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Direct Gloving Strategy: A Cluster-randomized Trial

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03119389
Enrollment
14418
Registered
2017-04-18
Start date
2016-01-01
Completion date
2017-11-30
Last updated
2020-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand Hygiene

Keywords

Hand Hygiene, Non-sterile glove use

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.

Interventions

BEHAVIORALDonning 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.

Sponsors

Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Composite Compliance With Expected Infection Prevention Practices Upon Entry to Contact Precaution-patient Rooms1 yearHealthcare 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

MeasureTime frameDescription
Proportion of Healthcare Worker Who Use Glove on Entry Into Contact Precaution Rooms1 yearProportion 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 Room1 yearProportion 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 Room1 yearProportion of healthcare worker compliance with hand hygiene upon exit from any patient room

Other

MeasureTime frameDescription
Mean Total Bacterial Colony Count1 yearMean bacterial colony count from gloves of healthcare workers in the intervention and control units

Countries

United States

Participant flow

Recruitment details

Units within each hospital were recruited to participate in the baseline study. Observation of healthcare worker hand hygiene and glove use were observed during the baseline period. Units with similar hand hygiene and glove use compliance were approached for participation in the study.

Participants by arm

ArmCount
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. Donning Non-Sterile Gloves without hand hygiene: 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. Individual healthcare workers within each unit were observed for the primary and secondary outcomes in order to obtain adherence to expected practice at entry to contact precaution rooms.
633
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. Donning Non-Sterile Gloves without hand hygiene: 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. Individual healthcare workers within each unit were observed for the primary and secondary outcomes in order to obtain adherence to expected practice at entry to contact precaution rooms.
6
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. Individual healthcare workers within each unit were observed for the primary and secondary outcomes in order to obtain adherence to expected practice at entry to contact precaution rooms.
927
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. Individual healthcare workers within each unit were observed for the primary and secondary outcomes in order to obtain adherence to expected practice at entry to contact precaution rooms.
7
Total1,573

Baseline characteristics

CharacteristicTotalHH Before Donning Non-Sterile GlovesDonning Non-Sterile Gloves Without HH
Adherence to expected practice at entry to contact precaution rooms518 Participants282 Participants236 Participants
Age, Customized
Unknown
1560 Participants927 Participants633 Participants
Race and Ethnicity Not Collected0 Participants
Sex/Gender, Customized
Unknown
1560 Participants927 Participants633 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 6,7000 / 6,158
other
Total, other adverse events
0 / 6,7000 / 6,158
serious
Total, serious adverse events
0 / 6,7000 / 6,158

Outcome results

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.

Time frame: 1 year

Population: The number analyzed is the number of observations made within each group of units randomized

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Donning Non-Sterile Gloves Without Hand HygieneNumber of Participants With Composite Compliance With Expected Infection Prevention Practices Upon Entry to Contact Precaution-patient Rooms1297 Participants
Hand Hygiene Before Donning Non-Sterile GlovesNumber of Participants With Composite Compliance With Expected Infection Prevention Practices Upon Entry to Contact Precaution-patient Rooms954 Participants
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

Time frame: 1 year

Population: The number analyzed is the number of observations made within each group of units randomized

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Donning Non-Sterile Gloves Without Hand HygieneProportion of Healthcare Workers Who Perform Hand Hygiene on Entry Into Non-contact Precaution Room1111 Participants
Hand Hygiene Before Donning Non-Sterile GlovesProportion of Healthcare Workers Who Perform Hand Hygiene on Entry Into Non-contact Precaution Room951 Participants
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

Time frame: 1 year

Population: The number analyzed is the number of observations made within each group of units randomized

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Donning Non-Sterile Gloves Without Hand HygieneProportion of Healthcare Worker Who Perform Hand Hygiene on Exit From Any Room1525 Participants
Hand Hygiene Before Donning Non-Sterile GlovesProportion of Healthcare Worker Who Perform Hand Hygiene on Exit From Any Room1587 Participants
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

Time frame: 1 year

Population: The number analyzed is the number of observations made within each group of units randomized

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Donning Non-Sterile Gloves Without Hand HygieneProportion of Healthcare Worker Who Use Glove on Entry Into Contact Precaution Rooms1297 Participants
Hand Hygiene Before Donning Non-Sterile GlovesProportion of Healthcare Worker Who Use Glove on Entry Into Contact Precaution Rooms1530 Participants
Other Pre-specified

Mean Total Bacterial Colony Count

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

Time frame: 1 year

Population: The number analyzed is the number of observations made within each group of units randomized

ArmMeasureValue (MEAN)
Donning Non-Sterile Gloves Without Hand HygieneMean Total Bacterial Colony Count16.3 Colony forming units
Hand Hygiene Before Donning Non-Sterile GlovesMean Total Bacterial Colony Count9.5 Colony forming units

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026