Cluster Randomized Trial of Hospitals to Assess Impact of Targeted Versus Universal Strategies to Reduce Methicillin-resistant Staphylococcus Aureus (MRSA) in Intensive Care Units (ICUs)

Harvard Pilgrim Health Care74,256 enrolled

Overview

The Randomized Evaluation of Decolonization versus Universal Clearance to Eliminate MRSA (REDUCE MRSA) Trial is a cluster randomized trial of the comparative effectiveness of three strategies to prevent methicillin-resistant Staphylococcus aureus (MRSA) in intensive care units. The three strategies to be evaluated are: * screening on admission followed by isolation of MRSA+ patients * screening on admission followed by isolation and decolonization of MRSA+ patients * universal decolonization on admission with no screening. The decolonization regimen involves bathing with chlorhexidine plus intra-nasal application of mupirocin. The main outcome will be MRSA+ clinical cultures. The study is a partnership between the CDC, the CDC Prevention Epicenters, and the Hospital Corporation of America.

Baseline data involving 12 months of data for participating hospitals (July 2008 - June 2009) was collected prior to randomization to account for size and ICU baseline prevalence of MRSA in randomization scheme. Randomization occurred at the hospital level. Eligibility survey was conducted to determine exclusion criteria. As of May 2010, enrollment has been closed. 45 hospitals were randomized, but two were found to meet exclusion criteria and were excluded. As-randomized (or as-assigned) analysis included 43 hospitals, representing 74 ICUs. Individual (patient-level) subject enrollment during intervention is 74,256.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Enrollment

74,256

Conditions

Methicillin-resistant Staphylococcus Aureus

Locations (42)

Alaska Regional

Anchorage, Alaska, United States

Los Robles Hosp & Med Ctr

Thousand Oaks, California, United States

The Medical Center of Aurora

Aurora, Colorado, United States

Blake Medical Center

Brandenton, Florida, United States

Brandon Hospital

Brandon, Florida, United States

Columbia Hosp Corp S Broward (Westside)

Outcomes

Primary Outcomes

Main Outcome: Patients With Nosocomial MRSA Clinical Cultures

Hazard ratio for ICU-attributable MRSA+ clinical cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.

Time frame: The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge.

Secondary Outcomes

MRSA Bloodstream Infection

Hazard ratio for ICU-attributable MRSA+ blood cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.

ICU-attributable All-pathogen Bloodstream Infection

Hazard ratio for ICU-attributable positive blood culture from any pathogen, comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.

Intervention Impact on Healthcare Costs

Costs (in dollars) per 1000 ICU-admissions associated with 3 ICU strategies to reduce ICU Bloodstream infection (BSI), (Arms 1-3).

Time frame: 12-month period

Blood Culture Contamination Rates

Odds ratio for ICU-attributable blood culture contamination rates, comparing Baseline to Intervention period across Arms, accounting for clustering by hospital.

Time frame: 24-month time frame for this analysis represents a 6-month baseline and 18-month intervention period.

Intervention Impact on Bacteriuria and Candiduria

Proportional hazard ratio for as-randomized, unadjusted, ICU-attributable bacteriuria, comparing Baseline to Intervention period across Arms, accounting for clustering by hospital. High-level bacteriuria is defined as ≥50,000 CFU/mL, high-level candiduria is defined as ≥50,000 CFU/mL.

Time frame: 30-month time frame represents 12-month baseline and 18-month intervention periods.

Intervention Impact on Mupirocin Susceptibility of MRSA Isolates

Odds ratio for MRSA+ isolates from ICU patients expressing low-level mupirocin resistance (LLMR) and high-level mupirocin resistance (HLMR), comparing baseline to intervention period across arms, accounting for clustering by hospital.

Time frame: 25-month time frame represents 7-month baseline and 18-month intervention periods

Intervention Impact on Chlorhexidine Susceptibility of MRSA Isolates

Frequency of MRSA+ isolates from ICU patients with reduced susceptibility to chlorhexidine (CHG) (MIC \>4 μg/ml), comparing baseline to intervention period across arms, accounting for clustering by hospital.