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2011 HSR&D National Meeting Abstract

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2011 National Meeting

2001 — Hybrid Effectiveness-Implementation Trial Designs for Enhanced Research Impact

Bauer MS (COLMR), Curran GM (Mental Health QUERI), Stetler CB (CIPRS), Mittman B (CIPRS)

Workshop Objectives:
Traditionally, clinical interventions have been tested in controlled trials, with successful innovations then studied in a distinct line of implementation research—-typically by a completely separate group of investigators with different skills and perspectives. This linear process is slow and inefficient. Hybrid trial designs combine elements of classical clinical trial design with state-of-the-art implementation research methods in the same protocol. Such designs involve careful attention to clinical intervention fidelity while introducing implementation methods such as formative and summative implementation evaluation to optimize intervention deployment and maximize implementation lessons learned. By the end of this workshop participants will: a) Be familiar with the concepts and methods of hybrid research design; b) Be able to identify Type I, II, and III hybrid designs; c) Identify, based on the state of the science, indications for a hybrid design, as well as appropriateness of each hybrid type; d) Be able to identify design decision trade-offs as applied specifically to hybrid designs; and e) Be able to apply these concepts and tools to a developing protocol of their own.

This 90-minute workshop will consist of: (a) a 45-minute presentation covering the basics of hybrid designs followed by (b) a 45-minute exercise series in which the audience first identifies hybrid aspects of study designs provided by faculty, and then applies hybrid concepts to their own developing protocols.

Target Audience:
Researchers with some background in either health services clinical trials or implementation studies who have an interest in developing a broader set of design skills to enhance implementation of their and others' work.

Assumed Audience Familiarity with Topic:
An earlier version of this workshop was well received at the 2010 QUERI-sponsored conference for new implementation investigators, “Enhancing Implementation Science in the VA.” We intend this workshop for a wider audience of HSR&D investigators at a similar level: Some familiarity with clinical trials and little to no familiarity with implementation science methods.

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