Reprint of: An introduction to effectiveness-implementation hybrid designs
Open accessAbstract
The traditional research pipeline that encourages a staged approach to moving an intervention from efficacy trials to the real world can take a long time. To address this issue, hybrid effectiveness-implementation designs were codified to promote examination of both effectiveness and implementation outcomes within a study. There are three types of hybrid designs and they vary based on their primary focus and the amount of emphasis on effectiveness versus implementation outcomes. A type 1 hybrid focuses primarily on the effectiveness outcomes of an intervention while exploring the "implementability" of the intervention. A type 2 hybrid has a dual focus on effectiveness and implementation outcomes; these designs allow for the simultaneous testing or piloting of implementation strategies during an effectiveness trial. A type 3 hybrid focuses primarily on implementation outcomes while also collecting effectiveness outcomes as they relate to uptake or fidelity of the intervention. This paper provides an introduction to these designs and describes each of the three types, design considerations, and examples for each.
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In Hybrid Type 2 trial designs, there is a dual purpose to test the clinical or public health effectiveness of the intervention on clinical or public health outcomes and to test or measure the impact of the implementation strategy on implementation outcomes.
“In Hybrid Type 2 trial designs, there is a dual purpose to test: (i) the clinical or public health effectiveness of the intervention on clinical or public health outcomes (e.g. measure of disease or health behaviour) and (ii) test or measure the impact of the implementation strategy on implementation outcomes (e.g. adoption of health policy in a community setting) [53].”
From Guidance for conducting feasibility and pilot studies for implementation trials (2020) · cites this paper as [53]
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Guidance for conducting feasibility and pilot studies for implementation trials
Pearson, N., Naylor, P.-J., Ashe, M. C., Fernandez, M., Yoong, S. L., & Wolfenden, L. (2020) · Pilot and Feasibility Studies · doi:10.1186/s40814-020-00634-w · Cited by 475 · see citing works
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- Authors
- Landes, S. J., McBain, S. A., & Curran, G. M.
- Affiliations
- Central Arkansas Veterans Healthcare System (US)
- Corresponding author
- Landes, Sara J.
- Venue
- Psychiatry Research
- Publisher
- Elsevier BV
- Published
- 2020-01
- Volume
- 283
- Pages
- 112630
- ISSN
- 0165-1781 (ISSN-L)
- OpenAlex
- W2986422866
- Cited by
- 190
- References
- 13
- Citations by year
- 2026: 27 · 2025: 30 · 2024: 32 · 2023: 32 · 2022: 37 · 2021: 23 · 2020: 8 · 2017: 1
- FWCI
- 23.18
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Psychiatry Research (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Funders
- U.S. Department of Veterans Affairs
- University of Arkansas for Medical Sciences
- Georgia Clinical and Translational Science Alliance
- National Institutes of Health
- NIH Clinical Center
- Topics
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Keywords
- implementation research, implementation outcomes, implementation strategies, intervention uptake, intervention fidelity, research design
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