in California or Nebraska or Iowa

• Patient is age 45 or older

Inclusion criteria for caregiver participants:

• Caregiver has primary responsibility for dementia patient that is eligible for and agrees to join the study

• Caregiver speaks English, Cantonese, or Spanish

• Caregiver is a legal adult

• Zarit-12 caregiver burden score greater than or equal to 17 at pre-randomization (baseline); this criteria is specific to this extension trial

Exclusion Criteria:

• 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 the investigator's trial

• Patient is pregnant

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Navigated Care
Telephone-based collaborative dementia care was delivered by a trained care team navigator, who provided education, support and care coordination with a team of dementia specialists (advanced practice nurse, social worker, and pharmacist). For more details, please see references below.

Locations

Country	Name	City	State
n/a

Sponsors (4)

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

References & Publications (10)

Bernstein A, Harrison KL, Dulaney S, Merrilees J, Bowhay A, Heunis J, Choi J, Feuer JE, Clark AM, Chiong W, Lee K, Braley TL, Bonasera SJ, Ritchie CS, Dohan D, Miller BL, Possin KL. The Role of Care Navigators Working with People with Dementia and Their C — View Citation

Bernstein A, Rogers KM, Possin KL, Steele NZR, Ritchie CS, Miller BL, Rankin KP. Primary Care Provider Attitudes and Practices Evaluating and Managing Patients with Neurocognitive Disorders. J Gen Intern Med. 2019 Sep;34(9):1691-1692. doi: 10.1007/s11606- — View Citation

Chen Y, Wilson L, Kornak J, Dudley RA, Merrilees J, Bonasera SJ, Byrne CM, Lee K, Chiong W, Miller BL, Possin KL. The costs of dementia subtypes to California Medicare fee-for-service, 2015. Alzheimers Dement. 2019 Jul;15(7):899-906. doi: 10.1016/j.jalz.2 — View Citation

Guterman EL, Allen IE, Josephson SA, Merrilees JJ, Dulaney S, Chiong W, Lee K, Bonasera SJ, Miller BL, Possin KL. Association Between Caregiver Depression and Emergency Department Use Among Patients With Dementia. JAMA Neurol. 2019 Oct 1;76(10):1166-1173. — View 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. — 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 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. — View Citation

Merrilees JJ, Bernstein A, Dulaney S, Heunis J, Walker R, Rah E, Choi J, Gawlas K, Carroll S, Ong P, Feuer J, Braley T, Clark AM, Lee K, Chiong W, Bonasera SJ, Miller BL, Possin KL. The Care Ecosystem: Promoting self-efficacy among dementia family caregiv — View Citation

Possin KL, Merrilees J, Bonasera SJ, Bernstein A, Chiong W, Lee K, Wilson L, Hooper SM, Dulaney S, Braley T, Laohavanich S, Feuer JE, Clark AM, Schaffer MW, Schenk AK, Heunis J, Ong P, Cook KM, Bowhay AD, Gearhart R, Chodos A, Naasan G, Bindman AB, Dohan — 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

Rosa TD, Possin KL, Bernstein A, Merrilees J, Dulaney S, Matuoka J, Lee KP, Chiong W, Bonasera SJ, Harrison KL, Kahn JG. Variations in Costs of a Collaborative Care Model for Dementia. J Am Geriatr Soc. 2019 Dec;67(12):2628-2633. doi: 10.1111/jgs.16076. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Quality of Life - AD (Alzheimer's Disease)	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	From baseline to 60 months
Secondary	Change in Health Care Utilization	Health care utilization based upon caregiver survey to assess emergency department, hospitalization, and ambulance use rates. Measures number of times utilized, with higher scores indicating a worse outcome. To be confirmed using Medicare claims data.	From baseline to 60 months
Secondary	Change in 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.	From baseline to 60 months
Secondary	Change in Patient Health Questionnaire 9 (PhQ-9).	An established 9-item measure administered to the caregiver. Higher scores represent more severe caregiver depression	From baseline to 60 months
Secondary	Change in Caregiver Self-Efficacy: 1-5 ordinal scale	A novel 4-item measure on a 1-5 ordinal scale to measure self-efficacy around dementia caregiving. Higher scores represent greater self-efficacy	From baseline to 60 months
Secondary	Time to Long Term Care Placement	Number of days post randomization until nursing home or assisted living placement, excluding temporary stays	From date of baseline survey to immediately following long term care placement, assessed up to 60 months