Implementation Research Designs

There are many types of research designs that can be used in dissemination and implementation (D&I) science, so selecting the best type of design to answer your research question is critically important. This section highlights foundational papers and trainings on the major types of designs and then provides additional resources for mixed methods approaches, stepped wedge and other rollout designs, and effectiveness–implementation hybrid designs.

Overview of Designs

An overview of research and evaluation designs for dissemination and implementation 
Brown, C. H., Curran, G., Palinkas, L. A., Aarons, G. A., Wells, K. B., Jones, L., Collins, L. M., Duan, N., Mittman, B. S., Wallace, A., Tabak, R. G., Ducharme, L., Chambers, D. A., Neta, G., Wiley, T., Landsverk, J., Cheung, K., & Cruden, G. (2017). An overview of research and evaluation designs for dissemination and implementation. Annual Review of Public Health, 38, 1–22. https://doi.org/10.1146/annurev-publhealth-031816-044215  (Paper)

For an introduction to the wide range of research designs that are used in D&I, this paper by Brown et al. (2017) is useful. It provides a comprehensive, field‑defining synthesis of research and evaluation designs in dissemination and implementation science, clarifying the strengths, limitations, and appropriate uses of various designs that have utility across the translational research continuum.

 

Variation in research designs used to test the effectiveness of dissemination and implementation strategies 
Mazzucca, S., Tabak, R. G., Pilar, M., Ramsey, A. T., Baumann, A. A., Kryzer, E., Lewis, E. M., Padek, M., Powell, B. J., & Brownson, R. C. (2018). Variation in research designs used to test the effectiveness of dissemination and implementation strategies: A review. Frontiers in Public Health, 6, Article 32. https://doi.org/10.3389/fpubh.2018.00032 (Paper)

This review by Mazzucca et al. (2018) systematically documents the diversity and evolution of research designs used to evaluate dissemination and implementation strategies, providing empirical guidance to improve methodological decision‑making in implementation science.

Mixed Methods and Qualitative Methods

Mixed method designs in implementation research 
Palinkas, L. A., Aarons, G. A., Horwitz, S. M., Chamberlain, P., Hurlburt, M., & Landsverk, J. (2011). Mixed method designs in implementation research. Administration and Policy in Mental Health and Mental Health Services Research, 38(1), 44–53. https://doi.org/10.1007/s10488-010-0314-z (Paper)

Palinkas et al. (2011) provides one of the earliest and most influential empirical frameworks for mixed methods designs in implementation research, demonstrating how integrating qualitative and quantitative approaches strengthens understanding of implementation processes, context, and mechanisms beyond what single‑method studies can achieve.

 

Mixed Methods in Implementation Science (Video; 57 minutes)
Dr. Lawrence Palinkas from the University of Southern California provides an overview of mixed methods designs in D&I science, which combines qualitative data with quantitative data to provide a deeper understanding of the implementation process. This webinar describes experiences with using mixed methods in different types of service systems. Dr. Palinkas’s presentation begins at the 3:00 minute mark.

 

Approaches to mixed methods dissemination and implementation research 
Green, C. A., Duan, N., Gibbons, R. D., Hoagwood, K. E., Palinkas, L. A., & Wisdom, J. P. (2015). Approaches to mixed methods dissemination and implementation research: Methods, strengths, caveats, and opportunities. Administration and Policy in Mental Health and Mental Health Services Research, 42(5), 508–523. https://doi.org/10.1007/s10488-014-0552-6 (Paper)

This paper by Green et al. (2015) synthesizes approaches to mixed methods D&I research, offering practical guidance on integrating qualitative and quantitative methods, clarifying their strengths and caveats, and identifying opportunities to advance theory‑driven and contextually informed implementation studies.

 

Fireside Chat on Qualitative Methods in Implementation Science (Video; 60 minutes)
In this webinar from NCI’s Advanced, this is a panel discussion of how qualitative methods can be effectively integrated into implementation research and addresses some of the key questions that have arisen about use of qualitative methods in D&I. After speaker introductions, the panel discussion begins around the 11:30 minute mark.

