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

Tracking Information

• First Submitted Date: March 30, 2017
• First Posted Date: April 18, 2017
• Results First Submitted Date: March 30, 2020
• Results First Posted Date: May 19, 2020
• Last Update Posted Date: May 19, 2020
• Actual Study Start Date: January 1, 2016
• Actual Primary Completion Date: November 30, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 6, 2020)

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.

Original Primary Outcome Measures (submitted: April 13, 2017)

Composite Compliance with expected infection prevention practices upon entry to contact Precaution-patient rooms [ Time Frame: HCW will be observed for about 1 minute before entering a contact room ]

HCWs in the usual care group will be recorded as compliant if HH AND glove use is observed at room entry; HCWs in the intervention group only need to have glove use observed to be considered compliant.

Current Secondary Outcome Measures (submitted: May 6, 2020)

• 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
• 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
• 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

Original Secondary Outcome Measures (submitted: April 13, 2017)

• Proportion of HCW who use glove on entry into Contact Precaution Rooms [ Time Frame: HCW will be observed for about 1 minute before entering a contact room ]
  Compliance with glove use upon entry to Contact Precaution-patient rooms for both groups
• Proportion of HCW who perform HH on entry into non-contact precaution room [ Time Frame: HCW will be observed for about 1 minute before entering a non-contact room ]
  Compliance with hand hygiene upon entry to non-contact precaution patient rooms
• Proportion of HCW who perform Hand Hygiene on exit from any room [ Time Frame: HCW will be observed for about 1 minute upon exit from any patient room ]
  Compliance with hand hygiene upon exit from any patient room

Current Other Pre-specified Outcome Measures (submitted: May 6, 2020)

Mean Total Bacterial Colony Count [ Time Frame: 1 year ]

Mean bacterial colony count from gloves of healthcare workers in the intervention and control units

Original Other Pre-specified Outcome Measures (submitted: April 13, 2017)

Difference in Total Aerobic Colony Counts [ Time Frame: The total time of participation from the healthcare worker will be approximately 2-3 minutes, the time needed to culture gloves after either hand hygiene and donning of gloves or just donning gloves ]

The Difference in Total Aerobic Colony Counts from gloves of healthcare workers in the intervention units and healthcare workers in the control units.

Descriptive Information

• Brief Title: Direct Gloving Strategy: A Cluster-randomized Trial
• Official Title: Efficacy of a Direct Gloving Strategy to Improve Compliance With Infection Prevention Practices: A Cluster-randomized Trial
• 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.

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Hand Hygiene

Intervention

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.

Study Arms

• 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
  Intervention: Behavioral: Donning Non-Sterile Gloves without HH
• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 6, 2020): 14418
• Original Estimated Enrollment (submitted: April 13, 2017): 14
• Actual Study Completion Date: November 30, 2017
• Actual Primary Completion Date: November 30, 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03119389
• Other Study ID Numbers: HP-00065259
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Kerri A Thom, University of Maryland, Baltimore
• Study Sponsor: University of Maryland, Baltimore
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)

Investigators

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

• PRS Account: University of Maryland, Baltimore
• Verification Date: May 2020