Collaborative Care Coordination Program for Alzheimer's Disease and Related Dementias

NCT05281744 | Completed DMC

• 2 other identifiers: AH0008435U54AG063546-03
• Study Type: interventional
• Target: 2,160
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease and Related Dementias (ADRD)

Keywords

dementia; informal caregiver; care consultation; care coordination

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Outpatient visits

  by 12 months

• Outpatient visits

  by 6 months

• Avoidable emergency department visits

  by 12 months

• Avoidable emergency department visits

  by 6 months

• Admission to long-term care facilities

  by 12 months

Study Arms (2)

Dementia Care Consultation program

EXPERIMENTAL

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

Behavioral: Dementia Care Consultation program

Routine Care

NO INTERVENTION

Members randomized into the control group will receive routine care.

Interventions

Dementia Care Consultation program BEHAVIORAL

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.

Dementia Care Consultation program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• 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
• Age 18 years or older
• Assume primary responsibility for members

Sponsors & Collaborators

• Tufts Health Plan: collaborator
• National Institute on Aging (NIA): collaborator
• Harvard Pilgrim Health Care: lead

Study Sites (1)

Tufts Health Plan

Watertown, Massachusetts, 02472, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Xiaojuan Li, PhD MSPH

  Harvard Pilgrim Health Care Institute

  PRINCIPAL INVESTIGATOR

• Richard Platt, MD MS

  Harvard Pilgrim Health Care Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 16, 2022
• Study Start: May 27, 2022
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: January 22, 2026

Record last verified: 2024-10

Locations

US (1)