Challenges in Conducting a Pragmatic Randomized Controlled Trial of Two Technology-Supported Approaches to Support Medication Treatment Decisions


This case study describes a cluster-randomized control trial comparing the effectiveness of two technology-based approaches to collaborative decision-making during mental health medication treatment visits. The case study reviews the impetus for the research trial, components of each approach, study design, and recruitment processes and discusses how diverse stakeholders were engaged in all aspects of the research. Throughout the case study, details regarding methodological processes and challenges specific to randomization, data collection, and primary outcome measures are explained. Through the presentation of these challenges and subsequent impacts on data interpretation, this case study offers insights into workable solutions and the importance of methodological transparency in the conduct of patient-centered comparative effective research in real-world settings.

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