Ignite Creation Date:
2024-05-06 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03445676
Status:
COMPLETED
Last Update Posted:
2020-05-07
First Post:
2018-02-06
Brief Title:
Effectiveness of an Alcohol-based Hand Rub to Clean Gloved Hands
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Multi-center Randomized Non-inferiority Trial to Determine if Using Alcohol-based Hand Rub to Clean Gloved Hands When an Indication for HH Arises During a Single Patient Encounter is as Effective as Current Recommendation and Standard Care
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Although little is known about compliance with the World Health Organization WHO 5 Moments of hand hygiene the few existing studies report a high number of opportunities and compliance ranging from just 22 to 60 Previous studies have reported an increased density of opportunities perceived insufficient time and glove use as factors associated with non-compliance A healthcare worker performing multiple tasks in one encounter may spend up to half the time in the room doing hand hygiene Strategies to reduce the time required for hand hygiene may in turn promote increased compliance and may ultimately be most effective in limiting microbial transmission In this study the investigators examine whether cleansing gloves at each hand hygiene opportunity at the point of care and reusing the same gloves is as effective as standard practice and the current recommendation remove gloves perform hand hygiene and don new gloves
Detailed Description:
During this multi-center randomized non-inferiority trial eligible healthcare personnel entering rooms of patients on Contact Precautions or other rooms in which hand hygiene HH is an expectation and who agree to study participation will be randomized to either ideal standard healthcare worker HCW will be directed by study personnel to remove gloves perform hand hygiene and replace gloves at each HH opportunity experimental glove-reuse HCW will be directed by study personnel to use alcohol-based hand rub ABHR to cleanse gloves at each HH opportunity or usual care study personnel silently observe and record what the HCW does at each HH opportunity without direction to the HCWCare for patients with C difficile will be excluded as ABHR is not recommended
This study will be performed at the University of Maryland Medical Center The RAdams Cowley Shock Trauma Hospital University of Iowa Hospitals and The Johns Hopkins Hospital Healthcare workers on any patient units will be potentially eligible but the investigators will strive for diversity across unit types eg adult med-surg general pediatrics adult ICUs emergency care areas and inpatient hemodialysis units The investigators will use a stratified block randomization scheme to ensure an equal number of participants from each participating unit and facility The HCW regardless of random assignment may choose to remove gloves at any point eg if gloves are heavily soiled or are compromised
All participants will be instructed on how to perform HH using the standardized WHO methodology and will also receive brief instruction regarding HH opportunities at the point of care using a WHO 5 Moments pamphlet Participants will don gloves and enter the room to perform patient care activities as planned Research staff will be in the room to monitor the HCW activity Research staff trained using the WHO Hand Hygiene Monitoring Method will identify HH opportunities At each opportunity the participant will be instructed to stop current activity in the intervention and ideal standard group Participants in the intervention group will be instructed to cleanse gloves using an ABHR in a standardized way and in a similar fashion to the WHO recommendations for HH Participants in the ideal standard group will be instructed to remove gloves perform HH using an ABHR and don new gloves The HCW will continue with planned activities and continue to cleanse gloves or perform HH according to study assignment for each opportunity until either the HCW has completed patient care or five HH events have occurred Study staff will record what the HCW randomized into the usual care arm does at each HH moment The investigators chose a maximum of five HH events because since most encounters will have five or fewer HH opportunities
After the final opportunity and after cleansing gloves and allowing them to dry Intervention Group glove reuse after donning new gloves Ideal Standard or at moment 5 or before room exit which ever comes first Usual Care Group the non-dominant gloved hand will be sampled by directly imprinting the non-dominant gloved hand onto an agar plate HCWs who have no HH opportunities while at the point of care eg a nurse who enters to the room and interacts only with the intravenous pump and performs HH at exit will be withdrawn from the study
This study will be performed at the University of Maryland Medical Center The RAdams Cowley Shock Trauma Hospital University of Iowa Hospitals and The Johns Hopkins Hospital Healthcare workers on any patient units will be potentially eligible but the investigators will strive for diversity across unit types eg adult med-surg general pediatrics adult ICUs emergency care areas and inpatient hemodialysis units The investigators will use a stratified block randomization scheme to ensure an equal number of participants from each participating unit and facility The HCW regardless of random assignment may choose to remove gloves at any point eg if gloves are heavily soiled or are compromised
All participants will be instructed on how to perform HH using the standardized WHO methodology and will also receive brief instruction regarding HH opportunities at the point of care using a WHO 5 Moments pamphlet Participants will don gloves and enter the room to perform patient care activities as planned Research staff will be in the room to monitor the HCW activity Research staff trained using the WHO Hand Hygiene Monitoring Method will identify HH opportunities At each opportunity the participant will be instructed to stop current activity in the intervention and ideal standard group Participants in the intervention group will be instructed to cleanse gloves using an ABHR in a standardized way and in a similar fashion to the WHO recommendations for HH Participants in the ideal standard group will be instructed to remove gloves perform HH using an ABHR and don new gloves The HCW will continue with planned activities and continue to cleanse gloves or perform HH according to study assignment for each opportunity until either the HCW has completed patient care or five HH events have occurred Study staff will record what the HCW randomized into the usual care arm does at each HH moment The investigators chose a maximum of five HH events because since most encounters will have five or fewer HH opportunities
After the final opportunity and after cleansing gloves and allowing them to dry Intervention Group glove reuse after donning new gloves Ideal Standard or at moment 5 or before room exit which ever comes first Usual Care Group the non-dominant gloved hand will be sampled by directly imprinting the non-dominant gloved hand onto an agar plate HCWs who have no HH opportunities while at the point of care eg a nurse who enters to the room and interacts only with the intravenous pump and performs HH at exit will be withdrawn from the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None