Gown and Glove Use to Prevent the Spread of Infection in VA Community Living Centers
| Tracking Information | |||||
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| First Received Date ICMJE | May 6, 2011 | ||||
| Last Updated Date | January 18, 2013 | ||||
| Start Date ICMJE | October 2012 | ||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
MRSA Transmission [ Time Frame: Will be measured during 6-25 episodes of care interactions scheduled over the 30 days following resident enrollment ] [ Designated as safety issue: No ] Presence of MRSA on gown or gloves worn by enrolled health care worker for research purposes while providing a specific type of care for enrolled resident |
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| Original Primary Outcome Measures ICMJE |
MRSA Transmission [ Time Frame: Will be measured during 25-40 episodes of care during five study visits scheduled over the 14 days following resident enrollment ] [ Designated as safety issue: No ] Presence of MRSA on gown or gloves worn by enrolled health care worker for research purposes while providing a specific type of care for enrolled resident |
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| Change History | Complete list of historical versions of study NCT01350479 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Gown and Glove Use to Prevent the Spread of Infection in VA Community Living Centers | ||||
| Official Title ICMJE | Gown and Glove Use to Prevent the Spread of Infection in VA Community Living Centers | ||||
| Brief Summary | Methicillin-resistant S. aureus (MRSA) infections are a common cause of morbidity and mortality in nursing home residents. MRSA is predominantly spread from patient-to-patient by health care workers. The use of gowns, gloves and hand washing prevents this spread; however, their use detracts from a patient-centered, home-like environment which is an important priority for nursing homes. The goal of this project is to determine when it is most important for health care workers to wear gowns and to wash their hands when caring for MRSA colonized veterans in community living centers. |
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| Detailed Description | Methicillin-resistant S. aureus (MRSA) infections are a common cause of morbidity and mortality in nursing home residents. MRSA is predominantly spread from patient-to-patient by health care workers. The use of gowns, gloves and hand washing prevents this spread; however, their use detracts from a patient-centered, home-like environment which is an important priority for nursing homes. The goal of this project is to determine when it is most important for health care workers to wear gowns and to wash their hands when caring for MRSA colonized veterans in community living centers. To meet this goal, we will enroll ~400 MRSA-colonized residents and health care workers from VA community living centers in four states and the District of Columbia. Each enrolled resident will be followed for 6-25 episodes of care observations over 30 days. During each observation, we will have health care workers wear disposable gowns and gloves during each care activity (e.g. wound dressing) that occurs during the study visit. At the end of each care activity, we will swab the gown and gloves prior to disposing of them. Each swab will be tested for MRSA to determine if MRSA from the resident was transferred to the healthcare worker's gown or gloves during that episode of care. The results of our analysis will be used to develop new infection control guidelines which balance patient safety and a home-like, patient-centered environment. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Swabs of the gowns and gloves of health care workers that interact with the participants will be tested for MRSA and other types of bacteria. Swabs from body sites (e.g. nose) of participants will be tested for MRSA and other types of bacteria. |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | MRSA colonized veterans residing in a participating VA Long Term Care Facility |
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| Condition ICMJE | Methicillin-Resistant Staphylococcus Aureus | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Group 1
MRSA colonized veterans residing in a participating VA Long Term Care Facility |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 400 | ||||
| Estimated Completion Date | December 2015 | ||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Resident:
Health Care Worker:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01350479 | ||||
| Other Study ID Numbers ICMJE | IIR 10-154 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Department of Veterans Affairs | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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