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

NCT ID: NCT05820295

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-17
• Study Completion Date: 2024-07-11

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.

Conditions

Cardiovascular Diseases; Myocardial Infarction; Atrial Fibrillation; Diabetes Mellitus; Heart Failure; Hyperlipidemias; Hypertension; Ischemic Heart Disease; Stroke; Transient Ischemic Attack

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Care coordination delivered based on perceived need

Intervention Type: 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.

Control

Usual care assigns patients to care coordinators in response to a discharge from a hospital or a direct referral from a physician.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa M Kern, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

New York Presbyterian Hospital - Weill Cornell Medicine

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1K18HS029255-01

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

22-09025263

Identifier Type: -

Identifier Source: org_study_id