Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Direct Gloving Strategy: A Cluster-randomized Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
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
Hide 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
Arm/Group Title Donning Non-Sterile Gloves Without HH HH Before Donning Non-Sterile Gloves Total
Hide 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
Hide 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%
1.Primary Outcome
Title Number of Participants With Composite Compliance With Expected Infection Prevention Practices Upon Entry to Contact Precaution-patient Rooms
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Proportion of healthcare worker compliance with glove use upon entry to Contact Precaution-patient rooms for both groups
Time Frame 1 year
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Proportion of healthcare worker compliance with hand hygiene upon entry into non-contact precaution patient rooms
Time Frame 1 year
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Proportion of healthcare worker compliance with hand hygiene upon exit from any patient room
Time Frame 1 year
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Mean bacterial colony count from gloves of healthcare workers in the intervention and control units
Time Frame 1 year
Hide Outcome Measure Data
Hide 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
Hide 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)
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
Hide 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%) 
Hide 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%) 
Hide 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%) 
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
Layout table for Results Point of Contact information
Name/Title: Kerri Thom
Organization: University of Maryland
Phone: 410-706-6124
EMail: kthom@som.umaryland.edu
Layout table for additonal information
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