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: May 1, 2014
Last verified: April 2014
  Purpose

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.


Condition
Methicillin-Resistant Staphylococcus Aureus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gown and Glove Use to Prevent the Spread of Infection in VA Community Living Centers

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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


Biospecimen Retention:   Samples Without DNA

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.


Estimated Enrollment: 400
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
MRSA colonized veterans residing in a participating VA Long Term Care Facility

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

MRSA colonized veterans residing in a participating VA Long Term Care Facility

Criteria

Inclusion Criteria:

Resident:

  • Age 18 years
  • Recent MRSA colonization (defined by one positive surveillance cultures in the last year).
  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350479

Locations
United States, District of Columbia
Washington DC VA Medical Center, Washington, DC
Washington, District of Columbia, United States, 20422
United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
Rehabilitation R&D Service, Baltimore, MD
Baltimore, Maryland, United States, 21202
Perry Point VA Medical Center VA Maryland Health Care System, Perry Point, MD
Perry Point, Maryland, United States, 21902
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
United States, New York
VA Western New York Healthcare System, Buffalo, NY
Buffalo, New York, United States, 14215
United States, Pennsylvania
Philadelphia VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Investigators
Principal Investigator: Mary-Claire Roghmann, MD University of Maryland
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01350479     History of Changes
Other Study ID Numbers: IIR 10-154
Study First Received: May 6, 2011
Last Updated: May 1, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Cross infection
Long term care

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on August 19, 2014