Methods: Mind the Gap

Webinar Series

Deconstruction of the Type 2 Hybrid Effectiveness-Implementation Study Design that Uses Two Randomized Controlled Trials

March 20, 2024
June Stevens
June Stevens, Ph.D.

University of North Carolina 
at Chapel Hill

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About the Webinar

Implementation research addresses barriers to the successful conduct of interventions aimed at improving health. Thus, implementation scientists are often interested in examining both the success of implementation strategies and health interventions. It can be argued that the most rigorous design to accomplish that goal would employ two randomized controlled trials—one testing implementation strategies on implementation outcomes and one testing an intervention on health-related outcomes. This type of study is called a dual randomized controlled trial (DRCT). Although the utility of the DRCT design is evident, the limited literature review revealed that this design is rare in the published literature.

This webinar reviews the basic components of implementation-effectiveness studies. Dr. Stevens then constructs a paradigm that breaks down the components of the DRCT and provides a step-by-step explanation of features of the design and recommendations for use. The design includes a minimum of three randomized arms, each comprised of an active or control implementation strategy paired with an active or control intervention. Examples are shown to demonstrate the use of the paradigm in different research settings.

About June Stevens

Dr. June Stevens is an Epidemiologist at the University of North Carolina (UNC) at Chapel Hill with over 25 years of experience as the Principal Investigator (PI) of NIH-funded Coordinating Centers for multi-center trials that are community-based. Currently she is PI of the Research Coordinating Center for the Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Risk (DECIPHeR) Alliance, which includes seven centers from around the country conducting implementation studies aimed at reducing disparities in cardiovascular risk. She has generated more than $32 million dollars in national-level grant funding as PI.   

Dr. Stevens served as Chair of the Department of Nutrition at UNC during the years that the graduate program was given a No. 1 ranking by the National Research Council, along with only three other Nutrition Departments in the United States. She has chaired NIH workshops and working groups tasked with recommending clinical guidelinesShe is a recipient of the Lifetime Achievement Award from the Obesity Society and the Centrum Research Award for Senior Investigators from the American Society for Nutrition, and holds a Distinguished Professorship from the American Institute for Cancer Research. She has been an invited expert for the World Health Organization, the American Heart Association, the Centers for Disease Control and Prevention, and numerous NIH study sections. 

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