Direct Gloving Strategy: A Cluster-randomized Trial

Hand Hygiene Clinical Trial

Official title:

Efficacy of a Direct Gloving Strategy to Improve Compliance With Infection Prevention Practices: A Cluster-randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03119389
• Other study ID #: HP-00065259
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: November 30, 2017

Study information

• Verified date: May 2020
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14418
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	University of Iowa Hospitals	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean Total Bacterial Colony Count	Mean bacterial colony count from gloves of healthcare workers in the intervention and control units	1 year
Primary	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	Proportion of Healthcare Worker Who Use Glove on Entry Into Contact Precaution Rooms	Proportion of healthcare worker compliance with glove use upon entry to Contact Precaution-patient rooms for both groups	1 year
Secondary	Proportion of Healthcare Workers Who Perform Hand Hygiene on Entry Into Non-contact Precaution Room	Proportion of healthcare worker compliance with hand hygiene upon entry into non-contact precaution patient rooms	1 year
Secondary	Proportion of Healthcare Worker Who Perform Hand Hygiene on Exit From Any Room	Proportion of healthcare worker compliance with hand hygiene upon exit from any patient room	1 year