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Cluster Randomized Trials in Comparative Effectiveness Research: Randomizing Hospitals to Test Methods for Prevention of Healthcare-Associated Infections

Platt, Richard MD, MS*; Takvorian, Samuel U. AB*; Septimus, Edward MD; Hickok, Jason MBA, RN; Moody, Julia MS; Perlin, Jonathan MD, PhD; Jernigan, John A. MD, MS; Kleinman, Ken ScD*; Huang, Susan S. MD, MPH§

doi: 10.1097/MLR.0b013e3181dbebcf
Comparative Effectiveness

Background: The need for evidence about the effectiveness of therapeutics and other medical practices has triggered new interest in methods for comparative effectiveness research.

Objective: Describe an approach to comparative effectiveness research involving cluster randomized trials in networks of hospitals, health plans, or medical practices with centralized administrative and informatics capabilities.

Research Design: We discuss the example of an ongoing cluster randomized trial to prevent methicillin-resistant Staphylococcus aureus (MRSA) infection in intensive care units (ICUs). The trial randomizes 45 hospitals to: (a) screening cultures of ICU admissions, followed by Contact Precautions if MRSA-positive, (b) screening cultures of ICU admissions followed by decolonization if MRSA-positive, or (c) universal decolonization of ICU admissions without screening.

Subjects: All admissions to adult ICUs.

Measures: The primary outcome is MRSA-positive clinical cultures occurring ≥2 days following ICU admission. Secondary outcomes include blood and urine infection caused by MRSA (and, separately, all pathogens), as well as the development of resistance to decolonizing agents.

Results: Recruitment of hospitals is complete. Data collection will end in Summer 2011.

Conclusions: This trial takes advantage of existing personnel, procedures, infrastructure, and information systems in a large integrated hospital network to conduct a low-cost evaluation of prevention strategies under usual practice conditions. This approach is applicable to many comparative effectiveness topics in both inpatient and ambulatory settings.

From the *Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA; †Hospital Corporation of America, Nashville, TN; ‡Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA; and §Division of Infectious Diseases and Health Policy Research Institute, University of California Irvine School of Medicine, Irvine, CA.

Supported by the Agency for Healthcare Research and Quality (59 HMN HHSA290-2005-0033=TO11), with supplemental funding from the Centers for Disease Control and Prevention (CDC Prevention Epicenters Program, U01CI000344).

R.P. has received research grants from Sanofi-Pasteur, GlaxoSmithKline, Pfizer, and TAP Pharmaceuticals in the past 2 years.

The findings and conclusions in this report are those of the authors, and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

Reprints: Richard Platt, MD, MS, Department of Population Medicine, 133 Brookline Avenue, 6th Floor, Boston, MA 02215. E-mail:

© 2010 Lippincott Williams & Wilkins, Inc.