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OpenTrials
Completed

NCT Number: NCT05820295

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Care coordination delivered based on perceived need

Behavioral

If patients in intervention group report on the survey that they experience difficulty coordinating care among their providers, the patient will be selected for care management services. Those services will attempt to address the problems with care coordination that the proxy reported.

Care coordination delivered based on usual care (e.g. discharge from hospital)

Behavioral

If a patient is discharged from a hospital, the patient will be selected for care management services.

Primary outcomes

  1. 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

  1. Acceptability

    Time frame: Up to 1 year of follow-up

    Number of people in each group who accept care management

  2. Appropriateness

    Time frame: Up to 1 year of follow-up

    Number of participants who requested care management services that were in scope for the care managers' credentials

  3. Fidelity

    Time frame: Up to 1 year of follow-up

    Number of participants who received care management services, among those who requested care management services.

  4. Efficiency

    Time frame: Up to 1 year of follow-up

    The total number of care management encounters per group. This measure allows more than one encounter per participant.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 19, 2023
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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