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

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05820295

Collaborator

Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)

400

Enrollment

Location

Arms

17.1

Anticipated Duration (Months)

23.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Myocardial Infarction Atrial Fibrillation Diabetes Mellitus Heart Failure Hyperlipidemias Hypertension Ischemic Heart Disease Stroke Transient Ischemic Attack	Behavioral: Care coordination delivered based on perceived need Behavioral: Care coordination delivered based on usual care (e.g. discharge from hospital)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
Active Comparator: Control 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) If a patient is discharged from a hospital, the patient will be selected for care management services.

Arm

Intervention/Treatment

Experimental: 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.

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.

Active Comparator: Control

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)

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

Outcome Measures

Primary Outcome Measures

Number of emergency department visits or hospital admissions [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

Secondary Outcome Measures

Acceptability, as measured by change in the number of self-reported problems with care coordination [Baseline; 1 month]
Change in the number of self-reported problems with care coordination at 1 month after the start of care coordination compared to baseline
Appropriateness, as measured by the number of care coordination activities in each group, listed by type [Up to 1 year]
The number of care coordination activities in each group (e.g., facilitating provider-provider communication, arranging transportation, etc.)
Fidelity, as measured by the percent of eligible individuals who receive care coordination services [Up to 1 year]
The percent of eligible individuals who receive care coordination services
Efficiency, as measured by the total number of care-coordinator hours used [Up to 1 year]
The total number of care-coordinator hours used in each study group

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)