Effectiveness-implementation hybrid designs: implications for quality improvement science

Presentation This article summarizes the three types of hybrid effectiveness-implementation designs and associated evaluation methods. It includes a discussion of how hybrid designs have the potential to enhance knowledge development and application of clinical interventions and implementation strategies in “real world” settings. The authors propose implications of hybrid designs for quality improvement research. Traditionally, researchers think of knowledge development and application as a uni-directional, step-wise, progression, in which different questions are addressed in isolation. First, a randomized clinical trial (RCT) is deployed to determine if an intervention implemented under controlled conditions has efficacy in specific populations. Next, “effectiveness research” methods determine if the effect remains when implemented in less controlled conditions with broader populations. Finally, “implementation research” methods, such as cluster randomized controlled trials, are deployed to understand the best methods to introduce the intervention into practice. While systematic, this unidirectional approach can take a great deal of time from the original efficacy study design to the final conclusions about implementation, and conditions may change so that original clinical and policy questions become less relevant [1]. Additionally, the unidirectional approach does not help us understand interaction effects between the intervention and the implementation strategy. Hybrid designs simultaneously evaluate the impact of interventions introduced in real world settings (e.g. “effectiveness”), and the implementation strategy. Such designs enhance the ability to identify important interventionimplementation interactions, which inform decisions about optimal deployment and generalized impact, and may accelerate the introduction of valuable innovations into practice. This has implications for quality improvement researchers, who are often guiding the deployment and evaluating the impact of interventions in healthcare settings.