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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) (REDUCE-MRSA)

Primary Purpose

Methicillin-resistant Staphylococcus Aureus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine bath and nasal mupirocin
Sponsored by
Harvard Pilgrim Health Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Methicillin-resistant Staphylococcus Aureus focused on measuring MRSA infection

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alaska Regional
  • Los Robles Hosp & Med Ctr
  • The Medical Center of Aurora
  • Blake Medical Center
  • Brandon Hospital
  • Columbia Hosp Corp S Broward (Westside)
  • Palms West Hospital
  • Plantation General
  • Regional Med Cr Bayonet Point
  • Largo Medical Center
  • Community Hospital
  • Orange Park Med Ctr
  • Fawcett Memorial Hospital
  • Doctors Hospital of Sarasota
  • South Bay Hospital
  • Capital Regional Med Ctr
  • Coliseum (Macon) Northside
  • Coliseum Medical Center
  • Cartersville Medical Center
  • Eastern Idaho Reg Med Ctr
  • Garden Park Medical Center
  • Lee's Summit Medical Center
  • Menorah Medical Center
  • Overland Park Regional Hospital
  • Research Belton Hospital
  • Moutainview Medical Center
  • Parkland Medical Center
  • Oklahoma University Medical Center
  • Grand Strand Regional Medical Center
  • Parkridge Medical Center
  • Centennial Medical Center
  • Stonecrest
  • St. David's Medical Center
  • Del Sol Medical Center
  • Las Palmas Medical Center
  • Medical Center of Plano
  • Methodist Hospital
  • Clear Lake Regional
  • Montgomery Regional Hospital
  • Columbia Alleghany Regional Hospital
  • Pulaski Community Hospital
  • Chippenham Johnston Willis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Arm 1: Usual Care-Active Surveillance

Arm 2: Targeted Decolonization

Arm 3: Universal Decolonization

Arm Description

Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+

Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+

Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.
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.
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.

Full Information

First Posted
September 19, 2009
Last Updated
March 22, 2017
Sponsor
Harvard Pilgrim Health Care
Collaborators
Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention, Hospital Corporation of America, University of California, Irvine, Department of Population Medicine, Harvard Medical School / Harvard Pilgrim Healthcare Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00980980
Brief Title
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)
Acronym
REDUCE-MRSA
Official Title
Cluster Randomized Trial of Hospitals to Assess Impact of Targeted Versus Universal
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard Pilgrim Health Care
Collaborators
Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention, Hospital Corporation of America, University of California, Irvine, Department of Population Medicine, Harvard Medical School / Harvard Pilgrim Healthcare Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Methicillin-resistant Staphylococcus Aureus
Keywords
MRSA infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Allocation
Randomized
Enrollment
74256 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Usual Care-Active Surveillance
Arm Type
No Intervention
Arm Description
Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
Arm Title
Arm 2: Targeted Decolonization
Arm Type
Active Comparator
Arm Description
Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+
Arm Title
Arm 3: Universal Decolonization
Arm Type
Active Comparator
Arm Description
Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine bath and nasal mupirocin
Intervention Description
The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
Primary Outcome Measure Information:
Title
Main Outcome: Patients With Nosocomial MRSA Clinical Cultures
Description
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 Outcome Measure Information:
Title
MRSA Bloodstream Infection
Description
Hazard ratio for ICU-attributable MRSA+ blood 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.
Title
ICU-attributable All-pathogen Bloodstream Infection
Description
Hazard ratio for ICU-attributable positive blood culture from any pathogen, 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.
Title
Intervention Impact on Healthcare Costs
Description
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
Title
Blood Culture Contamination Rates
Description
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.
Title
Intervention Impact on Bacteriuria and Candiduria
Description
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.
Title
Intervention Impact on Mupirocin Susceptibility of MRSA Isolates
Description
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
Title
Intervention Impact on Chlorhexidine Susceptibility of MRSA Isolates
Description
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.
Time Frame
25-month time frame represents 7-month baseline and 18-month intervention periods

