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Effectiveness-implementation Hybrid Designs

Combining Elements of Clinical Effectiveness and Implementation Research to Enhance Public Health Impact

Curran, Geoffrey M., PhD*; Bauer, Mark, MD; Mittman, Brian, PhD; Pyne, Jeffrey M., MD*; Stetler, Cheryl, PhD

doi: 10.1097/MLR.0b013e3182408812
Annals of HSR

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.

*Central Arkansas Veterans Healthcare System, and Department of Psychiatry, University of Arkansas for Medical Sciences, Little Rock, AR

VA Boston Healthcare System, Harvard Medical School, Boston, MA

Center for Implementation Practice and Research Support (CIPRS), VA Greater Los Angeles Healthcare System, Los Angeles, CA

Supported by a research grant for the Department of Veterans Affairs, Health Services Research and Development Service: MNT-05-152 (Pyne, PI) and also funded by a research grant from the National Institute on Drug Abuse: K01 DA15102 (Curran, PI).

The authors declare no conflict of interest.

Reprints: Geoffrey M. Curran, PhD, Department of Psychiatry, Division of Health Services Research, University of Arkansas for Medical Sciences, 4301 W. Markham St. #755, Little Rock, AR 72205. E-mail:

© 2012 Lippincott Williams & Wilkins, Inc.