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)

This study has been completed.

Sponsor:

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

Information provided by (Responsible Party):

Richard Platt, Harvard Pilgrim Health Care

ClinicalTrials.gov Identifier:

NCT00980980

First received: September 19, 2009

Last updated: March 22, 2017

Last verified: March 2017

History of Changes

Results First Received: May 14, 2014

Study Type:	Interventional
Study Design:	Allocation: Randomized; Primary Purpose: Prevention
Condition:	Methicillin-resistant Staphylococcus Aureus
Intervention:	Drug: Chlorhexidine bath and nasal mupirocin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
45 out of 165 Hospital Corporation of America (HCA) hospitals were recruited for this trial of adult ICUs. There was a 12-month baseline period from January 1 through December 31, 2009; a phase-in period from January 1 through April 7, 2010; and an 18-month intervention period from April 8, 2010 through September 30, 2011.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
74,256 patients were involved in the intervention period among adult ICUs from the 43 participating hospitals. Routinely collected information for about 48,390 individuals cared for during the baseline period was used for comparison to the experience of the patients in all three arms of the Intervention period.

Reporting Groups

Description

Arm 1: Usual Care-Active Surveillance

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

Arm 2: Targeted Decolonization

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

Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)

Arm 3: Universal Decolonization

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

Chlorhexidine bath and nasal mupirocin: 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)

Participant Flow: Overall Study

	Arm 1: Usual Care-Active Surveillance	Arm 2: Targeted Decolonization	Arm 3: Universal Decolonization
STARTED	16	14	13
COMPLETED	16	13	13
NOT COMPLETED	0	1	0
Withdrawal by Hospital	0	1	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
'Number of Participant' totals reflect total Baseline and Intervention participants combined. 45 hospitals were randomized to a study group, 2 dropped due to exclusion criteria, 43 began the assigned intervention. 1 hospital withdrew during the intervention and was included in as-assigned analyses.

Reporting Groups

	Description
Arm 1: Usual Care-Active Surveillance	Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
Arm 2: Targeted Decolonization	Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+ Chlorhexidine bath and nasal mupirocin: 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)
Arm 3: Universal Decolonization	Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Contact Precautions for MRSA+ Chlorhexidine bath and nasal mupirocin: 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)
Total	Total of all reporting groups

Baseline Measures

Arm 1: Usual Care-Active Surveillance

Arm 2: Targeted Decolonization

Arm 3: Universal Decolonization

Total

Overall Participants Analyzed
[Units: Participants]

39296

39970

43380

122646

Age
[Units: Years]
Median (Inter-Quartile Range)

Baseline Age

65
(52 to 77)

66
(53 to 77)

65
(51 to 77)

65
(52 to 77)

Intervention Age

65
(52 to 77)

66
(53 to 77)

65
(52 to 77)

Sex/Gender, Customized ^[1]
[Units: Participants]

Females - Baseline

7465

7183

8314

22962

Males - Baseline

8351

8035

9042

25428

Females - Intervention

11176

11683

12361

35220

Males - Intervention

12304

13069

13663

39036

^[1]	Proportion of female study participants, during baseline and intervention study phases.

Overall Number of Participants, by Phase ^[1]
[Units: Admissions]

Baseline Participants

15816

15218

17356

48390

Intervention Participants

23480

24752

26024

74256

^[1]	This table reflects number of admissions with an ICU stay during the Baseline and Intervention periods, separately. Please note that the table above, "Overall Number of Baseline Participants" reflects the total number of participants for which baseline characteristics were measured, across Baseline and Intervention phases combined.

Outcome Measures

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1. Primary:

Main Outcome: Patients With Nosocomial MRSA Clinical Cultures [ 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. ]

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2. Secondary:

MRSA Bloodstream Infection [ 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. ]

Show Outcome Measure 2

3. Secondary:

ICU-attributable All-pathogen Bloodstream Infection [ 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. ]

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4. Secondary:

Intervention Impact on Healthcare Costs [ Time Frame: 12-month period ]

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5. Secondary:

Blood Culture Contamination Rates [ Time Frame: 24-month time frame for this analysis represents a 6-month baseline and 18-month intervention period. ]

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6. Secondary:

Intervention Impact on Bacteriuria and Candiduria [ Time Frame: 30-month time frame represents 12-month baseline and 18-month intervention periods. ]

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7. Secondary:

Intervention Impact on Mupirocin Susceptibility of MRSA Isolates [ Time Frame: 25-month time frame represents 7-month baseline and 18-month intervention periods ]

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8. Secondary:

Intervention Impact on Chlorhexidine Susceptibility of MRSA Isolates [ Time Frame: 25-month time frame represents 7-month baseline and 18-month intervention periods ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Dr. Susan Huang
Organization: University of California, Irvine
phone: 949-824-5073
e-mail: sshuang@uci.edu

Publications of Results:

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.

Other Publications:

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.

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.

Responsible Party:	Richard Platt, Harvard Pilgrim Health Care
ClinicalTrials.gov Identifier:	NCT00980980 History of Changes
Other Study ID Numbers:	PH000223K HHSA2902005003I TO #11
Study First Received:	September 19, 2009
Results First Received:	May 14, 2014
Last Updated:	March 22, 2017

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