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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01350479
First received: May 6, 2011
Last updated: October 7, 2014
Last verified: October 2014

May 6, 2011
October 7, 2014
October 2012
June 2015   (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
Not Provided
Not Provided
Not Provided
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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, we will enroll ~400 MRSA-colonized residents and health care workers from VA community living centers in four states and the District of Columbia. Additionally, we 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, 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.

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
  • Group 1
    MRSA colonized veterans residing in a participating VA Long Term Care Facility
  • Group 2
    Non-MRSA colonized veterans residing in a participating VA Long Term Care Facility
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
400
December 2015
June 2015   (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 LAR with assent from participant

Health Care Worker:

  • Has direct interaction with participating residents at participating VA LTCF
  • Verbal informed consent

Exclusion Criteria:

Residents:

  • None

Health Care Worker:

  • Unable or unwilling to wear protective gown or gloves during HCW-resident interaction
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01350479
IIR 10-154
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Mary-Claire Roghmann, MD University of Maryland
Department of Veterans Affairs
October 2014

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