Direct Gloving Strategy: A Cluster-randomized Trial

• ClinicalTrials.gov Identifier: NCT03119389
• Recruitment Status: Completed
• First Posted: April 18, 2017
• Results First Posted: May 19, 2020
• Last Update Posted: May 19, 2020
• Sponsor: University of Maryland, Baltimore
• Collaborator: Agency for Healthcare Research and Quality (AHRQ)
• Information provided by (Responsible Party): Kerri A Thom, University of Maryland, Baltimore

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hand Hygiene	Behavioral: Donning Non-Sterile Gloves without HH	Not Applicable

Detailed Description:

This study seeks to investigate alternative strategies to hand hygiene (HH) and glove use in situations where glove use is required to perform health care activities in an effort to increase compliance with infection prevention efforts.

HH is the cornerstone of infection prevention. Despite the importance of and increased focus on HH, compliance remains low in healthcare settings (40% on average in a large meta-analysis). Insufficient time, high workload and under staffing are important barriers. Glove use, which is common and increasing, is another major barrier. New strategies are needed that improve time and efficiency particularly in settings where glove use is required (e.g. Contact Precautions). One area for further study is the requirement for HH prior to non-sterile glove use. This is a recommended practice with poor compliance that may be unnecessary. Furthermore, it may lead to reduced compliance with other recommended infection prevention practices, such as glove use. In this proposal the investigators identify a novel strategy of directly gloving without performing HH prior to non-sterile glove use as a potential solution.

In this study the investigators aim to perform a multicenter, cluster-randomized trial to evaluate the efficacy of direct gloving to improve compliance with infection prevention practices (i.e. HH and glove use). Herein, the investigators will evaluate the safety and efficacy of directly gloving (compared to performing HH prior to glove use) and assess whether this strategy will lead to increased compliance with both HH and glove use. The investigators previously demonstrated the safety of this strategy in a single-center randomized controlled pilot trial where the investigators found no difference in bacterial contamination of gloves of healthcare providers who either performed or did not perform HH prior to donning non-sterile gloves. Thus, with potentially no added benefit and in a setting where the investigators know that HH compliance is the lowest (i.e. prior to glove use), mandating HH prior to donning gloves as recommended in current guidelines could actually reduce both HH and glove compliance, placing patients at increased risk for developing infection.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14418 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Efficacy of a Direct Gloving Strategy to Improve Compliance With Infection Prevention Practices: A Cluster-randomized Trial
• Actual Study Start Date: January 1, 2016
• Actual Primary Completion Date: November 30, 2017
• Actual Study Completion Date: November 30, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Donning Non-Sterile Gloves without HH; 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; 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.
No Intervention: HH before donning Non-Sterile Gloves; 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

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Composite Compliance With Expected Infection Prevention Practices Upon Entry to Contact Precaution-patient Rooms [ Time Frame: 1 year ]
   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.

Secondary Outcome Measures :

1. Proportion of Healthcare Worker Who Use Glove on Entry Into Contact Precaution Rooms [ Time Frame: 1 year ]
   Proportion of healthcare worker compliance with glove use upon entry to Contact Precaution-patient rooms for both groups
2. Proportion of Healthcare Workers Who Perform Hand Hygiene on Entry Into Non-contact Precaution Room [ Time Frame: 1 year ]
   Proportion of healthcare worker compliance with hand hygiene upon entry into non-contact precaution patient rooms
3. Proportion of Healthcare Worker Who Perform Hand Hygiene on Exit From Any Room [ Time Frame: 1 year ]
   Proportion of healthcare worker compliance with hand hygiene upon exit from any patient room

Other Outcome Measures:

1. Mean Total Bacterial Colony Count [ Time Frame: 1 year ]
   Mean bacterial colony count from gloves of healthcare workers in the intervention and control units

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

For Aim B

Inclusion Criteria:

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

Exclusion Criteria:

• <18 years old

Contacts and Locations

Locations

United States, Iowa

University of Iowa Hospitals

Iowa City, Iowa, United States, 52242

United States, Maryland

University of Maryland Medical Center

Baltimore, Maryland, United States, 21201

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

University of Maryland, Baltimore

Agency for Healthcare Research and Quality (AHRQ)

Investigators

• Principal Investigator: Kerri Thom, MD, MS; University of Maryland, College Park

  Study Documents (Full-Text)

Documents provided by Kerri A Thom, University of Maryland, Baltimore:

Study Protocol and Statistical Analysis Plan  [PDF] October 13, 2015

More Information

• Responsible Party: Kerri A Thom, Principal Investigator, University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT03119389
• Other Study ID Numbers: HP-00065259
• First Posted: April 18, 2017
• Results First Posted: May 19, 2020
• Last Update Posted: May 19, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kerri A Thom, University of Maryland, Baltimore:

Hand Hygiene; Non-sterile glove use