Lessons learned from two randomized controlled trials: CITIES and STOP-DKD.
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2020-09
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Abstract
Background
Even well-designed, theoretically driven clinical trials can fall short of achieving the desired clinical outcomes. Our research team had an opportunity to conduct two randomized controlled trials that were enrolling patients in parallel. While both studies were targeting chronic disease management among patients with multiple comorbid conditions, the patient population and settings varied. The studies were the Cardiovascular Intervention Improvement Telemedicine Study (CITIES) and Simultaneous Risk Factor Control Using Telehealth to slow Progression of Diabetic Kidney Disease (STOP-DKD) studies. Both studies had null findings.Objectives
Our goal is to discuss common design considerations across CITIES and STOP-DKD and potential implications for the design of future randomized controlled trials.Methods
These were two 1:1 randomized controlled trials with attention control groups that recruited patients from various clinical practices in the Research Triangle area of North Carolina.Conclusions
We make three recommendations for future studies. First, we assert that it is important to allow for piloting the enrollment process to ensure that it is possible to identify and recruit a patient population that is well aligned with the clinical outcomes of the intervention. Second, analysis plans should be more targeted in their approach and should consider heterogeneity of treatment effects. Third, in order to support the transition of evidence generated from randomized controlled trials into clinical practice, it is important to consider even early stage randomized controlled trials through an implementation science lens.Trial registration
Simultaneous Risk Factor Control Using Telehealth to slow Progression of Diabetic Kidney Disease (STOP-DKD) NCT01829256; Cardiovascular Intervention Improvement Telemedicine Study NCT01142908.Type
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Zullig, Leah L, Megan M Oakes, Felicia McCant and Hayden B Bosworth (2020). Lessons learned from two randomized controlled trials: CITIES and STOP-DKD. Contemporary clinical trials communications, 19. p. 100612. 10.1016/j.conctc.2020.100612 Retrieved from https://hdl.handle.net/10161/29651.
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Leah L Zullig
Leah L. Zullig, PhD, MPH is a health services researcher and implementation scientist whose work focuses on accelerating the adoption of evidence-based practices to improve healthcare delivery and population health. She is a Professor in the Duke University Department of Population Health Sciences and an investigator with the Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT) at the Durham Veterans Affairs Health Care System.
Dr. Zullig is a recognized leader in implementation science. She directs INTERACT, the Implementation Science Research Collaborative, which fosters interdisciplinary collaborations across Duke University and with external partners to accelerate the translation of research into practice. She also leads the Dissemination and Implementation Catalyst within Duke's Clinical and Translational Science Award (CTSA) program and serves as Co-Leader of the Duke Cancer Institute's Cancer Prevention and Control Research Program.
Dr. Zullig's research spans three interconnected areas: improving the quality and delivery of cancer care; advancing cancer survivorship and chronic disease management; and enhancing medication adherence. Across these domains, she applies implementation science methods to develop, evaluate, and scale evidence-based interventions that promote equitable, high-quality care across diverse healthcare settings. Her research is characterized by strong partnerships with healthcare systems, ensuring that findings extend beyond publication to inform clinical practice, health system transformation, and policy.
Dr. Zullig has authored more than 200 peer-reviewed publications and has established a national reputation for leading pragmatic, health system-embedded research that improves patient outcomes and advances the science of implementation.
Dr. Zullig earned her Bachelor of Science in Health Promotion, Master of Public Health in Public Health Administration, and PhD in Health Policy.
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
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