Benefits of Universal Glove and Gowning (BUGG)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Yale New Haven Health System Center for Healthcare Solutions.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
University of Maryland
University of Iowa
Joint Commission on Accreditation of Healthcare Organizations
Information provided by (Responsible Party):
Yale New Haven Health System Center for Healthcare Solutions
ClinicalTrials.gov Identifier:
NCT01318213
First received: March 16, 2011
Last updated: January 3, 2012
Last verified: January 2012
  Purpose

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.


Condition
MRSA
VRE

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Effect of the Use of Universal Glove and Gowning on Healthcare Associated Infection Rates and Antibiotic Resistant Bacteria

Resource links provided by NLM:


Further study details as provided by Yale New Haven Health System Center for Healthcare Solutions:

Primary Outcome Measures:
  • Number of ICU Patients Who Acquire VRE or MRSA [ Time Frame: 9 months ] [ Designated as safety issue: No ]

    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.


Secondary Outcome Measures:
  • Number of ICU Patients Who Acquire CABSI,CAUTI or VAP [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    In all of the intensive-care units, catheter-associated bloodstream infection, catheter-associated urinary tract infection and ventilator-associated pneumonia rates will be measured in a standardized fashion at the cluster or group level. Data is collected on an individual patient basis in a de-identified fashion and will be reported to investigators at the cluster level

  • Changes from Baseline in 30-day Mortality Rate and ICU LOS [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Thirty-day mortality will be a binary outcome of either the patient died at 30-days or was alive at 30-days after ICU admission date. ICU length of stay will be a continuous variable. This information will be recorded on an individual basis by the coordinator but will be reported on a group-level to the research center.

  • Number of Adverse Events Occuring in the ICU [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    The study will look at a number of adverse events including 30-day mortality and the frequency of healthcare worker visits. Compliance with hand hygiene and the frequency of adverse events as measured by a modified Institute for Healthcare Improvement (IHI) trigger tool.


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


Estimated Enrollment: 2
Study Start Date: December 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01318213

Locations
United States, Maryland
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Yale New Haven Health System Center for Healthcare Solutions
University of Maryland
University of Iowa
Joint Commission on Accreditation of Healthcare Organizations
Investigators
Principal Investigator: Anthony D Harris, MD, MPH University of Maryland, Baltimore County
  More Information

No publications provided

Responsible Party: Yale New Haven Health System Center for Healthcare Solutions
ClinicalTrials.gov Identifier: NCT01318213     History of Changes
Other Study ID Numbers: ARHQ ACTION TO #5, HHSA290200600015i
Study First Received: March 16, 2011
Last Updated: January 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Yale New Haven Health System Center for Healthcare Solutions:
VRE
MRSA

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014