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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Cardiovascular Diseases; Heart Failure; Stroke; Hypertension; Diabetes Mellitus; Atrial Fibrillation; Transient Ischemic Attack; Hyperlipidemias; Ischemic Heart Disease
• Intervention / Treatment: Behavioral: Care coordination delivered based on usual care (e.g. discharge from hospital); Behavioral: Care coordination delivered based on perceived need

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	Number of people in each group who accept care management	Up to 1 year of follow-up
Appropriateness	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	Number of participants who received care management services, among those who requested care management services.	Up to 1 year of follow-up
Efficiency	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

• 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

Study record dates

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 (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: care coordination; accountable care organization
• Additional Relevant MeSH Terms: Endocrine System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Pathologic Processes; Heart Diseases; Metabolic Diseases; Arrhythmias, Cardiac; Glucose Metabolism Disorders; Brain Ischemia; Infarction; Necrosis; Dyslipidemias; Lipid Metabolism Disorders; Ischemia; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Stroke; Heart Failure; Hypertension; Ischemic Attack, Transient; Cardiovascular Diseases; Diabetes Mellitus; Atrial Fibrillation; Myocardial Ischemia; Myocardial Infarction; Hyperlipidemias
• 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