A framework for designing hybrid effectiveness-implementation trials for digital health interventions.

This article proposes methods for designing randomized controlled trials studying the implementation and effectiveness of digital interventions, meaning websites or applications ("apps") that patients use in healthcare. Deploying digital interventions for behavioral health differs from implementing traditional interventions such as medications or human-delivered therapy. Prior trial design guidance has ignored the existence of international governmental evidence standards, has paid insufficient attention to implementation reporting guidelines, and has not described methods for empirically testing the approach for organizing the delivery of digital interventions. This framework for designing hybrid effectiveness-implementation trials of digital behavioral health interventions helps researchers articulate research questions that matter to decision-makers and meaningfully contribute to implementation. The framework outlines three phases: 1) frame effectiveness and implementation questions in terms of the digital intervention components, types of clinical support for the digital intervention, and specific strategies for implementing the digital intervention; 2) define and delineate actors, activities, action targets, dose, temporality, and outcomes to maximize inference and reproducibility; and 3) specify trial design features used for hybrid classification. We illustrate the utility of this framework with two effectiveness-implementation studies of digital interventions for substance use. This framework can help researchers decide on appropriate methodology and help decision-makers apply findings.