Clinical trial NCT00980980: 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)
Official title: Cluster Randomized Trial of Hospitals to Assess Impact of Targeted Versus Universal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Methicillin-resistant Staphylococcus Aureus
Keywords: MRSA infection
Lead sponsor: Harvard Pilgrim Health Care
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: Centers for Disease Control and Prevention
name: Hospital Corporation of America
name: University of California, Irvine
name: Department of Population Medicine, Harvard Medical School / Harvard Pilgrim Healthcare Institute
First posted: 2009-09-21
Enrollment: 74256
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* 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:

* 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.

Primary outcomes:
measure: Main Outcome: Patients With Nosocomial MRSA Clinical Cultures
timeFrame: 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:
measure: MRSA Bloodstream Infection
timeFrame: 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.
measure: ICU-attributable All-pathogen Bloodstream Infection
timeFrame: 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.
measure: Intervention Impact on Healthcare Costs
timeFrame: 12-month period
measure: Blood Culture Contamination Rates
timeFrame: 24-month time frame for this analysis represents a 6-month baseline and 18-month intervention period.
measure: Intervention Impact on Bacteriuria and Candiduria
timeFrame: 30-month time frame represents 12-month baseline and 18-month intervention periods.
measure: Intervention Impact on Mupirocin Susceptibility of MRSA Isolates
timeFrame: 25-month time frame represents 7-month baseline and 18-month intervention periods
measure: Intervention Impact on Chlorhexidine Susceptibility of MRSA Isolates
timeFrame: 25-month time frame represents 7-month baseline and 18-month intervention periods
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Regional
state: Alaska
city: Thousand Oaks
country: United States
facility: Los Robles Hosp & Med Ctr
state: California
city: Aurora
country: United States
facility: The Medical Center of Aurora
state: Colorado
city: Brandenton
country: United States
facility: Blake Medical Center
state: Florida
city: Brandon
country: United States
facility: Brandon Hospital
state: Florida
city: Ft. Lauderdale
country: United States
facility: Columbia Hosp Corp S Broward (Westside)
state: Florida
city: Ft. Lauderdale
country: United States
facility: Palms West Hospital
state: Florida
city: Ft. Lauderdale
country: United States
facility: Plantation General
state: Florida
city: Hudson
country: United States
facility: Regional Med Cr Bayonet Point
state: Florida
city: Largo
country: United States
facility: Largo Medical Center
state: Florida
city: New Port Richey
country: United States
facility: Community Hospital
state: Florida
city: Orange Park
country: United States
facility: Orange Park Med Ctr
state: Florida
city: Port Charlotte
country: United States
facility: Fawcett Memorial Hospital
state: Florida
city: Sarasota
country: United States
facility: Doctors Hospital of Sarasota
state: Florida
city: Sun City Center
country: United States
facility: South Bay Hospital
state: Florida
city: Tallahassee
country: United States
facility: Capital Regional Med Ctr
state: Florida
city: Macon
country: United States
facility: Coliseum (Macon) Northside
state: Georgia
city: Macon
country: United States
facility: Coliseum Medical Center
state: Georgia
city: Tucker
country: United States
facility: Cartersville Medical Center
state: Georgia
city: Idaho Falls
country: United States
facility: Eastern Idaho Reg Med Ctr
state: Idaho
city: Gulfport
country: United States
facility: Garden Park Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: Lee's Summit Medical Center
state: Missouri
city: Kansas City
country: United States
facility: Menorah Medical Center
state: Missouri
city: Kansas City
country: United States
facility: Overland Park Regional Hospital
state: Missouri
city: Kansas City
country: United States
facility: Research Belton Hospital
state: Missouri
city: Las Vegas
country: United States
facility: Moutainview Medical Center
state: Nevada
city: Derry
country: United States
facility: Parkland Medical Center
state: New Hampshire
city: Oklahoma City
country: United States
facility: Oklahoma University Medical Center
state: Oklahoma
city: Myrtle Beach
country: United States
facility: Grand Strand Regional Medical Center
state: South Carolina
city: Chattanooga
country: United States
facility: Parkridge Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: Smyrna
country: United States
facility: Stonecrest
state: Tennessee
city: Austin
country: United States
facility: St. David's Medical Center
state: Texas
city: El Paso
country: United States
facility: Del Sol Medical Center
state: Texas
city: El Paso
country: United States
facility: Las Palmas Medical Center
state: Texas
city: Plano
country: United States
facility: Medical Center of Plano
state: Texas
city: San Antonio
country: United States
facility: Methodist Hospital
state: Texas
city: Webster
country: United States
facility: Clear Lake Regional
state: Texas
city: Blacksburg
country: United States
facility: Montgomery Regional Hospital
state: Virginia
city: LowMoor
country: United States
facility: Columbia Alleghany Regional Hospital
state: Virginia
city: Pulaski
country: United States
facility: Pulaski Community Hospital
state: Virginia
city: Richmond
country: United States
facility: Chippenham Johnston Willis
state: Virginia
Study officials:
affiliation: Department of Population Medicine, Harvard Medical School / Harvard Pilgrim Healthcare Institute
name: Richard Platt, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Corporation of America
name: Edward Septimus, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Irvine
name: Susan Huang, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Platt R, Takvorian SU, Septimus E, Hickok J, Moody J, Perlin J, Jernigan JA, Kleinman K, Huang SS. Cluster randomized trials in comparative effectiveness research: randomizing hospitals to test methods for prevention of healthcare-associated infections. Med Care. 2010 Jun;48(6 Suppl):S52-7. doi: 10.1097/MLR.0b013e3181dbebcf.
citation: Huang SS, Septimus E, Platt R. Targeted decolonization to prevent ICU infections. N Engl J Med. 2013 Oct 10;369(15):1470-1. doi: 10.1056/NEJMc1309704. No abstract available.
citation: Huang SS, Septimus E, Kleinman K, Moody J, Hickok J, Avery TR, Lankiewicz J, Gombosev A, Terpstra L, Hartford F, Hayden MK, Jernigan JA, Weinstein RA, Fraser VJ, Haffenreffer K, Cui E, Kaganov RE, Lolans K, Perlin JB, Platt R; CDC Prevention Epicenters Program; AHRQ DECIDE Network and Healthcare-Associated Infections Program. Targeted versus universal decolonization to prevent ICU infection. N Engl J Med. 2013 Jun 13;368(24):2255-65. doi: 10.1056/NEJMoa1207290. Epub 2013 May 29.