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

June 26, 2026 updated by: Weill Medical College of Cornell University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • New York Presbyterian Hospital - Weill Cornell Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Usual care assigns patients to care coordinators in response to a discharge from a hospital or a direct referral from a physician.
Behavioral: Care coordination delivered based on usual care (e.g. discharge from hospital)
If a patient is discharged from a hospital, the patient will be selected for care management services.
Experimental: Intervention
The intervention group will assign care coordinators to individuals based on perceived need for assistance with care coordination. Perceived need will be measured through a proxy's responses to a previously validated telephone survey on perceptions of care coordination.
Behavioral: Care coordination delivered based on perceived need
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Over 12 months (beginning 1 month after the start of care coordination)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: Up to 1 year of follow-up
Number of people in each group who accept care management
Up to 1 year of follow-up
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
Up to 1 year of follow-up
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.
Up to 1 year of follow-up
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.
Up to 1 year of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Lisa M Kern, MD, MPH, Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2023

Primary Completion (Actual)

May 31, 2024

Study Completion (Actual)

July 11, 2024

Study Registration Dates

First Submitted

April 7, 2023

First Submitted That Met QC Criteria

April 7, 2023

First Posted (Actual)

April 19, 2023

Study Record Updates

Last Update Posted (Actual)

July 23, 2026

Last Update Submitted That Met QC Criteria

June 26, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-09025263
  • 1K18HS029255-01 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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