Care Coordination Program for Dementia

(Co-CARE-AD Trial)

Overseen By Audrey Wolfe

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Harvard Pilgrim Health Care

Disqualifiers: Nursing home, Hospice, Dementia care program

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

2160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a randomized, pragmatic clinical trial to evaluate the effectiveness of a collaborative care-coordination program embedded in a health plan for people living with Alzheimer's disease and related dementias (ADRD) and their care partners versus usual care. The study population will include community-dwelling Medicare Advantage members living with ADRD and their care partners. Outcomes will be healthcare utilization outcomes of individuals with ADRD and include emergency department visits, outpatient visits, avoidable emergency department visits, and admission to long-term care facilities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current treatments, but it's best to confirm with the trial coordinators.

Is the Care Coordination Program for Dementia safe for humans?

The Care Coordination Program for Dementia, including similar programs like the Care Ecosystem and Memory Care Home Solutions, focuses on improving care and support for people with dementia and their caregivers. These programs have been evaluated for their impact on medication use and adverse health events, showing positive effects on patient care and satisfaction without indicating any safety concerns. ^{1 2 3 4 5}

How is the Dementia Care Consultation program treatment different from other treatments for dementia?

The Dementia Care Consultation program is unique because it focuses on care coordination through partnerships between medical centers and Alzheimer's Association chapters, using a telephone-based approach to support both individuals with dementia and their caregivers. This program emphasizes ongoing monitoring and long-term relationships, which is different from many treatments that focus solely on the patient without integrating caregiver support. ^{1 6 7 8 9}

What data supports the effectiveness of the Dementia Care Consultation treatment?

Research shows that care coordination programs for dementia, like the UCLA Alzheimer's and Dementia Care program, can improve behavioral and depressive symptoms in people with dementia and reduce caregiver strain and depression. Additionally, the Partners in Dementia Care program has been shown to help veterans with dementia by reducing unmet needs and feelings of isolation. ^{4 8 10 11 12}

Who Is on the Research Team?

Xiaojuan Li, PhD MSPH

Principal Investigator

Harvard Pilgrim Health Care Institute

Richard Platt, MD MS

Principal Investigator

Harvard Pilgrim Health Care Institute

Are You a Good Fit for This Trial?

This trial is for community-dwelling individuals enrolled in the Tufts Health Plan Medicare Advantage who have Alzheimer's disease or related dementias, along with their caregivers. Participants must meet certain health plan criteria to join.

Inclusion Criteria

Community-dwelling Tufts Health Plan Medicare Advantage members with ADRD and their caregivers will be selected to participate in the trial based on the following inclusion/

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a collaborative care-coordination program or routine care

6 months

Follow-up

Participants are monitored for healthcare utilization outcomes, including emergency department visits and admissions to long-term care facilities

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Dementia Care Consultation program

Trial Overview The study is testing a Dementia Care Consultation program designed to help manage Alzheimer's and related dementias. It compares this new care-coordination approach against the usual healthcare services provided by the health plan.

How Is the Trial Designed?

Group I: Dementia Care Consultation program Experimental Treatment 1 Intervention

The Dementia Care Consultation program provides an in-depth, personalized service for individuals and families facing ADRD.

Group II: Routine Care Active Control 1 Intervention

Members randomized into the control group will receive routine care.

Who Is Running the Clinical Trial?

Harvard Pilgrim Health Care

Lead Sponsor

Trials

61

Recruited

27,990,000+

Tufts Health Plan

Collaborator

Trials

1

Recruited

2,200+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

The novel dementia care coordination program did not significantly reduce the use of acute care or inpatient services, but it did lead to an increase in outpatient dementia and mental health visits over 18 months, indicating improved access to specialized care.

Participants in the intervention group significantly increased their use of home and community-based support services, suggesting that the program may help individuals with dementia remain in their homes longer and receive necessary support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Services Utilization in Older Adults with Dementia Receiving Care Coordination: The MIND at Home Trial. Amjad, H., Wong, SK., Roth, DL., et al.[2019]

The UCLA Alzheimer's and Dementia Care program showed overall improvements in behavioral and depressive symptoms for persons living with dementia and their caregivers after one year, despite disease progression.

