RAndomized Cluster Evaluation of Cardiac ARrest Systems (RACE-CARS) trial: Study rationale and design.
Date
2024-07
Journal Title
Journal ISSN
Volume Title
Repository Usage Stats
views
downloads
Citation Stats
Attention Stats
Abstract
Out-of-hospital cardiac arrest (OHCA) occurs in nearly 350,000 people each year in the United States (US). Despite advances in pre and in-hospital care, OHCA survival remains low and is highly variable across systems and regions. The critical barrier to improving cardiac arrest outcomes is not a lack of knowledge about effective interventions, but rather the widespread lack of systems of care to deliver interventions known to be successful. The RAndomized Cluster Evaluation of Cardiac ARrest Systems (RACE-CARS) trial is a 7-year pragmatic, cluster-randomized trial of 62 counties (57 clusters) in North Carolina using an established registry and is testing whether implementation of a customized set of strategically targeted community-based interventions improves survival to hospital discharge with good neurologic function in OHCA relative to control/standard care. The multifaceted intervention comprises rapid cardiac arrest recognition and systematic bystander CPR instructions by 9-1-1 telecommunicators, comprehensive community CPR training and enhanced early automated external defibrillator (AED) use prior to emergency medical systems (EMS) arrival. Approximately 20,000 patients are expected to be enrolled in the RACE CARS Trial over 4 years of the assessment period. The primary endpoint is survival to hospital discharge with good neurologic outcome defined as a cerebral performance category (CPC) of 1 or 2. Secondary outcomes include the rate of bystander CPR, defibrillation prior to arrival of EMS, and quality of life. We aim to identify successful community- and systems-based strategies to improve outcomes of OHCA using a cluster randomized-controlled trial design that aims to provide a high level of evidence for future application.
Type
Department
Description
Provenance
Subjects
Citation
Permalink
Published Version (Please cite this version)
Publication Info
Krychtiuk, Konstantin A, Monique A Starks, Hussein R Al-Khalidi, Daniel B Mark, Lisa Monk, Eric Yow, Lisa Kaltenbach, James G Jollis, et al. (2024). RAndomized Cluster Evaluation of Cardiac ARrest Systems (RACE-CARS) trial: Study rationale and design. American heart journal, 277. pp. 125–137. 10.1016/j.ahj.2024.07.013 Retrieved from https://hdl.handle.net/10161/31464.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
Collections
Scholars@Duke
Monique Anderson Starks
Hussein Rashid Al-Khalidi
My research interest includes design and analysis of cardiovascular clinical trials, medical devices, survival analysis, group-sequential analysis, time-to-recurrent or multiple events, continuous-time Markov models, stochastic process, linear model, dose-response modeling, design of experiments and adaptive designs.
Daniel Benjamin Mark
Dr. Mark is a clinical cardiologist with the rank of Professor of Medicine (with tenure) as well as Vice Chief for Academic Affairs in the Division of Cardiology, Department of Medicine at Duke University Medical Center. He is also the Director of Outcomes Research at the Duke Clinical Research Institute. He has been on the full-time faculty at Duke since 1985. Prior to that he completed his cardiology fellowship at Duke, his residency and internship at the University of Virginia Hospital, and received his medical degree from Tufts University and his Master’s degree from Harvard. In 1998, he was given the honor of being elected to the American Society for Clinical Investigators and in 2002 he was honored by election to the Association of American Physicians. These organizations are the two most prestigious honor societies in academic medicine. In 2009, Dr. Mark was awarded the American College of Cardiology Distinguished Scientist Award.
Dr. Mark's major research interests include medical economics and quality of life outcomes, outcomes research, and quality of medical care. Currently, Dr. Mark is directing a number of outcomes analyses for ongoing clinical trials including PROMISE (anatomic versus functional testing for coronary artery disease, NIH), CABANA (catheter ablation versus antiarrhythmic drug therapy for atrial fibrillation, NIH), ISCHEMIA (percutaneous coronary intervention versus optimal medical therapy for moderate-severe ischemia), and STICH (CABG +/- ventricular reconstruction versus medical therapy for ischemic heart disease, NIH). He was the principal author of the AHCPR Unstable Angina Guidelines and is a co-author of both the American College of Cardiology Guideline on Exercise Testing and their Coronary Stent Consensus Guideline. He is also the Editor of the American Heart Journal. Dr. Mark has published over 270 peer-reviewed articles, two books, and 80 book chapters. He lectures widely in the US, as well as in Canada, South America, and Europe.
