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Design of a dual randomized trial in a type 2 hybrid effectiveness-implementation study
June Stevens1, Sarah Denton Mills2, Mary-Louise Millett3
1Departments 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.
Implementation Science : IS
|November 23, 2023
Summary
Dual randomized controlled trials (DRCT) offer an efficient way to rigorously test both implementation strategies and interventions simultaneously. This study provides a framework to encourage wider adoption of this powerful research design.
Area of Science:
- Health Services Research
- Implementation Science
- Clinical Trial Design
Background:
- Dual randomized controlled trials (DRCT) are type 2 hybrid studies combining two randomized trials.
- One trial focuses on implementation strategies, while the other tests an intervention.
- DRCTs can accelerate evidence generation for real-world practice but are rarely used.
Purpose of the Study:
- To provide a clear paradigm and step-by-step explanation of the DRCT design.
- To offer recommendations for the effective use of DRCTs.
- To encourage broader adoption of DRCTs in research.
Main Methods:
- A conceptual framework is presented, breaking down DRCT components.
- Recommendations include a minimum of three randomized arms.
- Specific guidance is provided for selecting comparison/control arms to maximize utility.
Main Results:
- The paper distinguishes between the implementation and intervention testing strands.
- An active treatment arm with both strategy and intervention is advocated.
- Two distinct control arms are proposed: one for the implementation strategy and one for the intervention.
Conclusions:
- The complexity of DRCTs has limited their use.
- This paper aims to demystify DRCTs for implementation scientists and trialists.
- The authors encourage greater utilization of the DRCT design.
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