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


METHODS
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.


METHODS
All admissions to adult ICUs.


METHODS
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.
Platt
Richard
R
Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA 02215, USA. richard_platt@harvard.edu
Takvorian
Samuel U
SU
Septimus
Edward
E
Hickok
Jason
J
Moody
Julia
J
Perlin
Jonathan
J
Jernigan
John A
JA
Kleinman
Ken
K
Huang
Susan S
SS
D057186:Comparative Effectiveness Research / Q000379:methods*; D003428:Cross Infection / Q000517:prevention & control*; D006801:Humans; D017053:Infection Control / Q000379:methods*; D007362:Intensive Care Units / Q000458:organization & administration*; D055624:Methicillin-Resistant Staphylococcus aureus; D016032:Randomized Controlled Trials as Topic / Q000379:methods*