Benefits of Universal Glove and Gowning (BUGG)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01318213 |
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Recruitment Status : Unknown
Verified January 2012 by Yale New Haven Health System Center for Healthcare Solutions.
Recruitment status was: Active, not recruiting
First Posted : March 18, 2011
Last Update Posted : January 5, 2012
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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 or disease |
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| MRSA VRE |
Show Detailed Description
| Study Type : | Observational |
| Estimated Enrollment : | 2 participants |
| Time Perspective: | Prospective |
| Official Title: | Effect of the Use of Universal Glove and Gowning on Healthcare Associated Infection Rates and Antibiotic Resistant Bacteria |
| Study Start Date : | December 2010 |
| Estimated Primary Completion Date : | September 2012 |
| Estimated Study Completion Date : | September 2012 |
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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.
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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.
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- Number of ICU Patients Who Acquire VRE or MRSA [ Time Frame: 9 months ]
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.
- Number of ICU Patients Who Acquire CABSI,CAUTI or VAP [ Time Frame: 9 months ]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 ]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 ]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
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318213
| United States, Maryland | |
| University of Maryland, Baltimore | |
| Baltimore, Maryland, United States, 21201 | |
| Principal Investigator: | Anthony D Harris, MD, MPH | University of Maryland |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 ( Other Grant/Funding Number: AHRQ PRISM No. HHSA29032002T ) |
| First Posted: | March 18, 2011 Key Record Dates |
| Last Update Posted: | January 5, 2012 |
| Last Verified: | January 2012 |
Keywords provided by Yale New Haven Health System Center for Healthcare Solutions:
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VRE MRSA |