Referral Program for Cardiac Rehabilitation

Not yet recruiting at 2 trial locations

Overseen By Ray Stokes Peebles, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Death, Cognitive impairment, Arrhythmias, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 30

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program to determine if it can increase the number of Veterans attending cardiac rehab after hospital discharge. It compares the number of Veterans referred to rehab before and after the program's implementation. The goal is to assess whether the program results in more Veterans attending these crucial rehab sessions. Veterans who recently experienced heart issues, such as a heart attack or major heart surgery, in Nashville, Dallas, or Gainesville may qualify for this trial. As an unphased trial, it offers Veterans the opportunity to contribute to enhancing cardiac rehab access and support for others.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Veterans Cardiac Rehabilitation Referral Program is safe?

Research has shown that cardiac rehabilitation (CR) programs, such as the Veterans Cardiac Rehabilitation Referral Program (VCR2P), are generally safe for participants. One study found that home-based cardiac rehabilitation, similar to the VCR2P, reduced the risk of death by 36% among eligible patients. These programs not only improve health but are also well-tolerated.

Another study found no increased risk of long-term health problems for those participating in remotely delivered cardiac rehabilitation. This type of program can be done at home, making it accessible and safe for many people. These findings, based on similar programs, provide a good indication of the safety of the VCR2P.

In summary, evidence suggests that the Veterans Cardiac Rehabilitation Referral Program is likely safe and well-tolerated, based on similar cardiac rehabilitation programs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Veterans Cardiac Rehabilitation Referral Program because it aims to improve access to cardiac rehabilitation for veterans, a group that often faces unique barriers to healthcare. Unlike standard cardiac rehabilitation, which can be difficult for veterans to access due to logistical and systemic challenges, this program directly addresses these obstacles by providing a tailored referral process. The hope is that by streamlining how veterans are referred to cardiac rehabilitation, more will participate and benefit from these critical recovery and health-improving programs. This approach could lead to better health outcomes and quality of life for veterans recovering from cardiac events.

What evidence suggests that the Veterans Cardiac Rehabilitation Referral Program is effective for increasing cardiac rehabilitation participation?

Research shows that cardiac rehab improves patient health. Studies find that people who join these programs after heart surgeries or heart failure have healthier hearts and live longer. The Veterans Cardiac Rehabilitation Referral Program, provided to participants in this trial, aims to increase rehab participation, which is linked to fewer heart problems later. Additionally, exercise-based rehab helps with heart issues like ischemic cardiomyopathy, a type of heart disease. Overall, evidence supports that more referrals to cardiac rehab can help veterans improve their heart health. ^{4 6 7 8 9}

Who Is on the Research Team?

Justin M Bachmann, MD MPH

Principal Investigator

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Are You a Good Fit for This Trial?

This trial is for Veterans with cardiovascular disease who are being treated at VA medical centers in Nashville, Dallas, and Gainesville. It aims to improve their participation in cardiac rehabilitation programs.

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

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the Veterans Cardiac Rehabilitation Referral Program (VCR2P) to improve referral and participation rates

6 months

Ongoing monitoring and data collection

Follow-up

Participants are monitored for cardiac rehabilitation initiation and participation

6 months

Data collection at 30 days and 6 months post-discharge

What Are the Treatments Tested in This Trial?

Interventions

• Veterans Cardiac Rehabilitation Referral Program

Trial Overview The study tests the Veterans Cardiac Rehabilitation Referral Program (VCR2P) by comparing referral rates before and after its implementation over a period of 12 months across three VA medical centers.

How Is the Trial Designed?

Group I: Veterans Cardiac Rehabilitation Referral Program Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6404876/

Cardiac Rehabilitation Participation and Mortality After ... Heart failure, N (%), 7990 (18), 472 (16), 7518 (19), <0.001. Cerebrovascular disease, N (%), 5586 (13), 357 (12), 5229 (13), 0.11. Peripheral vascular disease, ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.116.003364

Referral to Cardiac Rehabilitation After Percutaneous ... Exercise-based rehabilitation for heart failure. Cochrane Database ... Exercise prescriptions for ischemic cardiomyopathy: a scoping review, Heart ...

3. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2669905

Veterans Health Administration Programs and Cardiac ... Hypertension, 1.16 (1.08-1.25), <.001 ; Hyperlipidemia, 1.58 (1.48-1.69), <.001 ; Heart failure, 0.82 (0.78-0.87), <.001 ; Valvular heart disease ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07079358

Improving Veteran Referral to Cardiac Rehabilitation There are three types of expanded access: Individual Patients: Allows a single patient, with a serious disease or condition who cannot ...

5. hsrd.research.va.gov hsrd.research.va.gov/research/citations/pubbriefs/articles.cfm?RecordID=914

Veterans with Heart Disease More Likely to Participate in ... Patient Outcomes for Multi-faceted Intervention for Veterans with Heart Failure Comparable to Usual Care ... Heart Attack and Coronary Death (11/01/2010) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10964460/

Safety and long-term outcomes of remote cardiac ... To systematically review the safety and the long-term mortality and morbidity risk-rates of the remotely-delivered cardiac rehabilitation (RDCR) ...

7. hsrd.research.va.gov hsrd.research.va.gov/research/citations/pubbriefs/articles.cfm?RecordID=675

Under-utilization of Cardiac Rehabilitation for Veterans ... Using VA data, investigators identified 47,051 Veterans who had been hospitalized in the VA healthcare system for MI, PCI, or CABG during FY07 through FY11. To ...

8. ahajournals.org ahajournals.org/doi/10.1161/JAHA.122.025856

Association of Home‐Based Cardiac Rehabilitation With ... Among patients eligible for CR, participation in HBCR was associated with 36% lower hazard of mortality.

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1071916417300362

Participation in Cardiac Rehabilitation Among Patients ... During the 5-year period, 66,710 veterans were hospitalized for HF. Only 1554 (2.3%) attended ≥1 session of outpatient CR. Among Medicare beneficiaries, 243,208 ...