NCT05820295

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

Completed NA Results posted Last updated 4 September 2025

What this trial tests

NA trial testing Care coordination delivered based on perceived need in Cardiovascular Diseases in 400 participants. Completed in 11 July 2024.

Timeline

17 May 2023

Primary endpoint
31 May 2024

11 July 2024

Quick facts

Lead sponsor	Weill Medical College of Cornell University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	400
Start date	17 May 2023
Primary completion	31 May 2024
Estimated completion	11 July 2024
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
• Myocardial Infarction — all drugs for Myocardial Infarction →
• Atrial Fibrillation — all drugs for Atrial Fibrillation →
• Diabetes Mellitus — all drugs for Diabetes Mellitus →

Sponsor

Weill Medical College of Cornell University

Who can join

65 and older, any sex, with Cardiovascular Diseases or Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Emergency Department Visits or Hospital Admissions Primary · 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.

Group	Value	95% CI
Intervention	0.25	0.21 – 0.31
Control	0.21	0.17 – 0.27

Acceptability Secondary · Up to 1 year of follow-up

Number of people in each group who accept care management

Group	Value	95% CI
Intervention	13
Control	17

Appropriateness Secondary · Up to 1 year of follow-up

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

Group	Value	95% CI
Intervention	13
Control	17

Fidelity Secondary · Up to 1 year of follow-up

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

Group	Value	95% CI
Intervention	13
Control	17

Efficiency Secondary · 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.

Group	Value	95% CI
Intervention	52
Control	45

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Care Coordination and Hospitalization in Older Adults With or at Risk for Cardiovascular Disease: A Randomized Clinical Trial.
   Kern LM, Aucapina JE, Banerjee S, Ringel JB, et al · · 2026 · PMID 42048081 · DOI 10.1001/jamanetworkopen.2026.9110
2. Gaps in the coordination of care for older adults with or at risk for cardiovascular disease.
   Kern LM, Aucapina JE, Banerjee S, Ringel JB, et al · · 2025 · PMID 40549347 · DOI 10.37765/ajmc.2025.89746