Direct Gloving Strategy: A Cluster-randomized Trial
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|ClinicalTrials.gov Identifier: NCT03119389|
Recruitment Status : Completed
First Posted : April 18, 2017
Results First Posted : May 19, 2020
Last Update Posted : May 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hand Hygiene||Behavioral: Donning Non-Sterile Gloves without HH||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||14418 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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
- Mean Total Bacterial Colony Count [ Time Frame: 1 year ]Mean bacterial colony count from gloves of healthcare workers in the intervention and control units
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119389
|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|
|Principal Investigator:||Kerri Thom, MD, MS||University of Maryland, College Park|