MRSA Clinical Trial
— BUGGOfficial title:
Effect of the Use of Universal Glove and Gowning on Healthcare Associated Infection Rates and Antibiotic Resistant Bacteria
Verified date | August 2019 |
Source | University of Maryland, Baltimore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 19856 |
Est. completion date | October 16, 2013 |
Est. primary completion date | October 4, 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland, Baltimore | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore | Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention, Joint Commission on Accreditation of Healthcare Organizations, University of Iowa |
United States,
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, Muñoz-Price L — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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: A patient who has an initial ICU surveillance culture that is negative for an antibiotic-resistant pathogen. Subsequent discharge surveillance culture within the same ICU admission that is positive for an antibiotic-resistant pathogen. |
9 months | |
Secondary | Number of ICU Patients Who Acquire CABSI | 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 | 9 months | |
Secondary | Number of ICU Patients Who Acquire CAUTI | In all of the intensive-care units, catheter-associated urinary tract infection 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 | 9 months | |
Secondary | Number of ICU Patients Who Acquire VAP | In all of the intensive-care units, 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 | 9 months | |
Secondary | Changes from Baseline in 30-day Mortality Rate | 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. This information will be recorded on an individual basis by the coordinator but will be reported on a group-level to the research center. | 9 months | |
Secondary | Changes from Baseline in ICU LOS | 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. | 9 months | |
Secondary | Number of Adverse Events Occuring in the ICU | 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. | 9 months |
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