Hand HygieneNCT03445676
Effectiveness of an Alcohol-based Hand Rub to "Clean" Gloved Hands
A study testing ABHR directly on gloves in people with Hand Hygiene, run by University of Maryland, Baltimore at 3 sites in United States.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hand Hygiene
- What is being tested?
- ABHR directly on gloves
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,450 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Mar 2017to 1 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthcare worker who directly interacts with patients on Contact Precautions
Who cannot join
- Adults <18 years of age
- Care for patients with known C. difficile infection
- No hand hygiene opportunities while at the point of care
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
Johns Hopkins Hospital
Baltimore, Maryland, 21287
University of Iowa Hospitals
Iowa City, Iowa, 52242
About this study
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
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).
Read the 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 HCW).Care 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 R.Adams 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 (e.g. 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 (e.g. 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 (e.g. 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
- Conditions
- Hand Hygiene
- Being tested
- ABHR directly on gloves
- Keywords
- Hand Hygiene, WHO 5-moments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABHR directly on glovesBehavioural
HCW will be directed by study personnel to use alcohol-based hand rub (ABHR) to cleanse gloves at each hand hygiene opportunity
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Study personnel silently observe and record what the healthcare worker does at each hand hygiene opportunity without direction to the healthcare worker |
| ABHR directly on gloves | Experimental | Healthcare worker will be directed by study personnel to use alcohol-based hand rub (ABHR) to cleanse gloves at each hand hygiene opportunity Receives: Behavioral: ABHR directly on gloves |
| Ideal Standard | Placebo comparator | Healthcare worker will be directed by study personnel to remove gloves, perform hand hygiene and replace gloves at each hand hygiene opportunity Receives: Behavioral: ABHR directly on gloves |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total bacteria colony forming units
Total bacterial colony forming units cultured from gloved hands will be compared between the intervention and usual care group and between the intervention and ideal standard using a comparison of proportions.
Measured: Through study completion,about 1 year
Secondary outcomes (1)
Presence of pathogenic organisms
The presence of pathogenic bacteria on gloved hands in each arm during a single patient encounter
Measured: Through study completion,about 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start15 Mar 2017
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand HygieneStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,450 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Kerri A Thom, University of Maryland, Baltimore
- Investigators
- Kerri Thom, MD, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445676
- Sponsor's protocol ID
- HP-00065976/69543
- Status last verified
- May 2020
- First submitted
- 6 Feb 2018
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thom KA, Rock C, Robinson GL, Reisinger HRS, Baloh J, Chasco E, Liang Y, Li S, Diekema DJ, Herwaldt LA, Johnson JK, Harris AD, Perencevich EN. Alcohol-based decontamination of gloved hands: A randomized controlled trial. Infect Control Hosp Epidemiol. 2024 Apr;45(4):467-473. doi: 10.1017/ice.2023.243. Epub 2023 Nov 23.
PubMed 37994538
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03445676
- Acronym / sponsor ID
- HP-00065976/69543
- Conditions
- Hand Hygiene
- Keywords
- Hand Hygiene, WHO 5-moments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,450 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 HCW).Care 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 R.Adams 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 (e.g. 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 (e.g. 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 (e.g. 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Study personnel silently observe and record what the healthcare worker does at each hand hygiene opportunity without direction to the healthcare worker |
| ABHR directly on gloves | Experimental | Behavioral: ABHR directly on glovesHealthcare worker will be directed by study personnel to use alcohol-based hand rub (ABHR) to cleanse gloves at each hand hygiene opportunity |
| Ideal Standard | Placebo comparator | Behavioral: ABHR directly on glovesHealthcare worker will be directed by study personnel to remove gloves, perform hand hygiene and replace gloves at each hand hygiene opportunity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthcare worker who directly interacts with patients on Contact Precautions
Key exclusion criteria (3 listed)
- Adults <18 years of age
- Care for patients with known C. difficile infection
- No hand hygiene opportunities while at the point of care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABHR directly on glovesHCW will be directed by study personnel to use alcohol-based hand rub (ABHR) to cleanse gloves at each hand hygiene opportunity | Behavioural | ABHR directly on gloves, Ideal Standard |
Primary outcome
Total bacteria colony forming units
Time frame: Through study completion,about 1 year
Total bacterial colony forming units cultured from gloved hands will be compared between the intervention and usual care group and between the intervention and ideal standard using a comparison of proportions.
1 secondary outcome
Presence of pathogenic organisms
Time frame: Through study completion,about 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Derived from this study: PubMed 37994538Thom KA, Rock C, Robinson GL, Reisinger HRS, Baloh J, Chasco E, Liang Y, Li S, Diekema DJ, Herwaldt LA, Johnson JK, Harris AD, Perencevich EN. Alcohol-based decontamination of gloved hands: A randomized controlled trial. Infect Control Hosp Epidemiol. 2024 Apr;45(4):467-473. doi: 10.1017/ice.2023.243. Epub 2023 Nov 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerri Thom, MD principal investigator
University of Maryland, College Park
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABHR directly on gloves in people with Hand Hygiene, run by University of Maryland, Baltimore at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total bacteria colony forming units (time frame: Through study completion,about 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03445676, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2020.