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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
367

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 26, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 26, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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