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Gown and Glove Use to Prevent the Spread of Infection in VA Community Living Centers

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01350479
First received: May 6, 2011
Last updated: July 21, 2016
Last verified: July 2016

May 6, 2011
July 21, 2016
October 2012
January 2016   (final data collection date for primary outcome measure)
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
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
Complete list of historical versions of study NCT01350479 on ClinicalTrials.gov Archive Site
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Gown and Glove Use to Prevent the Spread of Infection in VA Community Living Centers
Gown and Glove Use to Prevent the Spread of Infection in VA Community Living Centers
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.
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, the investigators will enroll ~400 MRSA-colonized residents and health care workers from VA community living centers in four states and the District of Columbia. Additionally, the investigators will enroll some non-MRSA colonized residents as control subjects. Each enrolled resident will be followed for 6-25 episodes of care observations over 30 days. During each observation, the investigators 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, the investigators 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 the investigators' analysis will be used to develop new infection control guidelines which balance patient safety and a home-like, patient-centered environment.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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.
Non-Probability Sample
Veterans residing in a participating VA Long Term Care Facility
Methicillin-Resistant Staphylococcus Aureus
Not Provided
  • MRSA colonized
    Residents with history of MRSA in the past year
  • Not MRSA colonized
    Residents without history of MRSA in the past year
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
203
December 2016
January 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

Resident:

  • Age 18 years
  • Reside in a participating LTCF for rehabilitation, skilled nursing or maintenance care
  • Expected length of stay of >4 weeks from enrollment
  • Written informed consent from participant, or written informed consent from legally authorized representative (LAR) with assent from participant

Health Care Worker:

  • Has direct interaction with participating residents at participating VA Long Term Care Facility (LTCF)
  • Verbal informed consent

Exclusion Criteria:

Residents:

Health Care Worker:

  • Unable or unwilling to wear protective gown or gloves during healthcare workers (HCW)-resident interaction
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01350479
IIR 10-154
No
No
Not Provided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Mary-Claire Roghmann, MD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
VA Office of Research and Development
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP