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Targeted Gown and Glove Intervention in Nursing Homes (TAGG)

Primary Purpose

Staphylococcus Aureus, Carbapenem Resistant Gram Negative Bacteria

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Targeted gown and gloves use
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Staphylococcus Aureus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

  • University of Maryland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Baseline

Arm Description

Targeted gown and glove use for high risk care activities in high risk residents

Standard of Care

Outcomes

Primary Outcome Measures

Staphylococcus aureus acquisition as determined by surveillance cultures in short stay residents
Rate of Staphylococcus aureus acquisition by short stay residents comparing the baseline and intervention periods
Carbapenem-resistant gram-negative bacteria acquisition as determined by surveillance cultures in short stay residents
Rate of carbapenem-resistant gram-negative bacteria acquisition by short stay residents comparing the baseline and intervention periods
Percentage of high risk patients correctly identified and placed on contact precautions
Percentage of high risk patients with wound and medical devices correctly identified and placed on contact precautions
Percentage of healthcare workers using personal protective equipment during high risk care
Percentage of healthcare workers using personal protective equipment when performing high risk care on high-risk residents

Secondary Outcome Measures

Full Information

First Posted
December 6, 2019
Last Updated
November 15, 2022
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT04200508
Brief Title
Targeted Gown and Glove Intervention in Nursing Homes
Acronym
TAGG
Official Title
Cluster Randomized Trial With Cross-over of Targeted Gown and Glove Intervention to Prevent Staphylococcus Aureus and Carbapenem-resistant Gram-negative Bacteria Acquisition in Community-based Nursing Homes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped due to COVID-19 in March 2022. It will not resume because the intervention, enhanced barrier precautions, has been recommended by the CDC and Prevention for nursing homes and is currently being implemented.
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
March 10, 2020 (Actual)
Study Completion Date
March 10, 2020 (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 project will assess the feasibility of a cluster-randomized trial with crossover of our intervention, targeted gown and glove use, among high-risk residents of community nursing homes to prevent Staphylococcus aureus and carbapenem gram negative bacteria acquisition and infection.
Detailed Description
Nursing homes are settings with a high rate of Staphylococcus aureus (SA) and carbapenem -resistant Gram-negative bacteria (C-GNB) acquisition, which can lead to infection, particularly for short stay residents who are recovering from an acute illness. The current standard of care for preventing antibiotic-resistant bacteria acquisition 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 intervention is gown and glove use for high-risk care of high-risk residents based on prior research showing the increased risk of transmission from residents to healthcare workers' hands and clothing associated with certain care activities. Rather than wearing gowns and gloves for all care activities to prevent transmission (as would be indicated for Contact Precautions), gown and glove use is targeted to specific resident care activities (e.g., bathing, dressing, and toileting) with prolonged resident-staff contact. The intervention will occur on units with a mix of long stay and short stay residents, within the nursing home with the NH as the unit of analysis. The primary outcome will be SA, both methicillin-resistant Staphylococcus aureus (MRSA), and methicillin susceptible Staphylococcus aureus (MSSA), and C-GNB acquisition as determined by surveillance cultures in short stay residents, which is a more frequent outcome than infection. During an 8-12 week baseline period, SA and C-GNB acquisition will be assessed via culture and use of gown and gloves for high-risk care of high-risk residents shall be assessed at all nursing homes. A 4-week training period shall occur for each of the nursing homes prior to the start of the intervention period where the NH staff shall be trained on the targeted gown and glove approach. The training period shall be followed by an 8-12 week intervention period, during which SA and C-GNB acquisition shall be assessed via culture and use of own and gloves for high risk care of high-risk residents shall again be assessed and compared to the baseline period. Each nursing home shall act as their own control, via direct comparison of each nursing home during the intervention to itself during the baseline period, reducing variability. The two nursing homes in group 1 shall be trained on and then implement the intervention during study period 1, while the two nursing homes in group 2 continue the baseline period. The two nursing homes in group 2 shall then undergo training and implementation the intervention in study period 2 while the group 1 nursing homes have a washout period then the cross-over baseline observations and cultures. The baseline period, intervention period, and the cross-over baseline period shall each continue for 8-12 weeks aiming for at least 100 resident admissions during each of the study periods (baseline period, intervention period, and cross-over baseline period). Some facilities may not reach 100, but the average across must exceed 100 each.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcus Aureus, Carbapenem Resistant Gram Negative Bacteria

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Nursing home units with a mix of long- and short-stay residents will be the unit of analysis. All nursing homes participating will go through a 8-12 week baseline. Two nursing homes will be randomized to perform the intervention, while the other two continue with an extended baseline. After 8-12 weeks, there will be a washout period of 4 weeks and then the nursing homes will crossover; nursing homes that were in the intervention arm will go back to baseline and those in the extended baseline will perform the intervention. Throughout each study period, we will be assessing Staphylococcus aureus and carbapenem resistant gram-negative bacteria acquisition among residents on each of the nursing homes units being studied
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Targeted gown and glove use for high risk care activities in high risk residents
Arm Title
Baseline
Arm Type
No Intervention
Arm Description
Standard of Care
Intervention Type
Other
Intervention Name(s)
Targeted gown and gloves use
Intervention Description
Gown and glove use for high risk care activities in high risk residents
Primary Outcome Measure Information:
Title
Staphylococcus aureus acquisition as determined by surveillance cultures in short stay residents
Description
Rate of Staphylococcus aureus acquisition by short stay residents comparing the baseline and intervention periods
Time Frame
1 year
Title
Carbapenem-resistant gram-negative bacteria acquisition as determined by surveillance cultures in short stay residents
Description
Rate of carbapenem-resistant gram-negative bacteria acquisition by short stay residents comparing the baseline and intervention periods
Time Frame
1 year
Title
Percentage of high risk patients correctly identified and placed on contact precautions
Description
Percentage of high risk patients with wound and medical devices correctly identified and placed on contact precautions
Time Frame
1 year
Title
Percentage of healthcare workers using personal protective equipment during high risk care
Description
Percentage of healthcare workers using personal protective equipment when performing high risk care on high-risk residents
Time Frame
1 year

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
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Targeted Gown and Glove Intervention in Nursing Homes

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