Improving Veteran Referral to Cardiac Rehabilitation

NCT ID: NCT07079358

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 816 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2027-07-01
• Study Completion Date: 2029-12-31

Brief Summary

This study will test whether the Veterans Cardiac Rehabilitation Referral Program (VCR2P) improves cardiac rehabilitation participation by studying 816 Veterans across three VA medical centers in Nashville, Dallas, and Gainesville over 12 months. The trial compares referral rates from the 6 months before implementing the program to 6 months after, using a "before and after" design since randomization would be impractical. The study will measure whether the program increases the proportion of eligible Veterans who receive cardiac rehabilitation referrals and whether more Veterans actually attend rehabilitation sessions. Additionally, focus groups with physicians, nurses, and Veterans will identify what helps or hinders the program's success, providing essential insights for expanding this intervention to other VA facilities nationwide if it proves effective.

Detailed Description

This study seeks to evaluate the Veterans Cardiac Rehabilitation Referral Program (VCR2P) using a type 2 hybrid effectiveness-implementation design. The trial involves a single-arm, pre-post trial at three VA medical centers, enrolling a total of 816 Veterans who are eligible for cardiac rehabilitation (CR). The primary objective is to assess the program's impact on two key outcomes: CR referral rates and CR initiation rates. Secondary implementation outcomes will include measures such as reach, adoption, fidelity, maintenance, and cost, providing a comprehensive understanding of how the intervention performs in real-world VA settings. This evaluation will be guided by implementation science frameworks to ensure the program is scalable and sustainable. A summative evaluation will be conducted to inform broader implementation across the Veterans Health Administration. The goal is to determine not only whether VCR2P improves referral and participation in CR but also how it can be feasibly integrated into routine care to close quality gaps and enhance cardiovascular outcomes for Veterans.

Conditions

Cardiovascular Disease; Cardiac Rehabilitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Veterans Cardiac Rehabilitation Referral Program

All eligible Veterans hospitalized with cardiac rehabilitation-eligible conditions (acute myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention, cardiac valve surgery, or systolic heart failure) will receive the VCR2P intervention.

Group Type: EXPERIMENTAL

Veterans Cardiac Rehabilitation Referral Program

Intervention Type: BEHAVIORAL

1. A CDS tool that identifies Veterans hospitalized with CR-eligible conditions and prompts physicians to refer them to CR.

2. Educational materials that explain to Veterans the benefits and importance of participating in CR.

3. Defined responsibilities for a facility-based CR referral coordinator who will support development and oversight of the referral process.

Interventions

Veterans Cardiac Rehabilitation Referral Program

1. A CDS tool that identifies Veterans hospitalized with CR-eligible conditions and prompts physicians to refer them to CR.

2. Educational materials that explain to Veterans the benefits and importance of participating in CR.

3. Defined responsibilities for a facility-based CR referral coordinator who will support development and oversight of the referral process.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• All Veterans hospitalized with acute myocardial infarction, percutaneous coronary intervention, cardiac valve surgery, coronary artery bypass grafting, or systolic heart failure at the three participating VA medical centers (Nashville, Dallas, and Gainesville).

Exclusion Criteria

• however, post-hoc analysis will exclude Veterans with documented reasons preventing CR attendance including death during hospitalization or within 30 days of discharge, discharge to inpatient rehabilitation or skilled nursing facilities, significant cognitive impairment, high-risk ventricular arrhythmias, or explicit refusal of CR services.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Justin M Bachmann, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Locations

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, United States

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, United States

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, United States

Countries

United States

Central Contacts

Justin M Bachmann, MD MPH

Role: CONTACT

justin.bachmann2@va.gov

(615) 327-4751

Ray Stokes Peebles, MD

Role: CONTACT

Ray.Peebles@va.gov

(615) 327-4751

Facility Contacts

David Winchester, MD

Role: primary

David.Winchester@va.gov

352-376-1611

Justin M Bachmann, MD MPH

Role: primary

justin.bachmann2@va.gov

615-327-4751

Ray Stokes Peebles, MD

Role: backup

Ray.Peebles@va.gov

(615) 327-4751

Katherine Michelis, MD

Role: primary

Katherine.Michelis@va.gov

214-742-8387

Other Identifiers

IIR 23-171

Identifier Type: -

Identifier Source: org_study_id