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

• Study Type: Interventional
• 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
• Enrollment: 14418

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.
Pre-assignment Details

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
	Number of participants	Number of units (healthcare units)	Number of participants	Number of units (healthcare units)
Started	6791	7	7627	6
Completed	6791	7	7627	6
Not Completed	0	0	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 Number of Baseline Participants		633	927	1560
Overall Number of Units Analyzed; Type of Units Analyzed: Healthcare units		6	7	13
Baseline Analysis Population Description		Healthcare workers are expected to perform hand hygiene before donning gloves when entering contact precaution rooms. In the baseline, healthcare worker compliance to performing hand hygiene before donning gloves was observed within each healthcare unit.
Age, Customized; Measure Type: Count of Participants; Unit of measure: Participants
Unknown	Number Analyzed	633 participants	927 participants	1560 participants
		633 100.0%	927 100.0%	1560 100.0%
Sex/Gender, Customized; Measure Type: Count of Participants; Unit of measure: Participants
Unknown	Number Analyzed	633 participants	927 participants	1560 participants
		633 100.0%	927 100.0%	1560 100.0%
Race and Ethnicity Not Collected [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants	0 participants	0 participants
				0
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Adherence to expected practice at entry to contact precaution rooms; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	633 participants	927 participants	1560 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
Overall Number of Participants Analyzed	1491	2299
Measure Type: Count of Participants; Unit of Measure: Participants
	1297 87.0%	954 41.5%

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.
Overall Number of Participants Analyzed	1491	2299
Measure Type: Count of Participants; Unit of Measure: Participants
	1297 87.0%	1530 66.6%

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.
Overall Number of Participants Analyzed	1688	1315
Measure Type: Count of Participants; Unit of Measure: Participants
	1111 65.8%	951 72.3%

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.
Overall Number of Participants Analyzed	1785	1897
Measure Type: Count of Participants; Unit of Measure: Participants
	1525 85.4%	1587 83.7%

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.
Overall Number of Participants Analyzed	1194	1189
Mean (Full Range); Unit of Measure: Colony forming units
	16.3; (0 to 300)	9.5; (0 to 300)

Adverse Events

Time Frame	Adverse events were collected during the baseline of 6 months and intervention period of 1 year
Adverse Event Reporting Description	[Not Specified]
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 (%)	Affected / at Risk (%)
Total	0/6700 (0.00%)	0/6158 (0.00%)
Serious Adverse Events
	HH Before Donning Non-Sterile Gloves	Donning Non-Sterile Gloves Without HH
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/6700 (0.00%)	0/6158 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	HH Before Donning Non-Sterile Gloves	Donning Non-Sterile Gloves Without HH
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/6700 (0.00%)	0/6158 (0.00%)

Limitations and 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.

Results Point of Contact

• Name/Title: Kerri Thom
• Organization: University of Maryland
• Phone: 410-706-6124
• EMail: kthom@som.umaryland.edu

• Responsible Party: Kerri A Thom, University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT03119389
• Other Study ID Numbers: HP-00065259
• First Submitted: March 30, 2017
• First Posted: April 18, 2017
• Results First Submitted: March 30, 2020
• Results First Posted: May 19, 2020
• Last Update Posted: May 19, 2020