Methicillin-Resistant Staphylococcus AureusNCT01350479
Gown and Glove Use to Prevent the Spread of Infection in VA Community Living Centers
An observational study of Methicillin-Resistant Staphylococcus Aureus, run by VA Office of Research and Development at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Methicillin-Resistant Staphylococcus Aureus
- How many people
- 203 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Oct 2012to 1 Nov 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Veterans residing in a participating VA Long Term Care Facility
Who may be able to join
- 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
Who cannot join
- Residents:
- None
- Health Care Worker:
- Unable or unwilling to wear protective gown or gloves during healthcare workers (HCW)-resident interaction
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
Rehabilitation R&D Service, Baltimore, MD
Baltimore, Maryland, 21202
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
VA Western New York Healthcare System, Buffalo, NY
Buffalo, New York, 14215
Perry Point VA Medical Center VA Maryland Health Care System, Perry Point, MD
Perry Point, Maryland, 21902
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, 20422
About this study
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.
Read the 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.
- Keywords
- Cross infection, Long term care
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MRSA colonized | Residents with history of MRSA in the past year | |
| Not MRSA colonized | Residents without history of MRSA in the past year |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Will be measured during 6-25 episodes of care interactions scheduled over the 30 days following resident enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2011 (estimated)
- Study start1 Oct 2012
- Primary completion15 Jan 2016
- Study completion1 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Methicillin-Resistant Staphylococcus AureusStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Mary-Claire Roghmann, MD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350479
- Sponsor's protocol ID
- IIR 10-154
- Status last verified
- Sep 2017
- First submitted
- 6 May 2011
- Last updated
- 5 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28431853Jackson 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.
PubMed 30351349Roghmann 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.
PubMed 28826425Blanco 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.
PubMed 28717036
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gown and Glove Use to Prevent the Spread of Infection in VA Community Living Centers
- ClinicalTrials.gov ID
- NCT01350479
- Acronym / sponsor ID
- IIR 10-154
- Keywords
- Cross infection, Long term care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2012 (actual)
- Primary completion
- 15 Jan 2016 (actual)
- Study completion
- 1 Nov 2016 (actual)
- First posted
- 9 May 2011 (estimated)
- Results
- Posted 15 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRSA colonized | – | –Residents with history of MRSA in the past year |
| Not MRSA colonized | – | –Residents without history of MRSA in the past year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans residing in a participating VA Long Term Care Facility
Key inclusion criteria (8 listed)
- 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
- Has direct interaction with participating residents at participating VA Long Term Care Facility (LTCF)
Key exclusion criteria (4 listed)
- None
- Unable or unwilling to wear protective gown or gloves during healthcare workers (HCW)-resident interaction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MRSA Transmission
Time frame: Will be measured during 6-25 episodes of care interactions scheduled over the 30 days following resident enrollment
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28431853Pineles 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.
- Derived from this study: PubMed 30351349Jackson 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.
- Derived from this study: PubMed 28826425Roghmann 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.
- Derived from this study: PubMed 28717036Blanco 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary-Claire Roghmann, MD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Methicillin-Resistant Staphylococcus Aureus, run by VA Office of Research and Development at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01350479, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2017.