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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRSA colonized | Residents with history of MRSA in the past year | ||
| Not MRSA colonized | Residents without history of MRSA in the past year |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Resident:
Health Care Worker:
Exclusion Criteria:
Residents:
Health Care Worker:
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Veterans residing in a participating VA Long Term Care Facility
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| Name | Affiliation | Role |
|---|---|---|
| Mary-Claire Roghmann, MD | Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington DC VA Medical Center, Washington, DC | Washington D.C. | District of Columbia | 20422 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28431853 | Result | 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. | |
| 30351349 |
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Three participants withdrew from the study prior to cultures being obtained and were not assigned to a study group.
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| ID | Title | Description |
|---|---|---|
| FG000 | MRSA Colonized | Residents colonized with MRSA by culture at study admission |
| FG001 | Not MRSA Colonized | Residents not colonized with MRSA by culture at study admission |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MRSA Colonized | Residents colonized with MRSA by culture at study admission |
| BG001 | Not MRSA Colonized | Residents not colonized with MRSA by culture at study admission |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | We analyzed the number of gown and glove swabs from HCW interacting with MRSA and non-MRSA colonized residents. | Posted | Number | Proportion of swabs positive for MRSA | Will be measured during 6-25 episodes of care interactions scheduled over the 30 days following resident enrollment | swabs | swabs |
|
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Only serious adverse events were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MRSA Colonized | Residents colonized with MRSA by culture at study admission |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Residents transferred from nursing home to acute care hospital, unrelated to study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary-Claire Roghmann | VA Maryland Healthcare System | 410-706-0062 | mroghman@epi.umaryland.edu |
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| ID | Term |
|---|---|
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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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.
| Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| Rehabilitation R&D Service, Baltimore, MD | Baltimore | Maryland | 21202 | United States |
| Perry Point VA Medical Center VA Maryland Health Care System, Perry Point, MD | Perry Point | Maryland | 21902 | United States |
| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston | Massachusetts | 02130 | United States |
| VA Western New York Healthcare System, Buffalo, NY | Buffalo | New York | 14215 | United States |
| South Texas Health Care System, San Antonio, TX | San Antonio | Texas | 78229 | United States |
| Derived |
| 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. |
| 28826425 | Derived | 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. |
| 28717036 | Derived | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Swabs collected from healthcare workers interacting with residents not colonized with MRSA by culture on enrollment |
|
|
| 9 |
| 94 |
| 0 |
| 0 |
| EG001 | Not MRSA Colonized | Residents not colonized with MRSA by culture at study admission | 8 | 106 | 0 | 0 |
|
| Death | General disorders | Death of resident unrelated to study |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |