Clinical trial NCT01350479: Gown and Glove Use to Prevent the Spread of Infection in VA Community Living Centers
Official title: Gown and Glove Use to Prevent the Spread of Infection in VA Community Living Centers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Methicillin-Resistant Staphylococcus Aureus
Keywords: Cross infection
Long term care
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2011-05-09
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Veterans residing in a participating VA Long Term Care Facility

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.

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, 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.

Eligibility criteria: 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:

* None

Health Care Worker:

* Unable or unwilling to wear protective gown or gloves during healthcare workers (HCW)-resident interaction

Primary outcomes:
measure: MRSA Transmission
timeFrame: Will be measured during 6-25 episodes of care interactions scheduled over the 30 days following resident enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Washington, D.C.
country: United States
facility: Washington DC VA Medical Center, Washington, DC
state: District of Columbia
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
city: Baltimore
country: United States
facility: Rehabilitation R&D Service, Baltimore, MD
state: Maryland
city: Perry Point
country: United States
facility: Perry Point VA Medical Center VA Maryland Health Care System, Perry Point, MD
state: Maryland
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
city: Buffalo
country: United States
facility: VA Western New York Healthcare System, Buffalo, NY
state: New York
city: San Antonio
country: United States
facility: South Texas Health Care System, San Antonio, TX
state: Texas
Study officials:
affiliation: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
name: Mary-Claire Roghmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 during care of residents in Veterans Affairs nursing homes. Am J Infect Control. 2017 Sep 1;45(9):947-953. doi: 10.1016/j.ajic.2017.03.004. Epub 2017 Apr 18.
citation: Jackson SS, Lydecker AD, Magder LS, Roghmann MC. Development and Validation of a Clinical Prediction Rule to Predict Transmission of Methicillin-Resistant Staphylococcus aureus in Nursing Homes. Am J Epidemiol. 2019 Jan 1;188(1):214-221. doi: 10.1093/aje/kwy220.
citation: Roghmann MC, Andronescu LR, Stucke EM, Johnson JK. Clostridium difficile Colonization of Nursing Home Residents. Infect Control Hosp Epidemiol. 2017 Oct;38(10):1267-1268. doi: 10.1017/ice.2017.172. Epub 2017 Aug 22. No abstract available.
citation: Blanco N, Pineles L, Lydecker AD, Johnson JK, Sorkin JD, Morgan DJ; VA Gown and Glove Investigators; Roghmann MC. Transmission of Resistant Gram-Negative Bacteria to Health Care Worker Gowns and Gloves during Care of Nursing Home Residents in Veterans Affairs Community Living Centers. Antimicrob Agents Chemother. 2017 Sep 22;61(10):e00790-17. doi: 10.1128/AAC.00790-17. Print 2017 Oct.