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

Methicillin-Resistant Staphylococcus Aureus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01350479
• Other study ID #: IIR 10-154
• Status: Completed
• Phase: N/A
• First received: May 6, 2011
• Last updated: September 6, 2017
• Start date: October 1, 2012
• Est. completion date: November 1, 2016

Study information

• Verified date: September 2017
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: November 1, 2016
• Est. primary completion date: January 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Methicillin-Resistant Staphylococcus Aureus
• Staphylococcal Infections

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland
United States	Rehabilitation R&D Service, Baltimore, MD	Baltimore	Maryland
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts
United States	VA Western New York Healthcare System, Buffalo, NY	Buffalo	New York
United States	Perry Point VA Medical Center VA Maryland Health Care System, Perry Point, MD	Perry Point	Maryland
United States	South Texas Health Care System, San Antonio, TX	San Antonio	Texas
United States	Washington DC VA Medical Center, Washington, DC	Washington, D.C.	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Pineles L, Morgan DJ, Lydecker A, Johnson JK, Sorkin JD, Langenberg P, Blanco N, Lesse A, Sellick J, Gupta K, Leykum L, Cadena J, Lepcha N, Roghmann MC. Transmission of methicillin-resistant Staphylococcus aureus to health care worker gowns and gloves dur — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRSA Transmission	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	Will be measured during 6-25 episodes of care interactions scheduled over the 30 days following resident enrollment