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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05820295
Other study ID # 22-09025263
Secondary ID 1K18HS029255-01
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 17, 2023
Est. completion date September 2024

Study information

Verified date April 2024
Source Weill Medical College of Cornell University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 400
Est. completion date September 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
United States New York Presbyterian Hospital - Weill Cornell Medicine New York New York

Sponsors (2)

Lead Sponsor Collaborator
Weill Medical College of Cornell University Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of emergency department visits or hospital admissions Occurrence of an emergency department visit or hospital admission, as measured in Medicare claims Over 12 months (beginning 1 month after the start of care coordination)
Secondary Acceptability, as measured by change in the number of self-reported problems with care coordination Change in the number of self-reported problems with care coordination at 1 month after the start of care coordination compared to baseline Baseline; 1 month
Secondary Appropriateness, as measured by the number of care coordination activities in each group, listed by type The number of care coordination activities in each group (e.g., facilitating provider-provider communication, arranging transportation, etc.) Up to 1 year
Secondary Fidelity, as measured by the percent of eligible individuals who receive care coordination services The percent of eligible individuals who receive care coordination services Up to 1 year
Secondary Efficiency, as measured by the total number of care-coordinator hours used The total number of care-coordinator hours used in each study group Up to 1 year
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