Speaker
John Fortney, PhD
Professor
Department of Psychiatry and Behavioral Sciences
University of Washington
Senior Research Career Scientist
HSR Center of Innovation for Veteran-Centered and Value-Driven Care
VA Puget Sound Health Care System
Keywords
Pragmatic; Implementation; Hybrid-Effectiveness; Trial Types
Key Points
- Pragmatic trials are primarily designed to determine the effectiveness of a clinical intervention under the usual conditions in which it will be applied. A hybrid-effectiveness implementation trial assesses both clinical effectiveness and implementation.
- Dr. Fortney walked through the translational research pipeline, which flows from explanatory trials to pragmatic trials to implementation research. Ideally, the end product is improved processes and outcomes.
- While the differences between explanatory, pragmatic, and implementation trials is well understood, the differences and similarities between pragmatic trials and hybrid type trials are not well understood.
- Pragmatic Trials (PTs) and Hybrid Type 1 Trials (HT1) aim to test the effectiveness of clinical interventions, with patient outcomes as their primary outcomes. Hybrid Type 3 Trials (HT3) look at whether a given implementation strategy successfully promotes intervention uptake. Hybrid Type 2 Trials (HT2) compare two clinical interventions and one or two implementation strategies.
- Whereas HT1s utilize artificial implementation strategies, PTs, HT2s, and HT3s utilize practical implementation strategies that they expect to be replicable outside of a research context.
- Dr. Fortney provided resources, including a question tree and case examples, to aid researchers in identifying or choosing a trial type. He also provided several guidelines, including:
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- HT1 trial types should be used to determine whether a clinical intervention can be effective when delivered in routine care.
- Pragmatic and HT2 trial types should be used to determine whether an evidence-based clinical intervention(s) is effective when delivered with practical implementation strategies in routine care.
- HT2 and HT3 trial types should be used to determine whether practical and novel implementation strategies successfully promote the uptake of evidence-based clinical interventions.
Discussion Themes
The distinction between artificial implementation strategies and evidence-based, or practical, implementation strategies is not always black and white, and will often fall somewhere on the Artificial → Practical continuum.
This research team laid out some of the subtler differences in research objectives between study types, and the elements studies need to successfully address those objectives. Reviewers and researchers alike need to be careful in thinking these distinctions through and understanding them.