Keywords: cost-effectiveness analysis, disease management, quality of life assessment, resource use.
Sana Mustapha Al-Khatib
Dr. Sana M. Al-Khatib is a tenured Professor of Medicine at Duke University Medical Center, a board-certified clinical electrophysiologist and an experienced clinical researcher in cardiac arrhythmias. She is currently the Director of the Fellowship Program at the Duke Clinical Research Institute. As a graduate of the NIH-funded Clinical Research Training Program, she is one of a few electrophysiologists nationwide with expertise in quantitative research methods. Her clinical expertise is in sudden cardiac death prevention, atrial fibrillation and ventricular arrhythmias, and implantable cardiac devices. Her research expertise lies in the design and conduct of clinical trials, outcomes research, and cost-effectiveness analyses. She is a recipient of a National Heart, Lung and Blood Institute’s R-01 grant titled “Implantable Cardioverter Defibrillator Therapy in Patients with Heart Failure” (2009-2013) and of an American Heart Association Career Development Award (2002-2006). She is a Co-Principal Investigator on an NHLBI-funded T-32 Postdoctoral Training in Cardiovascular Clinical Research and is a co-investigator on several NIH-funded projects. She has more than 350 publications in peer-reviewed journals. She has established several collaborative research efforts both within and outside her institution. The goals of these collaborations are to synergize efforts aimed at improving the survival and quality of life of patients at risk for sudden cardiac death and those with atrial and ventricular arrhythmias through clinical trials and outcomes-based research and to evaluate study design and data analysis in order to improve the quality of research done in these arenas. Dr. Al-Khatib is a Senior Associate Editor for Circulation and is on the Editorial Board for Circulation: Arrhythmia and Electrophysiology, Heart Rhythm, Journal of Cardiovascular Electrophysiology, JACC:EP, the Cardiovascular Digital Health Journal, and the American Heart Journal. Dr. Al-Khatib has served on multiple national committees including the Heart Rhythm Society Board of Trustees (current), the Heart Rhythm Society Finance Committee (current), the Heart Rhythm Society Audit Committee (current), the Heart Rhythm Society Health Policy committee (past), the Heart Rhythm Society Legislative subcommittee (past), and the Heart Rhythm Society Program Planning committee (past). She chaired the 2017 AHA/ACC/HRS Guideline for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.
Hayden Barry Bosworth
Dr. Bosworth is a health services researcher and Deputy Director of the Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT) at the Durham VA Medical Center. He is also Vice Chair of Education and Professor of Population Health Sciences. He is also a Professor of Medicine, Psychiatry, and Nursing at Duke University Medical Center and Adjunct Professor in Health Policy and Administration at the School of Public Health at the University of North Carolina at Chapel Hill. His research interests comprise three overarching areas of research: 1) clinical research that provides knowledge for improving patients’ treatment adherence and self-management in chronic care; 2) translation research to improve access to quality of care; and 3) eliminate health care disparities.
Dr. Bosworth is the recipient of an American Heart Association established investigator award, the 2013 VA Undersecretary Award for Outstanding Achievement in Health Services Research (The annual award is the highest honor for VA health services researchers), and a VA Senior Career Scientist Award. In terms of self-management, Dr. Bosworth has expertise developing interventions to improve health behaviors related to hypertension, coronary artery disease, and depression, and has been developing and implementing tailored patient interventions to reduce the burden of other chronic diseases. These trials focus on motivating individuals to initiate health behaviors and sustaining them long term and use members of the healthcare team, particularly pharmacists and nurses. He has been the Principal Investigator of over 30 trials resulting in over 400 peer reviewed publications and four books. This work has been or is being implemented in multiple arenas including Medicaid of North Carolina, private payers, The United Kingdom National Health System Direct, Kaiser Health care system, and the Veterans Affairs.