Stepped Wedge and Other Rollout Designs

The stepped wedge cluster randomised trial 
Hemming, K., Haines, T. P., Chilton, P. J., Girling, A. J., & Lilford, R. J. (2015). The stepped wedge cluster randomised trial. BMJ, 350, h391. https://doi.org/10.1136/bmj.h391 (Paper)

Hemming et al. (2015) provides the foundational methodological guidance for stepped wedge cluster randomized trials, clearly articulating their rationale, design features, analytic considerations, and reporting standards, which has enabled rigorous evaluation of implementation and policy interventions when traditional randomized designs are impractical.

 

Rollout trial designs in implementation research are often necessary and sometimes preferred 
Simon, G. E., Garner, B. R., Smith, J. D., Wyman, P. A., Matson, T. E., Chin-Purcell, L., Cero, I., Vermeer, W., Johnson, K. A., Prado, G., & Brown, C. H. (2025). Rollout trial designs in implementation research are often necessary and sometimes preferred. Implementation Science, 20, Article 11. https://doi.org/10.1186/s13012-025-01422-x (Paper)

This article by Simon et al. (2025) articulates the ethical, scientific, and practical rationales for using rollout trial designs—including stepped wedge designs—in implementation research, clarifying when such designs are not merely second-best alternatives but are often necessary or even preferred for evaluating real‑world implementation and policy interventions.

 

What scientific inferences can be made with randomized implementation rollout trials 
Brown, C. H., Smith, J. D., Haegerich, T., Simon, G., Cero, I., Aarons, G. A., Prado, G., Wyman, P., Kane, J., Robinson, D., Walunas, T. L., Zimmerman, L., Vermeer, W., Chin‑Purcell, L., McNulty, M., Christopoulos, K. A., Garner, B., & McGovern, M. (2026). What scientific inferences can be made with randomized implementation rollout trials. Implementation Science, 21, Article 7. https://doi.org/10.1186/s13012-025-01465-0 (Paper)

This article by Brown et al. (2026) provides a comprehensive conceptual and methodological framework for randomized implementation rollout trials (of which stepped wedge trials are one variant), clarifying what causal and comparative scientific inferences can be drawn from stepped wedge and related rollout designs and offering practical guidance on selecting designs, assignment strategies, and analytic approaches. The Supplementary Information files provide R code to assist statisticians in designing these types of trials.

Hybrid Effectiveness-Implementation Designs

Hybrid Studies: 10-year Update (Video; 47 minutes)
Hybrid designs offer opportunities to study both implementation outcomes and effectiveness outcomes, and there are different types of hybrid designs based on the relative importance placed on those implementation and effectiveness outcomes. Dr. Smith’s presentation begins around the 6:30 minute mark.

 

Effectiveness–implementation hybrid designs
Curran, G. M., Bauer, M., Mittman, B., Pyne, J. M., & Stetler, C. (2012). Effectiveness–implementation hybrid designs: Combining elements of clinical effectiveness and implementation research to enhance public health impact. Medical Care, 50(3), 217–226. https://doi.org/10.1097/MLR.0b013e3182408812  (Paper)

This seminar paper by Curran et al. (2012) it introduced the effectiveness–implementation hybrid design framework, providing a practical typology that allows researchers to simultaneously evaluate clinical effectiveness and implementation processes, thereby accelerating the translation of evidence-based interventions into real-world practice.

 

An introduction to effectiveness–implementation hybrid designs 
Landes, S. J., McBain, S. A., & Curran, G. M. (2019). An introduction to effectiveness–implementation hybrid designs. Psychiatry Research, 280, 112513. https://doi.org/10.1016/j.psychres.2019.112513 (Paper)

In this more recent paper, Landes et al. (2019) clarify and operationalize effectiveness–implementation hybrid designs by providing a concise conceptual overview and practical guidance for selecting Hybrid Types 1–3, helping researchers more deliberately integrate effectiveness and implementation questions within a single study.