Preventing the Spread of Infection in Nursing Homes

September 11, 2023 updated by: Mary-Claire Roghmann, University of Maryland, Baltimore

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

367

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Belcamp, Maryland, United States, 21017
        • Lorien Riverside
      • Lutherville-Timonium, Maryland, United States, 21093
        • Lorien Mays Chapel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention: Targeted gown and glove use
Additional gowns and gloves used for high risk care activities
Other: Targeted gown and glove use
Gown and glove use for high risk care activities in high risk residents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of Staphylococcus Aureus Acquisition: Percentage of Short Stay Participants Who Acquired MRSA or MSSA (or Both) During the Study Period
Time Frame: 5 months: 2 months in the baseline period, one month to prep the intervention, then 2 months in the intervention period
Rates of Staphylococcus aureus acquisition in the baseline and intervention periods: Participants were swabbed in the anterior nares and inguinal fold at nursing home admission (or start of study period) and again at discharge (or end of study period). This is the percentage of participants who acquired MRSA or MSSA (or both) during the study period.
5 months: 2 months in the baseline period, one month to prep the intervention, then 2 months in the intervention period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of Staphylococcus Aureus Transmission: Percentage of Short Stay Participants Who Acquired MRSA or MSSA (or Both) From MRSA/MSSA Transmission From Another Study Participant During the Study Period
Time Frame: 5 months
Rates of Staphylococcus aureus transmission in the baseline and intervention periods: Participants were swabbed in the anterior nares and inguinal fold at nursing home admission (or start of study period) and again at discharge (or end of study period). The DNA sequences of each SA isolate from each acquisition were evaluated to see if there was a match to another epidemiologically linked (same floor, same study period) SA isolate. This is the percentage of participants who acquired MRSA or MSSA (or both) from MRSA/MSSA transmission from another study participant during the study period.
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2017

Primary Completion (Actual)

July 26, 2018

Study Completion (Actual)

July 26, 2018

Study Registration Dates

First Submitted

October 18, 2017

First Submitted That Met QC Criteria

October 23, 2017

First Posted (Actual)

October 24, 2017

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00077879

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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