Effectiveness-implementation Hybrid Designs

TLDR

Blending clinical effectiveness and implementation research can yield faster translational gains, more effective implementation strategies, and better decision‑making information than pursuing them separately. The study proposes a hybrid effectiveness‑implementation typology, outlines its rationale and design decisions, and illustrates these with real‑world examples. The authors define three hybrid types: (1) testing a clinical intervention while collecting implementation data; (2) simultaneously testing clinical and implementation strategies; and (3) testing an implementation strategy while monitoring the clinical intervention’s impact. The hybrid typology, still evolving, offers a dual‑focus design that could accelerate the translation of evidence into routine practice, complementing traditional effectiveness and implementation trials.

Abstract

Objectives: This study proposes methods for blending design components of clinical effectiveness and implementation research. Such blending can provide benefits over pursuing these lines of research independently; for example, more rapid translational gains, more effective implementation strategies, and more useful information for decision makers. This study proposes a "hybrid effectiveness-implementation" typology, describes a rationale for their use, outlines the design decisions that must be faced, and provides several real-world examples. Results: An effectiveness-implementation hybrid design is one that takes a dual focus a priori in assessing clinical effectiveness and implementation. We propose 3 hybrid types: (1) testing effects of a clinical intervention on relevant outcomes while observing and gathering information on implementation; (2) dual testing of clinical and implementation interventions/strategies; and (3) testing of an implementation strategy while observing and gathering information on the clinical intervention's impact on relevant outcomes. Conclusions: The hybrid typology proposed herein must be considered a construct still in evolution. Although traditional clinical effectiveness and implementation trials are likely to remain the most common approach to moving a clinical intervention through from efficacy research to public health impact, judicious use of the proposed hybrid designs could speed the translation of research findings into routine practice.