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)
- Conditions
- Methicillin-resistant Staphylococcus Aureus
- Interventions
- Registration Number
- NCT00980980
- Lead Sponsor
- Harvard Pilgrim Health Care
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74256
- Inclusion criteria will include all HCA hospitals that reside in US states where physicians do NOT routinely prescribe decolonization for MRSA + ICU patients.
- Exclusion criteria will include hospitals where ICU physicians often prescribe decolonization for MRSA+ ICU patients.
- Dedicated burn ICUs will also be excluded due to the inability to perform routine bathing.
- Finally, since the intent is to assess the intervention in adult ICUs, pediatric hospitals will be excluded although patients <13 years old that are admitted to participating adult ICUs will be included in the unit-based intervention.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Arm 2: Targeted Decolonization Chlorhexidine bath and nasal mupirocin Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+ Arm 3: Universal Decolonization Chlorhexidine bath and nasal mupirocin Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+
- Primary Outcome Measures
Name Time Method Main Outcome: Patients With Nosocomial MRSA Clinical Cultures 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. Hazard ratio for ICU-attributable MRSA+ clinical cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.
- Secondary Outcome Measures
Name Time Method MRSA Bloodstream Infection 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. Hazard ratio for ICU-attributable MRSA+ blood cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.
Intervention Impact on Chlorhexidine Susceptibility of MRSA Isolates 25-month time frame represents 7-month baseline and 18-month intervention periods 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.
ICU-attributable All-pathogen Bloodstream Infection 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. 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 12-month period Costs (in dollars) per 1000 ICU-admissions associated with 3 ICU strategies to reduce ICU Bloodstream infection (BSI), (Arms 1-3).
Intervention Impact on Bacteriuria and Candiduria 30-month time frame represents 12-month baseline and 18-month intervention periods. 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.
Blood Culture Contamination Rates 24-month time frame for this analysis represents a 6-month baseline and 18-month intervention period. Odds ratio for ICU-attributable blood culture contamination rates, comparing Baseline to Intervention period across Arms, accounting for clustering by hospital.
Intervention Impact on Mupirocin Susceptibility of MRSA Isolates 25-month time frame represents 7-month baseline and 18-month intervention periods 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.
Trial Locations
- Locations (42)
The Medical Center of Aurora
🇺🇸Aurora, Colorado, United States
Research Belton Hospital
🇺🇸Kansas City, Missouri, United States
Plantation General
🇺🇸Ft. Lauderdale, Florida, United States
Menorah Medical Center
🇺🇸Kansas City, Missouri, United States
Brandon Hospital
🇺🇸Brandon, Florida, United States
Regional Med Cr Bayonet Point
🇺🇸Hudson, Florida, United States
Overland Park Regional Hospital
🇺🇸Kansas City, Missouri, United States
Largo Medical Center
🇺🇸Largo, Florida, United States
Columbia Alleghany Regional Hospital
🇺🇸LowMoor, Virginia, United States
Fawcett Memorial Hospital
🇺🇸Port Charlotte, Florida, United States
Capital Regional Med Ctr
🇺🇸Tallahassee, Florida, United States
Coliseum (Macon) Northside
🇺🇸Macon, Georgia, United States
Cartersville Medical Center
🇺🇸Tucker, Georgia, United States
Parkridge Medical Center
🇺🇸Chattanooga, Tennessee, United States
Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Los Robles Hosp & Med Ctr
🇺🇸Thousand Oaks, California, United States
Blake Medical Center
🇺🇸Brandenton, Florida, United States
Columbia Hosp Corp S Broward (Westside)
🇺🇸Ft. Lauderdale, Florida, United States
Palms West Hospital
🇺🇸Ft. Lauderdale, Florida, United States
Doctors Hospital of Sarasota
🇺🇸Sarasota, Florida, United States
Coliseum Medical Center
🇺🇸Macon, Georgia, United States
Del Sol Medical Center
🇺🇸El Paso, Texas, United States
Las Palmas Medical Center
🇺🇸El Paso, Texas, United States
Methodist Hospital
🇺🇸San Antonio, Texas, United States
Eastern Idaho Reg Med Ctr
🇺🇸Idaho Falls, Idaho, United States
Moutainview Medical Center
🇺🇸Las Vegas, Nevada, United States
Parkland Medical Center
🇺🇸Derry, New Hampshire, United States
Alaska Regional
🇺🇸Anchorage, Alaska, United States
Grand Strand Regional Medical Center
🇺🇸Myrtle Beach, South Carolina, United States
Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
Stonecrest
🇺🇸Smyrna, Tennessee, United States
South Bay Hospital
🇺🇸Sun City Center, Florida, United States
Clear Lake Regional
🇺🇸Webster, Texas, United States
Chippenham Johnston Willis
🇺🇸Richmond, Virginia, United States
St. David's Medical Center
🇺🇸Austin, Texas, United States
Montgomery Regional Hospital
🇺🇸Blacksburg, Virginia, United States
Pulaski Community Hospital
🇺🇸Pulaski, Virginia, United States
Garden Park Medical Center
🇺🇸Gulfport, Mississippi, United States
Lee's Summit Medical Center
🇺🇸Kansas City, Missouri, United States
Medical Center of Plano
🇺🇸Plano, Texas, United States
Community Hospital
🇺🇸New Port Richey, Florida, United States
Orange Park Med Ctr
🇺🇸Orange Park, Florida, United States