Preventing the Spread of Infection in Nursing Homes
Primary Purpose
Staphylococcus Aureus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Targeted gown and glove use
Sponsored by
About this trial
This is an interventional prevention trial for Staphylococcus Aureus
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years
- Reside in a participating nursing home
Exclusion Criteria:
- Identified by nursing home staff as combative or with other behavioral problems which could lead to agitation if approached by project staff
Sites / Locations
- Lorien Riverside
- Lorien Mays Chapel
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention: Targeted gown and glove use
Arm Description
Additional gowns and gloves used for high risk care activities
Outcomes
Primary Outcome Measures
Rates of Staphylococcus aureus acquisition
Rates of Staphylococcus aureus acquisition in the baseline and intervention periods
Secondary Outcome Measures
Rates of Staphylococcus aureus transmission
Rates of Staphylococcus aureus transmission in the baseline and intervention periods
Full Information
NCT ID
NCT03319368
First Posted
October 18, 2017
Last Updated
April 8, 2022
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT03319368
Brief Title
Preventing the Spread of Infection in Nursing Homes
Official Title
Implementation of a Novel Strategy to Prevent Staphylococcus Aureus (SA) Acquisition in Community-Based Nursing Homes to Prevent Invasive SA Infection - Feasibility and Pilot to Guide a Multicenter Stepped Wedge Cluster Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 18, 2017 (Actual)
Primary Completion Date
July 26, 2018 (Actual)
Study Completion Date
July 26, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the feasibility of targeting more frequent gown and glove use for specific high risk moments of care in specific nursing home residents in order to prevent Staphylococcus aureus (SA) acquisition and infection.
Detailed Description
Nursing homes are settings with a high rate of Staphylococcus aureus (SA) acquisition, which leads to infection, particularly for short stay residents. The current standard of care for preventing SA acquisition and SA infection in nursing homes is Standard Precautions (gowns and gloves for anticipated contact with blood, body fluids, skin breakdown or mucous membranes) for all residents.
The investigators propose a feasibility study of a novel strategy, the addition of targeted gown and glove use, to prevent SA acquisition and SA infection in residents of nursing homes. Rather than wearing gowns and gloves for all care activities to prevent transmission, gown and glove use can be targeted to specific high risk "moments" of care for specific high risk residents. High risk "moments" for gown and glove use are care activities most likely to transmit SA based on prior research. Residents with chronic wounds and medical devices are: 1) most likely to be colonized with SA; 2) most likely to acquire SA; 3) most likely to transmit SA to healthcare worker clothing and hands; and 4) most likely to develop a SA infection based on prior research and thus would be considered high risk residents.
The investigators will perform a quasi-experimental (before-after) study of this intervention, targeted gown and glove use, at two community-based nursing homes to demonstrate its feasibility and evaluate its effect on SA acquisition and SA infection rates.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcus Aureus
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
367 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention: Targeted gown and glove use
Arm Type
Experimental
Arm Description
Additional gowns and gloves used for high risk care activities
Intervention Type
Other
Intervention Name(s)
Targeted gown and glove use
Intervention Description
Gown and glove use for high risk care activities in high risk residents
Primary Outcome Measure Information:
Title
Rates of Staphylococcus aureus acquisition
Description
Rates of Staphylococcus aureus acquisition in the baseline and intervention periods
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Rates of Staphylococcus aureus transmission
Description
Rates of Staphylococcus aureus transmission in the baseline and intervention periods
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years
Reside in a participating nursing home
Exclusion Criteria:
Identified by nursing home staff as combative or with other behavioral problems which could lead to agitation if approached by project staff
Facility Information:
Facility Name
Lorien Riverside
City
Belcamp
State/Province
Maryland
ZIP/Postal Code
21017
Country
United States
Facility Name
Lorien Mays Chapel
City
Lutherville-Timonium
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33077004
Citation
Lydecker AD, Osei PA, Pineles L, Johnson JK, Meisel J, Stine OC, Magder L, Gurses AP, Hebden J, Oruc C, Mody L, Jacobs Slifka K, Stone ND, Roghmann MC. Targeted gown and glove use to prevent Staphylococcus aureus acquisition in community-based nursing homes: A pilot study. Infect Control Hosp Epidemiol. 2021 Apr;42(4):448-454. doi: 10.1017/ice.2020.1219. Epub 2020 Oct 20.
Results Reference
derived
Learn more about this trial
Preventing the Spread of Infection in Nursing Homes
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