The unrecognized role of fidelity in effectiveness-implementation hybrid trials: simulation study and guidance for implementation researchers.

ABSTRACT:

Background

Effectiveness-implementation hybrid designs are a relatively new approach to evaluate efficacious interventions in real-world settings while concurrently gathering information on the implementation. Intervention fidelity can significantly influence the effectiveness of an intervention during implementation. However little guidance exists for applied researchers conducting effectiveness-implementation hybrid trials regarding the impact of fidelity on intervention effects and power.

Methods

We conducted a simulation study based on parameters from a clinical example study. For the simulation, we explored parallel and stepped-wedge cluster randomized trials (CRTs) and hypothetical patterns of fidelity increase during implementation: slow, linear, and fast. Based on fi

SUBMITTER: Trutschel D 

PROVIDER: S-EPMC10183132 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature