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

NCT05820295 | Completed Results

• 2 other identifiers: 22-090252631K18HS029255-01
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

care coordination; accountable care organization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 Arms (2)

Intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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)

Interventions

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.

Intervention

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.

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

New York Presbyterian Hospital - Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Arrhythmias, Cardiac; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Dyslipidemias; Lipid Metabolism Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia

Results Point of Contact

• Title: Lisa Kern, MD, MPH
• Organization: Weill Cornell Medicine

lmk2003@med.cornell.edu

646-962-5889

Study Officials

• Lisa M Kern, MD, MPH

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: April 19, 2023
• Study Start: May 17, 2023
• Primary Completion: May 31, 2024
• Study Completion: July 11, 2024
• Last Updated: September 4, 2025
• Results First Posted: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)