Clinical trial NCT05820295: Improving How Older Adults at Risk for Cardiovascular Outcomes Are Selected for Care Coordination
Official title: Improving How Older Adults at Risk for Cardiovascular Outcomes Are Selected for Care Coordination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2023-04-19
Enrollment: 400
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of emergency department visits or hospital admissions
timeFrame: Over 12 months (beginning 1 month after the start of care coordination)
Secondary outcomes:
measure: Acceptability, as measured by change in the number of self-reported problems with care coordination
timeFrame: Baseline; 1 month
measure: Appropriateness, as measured by the number of care coordination activities in each group, listed by type
timeFrame: Up to 1 year
measure: Fidelity, as measured by the percent of eligible individuals who receive care coordination services
timeFrame: Up to 1 year
measure: Efficiency, as measured by the total number of care-coordinator hours used
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital - Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Lisa M Kern, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: