Direct Gloving Strategy: A Cluster-randomized Trial

• Sponsor: University of Maryland, Baltimore (Other)
• Overall Status: Completed
• CT.gov ID: NCT03119389
• Collaborator: Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)
• Enrollment: 14,418
• Locations: 3
• Arms: 2
• Actual Duration (Months): 23
• Patients Per Site: 4806
• Patients Per Site Per Month: 209.3

Study Details

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	N/A

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
• 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: Jan 1, 2016
• Actual Primary Completion Date: Nov 30, 2017
• Actual Study Completion Date: Nov 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 [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 [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 [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 [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 [1 year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

	Site	City	State	Country	Postal Code
1	University of Iowa Hospitals	Iowa City	Iowa	United States	52242
2	University of Maryland Medical Center	Baltimore	Maryland	United States	21201
3	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)

• Study Protocol and Statistical Analysis Plan - Oct 13, 2015

More Information

Publications

None provided.

• Responsible Party: Kerri A Thom, Principal Investigator, University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT03119389
• Other Study ID Numbers: HP-00065259
• First Posted: Apr 18, 2017
• Last Update Posted: May 19, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• 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, Principal Investigator, University of Maryland, Baltimore: Hand Hygiene; Non-sterile glove use

Study Results

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.

Arm/Group Title	HH Before Donning Non-Sterile Gloves	Donning Non-Sterile Gloves Without HH
Arm/Group Description	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 percentages for each outcome.	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 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. Individual healthcare workers within each unit were observed for the primary and secondary outcomes in order to obtain percentages for each outcome.
Period Title: Overall Study
STARTED	6791	7627
COMPLETED	6791	7627
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Donning Non-Sterile Gloves Without HH	HH Before Donning Non-Sterile Gloves	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	633	927	1560
Overall healthcare units	6	7	13
Age, Customized (Count of Participants)
Unknown	633 100%	927 100%	1560 100%
Sex/Gender, Customized (Count of Participants)
Unknown	633 100%	927 100%	1560 100%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Adherence to expected practice at entry to contact precaution rooms (Count of Participants)
Count of Participants [Participants]	236 37.3%	282 30.4%	518 33.2%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Composite Compliance With Expected Infection Prevention Practices Upon Entry to Contact Precaution-patient Rooms
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Donning Non-Sterile Gloves Without Hand Hygiene	Hand Hygiene Before Donning Non-Sterile Gloves
Arm/Group Description	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 outcome in order to obtain unit adherence for the primary outcome	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 outcome in order to obtain unit adherence for the primary outcome
Measure Participants	1491	2299
Count of Participants [Participants]	1297 204.9%	954 102.9%

2. Secondary Outcome

Title	Proportion of Healthcare Worker Who Use Glove on Entry Into Contact Precaution Rooms
Description	Proportion of healthcare worker compliance with glove use upon entry to Contact Precaution-patient rooms for both groups
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Donning Non-Sterile Gloves Without Hand Hygiene	Hand Hygiene Before Donning Non-Sterile Gloves
Arm/Group Description	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.	In this arm, entire units will be assigned education that hand hygiene before donning non-sterile gloves IS necessary.
Measure Participants	1491	2299
Count of Participants [Participants]	1297 204.9%	1530 165%

3. Secondary Outcome

Title	Proportion of Healthcare Workers Who Perform Hand Hygiene on Entry Into Non-contact Precaution Room
Description	Proportion of healthcare worker compliance with hand hygiene upon entry into non-contact precaution patient rooms
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Donning Non-Sterile Gloves Without Hand Hygiene	Hand Hygiene Before Donning Non-Sterile Gloves
Arm/Group Description	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.	In this arm, entire units will be assigned education that hand hygiene before donning non-sterile gloves IS necessary.
Measure Participants	1688	1315
Count of Participants [Participants]	1111 175.5%	951 102.6%

4. Secondary Outcome

Title	Proportion of Healthcare Worker Who Perform Hand Hygiene on Exit From Any Room
Description	Proportion of healthcare worker compliance with hand hygiene upon exit from any patient room
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Donning Non-Sterile Gloves Without Hand Hygiene	Hand Hygiene Before Donning Non-Sterile Gloves
Arm/Group Description	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.	In this arm, entire units will be assigned education that hand hygiene before donning non-sterile gloves IS necessary.
Measure Participants	1785	1897
Count of Participants [Participants]	1525 240.9%	1587 171.2%

5. Other Pre-specified Outcome

Title	Mean Total Bacterial Colony Count
Description	Mean bacterial colony count from gloves of healthcare workers in the intervention and control units
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Donning Non-Sterile Gloves Without Hand Hygiene	Hand Hygiene Before Donning Non-Sterile Gloves
Arm/Group Description	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.	In this arm, entire units will be assigned education that hand hygiene before donning non-sterile gloves IS necessary.
Measure Participants	1194	1189
Mean (Full Range) [Colony forming units]	16.3	9.5

Adverse Events

Time Frame	Adverse events were collected during the baseline of 6 months and intervention period of 1 year
Arm/Group Title	HH Before Donning Non-Sterile Gloves		Donning Non-Sterile Gloves Without HH
Arm/Group Description	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		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 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.
All Cause Mortality
	HH Before Donning Non-Sterile Gloves		Donning Non-Sterile Gloves Without HH
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6700 (0%)		0/6158 (0%)
Serious Adverse Events
	HH Before Donning Non-Sterile Gloves		Donning Non-Sterile Gloves Without HH
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6700 (0%)		0/6158 (0%)
Other (Not Including Serious) Adverse Events
	HH Before Donning Non-Sterile Gloves		Donning Non-Sterile Gloves Without HH
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6700 (0%)		0/6158 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.