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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 816}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2025-07-14', 'studyFirstSubmitQcDate': '2025-07-14', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac rehabilitation referral', 'timeFrame': 'From hospital admission to 30 days after discharge', 'description': 'Proportion of eligible Veterans referred to cardiac rehabilitation.'}], 'secondaryOutcomes': [{'measure': 'Cardiac rehabilitation initiation', 'timeFrame': 'Within 6 months of hospital discharge', 'description': 'Proportion of eligible Veterans attending at least one cardiac rehabilitation session.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac Rehabilitation', 'Hybrid Effectiveness-Implementation Trial'], 'conditions': ['Cardiovascular Disease', 'Cardiac Rehabilitation']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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).\n\nExclusion Criteria:\n\n* No exclusion criteria during the intervention period\n\n * 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.'}, 'identificationModule': {'nctId': 'NCT07079358', 'briefTitle': 'Improving Veteran Referral to Cardiac Rehabilitation', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Improving Veteran Referral to Cardiac Rehabilitation: A Hybrid Effectiveness-Implementation Trial', 'orgStudyIdInfo': {'id': 'IIR 23-171'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Veterans Cardiac Rehabilitation Referral Program', 'description': '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.', 'interventionNames': ['Behavioral: Veterans Cardiac Rehabilitation Referral Program']}], 'interventions': [{'name': 'Veterans Cardiac Rehabilitation Referral Program', 'type': 'BEHAVIORAL', 'description': '1. A CDS tool that identifies Veterans hospitalized with CR-eligible conditions and prompts physicians to refer them to CR.\n2. Educational materials that explain to Veterans the benefits and importance of participating in CR.\n3. Defined responsibilities for a facility-based CR referral coordinator who will support development and oversight of the referral process.', 'armGroupLabels': ['Veterans Cardiac Rehabilitation Referral Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32608-1135', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'contacts': [{'name': 'David Winchester, MD', 'role': 'CONTACT', 'email': 'David.Winchester@va.gov', 'phone': '352-376-1611'}], 'facility': 'North Florida/South Georgia Veterans Health System, Gainesville, FL', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '37212-2637', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'contacts': [{'name': 'Justin M Bachmann, MD MPH', 'role': 'CONTACT', 'email': 'justin.bachmann2@va.gov', 'phone': '615-327-4751'}, {'name': 'Ray Stokes Peebles, MD', 'role': 'CONTACT', 'email': 'Ray.Peebles@va.gov', 'phone': '(615) 327-4751'}, {'name': 'Justin M Bachmann, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tennessee Valley Healthcare System Nashville Campus, Nashville, TN', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75216-7167', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Katherine Michelis, MD', 'role': 'CONTACT', 'email': 'Katherine.Michelis@va.gov', 'phone': '214-742-8387'}], 'facility': 'VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'centralContacts': [{'name': 'Justin M Bachmann, MD MPH', 'role': 'CONTACT', 'email': 'justin.bachmann2@va.gov', 'phone': '(615) 327-4751'}, {'name': 'Ray Stokes Peebles, MD', 'role': 'CONTACT', 'email': 'Ray.Peebles@va.gov', 'phone': '(615) 327-4751'}], 'overallOfficials': [{'name': 'Justin M Bachmann, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tennessee Valley Healthcare System Nashville Campus, Nashville, TN'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}