Design of a dual randomized trial in a type 2 hybrid effectiveness—implementation study
Abstract 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 implementati...
Saved in:
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2023-11-01
|
| Series: | Implementation Science |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13012-023-01317-9 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832594554788773888 |
|---|---|
| author | June Stevens Sarah Denton Mills Mary-Louise Millett Feng-Chang Lin Jennifer Leeman |
| author_facet | June Stevens Sarah Denton Mills Mary-Louise Millett Feng-Chang Lin Jennifer Leeman |
| author_sort | June Stevens |
| collection | DOAJ |
| description | Abstract 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. |
| format | Article |
| id | doaj-art-7db9492a10a44e199fce93f02f50ec69 |
| institution | Kabale University |
| issn | 1748-5908 |
| language | English |
| publishDate | 2023-11-01 |
| publisher | BMC |
| record_format | Article |
| series | Implementation Science |
| spelling | doaj-art-7db9492a10a44e199fce93f02f50ec692025-01-19T12:33:37ZengBMCImplementation Science1748-59082023-11-0118111010.1186/s13012-023-01317-9Design of a dual randomized trial in a type 2 hybrid effectiveness—implementation studyJune Stevens0Sarah Denton Mills1Mary-Louise Millett2Feng-Chang Lin3Jennifer Leeman4Departments of Nutrition and Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel HillLineberger Comprehensive Cancer Center, Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel HillUTHealth Houston Institute for Implementation Science, University of Texas Health Science Center at HoustonDepartment of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel HillSchool of Nursing, University of North Carolina at Chapel HillAbstract 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.https://doi.org/10.1186/s13012-023-01317-9Randomized trialMethodsImplementation science |
| spellingShingle | June Stevens Sarah Denton Mills Mary-Louise Millett Feng-Chang Lin Jennifer Leeman Design of a dual randomized trial in a type 2 hybrid effectiveness—implementation study Implementation Science Randomized trial Methods Implementation science |
| title | Design of a dual randomized trial in a type 2 hybrid effectiveness—implementation study |
| title_full | Design of a dual randomized trial in a type 2 hybrid effectiveness—implementation study |
| title_fullStr | Design of a dual randomized trial in a type 2 hybrid effectiveness—implementation study |
| title_full_unstemmed | Design of a dual randomized trial in a type 2 hybrid effectiveness—implementation study |
| title_short | Design of a dual randomized trial in a type 2 hybrid effectiveness—implementation study |
| title_sort | design of a dual randomized trial in a type 2 hybrid effectiveness implementation study |
| topic | Randomized trial Methods Implementation science |
| url | https://doi.org/10.1186/s13012-023-01317-9 |
| work_keys_str_mv | AT junestevens designofadualrandomizedtrialinatype2hybrideffectivenessimplementationstudy AT sarahdentonmills designofadualrandomizedtrialinatype2hybrideffectivenessimplementationstudy AT marylouisemillett designofadualrandomizedtrialinatype2hybrideffectivenessimplementationstudy AT fengchanglin designofadualrandomizedtrialinatype2hybrideffectivenessimplementationstudy AT jenniferleeman designofadualrandomizedtrialinatype2hybrideffectivenessimplementationstudy |