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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Failure, Cardiovascular Diseases, Myocardial Infarction, Atrial Fibrillation, Diabetes Mellitus, Hyperlipidemias, Hypertension, Ischemic Heart Disease, Stroke, Transient Ischemic Attack

Intervention / Treatment
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* Behavioral: Care coordination delivered based on perceived need
* Behavioral: Care coordination delivered based on usual care (e.g. discharge from hospital)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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.<br>|
| Active Comparator: Control<br>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)<br>* If a patient is discharged from a hospital, the patient will be selected for care management services.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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care coordination, accountable care organization