Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT07079358
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-23
First Post:
2025-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Veteran Referral to Cardiac Rehabilitation
Sponsor:
VA Office of Research and Development
Organization:
Study Overview
Official Title:
Improving Veteran Referral to Cardiac Rehabilitation: A Hybrid Effectiveness-Implementation Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: