Design of a dual randomized trial in a type 2 hybrid effectiveness-implementation study.
June Stevens, Sarah Denton Mills, Mary-Louise Millett, Feng-Chang Lin, Jennifer Leeman
Author Information
June Stevens: Departments of Nutrition and Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA. June_Stevens@unc.edu. ORCID
Sarah Denton Mills: Lineberger Comprehensive Cancer Center, Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, USA.
Mary-Louise Millett: UTHealth Houston Institute for Implementation Science, University of Texas Health Science Center at Houston, Houston, TX, 77030, USA.
Feng-Chang Lin: Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA.
Jennifer Leeman: School of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA.
BACKGROUND: Dual randomized controlled trials (DRCT) are type 2 hybrid studies that include two randomized trials: one testing implementation strategies and one testing an intervention. We argue that this study design offers efficiency by providing rigorous investigation of both implementation and intervention in one study and has potential to accelerate generation of the evidence needed to translate interventions that work into real-world practice. Nevertheless, studies using this design are rare in the literature. MAIN TEXT: We construct a paradigm that breaks down the components of the DRCT and provide a step-by-step explanation of features of the design and recommendations for use. A clear distinction is made between the dual strands that test the implementation versus the intervention, and a minimum of three randomized arms is advocated. We suggest an active treatment arm that includes both the implementation strategy and intervention that are hypothesized to be superior. We suggest two comparison/control arms: one to test the implementation strategy and the second to test the intervention. Further, we recommend selection criteria for the two control arms that place emphasis on maximizing the utility of the study design to advance public health practice. CONCLUSIONS: On the surface, the design of a DRCT can appear simple, but actual application is complex. We believe it is that complexity that has limited its use in the literature. We hope that this paper will give both implementation scientists and trialists who are not familiar with implementation science a better understanding of the DRCT design and encouragement to use it.
