Cluster randomized trials in comparative effectiveness research: randomizing hospitals to test methods for prevention of healthcare-associated infections.

Abstract:

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 >or=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.

journal_name

Med Care

journal_title

Medical care

authors

Platt R,Takvorian SU,Septimus E,Hickok J,Moody J,Perlin J,Jernigan JA,Kleinman K,Huang SS

doi

10.1097/MLR.0b013e3181dbebcf

subject

Has Abstract

pub_date

2010-06-01 00:00:00

pages

S52-7

issue

6 Suppl

eissn

0025-7079

issn

1537-1948

journal_volume

48

pub_type

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