Clinical trial NCT05651308: Improving How People Living With Dementia Are Selected for Care Coordination
Official title: Improving How People Living With Dementia Are Selected for Care Coordination: A Pragmatic Clinical Trial Embedded in an Accountable Care Organization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: care coordination
accountable care organization
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Brown University
First posted: 2022-12-15
Enrollment: 385
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Many people living with dementia (PLWD) and their care partners may benefit from the assistance of a care coordinator, a member of the medical team who facilitates communication among all the people involved. However, care coordinators' time is limited, and there is uncertainty about which patients should be selected to receive their help. This pragmatic clinical trial embedded in an accountable care organization will determine the comparative effectiveness of two approaches for assigning care coordinators to PLWD.

Detailed description: This project will use a pragmatic clinical trial embedded in an accountable care organization (ACO) to determine the comparative effectiveness of two different approaches for selecting PLWD to receive support from care coordinators: (1) an approach that assigns PLWD to care coordinators based on care partners' self-reported difficulty with care coordination, or (2) usual care, which generally assigns PLWD to care coordinators after hospital discharge, regardless of perceived need. The investigators will include community-dwelling Medicare beneficiaries ≥65 years old with dementia who have been attributed to the NewYork Quality Care ACO and who have fragmented care. The investigators will randomize the participants into two groups. This study is highly pragmatic, and the intervention is sustainable and scalable. Moreover, the proposed approach has the potential to improve care delivery and outcomes for PLWD.

Eligibility criteria: Inclusion Criteria:

* Medicare beneficiaries ≥65 years old who:
* Are attributed to the NewYork Quality Care accountable care organization by Medicare,
* Have dementia (as measured in claims using the Bynum standard 1-year definition),
* Reside in the community, and
* Had fragmented ambulatory care in the previous 12 months (defined as a reversed Bice-Boxerman Index greater than or equal to the median score for this population, using Medicare claims)

Exclusion Criteria:

* Those who reside in long-term care or nursing home facilities (based on addresses in Medicare claims), or
* Enrolled in home hospice

Primary outcomes:
measure: Number of Emergency Department Visits or Hospital Admissions
timeFrame: Over 12 months (beginning 1 month after the start of care coordination)
Secondary outcomes:
measure: Acceptability
timeFrame: Up to 1 year
measure: Appropriateness
timeFrame: Up to 1 year
measure: Fidelity
timeFrame: Up to 1 year
measure: Efficiency
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital - Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Lisa M Kern, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Vincent Mor, PhD
role: STUDY_DIRECTOR
References: