Preventing the Spread of Infection in Nursing Homes

Sponsor

University of Maryland, Baltimore (Other)

Overall Status

Completed

CT.gov ID

NCT03319368

Collaborator

(none)

367

Enrollment

Locations

Arm

7.2

Actual Duration (Months)

183.5

Patients Per Site

25.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Staphylococcus Aureus	Other: Targeted gown and glove use	N/A

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:

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 Design

Study Type:

Interventional

Actual Enrollment :

367 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Dec 18, 2017

Actual Primary Completion Date :

Jul 26, 2018

Actual Study Completion Date :

Jul 26, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Rates of Staphylococcus aureus acquisition [5 months]
Rates of Staphylococcus aureus acquisition in the baseline and intervention periods

Secondary Outcome Measures

Rates of Staphylococcus aureus transmission [5 months]
Rates of Staphylococcus aureus transmission in the baseline and intervention periods

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lorien Riverside	Belcamp	Maryland	United States	21017
2	Lorien Mays Chapel	Lutherville-Timonium	Maryland	United States	21093

Sponsors and Collaborators

University of Maryland, Baltimore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mary-Claire Roghmann, Professor, University of Maryland, Baltimore

ClinicalTrials.gov Identifier:

NCT03319368

Other Study ID Numbers:

HP-00077879

First Posted:

Oct 24, 2017

Last Update Posted:

Apr 15, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Staphylococcal Infections

Study Results

No Results Posted as of Apr 15, 2022