Areas of Expertise: Health Behavior, Health Services Research, Implementation Science, Health Measurement, and Health Policy
Audrey L Blewer
Dr. Blewer is an epidemiologist and resuscitation scientist who has focused her areas of inquiry within the domains of resuscitation science, epidemiology, implementation science, and health disparities. She is an Assistant Professor in the Department of Family Medicine and Community Health, Department of Population Health Sciences, and School of Nursing. She also has a joint appointment at Duke-NUS Medical School in the Department of Health Services and Systems Research.
Dr. Blewer has published in several noteworthy journals such as Circulation, Lancet Public Health, Circulation Cardiovascular Quality and Outcomes, and Critical Care Medicine. She is recognized in the field of resuscitation science nationally and internationally. Dr. Blewer is contributing to the upcoming American Heart Association Guidelines writing group for Resuscitation Education and serves on the Editorial Board for the journal Resuscitation Plus. Dr. Blewer works on interdisciplinary research projects at both Duke and Duke-NUS Medical Center
Allison A. Lewinski
As a nurse scientist and health services researcher, with a joint appointment between the Duke University School of Nursing (DUSON) and the Durham Veterans Affairs Health Care System (VHA), I have acquired expertise in the areas of diabetes distress, qualitative research methods, and virtual care (e.g., telehealth, digital health) as a method of care delivery. My research focuses on the current and potential ability of virtual care interventions to reduce distress, improve self-management, increase access to evidence-based care delivery, and improve patient and population health outcomes. My collaborative and interdisciplinary research focuses on how patient-, provider-, and system-level factors influence virtual care use and outcomes. As evidence of its growing significance and impact at DUSON and the VHA, my work has been well funded, published in high-impact journals, presented at select conferences, and used to guide health system decision-making. I am a sought-after teacher and mentor because I connect my research interests to teaching students and mentees rigorous and systematic research approaches. I am frequently asked by local and national colleagues to provide guidance on distress, qualitative research methods, and virtual care approaches used in grants, projects, and manuscripts.
My research contributions have focused on alleviating psychosocial distress, developing and implementing multi-level virtual care interventions, and enhancing qualitative methods. As a staff nurse, I witnessed the psychosocial distress of patients who experience challenges in obtaining care which led to my interest in diabetes distress. I aspire and work to improve health outcomes for individuals with chronic illness by developing equitable and sustainable multi-level virtual care interventions and assessing their implementation and adaptation. Virtual care describes any remote interaction between a patient and/or members of their care team. To achieve these goals, I use qualitative methods and implementation science approaches to enhance alignment between patient, modality, disease state, and social and environmental context; my collective assessments address for whom and what purposes, in what situations and contexts, when in a disease course or clinical activity, and in what specific ways such interventions are effective. My focus on the uptake and adoption of virtual care to address psychosocial distress considers interactions with patients, between patients and clinicians, and within health care systems and the larger population.
Christopher Bull Granger
Research:
My primary research interest is in conduct and methodology of large randomized clinical trials in heart disease. I have led a number of large international clinical studies in heart attacks, unstable angina, heart failure, and atrial fibrillation. I have lead clinical studies of blood thinners and coronary intervention for heart attacks, stroke prevention in atrial fibrillation, and prevention of heart attack for patients with coronary artery disease. I have been co-director of the Reperfusion of Acute MI in Carolina Emergency Departments (RACE) project that is a North Carolina state-wide program to improve reperfusion care for acute myocardial infarction. I serve as the Chairman of the American Heart Association Mission: Lifeline program to improve heart attack care nationally as well as the American College of Cardiology/American Heart Association guideline committee for heart attack care. I have also studied the effects of genetic variation on heart disease. I work with the National Institute of Health and the Federal Drug Administration on evaluation of heart disease and of new drugs. I have developed tools to predict which patients are at risk for death, heart attack, and need for hospitalization.
Unless otherwise indicated, scholarly articles published by Duke faculty members are made available here with a CC-BY-NC (Creative Commons Attribution Non-Commercial) license, as enabled by the Duke Open Access Policy. If you wish to use the materials in ways not already permitted under CC-BY-NC, please consult the copyright owner. Other materials are made available here through the author’s grant of a non-exclusive license to make their work openly accessible.