Trial Outcomes & Findings for Direct Gloving Strategy: A Cluster-randomized Trial (NCT NCT03119389)
NCT ID: NCT03119389
Last Updated: 2020-05-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
14418 participants
Primary outcome timeframe
1 year
Results posted on
2020-05-19
Participant Flow
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.
Unit of analysis: healthcare units
Participant milestones
| Measure |
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 percentages for each outcome.
|
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 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.
|
|---|---|---|
|
Overall Study
STARTED
|
6791 7
|
7627 6
|
|
Overall Study
COMPLETED
|
6791 7
|
7627 6
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Donning Non-Sterile Gloves Without HH
n=6 healthcare units
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.
|
HH Before Donning Non-Sterile Gloves
n=7 healthcare units
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
n=13 healthcare units
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Unknown
|
633 Participants
n=633 Participants
|
927 Participants
n=927 Participants
|
1560 Participants
n=1560 Participants
|
|
Sex/Gender, Customized
Unknown
|
633 Participants
n=633 Participants
|
927 Participants
n=927 Participants
|
1560 Participants
n=1560 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Adherence to expected practice at entry to contact precaution rooms
|
236 Participants
n=633 Participants
|
282 Participants
n=927 Participants
|
518 Participants
n=1560 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: The number analyzed is the number of observations made within each group of units randomized
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.
Outcome measures
| Measure |
Donning Non-Sterile Gloves Without Hand Hygiene
n=1491 Participants
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
|
Hand Hygiene Before Donning Non-Sterile Gloves
n=2299 Participants
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
|
|---|---|---|
|
Number of Participants With Composite Compliance With Expected Infection Prevention Practices Upon Entry to Contact Precaution-patient Rooms
|
1297 Participants
|
954 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The number analyzed is the number of observations made within each group of units randomized
Proportion of healthcare worker compliance with glove use upon entry to Contact Precaution-patient rooms for both groups
Outcome measures
| Measure |
Donning Non-Sterile Gloves Without Hand Hygiene
n=1491 Participants
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
|
Hand Hygiene Before Donning Non-Sterile Gloves
n=2299 Participants
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
|
|---|---|---|
|
Proportion of Healthcare Worker Who Use Glove on Entry Into Contact Precaution Rooms
|
1297 Participants
|
1530 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The number analyzed is the number of observations made within each group of units randomized
Proportion of healthcare worker compliance with hand hygiene upon entry into non-contact precaution patient rooms
Outcome measures
| Measure |
Donning Non-Sterile Gloves Without Hand Hygiene
n=1688 Participants
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
|
Hand Hygiene Before Donning Non-Sterile Gloves
n=1315 Participants
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
|
|---|---|---|
|
Proportion of Healthcare Workers Who Perform Hand Hygiene on Entry Into Non-contact Precaution Room
|
1111 Participants
|
951 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The number analyzed is the number of observations made within each group of units randomized
Proportion of healthcare worker compliance with hand hygiene upon exit from any patient room
Outcome measures
| Measure |
Donning Non-Sterile Gloves Without Hand Hygiene
n=1785 Participants
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
|
Hand Hygiene Before Donning Non-Sterile Gloves
n=1897 Participants
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
|
|---|---|---|
|
Proportion of Healthcare Worker Who Perform Hand Hygiene on Exit From Any Room
|
1525 Participants
|
1587 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearPopulation: The number analyzed is the number of observations made within each group of units randomized
Mean bacterial colony count from gloves of healthcare workers in the intervention and control units
Outcome measures
| Measure |
Donning Non-Sterile Gloves Without Hand Hygiene
n=1194 Participants
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
|
Hand Hygiene Before Donning Non-Sterile Gloves
n=1189 Participants
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
|
|---|---|---|
|
Mean Total Bacterial Colony Count
|
16.3 Colony forming units
Interval 0.0 to 300.0
|
9.5 Colony forming units
Interval 0.0 to 300.0
|
Adverse Events
HH Before Donning Non-Sterile Gloves
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Donning Non-Sterile Gloves Without HH
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place