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Platt, MD, MS
Organizational Affiliation
Department of Population Medicine, Harvard Medical School / Harvard Pilgrim Healthcare Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edward Septimus, MD
Organizational Affiliation
Hospital Corporation of America (HCA)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan Huang, MD MPH
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alaska Regional
City
Anchorage
State/Province
Alaska
Country
United States
Facility Name
Los Robles Hosp & Med Ctr
City
Thousand Oaks
State/Province
California
Country
United States
Facility Name
The Medical Center of Aurora
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Blake Medical Center
City
Brandenton
State/Province
Florida
Country
United States
Facility Name
Brandon Hospital
City
Brandon
State/Province
Florida
Country
United States
Facility Name
Columbia Hosp Corp S Broward (Westside)
City
Ft. Lauderdale
State/Province
Florida
Country
United States
Facility Name
Palms West Hospital
City
Ft. Lauderdale
State/Province
Florida
Country
United States
Facility Name
Plantation General
City
Ft. Lauderdale
State/Province
Florida
Country
United States
Facility Name
Regional Med Cr Bayonet Point
City
Hudson
State/Province
Florida
Country
United States
Facility Name
Largo Medical Center
City
Largo
State/Province
Florida
Country
United States
Facility Name
Community Hospital
City
New Port Richey
State/Province
Florida
Country
United States
Facility Name
Orange Park Med Ctr
City
Orange Park
State/Province
Florida
Country
United States
Facility Name
Fawcett Memorial Hospital
City
Port Charlotte
State/Province
Florida
Country
United States
Facility Name
Doctors Hospital of Sarasota
City
Sarasota
State/Province
Florida
Country
United States
Facility Name
South Bay Hospital
City
Sun City Center
State/Province
Florida
Country
United States
Facility Name
Capital Regional Med Ctr
City
Tallahassee
State/Province
Florida
Country
United States
Facility Name
Coliseum (Macon) Northside
City
Macon
State/Province
Georgia
Country
United States
Facility Name
Coliseum Medical Center
City
Macon
State/Province
Georgia
Country
United States
Facility Name
Cartersville Medical Center
City
Tucker
State/Province
Georgia
Country
United States
Facility Name
Eastern Idaho Reg Med Ctr
City
Idaho Falls
State/Province
Idaho
Country
United States
Facility Name
Garden Park Medical Center
City
Gulfport
State/Province
Mississippi
Country
United States
Facility Name
Lee's Summit Medical Center
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Menorah Medical Center
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Overland Park Regional Hospital
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Research Belton Hospital
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Moutainview Medical Center
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Parkland Medical Center
City
Derry
State/Province
New Hampshire
Country
United States
Facility Name
Oklahoma University Medical Center
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Grand Strand Regional Medical Center
City
Myrtle Beach
State/Province
South Carolina
Country
United States
Facility Name
Parkridge Medical Center
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
Centennial Medical Center
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Stonecrest
City
Smyrna
State/Province
Tennessee
Country
United States
Facility Name
St. David's Medical Center
City
Austin
State/Province
Texas
Country
United States
Facility Name
Del Sol Medical Center
City
El Paso
State/Province
Texas
Country
United States
Facility Name
Las Palmas Medical Center
City
El Paso
State/Province
Texas
Country
United States
Facility Name
Medical Center of Plano
City
Plano
State/Province
Texas
Country
United States
Facility Name
Methodist Hospital
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Clear Lake Regional
City
Webster
State/Province
Texas
Country
United States
Facility Name
Montgomery Regional Hospital
City
Blacksburg
State/Province
Virginia
Country
United States
Facility Name
Columbia Alleghany Regional Hospital
City
LowMoor
State/Province
Virginia
Country
United States
Facility Name
Pulaski Community Hospital
City
Pulaski
State/Province
Virginia
Country
United States
Facility Name
Chippenham Johnston Willis
City
Richmond
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20473200
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.
Results Reference
background
PubMed Identifier
24106942
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.
Results Reference
background
PubMed Identifier
23718152
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. Erratum In: N Engl J Med. 2013 Aug 8;369(6):587. N Engl J Med. 2014 Feb 27;370(9):886.
Results Reference
result
Links:
URL
http://www.ahrq.gov/professionals/systems/hospital/universal_icu_decolonization/index.html
Description
AHRQ Toolkit: Universal ICU Decolonization: An Enhanced Protocol

Learn more about this trial

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)

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