Collaborative Care Coordination Program for Alzheimer's Disease and Related Dementias (Co-CARE-AD)

Collaborative Care Coordination Program for Alzheimer's Disease and Related Dementias (Co-CARE-AD)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alzheimer's Disease and Related Dementias (ADRD)
• Intervention / Treatment: Behavioral: Dementia Care Consultation program

• Study Type: Interventional
• Enrollment (Actual): 2160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katie Haffenreffer; Phone Number: 617-867-4807; Email: katie_haffenreffer@harvardpilgrim.org
• Study Contact Backup: Name: Audrey Wolfe; Email: audrey_wolfe@harvardpilgrim.org

Study Locations

• United States
  • Massachusetts
    • Watertown, Massachusetts, United States, 02472
      • Tufts Health Plan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dementia Care Consultation program; The Dementia Care Consultation program provides an in-depth, personalized service for individuals and families facing ADRD.	Behavioral: Dementia Care Consultation program; 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.
No Intervention: Routine Care; Members randomized into the control group will receive routine care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause emergency department visits	Number of all-cause emergency department visits per member living with ADRD over the 12-month follow-up period.	by 12 months
All-cause emergency department visits	Number of all-cause emergency department visits per member living with ADRD over the 6-month follow-up period.	by 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outpatient visits	Number of outpatient visits per member living with ADRD over the 12-month follow-up period.	by 12 months
Outpatient visits	Number of outpatient visits per member living with ADRD over the 6-month follow-up period.	by 6 months
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.	by 12 months
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.	by 6 months
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.	by 12 months
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.	by 6 months

Collaborators and Investigators

• Sponsor: Harvard Pilgrim Health Care
• Collaborators: National Institute on Aging (NIA); Tufts Health Plan
• Investigators: Principal Investigator: Xiaojuan Li, PhD MSPH, Harvard Pilgrim Health Care Institute; Principal Investigator: Richard Platt, MD MS, Harvard Pilgrim Health Care Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2022
• Primary Completion (Estimated): October 25, 2024
• Study Completion (Estimated): March 28, 2025

Study Registration Dates

• First Submitted: February 25, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: dementia; informal caregiver; care coordination; care consultation
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: AH000843; 5U54AG063546-03 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No