Cardiovascular DiseaseNCT07079358
Improving Veteran Referral to Cardiac Rehabilitation
A study testing Veterans Cardiac Rehabilitation Referral Program in people with Cardiovascular Disease and Cardiac Rehabilitation, run by VA Office of Research and Development at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease, Cardiac Rehabilitation
- What is being tested?
- Veterans Cardiac Rehabilitation Referral Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 816 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Feb 2026to 31 Dec 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 cardiac rehabilitation (CR) services.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216-7167
Katherine C Michelis, (214) 857-1472, katherine.michelis@va.gov
Katherine C Michelis
- Recruiting
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608-1135
David E Winchester, MD MS BS, (352) 548-6000 ext. 7563, David.Winchester@va.gov
David E Winchester, MD MS BS
- Recruiting
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, 37212-2637
Justin M Bachmann, MD MPH, (615) 327-4751, justin.bachmann2@va.gov
Talat A Ikizler, MD, (615) 873-7526, Talat.Ikizler@va.gov
About this study
Official title: 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.
Read the 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
- Being tested
- Veterans Cardiac Rehabilitation Referral Program
- Keywords
- Cardiac Rehabilitation, Hybrid Effectiveness-Implementation Trial
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veterans Cardiac Rehabilitation Referral ProgramBehavioural
- A CDS tool that identifies Veterans hospitalized with CR-eligible conditions and prompts physicians to refer them to CR.
- Educational materials that explain to Veterans the benefits and importance of participating in CR.
- Defined responsibilities for a facility-based CR referral coordinator who will support development and oversight of the referral process.
| Study group | Role | What they receive |
|---|---|---|
| Veterans Cardiac Rehabilitation Referral Program | Experimental | 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. Receives: Behavioral: Veterans Cardiac Rehabilitation Referral Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac rehabilitation referral
Proportion of eligible Veterans referred to cardiac rehabilitation.
Measured: From hospital admission to 30 days after discharge
Secondary outcomes (1)
Cardiac rehabilitation initiation
Proportion of eligible Veterans attending at least one cardiac rehabilitation session.
Measured: Within 6 months of hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start23 Feb 2026
- Primary completion1 Jul 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-arm, pre-post intervention study comparing cardiac rehabilitation referral rates 6 months before and 6 months after implementing the Veterans Cardiac Rehabilitation Referral Program (VCR2P) at three VA medical centers.
- Masking
- None (open label)
- Enrolment
- 816 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Justin M Bachmann, MD MPH, Principal investigator, Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079358
- Sponsor's protocol ID
- IIR 23-171
- Other IDs
- 1I01HX003889-01A2
- Status last verified
- Sep 2026
- First submitted
- 14 Jul 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No