Targeted Gown and Glove Intervention in Nursing Homes

NCT04200508 | Terminated

• 1 other identifier: HP-00088648
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Staphylococcus Aureus; Carbapenem Resistant Gram Negative Bacteria

Outcome Measures

Primary Outcomes (4)

• 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

  1 year

• 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

  1 year

• 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

  1 year

• 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

  1 year

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Targeted gown and gloves use

Baseline

NO INTERVENTION

Standard of Care

Interventions

Targeted gown and gloves use OTHER

Gown and glove use for high risk care activities in high risk residents

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Reside in a participating nursing home

You may not qualify if:

• Identified by nursing home staff as combative or with other behavioral problems which could lead to agitation if approached by project staff

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 16, 2019
• Study Start: March 1, 2020
• Primary Completion: March 10, 2020
• Study Completion: March 10, 2020
• Last Updated: November 18, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)