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Clinical Trials/NCT05820295
NCT05820295
Completed
Not Applicable

Improving How Older Adults at Risk for Cardiovascular Outcomes Are Selected for Care Coordination

Weill Medical College of Cornell University1 site in 1 country400 target enrollmentMay 17, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
Weill Medical College of Cornell University
Enrollment
400
Locations
1
Primary Endpoint
Number of Emergency Department Visits or Hospital Admissions
Status
Completed
Last Updated
8 months ago

Overview

Brief Summary

This pragmatic clinical trial embedded in an accountable care organization will determine the comparative effectiveness of two approaches for assigning care coordinators to older adults at risk for cardiovascular outcomes. The hypothesis is that assigning care coordinators to older adults based on perceived need will be more effective at preventing emergency department visits and hospitalizations compared to usual care.

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 older adults at risk for cardiovascular outcomes to receive support from care coordinators: (1) an approach that assigns older adults to care coordinators based on self-reported difficulty with care coordination, or (2) usual care, which generally assigns older adults to care coordinators after hospital discharge, regardless of perceived need. The investigators will include community-dwelling Medicare beneficiaries ≥65 years old with cardiovascular disease (CVD) or 1 or more CVD risk factors 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 older adults at risk for cardiovascular outcomes.

Registry
clinicaltrials.gov
Start Date
May 17, 2023
End Date
July 11, 2024
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Medicare beneficiaries 65 years and older,
  • Attributed to the NewYork Quality Care accountable care organization,
  • Are community-dwelling,
  • Have cardiovascular disease or 1 or more cardiovascular risk factors, and
  • Had highly fragmented ambulatory care in the prior year (defined as a reversed Bice-Boxerman Index greater than or equal to 0.85)

Exclusion Criteria

  • Those who reside in long-term care or nursing home facilities (based on addresses in Medicare claims)
  • Enrolled in home hospice
  • Dementia (as measured in claims using the Bynum Standard 1-year definition)

Outcomes

Primary Outcomes

Number of Emergency Department Visits or Hospital Admissions

Time Frame: Over 12 months (beginning 1 month after the start of care coordination)

Occurrence of an emergency department visit or hospital admission, as measured in Medicare claims. This outcome measure allows more than one event per participant.

Secondary Outcomes

  • Acceptability(Up to 1 year of follow-up)
  • Appropriateness(Up to 1 year of follow-up)
  • Fidelity(Up to 1 year of follow-up)
  • Efficiency(Up to 1 year of follow-up)

Study Sites (1)

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