NCT01350479

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2011

Completed
1.4 years until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
4 months until next milestone

Results Posted

Study results publicly available

March 15, 2017

Completed
Last Updated

October 5, 2017

Status Verified

September 1, 2017

Enrollment Period

3.3 years

First QC Date

May 6, 2011

Results QC Date

November 16, 2016

Last Update Submit

September 6, 2017

Conditions

Keywords

Cross infectionLong term care

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

MRSA colonized

Residents with history of MRSA in the past year

Not MRSA colonized

Residents without history of MRSA in the past year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Veterans residing in a participating VA Long Term Care Facility

You may qualify if:

  • 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

You may not qualify if:

  • Residents:
  • None
  • Health Care Worker:
  • Unable or unwilling to wear protective gown or gloves during healthcare workers (HCW)-resident interaction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Washington DC VA Medical Center, Washington, DC

Washington D.C., District of Columbia, 20422, United States

Location

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

Rehabilitation R&D Service, Baltimore, MD

Baltimore, Maryland, 21202, United States

Location

Perry Point VA Medical Center VA Maryland Health Care System, Perry Point, MD

Perry Point, Maryland, 21902, United States

Location

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130, United States

Location

VA Western New York Healthcare System, Buffalo, NY

Buffalo, New York, 14215, United States

Location

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, 78229, United States

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

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.

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Mary-Claire Roghmann
Organization
VA Maryland Healthcare System

Study Officials

  • Mary-Claire Roghmann, MD

    Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2011

First Posted

May 9, 2011

Study Start

October 1, 2012

Primary Completion

January 15, 2016

Study Completion

November 1, 2016

Last Updated

October 5, 2017

Results First Posted

March 15, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations