Clinical trial NCT05281744: Collaborative Care Coordination Program for Alzheimer's Disease and Related Dementias
Official title: Collaborative Care Coordination Program for Alzheimer's Disease and Related Dementias (Co-CARE-AD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alzheimer's Disease and Related Dementias (ADRD)
Keywords: dementia
informal caregiver
care consultation
care coordination
Lead sponsor: Harvard Pilgrim Health Care
Sponsor class: OTHER
Collaborators: name: Tufts Health Plan
name: National Institute on Aging (NIA)
First posted: 2022-03-16
Enrollment: 2160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: All-cause emergency department visits
timeFrame: by 12 months
measure: All-cause emergency department visits
timeFrame: by 6 months
Secondary outcomes:
measure: Outpatient visits
timeFrame: by 12 months
measure: Outpatient visits
timeFrame: by 6 months
measure: Avoidable emergency department visits
timeFrame: by 12 months
measure: Avoidable emergency department visits
timeFrame: by 6 months
measure: Admission to long-term care facilities
timeFrame: by 12 months
measure: Admission to long-term care facilities
timeFrame: by 6 months
Other outcomes:
Locations:
city: Watertown
country: United States
facility: Tufts Health Plan
state: Massachusetts
Study officials:
affiliation: Harvard Pilgrim Health Care Institute
name: Xiaojuan Li, PhD MSPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard Pilgrim Health Care Institute
name: Richard Platt, MD MS
role: PRINCIPAL_INVESTIGATOR
References: