Beyond RCTs: Innovations in research design and methods to advance implementation science

AbstractImplementation Science (IS) studies the adoption of interventions into clinical practice, taking into account real-world populations and clinical settings. While randomized control trials (RCTs) assess the efficacy of interventions, implementation research is necessary to assess the implementation of these interventions. IS attempts to understand and address the processes used, as well as possible barriers and facilitators to adoption by providers and organizational systems. This paper introduces several study designs and methods that are critical to inform IS studies including pragmatic trials, hybrid designs, qualitative research methods, and mixed methods. Pragmatic trials aim to assess the effectiveness of interventions in routine clinical practice and hybrid designs measure both intervention effects and assess how they are implemented. Qualitative research methods require the consideration of numerous contextual factors, such as providers’ perspectives and environmental variables that are not...