Benefits of Universal Glove and Gowning

NCT01318213 | Completed DMC

• 2 other identifiers: HP-00047673HHSA290200600015i
• Study Type: observational
• Target: 19,856
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test if doctors, nurses and other people who take care of patients in hospitals wearing gloves and gown for all contact with patients in an intensive care unit (ICU) will:

• Decrease the chance of patients getting an infection while in the hospital
• Decrease the chance of patients picking up bacteria as a result of being in the hospital
• Decrease the time a patient spends in the ICU or in the hospital
• Increase the frequency of adverse events The study will also look at whether making doctors, nurses and other people who take care of patients wear gloves and gown for all contact with patients will decrease the amount of time healthcare workers spend with patients. This study will gather information by comparing what happens in ICUs that continue to do what they were doing before the study with what happens in ICUs that require healthcare workers to wear gloves and gown for all contact with patients. This study will provide information that will help to make being in the hospital safer for all patients.

Conditions

MRSA; VRE

Keywords

VRE; MRSA

Outcome Measures

Primary Outcomes (1)

• Number of ICU Patients Who Acquire VRE or MRSA

  The outcome of interest is the acquisition of VRE or MRSA as determined by peri-anal surveillance cultures for VRE and by nasal surveillance cultures for MRSA. The outcomes will be analyzed both individually and collectively. Acquisition will be defined as: 1. A patient who has an initial ICU surveillance culture that is negative for an antibiotic-resistant pathogen. 2. Subsequent discharge surveillance culture within the same ICU admission that is positive for an antibiotic-resistant pathogen.

  9 months

Secondary Outcomes (6)

• Number of ICU Patients Who Acquire CABSI

  9 months

• Number of ICU Patients Who Acquire CAUTI

  9 months

• Number of ICU Patients Who Acquire VAP

  9 months

• Changes from Baseline in 30-day Mortality Rate

  9 months

• Changes from Baseline in ICU LOS

  9 months

Study Arms (2)

Intervention Arm

The intervention will consist of wearing gloves and gowns for all patient contact in the ICUs that are randomized to receive the intervention. During the intervention phases of the study, all healthcare workers (nurses, physicians, nurse extenders, respiratory therapists, social workers etc.) in the intervention group will be required to wear gloves and gowns for patient contact and when entering any patient room. In essence, healthcare workers will apply the CDC Contact Precautions guidelines for ALL patients.

Non-intervention - Usual Standard of Care

The non-intervention units will follow their present standard of care. For all of these units, this will consist of healthcare workers following Contact Precautions (gloves and gowns) only for patients known to have antibiotic-resistant bacteria such as VRE and MRSA based on previous admission clinical and surveillance cultures or clinical cultures from the present admission. This represents on average 20-25% of patients on Contact Precautions. For the rest of the patients standard precautions will be followed.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients in medical, surgical or combined medical/surgical ICUs.

You may qualify if:

• ICUs to be included are: adult medical, surgical or combined medical surgical ICU as defined below:
• Medical ICU (MICU) \> 80% of patients have a medical condition and have not undergone a surgical procedure during the current hospital stay
• Surgical ICU (SICU) \> 80% of the patients have undergone a surgical procedure during the current hospital stay
• Combined Medical/Surgical ICU (MICU/SICU) - a roughly equivalent mixture of patients with medical conditions who have not undergone surgical procedures and patients who have undergone surgical procedures during the current hospital stay. Each group makes up \> 20% and less than 80% of the total number of patients
• Ability to collect the data required for analysis
• Written approval of the study from the institution's IRB. The institution may opt to use the IRB approval provided by the centralized IRB at the University of Maryland, School of Medicine
• Memorandum of Understanding signed by the ICU Medical Director, ICU Nurse Manager or Director and the Hospital Epidemiologist indicating a commitment to supporting enrollment of an ICU and completion the study
• Ability to be matched with another ICU based on baseline acquisition of resistant bacteria on culture
• Agreement to not perform active surveillance for MRSA or VRE that will be fed back to patients during the study period

You may not qualify if:

• Pediatric ICUs and other non-medical or non-surgical ICUs will be excluded

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator
• Centers for Disease Control and Prevention: collaborator
• University of Iowa: collaborator
• Joint Commission on Accreditation of Healthcare Organizations: collaborator

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

Related Publications (3)

• Harris AD, Pineles L, Belton B, Johnson JK, Shardell M, Loeb M, Newhouse R, Dembry L, Braun B, Perencevich EN, Hall KK, Morgan DJ; Benefits of Universal Glove and Gown (BUGG) Investigators; Shahryar SK, Price CS, Gadbaw JJ, Drees M, Kett DH, Munoz-Price LS, Jacob JT, Herwaldt LA, Sulis CA, Yokoe DS, Maragakis L, Lissauer ME, Zervos MJ, Warren DK, Carver RL, Anderson DJ, Calfee DP, Bowling JE, Safdar N. Universal glove and gown use and acquisition of antibiotic-resistant bacteria in the ICU: a randomized trial. JAMA. 2013 Oct 16;310(15):1571-80. doi: 10.1001/jama.2013.277815.

  PMID: 24097234 RESULT

• Morgan DJ, Dubberke ER, Hink T, Paszkiewicz G, Burnham CD, Pineles L, Magder L, Johnson JK, Leekha S, Harris AD. The Impact of Universal Glove and Gown Use on Clostridioides Difficile Acquisition: A Cluster-Randomized Trial. Clin Infect Dis. 2023 Feb 8;76(3):e1202-e1207. doi: 10.1093/cid/ciac519.

  PMID: 35776131 DERIVED

• Harris AD, Morgan DJ, Pineles L, Magder L, O'Hara LM, Johnson JK. Acquisition of Antibiotic-Resistant Gram-negative Bacteria in the Benefits of Universal Glove and Gown (BUGG) Cluster Randomized Trial. Clin Infect Dis. 2021 Feb 1;72(3):431-437. doi: 10.1093/cid/ciaa071.

  PMID: 31970393 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasal and peri-rectal culture samples will be banked in the research laboratory of Dr. J. Kristie Johnson at the University of Maryland, School of Medicine. The samples will be labeled with a participant ID without any personal identifiers. The entire sample will not be used for this study. The remaining samples will be used for future research to answer any infection control questions that arise about infection control in intensive care units that may be answered with these samples. The remaining samples will be frozen and stored indefinitely. The freezing method that will allow the study of other bacteria has been validated. Depending upon the results, there may be some rationale for thawing the samples and processing them for other antibiotic-resistant bacteria

Study Officials

• Anthony D Harris, MD, MPH

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 16, 2011
• First Posted: March 18, 2011
• Study Start: December 1, 2010
• Primary Completion: October 4, 2012
• Study Completion: October 16, 2013
• Last Updated: August 20, 2019

Record last verified: 2019-08

Locations

US (1)