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

Primary Purpose

Cardiovascular Diseases, Myocardial Infarction, Atrial Fibrillation

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Care coordination delivered based on perceived need
Care coordination delivered based on usual care (e.g. discharge from hospital)
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cardiovascular Diseases focused on measuring care coordination, accountable care organization

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • New York Presbyterian Hospital - Weill Cornell Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

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.

Usual care assigns patients to care coordinators in response to a discharge from a hospital or a direct referral from a physician.

Outcomes

Primary Outcome Measures

Number of emergency department visits or hospital admissions
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
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
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
The percent of eligible individuals who receive care coordination services
Efficiency, as measured by the total number of care-coordinator hours used
The total number of care-coordinator hours used in each study group

Full Information

First Posted
April 7, 2023
Last Updated
May 18, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT05820295
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 17, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Usual care assigns patients to care coordinators in response to a discharge from a hospital or a direct referral from a physician.
Intervention Type
Behavioral
Intervention Name(s)
Care coordination delivered based on perceived need
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Care coordination delivered based on usual care (e.g. discharge from hospital)
Intervention Description
If a patient is discharged from a hospital, the patient will be selected for care management services.
Primary Outcome Measure Information:
Title
Number of emergency department visits or hospital admissions
Description
Occurrence of an emergency department visit or hospital admission, as measured in Medicare claims
Time Frame
Over 12 months (beginning 1 month after the start of care coordination)
Secondary Outcome Measure Information:
Title
Acceptability, as measured by change in the number of self-reported problems with care coordination
Description
Change in the number of self-reported problems with care coordination at 1 month after the start of care coordination compared to baseline
Time Frame
Baseline; 1 month
Title
Appropriateness, as measured by the number of care coordination activities in each group, listed by type
Description
The number of care coordination activities in each group (e.g., facilitating provider-provider communication, arranging transportation, etc.)
Time Frame
Up to 1 year
Title
Fidelity, as measured by the percent of eligible individuals who receive care coordination services
Description
The percent of eligible individuals who receive care coordination services
Time Frame
Up to 1 year
Title
Efficiency, as measured by the total number of care-coordinator hours used
Description
The total number of care-coordinator hours used in each study group
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa M Kern, MD, MPH
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Presbyterian Hospital - Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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