We seek renewal for a Core Clinical Center for the Cardiothoracic Surgical Trials Network (CTSN) and Clinical Research Skills Development Program (CRSDP). During the nearly 50-year history of cardiac surgery, 30+ years were dominated by coronary artery bypass grafting (CABG). Percutaneous coronary intervention then replaced CABG as initial treatment of coronary disease;now percutaneous valve procedures threaten the specialty once again. To redefine itself, secure evidence of efficacy and safety of new therapies must replace both reaction and enthusiasm. Yet there are both local and inherent obstacles to patient recruitment for surgical trials. A Network of high-volume Clinical Centers, performing good (important, feasible) proof-of-concept trials and observational registries, is needed. Cleveland Clinic, North America's highest-volume, highest-ranked heart program, has the desire, capacity, and capability to participate fully in CTSN as a Core Clinical Center.
Our aims are to develop and implement innovative approaches for patient identification, recruitment, and retention for challenging cardiothoracic surgical studies within the context of 1) our site and 2) a Network of clinical centers, Data Coordinating Center, and NHLBI. We then apply innovative approaches for patient identification, recruitment, and retention to three Mock Studies. Innovative approaches are data-driven, based on a 1000-patient panel convened in May 2012 to tell us what influenced them to volunteer, or refuse to volunteer, or want to volunteer for clinical trials. Four themes emerged: 1) their personal physician introduced them to the study and they were recruited by Clinic physicians, 2) they wanted to contribute to new knowledge, 3) they wanted full information they could understand, and 4) they wanted incentives. To address these themes, we assembled an extensive leadership team based on Protocol Heart Teams and Brain Teams, coupled with several support Boards. We propose extensive web-based Marketing and Information Technology tools to identify potential research subjects, a novel integration of clinical and trials workflow for recruiting patients by Protocol Heart Teams, and emerging technology for retaining and following patients.

Public Health Relevance

The specialty of cardiothoracic surgery needs redirection, with innovation coupled with rigorous multi-center testing of new therapies to be certain of their value. However, identifying, recruiting, retaining, and following patients in surgical trials that could be game-changing and dramatically lower cost of care while improving outcome is fraught with barriers. We propose novel solutions~web-based, technology-based, and clinical workflow-based--to overcome these based on findings of a lOOD-patient panel.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Research Project with Complex Structure Cooperative Agreement (UM1)
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Special Emphasis Panel (ZHL1-CSR-H (F1))
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Miller, Marissa A
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Cleveland Clinic Lerner
Schools of Medicine
United States
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