- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07079358
- Original Trial
Improving Veteran Referral to Cardiac Rehabilitation
June 15, 2026 updated by: VA Office of Research and Development
Improving Veteran Referral to Cardiac Rehabilitation: A Hybrid Effectiveness-Implementation Trial
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
816
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Justin M Bachmann, MD MPH
- Phone Number: (615) 327-4751
- Email: justin.bachmann2@va.gov
Study Contact Backup
- Name: Ray Stokes Peebles, MD
- Phone Number: (615) 327-4751
- Email: Ray.Peebles@va.gov
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32608-1135
- Recruiting
- North Florida/South Georgia Veterans Health System, Gainesville, FL
-
Contact:
- David E Winchester, MD MS BS
- Phone Number: 7563 352-548-6000
- Email: David.Winchester@va.gov
-
Sub-Investigator:
- David E Winchester, MD MS BS
-
-
Tennessee
-
Nashville, Tennessee, United States, 37212-2637
- Recruiting
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
-
Contact:
- Justin M Bachmann, MD MPH
- Phone Number: 615-327-4751
- Email: justin.bachmann2@va.gov
-
Principal Investigator:
- Justin M Bachmann, MD MPH
-
Contact:
- Ray Stokes Peebles, MD
- Phone Number: (615) 327-4751
- Email: Ray.Peebles@va.gov
-
-
Texas
-
Dallas, Texas, United States, 75216-7167
- Recruiting
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
-
Contact:
- Katherine C Michelis
- Phone Number: 214-857-1472
- Email: katherine.michelis@va.gov
-
Sub-Investigator:
- Katherine C Michelis
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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:
No exclusion criteria during the intervention period
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiac rehabilitation referral
Time Frame: From hospital admission to 30 days after discharge
|
Proportion of eligible Veterans referred to cardiac rehabilitation.
|
From hospital admission to 30 days after discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiac rehabilitation initiation
Time Frame: Within 6 months of hospital discharge
|
Proportion of eligible Veterans attending at least one cardiac rehabilitation session.
|
Within 6 months of hospital discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Justin M Bachmann, MD MPH, Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 23, 2026
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
December 31, 2029
Study Registration Dates
First Submitted
July 14, 2025
First Submitted That Met QC Criteria
July 14, 2025
First Posted (Actual)
July 23, 2025
Study Record Updates
Last Update Posted (Actual)
June 17, 2026
Last Update Submitted That Met QC Criteria
June 15, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 23-171
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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