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

Stroke Clinical Trial

Official title:

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

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
• 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
• 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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiovascular Diseases
• Coronary Artery Disease
• Diabetes Mellitus
• Heart Failure
• Hyperlipidemias
• Hypertension
• Ischemia
• Ischemic Attack, Transient
• Ischemic Heart Disease
• Myocardial Infarction
• Myocardial Ischemia
• Stroke
• Transient Ischemic Attack

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