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

Abstract

Implementation 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 easily quantifiable, whereas mixed methods integrates both quantitative and qualitative designs. Hypothetical studies of the implementation of a swallowing screening protocol and of a school-based literacy intervention are used to illustrate the use of these approaches. The application of pragmatic and hybrid designs, and qualitative and mixed methods hold promise for gathering evidence that may improve the quality and efficiency of services provided by speech-language pathologists and other related professions.