Direct Gloving Strategy: A Cluster-randomized Trial

NCT03119389 | Completed Results

• 1 other identifier: HP-00065259
• Study Type: interventional
• Target: 14,418
• Locations: 1 country
• Sites: 3

Brief Summary

The necessity of Hand hygiene (HH) before donning non-sterile gloves is unknown. Furthermore, because of the additional time required to cleanse hands and then don gloves, as well as the cumbersome nature of applying gloves to recently washed hands, this practice leads to non-compliance with both HH and glove use - placing patients at risk. In a pilot study, the investigators performed a randomized trial of 230 healthcare workers and demonstrated no difference in total bacterial colony counts or identification of pathogenic bacteria from the gloves of persons who either performed HH or did not perform HH prior to putting on non-sterile gloves. If unnecessary, HH before non-sterile glove use wastes valuable time, which might otherwise be spent engaged in direct patient care. And removing this unnecessary step may lead to increased compliance with infection prevention measures. In Aim A, the investigators will perform a multi-center randomized control trial to evaluate the efficacy of a direct gloving strategy to improve compliance with infection prevention practices. In Aim B, the investigators will perform a nested multi-center validation study, where the gloved hands of healthcare workers will be randomly sampled to determine bacterial contamination of non-sterile gloves after donning.

Conditions

Hand Hygiene

Keywords

Hand Hygiene; Non-sterile glove use

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Composite Compliance With Expected Infection Prevention Practices Upon Entry to Contact Precaution-patient Rooms

  Healthcare workers in the usual care group will be recorded as compliant if hand hygiene AND glove use is observed at room entry; healthcare workers in the intervention group only need to have glove use observed to be considered compliant.

  1 year

Secondary Outcomes (3)

• Proportion of Healthcare Worker Who Use Glove on Entry Into Contact Precaution Rooms

  1 year

• Proportion of Healthcare Workers Who Perform Hand Hygiene on Entry Into Non-contact Precaution Room

  1 year

• Proportion of Healthcare Worker Who Perform Hand Hygiene on Exit From Any Room

  1 year

Other Outcomes (1)

• Mean Total Bacterial Colony Count

  1 year

Study Arms (2)

Donning Non-Sterile Gloves without HH

EXPERIMENTAL

In this arm, entire units will be assigned education that hand hygiene before donning non-sterile gloves is NOT necessary. For Aim A, observations will be made on compliance at entry and exit with hand hygiene and glove use. For Aim B, samples will be obtained from the gloves after donning to determine total aerobic colony counts and to identify important hospital pathogens

Behavioral: Donning Non-Sterile Gloves without HH

HH before donning Non-Sterile Gloves

NO INTERVENTION

In this arm, entire units will be assigned education that hand hygiene before donning non-sterile gloves IS necessary. For Aim A, observations will be made on compliance at entry and exit with hand hygiene and glove use. For Aim B, samples will be obtained from the gloves after donning to determine total aerobic colony counts and to identify important hospital pathogens

Interventions

Donning Non-Sterile Gloves without HH BEHAVIORAL

Current practice is to perform hand hygiene before donning of non-sterile gloves. In units assigned to the intervention, healthcare workers within the units will be educated that performing hand hygiene before donning non-sterile gloves is not necessary.

Donning Non-Sterile Gloves without HH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Health professional at one of the study sites
• Has direct interaction with patients at study sites (healthcare worker)

You may not qualify if:

• \<18 years old

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (3)

University of Iowa Hospitals

Iowa City, Iowa, 52242, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• Thom KA, Rock C, Robinson GL, Reisinger HS, Baloh J, Li S, Diekema DJ, Herwaldt LA, Johnson JK, Harris AD, Perencevich EN. Direct Gloving vs Hand Hygiene Before Donning Gloves in Adherence to Hospital Infection Control Practices: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2336758. doi: 10.1001/jamanetworkopen.2023.36758.

  PMID: 37883088 DERIVED

Results Point of Contact

• Title: Kerri Thom
• Organization: University of Maryland

kthom@som.umaryland.edu

410-706-6124

Study Officials

• Kerri Thom, MD, MS

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 18, 2017
• Study Start: January 1, 2016
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: May 19, 2020
• Results First Posted: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)