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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program designed to help individuals with Alzheimer's disease and related dementias (ADRD) and their caregivers manage care more effectively. The goal is to determine if this program reduces hospital visits and the need for long-term care compared to usual care. Participants will either receive personalized support through the Dementia Care Consultation program or continue with their regular care routine. Eligible participants include members of the Tufts Health Plan Medicare Advantage who have been diagnosed with ADRD and are living at home, along with their primary caregivers. As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies for ADRD.

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.

What prior data suggests that this care coordination program is safe for individuals with dementia?

Research has shown that dementia care programs, such as the Dementia Care Consultation program, provide educational resources, safety tips, and future planning assistance for individuals with Alzheimer's disease and related dementias (ADRD). Studies have found these programs to be generally well-received. They aim to support both individuals with dementia and their caregivers without introducing new medications or medical procedures.

Although specific data on side effects from the Dementia Care Consultation program is not available, its focus suggests a low risk. The program primarily involves education and planning, which are unlikely to cause harm. It is designed to improve understanding and management of dementia, potentially reducing stress for both patients and caregivers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Dementia Care Consultation program because it offers a personalized approach to managing Alzheimer's Disease and Related Dementias (ADRD). Unlike standard care, which often involves general medical management and medication, this program provides tailored support and resources for individuals and their families. By focusing on specific needs and coordinating care, it aims to improve quality of life and overall outcomes for those affected by dementia. This personalized strategy is what sets it apart and offers hope for more effective management of the condition.

What evidence suggests that the Dementia Care Consultation program is effective for Alzheimer's disease and related dementias?

Research has shown that the Dementia Care Consultation program, which participants in this trial may receive, can assist people with Alzheimer's and related dementias (ADRD) and their caregivers. One study found that participants experienced fewer behavioral and depressive symptoms, even as the disease progressed. Caregivers reported increased satisfaction with care after three months, and this satisfaction remained high for 18 months. Another study found that these care programs boosted caregivers' confidence in managing dementia. Although some studies did not observe significant changes in patient behavior, the overall benefits for caregivers suggest that this program can effectively support families dealing with ADRD. ^{1 6 7 8 9}

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 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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8084597/

Caregiver Outcomes of a Dementia Care Program - PMC At one year, despite disease progression, overall the PLWDs' behavioral and depressive symptoms improved. In addition, at one-year, overall caregiver depression ...

2. uclahealth.org uclahealth.org/news/release/d-care-study-finds-caregiver-satisfaction-higher-with

D-CARE study finds caregiver satisfaction higher with ... Higher caregiver satisfaction with care was observed after 3 months of care delivery and remained consistent throughout the 18-month study.

3. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2829720

Health System, Community-Based, or Usual Dementia ... In this randomized clinical trial of dementia care programs, there were no significant differences between a health system–based vs a community-based care ...

4. ysph.yale.edu ysph.yale.edu/news-article/study-finds-no-differences-between-dementia-care-approaches-on-patient-behavioral-symptoms-or-caregiver-strain/

Study finds no differences between dementia care ... But the study, the largest pragmatic trial on dementia care, finds that comprehensive care improved caregiver self-efficacy.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0883941724000633

Effectiveness of a health education program for people with ... This study assesses the effectiveness of a health education program on caregiving outcomes for people with dementia and their families.

6. cms.gov cms.gov/priorities/innovation/data-and-reports/2022/dementia-care-synthesis-1989-2020

Dementia Care Projects: Synthesis of Evaluation Results ... This study synthesized evaluation results from CMS-funded work on dementia care to increase our understanding of the components used (e.g., ...

7. ptoutcomes.com ptoutcomes.com/contentassets/2bc378efdd33432f951697af8cc938f7/2021-measure-286_dementia-safety-concern-screening-followup-patients-dementia.pdf

Quality ID #286: Dementia: Safety Concern Screening and ... MEASURE TYPE: Process – High Priority. DESCRIPTION: Percentage of patients with dementia or their caregiver(s) for whom there was a documented safety ...

8. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/trc2.70091

Care staff perspectives of clinically meaningful outcomes for ... Persons with dementia (PWD) have high care needs, and options for age-appropriate and meaningful activities become more limited with decline.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9237299/

Dementia patient and caregiver relevant outcomes ... Ten states routinely collect outcome data in ADS. Among these, 80% assess cognitive function. All 10 states capture PLWD's ability to complete activities of ...