A mixed-methods study identified seven areas for improvement in the program, highlighting that while some caregivers felt they did not benefit clinically, 85% still found the program very or extremely beneficial due to the supportive relationship with dementia care experts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregiver outcomes of a dementia care program. Evertson, LC., Jennings, LA., Reuben, DB., et al.[2022]

The UCLA Alzheimer's and Dementia Care program effectively partners with community-based organizations to provide comprehensive, patient-centered care for individuals with dementia, aiming to improve their quality of life and reduce caregiver strain.

Initial results from the first 150 participants indicate that the program's care plans commonly include referrals to support groups and caregiver training, highlighting its focus on holistic support for both patients and caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The University of California at Los Angeles Alzheimer's and Dementia Care program for comprehensive, coordinated, patient-centered care: preliminary data. Reuben, DB., Evertson, LC., Wenger, NS., et al.[2021]

The DementiaNet program, which lasted for 2 years, significantly improved collaboration among 35 primary care networks and enhanced the quality of dementia care, with measurable increases in both areas during the program.

These improvements in collaboration and care quality were sustained even after the program ended, suggesting that DementiaNet successfully facilitated a lasting transition to integrated primary dementia care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DementiaNet facilitates a sustainable transition toward integrated primary dementia care: A long-term evaluation. Oostra, DL., Nieuwboer, MS., Melis, RJF., et al.[2023]

The Dementia Care Coordination Program effectively utilizes the medical system to identify and refer families to support services, showing high satisfaction rates among stakeholders, including physicians and caregivers.

The program's health plan model demonstrates significant potential for early detection of clients needing support, although improvements in information sharing and data tracking are necessary for optimal functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Dementia Care Coordination Program: Engaging Health Systems in Caregiver Supports. Nadash, P., Silverstein, NM., Porell, F.[2019]

The Care Ecosystem (CE) program significantly reduced the use of potentially inappropriate medications (PIMs) among 490 community-dwelling individuals living with dementia over a 12-month period, with a notable decrease of 0.35 PIMs per participant compared to usual care.

The CE intervention not only lowered the overall number of PIMs, including anticholinergics, benzodiazepines, and opioids, but also led to more frequent adjustments in anti-dementia medication regimens, indicating an optimization of medication use in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of collaborative dementia care on potentially inappropriate medication use: Outcomes from the Care Ecosystem randomized clinical trial. Liu, AK., Possin, KL., Cook, KM., et al.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Health Services Utilization in Older Adults with Dementia Receiving Care Coordination: The MIND at Home Trial. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Caregiver outcomes of a dementia care program. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A controlled trial of Partners in Dementia Care: veteran outcomes after six and twelve months. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The University of California at Los Angeles Alzheimer's and Dementia Care program for comprehensive, coordinated, patient-centered care: preliminary data. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

DementiaNet facilitates a sustainable transition toward integrated primary dementia care: A long-term evaluation. [2023]

6. England pubmed.ncbi.nlm.nih.gov

The Dementia Care Coordination Program: Engaging Health Systems in Caregiver Supports. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

[Gerontopsychiatric Consultation-Liaison Service--pioneers wait for imitators]. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Supporting Family Caregivers of Persons With Dementia in the Community: Description of the 'Memory Care Home Solutions' Program and Its Impacts. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Effect of collaborative dementia care on potentially inappropriate medication use: Outcomes from the Care Ecosystem randomized clinical trial. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Partners in dementia care: a care coordination intervention for individuals with dementia and their family caregivers. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Impact of the care coordination program "Partners in Dementia Care" on veterans' hospital admissions and emergency department visits. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Dementia-Capable Care Coordination in Duals Demonstration Programs: Workforce Needs, Promising Practices, and Policy. [2018]