Back to resultsCollaborative Care Coordination Program for Alzheimer's Disease and Related Dementias (Co-CARE-AD)
Primary Purpose
Alzheimer's Disease and Related Dementias (ADRD)
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dementia Care Consultation program
Sponsored by
About this trial
This is an interventional supportive care trial for Alzheimer's Disease and Related Dementias (ADRD) focused on measuring dementia, informal caregiver, care consultation, care coordination
Eligibility 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/exclusion criteria:
Inclusion Criteria (for members with ADRD)
- Member of Tufts Health Plan Medicare Advantage plan
- Medical and pharmacy insurance coverage in at least the prior 12 months
- Have ≥1 ICD-10-CM diagnosis code for ADRD or dispensing for pharmacological treatment for ADRD in the prior 12 months
Exclusion Criteria (for members with ADRD):
- Reside in a nursing home or skilled nursing facility
- Enrolled in a hospice program
- Receiving or have received the Dementia Care Consultation program as part of the existing program at the time of enrollment
Inclusion Criteria (for caregivers)
- Age 18 years or older
- Assume primary responsibility for members
Sites / Locations
- Tufts Health Plan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Dementia Care Consultation program
Routine Care
Arm Description
The Dementia Care Consultation program provides an in-depth, personalized service for individuals and families facing ADRD.
Members randomized into the control group will receive routine care.
Outcomes
Primary Outcome Measures
All-cause emergency department visits
Number of all-cause emergency department visits per member living with ADRD over the 12-month follow-up period.
All-cause emergency department visits
Number of all-cause emergency department visits per member living with ADRD over the 6-month follow-up period.
Secondary Outcome Measures
Outpatient visits
Number of outpatient visits per member living with ADRD over the 12-month follow-up period.
Outpatient visits
Number of outpatient visits per member living with ADRD over the 6-month follow-up period.
Avoidable emergency department visits
Number avoidable emergency department visits (defined using the validated New York University ED visit algorithm) per member living with ADRD over the 12-month follow-up period.
Avoidable emergency department visits
Number avoidable emergency department visits (defined using the validated New York University ED visit algorithm) per member living with ADRD over the 6-month follow-up period.
Admission to long-term care facilities
Number of members living with ADRD with the first admission to long-term care facilities over the 12-month follow-up period.
Admission to long-term care facilities
Number of members living with ADRD with the first admission to long-term care facilities over the 6-month follow-up period.
Full Information
NCT ID
NCT05281744
First Posted
February 25, 2022
Last Updated
July 31, 2023
Sponsor
Harvard Pilgrim Health Care
Collaborators
Tufts Health Plan, National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05281744
Brief Title
Collaborative Care Coordination Program for Alzheimer's Disease and Related Dementias
Acronym
Co-CARE-AD
Official Title
Collaborative Care Coordination Program for Alzheimer's Disease and Related Dementias (Co-CARE-AD)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 27, 2022 (Actual)
Primary Completion Date
October 25, 2024 (Anticipated)
Study Completion Date
March 28, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard Pilgrim Health Care
Collaborators
Tufts Health Plan, National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease and Related Dementias (ADRD)
Keywords
dementia, informal caregiver, care consultation, care coordination
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dementia Care Consultation program
Arm Type
Experimental
Arm Description
The Dementia Care Consultation program provides an in-depth, personalized service for individuals and families facing ADRD.
Arm Title
Routine Care
Arm Type
No Intervention
Arm Description
Members randomized into the control group will receive routine care.
Intervention Type
Behavioral
Intervention Name(s)
Dementia Care Consultation program
Intervention Description
The Dementia Care Consultation program uses a telephone-based intervention to provide an in-depth, personalized service for individuals living with ADRD and their care partners. It consists of comprehensive needs assessments, creation and implementation of personalized care plans, monitoring and revising care plans, disease education and support coaching, referrals to community-based organizations for service and support, and access to assistance.
Primary Outcome Measure Information:
Title
All-cause emergency department visits
Description
Number of all-cause emergency department visits per member living with ADRD over the 12-month follow-up period.
Time Frame
by 12 months
Title
All-cause emergency department visits
Description
Number of all-cause emergency department visits per member living with ADRD over the 6-month follow-up period.
Time Frame
by 6 months
Secondary Outcome Measure Information:
Title
Outpatient visits
Description
Number of outpatient visits per member living with ADRD over the 12-month follow-up period.
Time Frame
by 12 months
Title
Outpatient visits
Description
Number of outpatient visits per member living with ADRD over the 6-month follow-up period.
Time Frame
by 6 months
Title
Avoidable emergency department visits
Description
Number avoidable emergency department visits (defined using the validated New York University ED visit algorithm) per member living with ADRD over the 12-month follow-up period.
Time Frame
by 12 months
Title
Avoidable emergency department visits
Description
Number avoidable emergency department visits (defined using the validated New York University ED visit algorithm) per member living with ADRD over the 6-month follow-up period.
Time Frame
by 6 months
Title
Admission to long-term care facilities
Description
Number of members living with ADRD with the first admission to long-term care facilities over the 12-month follow-up period.
Time Frame
by 12 months
Title
Admission to long-term care facilities
Description
Number of members living with ADRD with the first admission to long-term care facilities over the 6-month follow-up period.
Time Frame
by 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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/exclusion criteria:
Inclusion Criteria (for members with ADRD)
Member of Tufts Health Plan Medicare Advantage plan
Medical and pharmacy insurance coverage in at least the prior 12 months
Have ≥1 ICD-10-CM diagnosis code for ADRD or dispensing for pharmacological treatment for ADRD in the prior 12 months
Exclusion Criteria (for members with ADRD):
Reside in a nursing home or skilled nursing facility
Enrolled in a hospice program
Receiving or have received the Dementia Care Consultation program as part of the existing program at the time of enrollment
Inclusion Criteria (for caregivers)
Age 18 years or older
Assume primary responsibility for members
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaojuan Li, PhD MSPH
Organizational Affiliation
Harvard Pilgrim Health Care Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Platt, MD MS
Organizational Affiliation
Harvard Pilgrim Health Care Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Health Plan
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Collaborative Care Coordination Program for Alzheimer's Disease and Related Dementias
We'll reach out to this number within 24 hrs