Hand Hygiene ComplianceNCT07607145
Tailor VHA HH Bundle for Acute Mental Health Care
A study testing Tailored Hand Hygiene Bundle and Non-Alcohol Based Hand Sanitizer in people with Hand Hygiene Compliance, run by VA Office of Research and Development at 4 sites in United States.
Trial summary
Mental health settings are particularly vulnerable to outbreaks and transmission due to infectious pathogens like norovirus. This occurs since access to soap and water (sinks) is limited for safety reasons and alcohol hand rub is not available outside patient rooms because of concerns for ingestion and fire. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hand Hygiene Compliance
- What is being tested?
- Tailored Hand Hygiene Bundle and Non-Alcohol Based Hand Sanitizer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jun 2026to 30 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- VA mental health care workers on inpatient mental health units
- Quality improvement staff including infection control
Who cannot join
- Outpatient care settings
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030
Geneva Wilson, PhD, 708-202-8387 ext. 22935, geneva.wilson2@va.gov
Charlesnika Evans, 7082024868, charlesnika.evans@va.gov
- Recruiting
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, 52246-2292
Eli N Perencevich, MD MS BS, (319) 338-0581 ext. 3535, eli.perencevich@va.gov
Eli N. Perencevich, MD MS BS
- Recruiting
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705-2254
Marin Schweizer-Looby, PhD, 608-256-1901, marin.schweizer-looby@va.gov
- Recruiting
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
Jonathan Alpern, MD, 612-467-4183, jonathan.alpern@va.gov
About this study
Official title: Tailor the Evidence-based Practice Veteran Health Administration (VHA) Hand Hygiene (HH) Bundle for Acute Mental Health Care Settings and Improve Hand Hygiene Compliance (QUE 25-023)
Mental health settings are particularly vulnerable to outbreaks and transmission due to infectious pathogens like norovirus. This occurs since access to soap and water (sinks) is limited for safety reasons and alcohol hand rub is not available outside patient rooms because of concerns for ingestion and fire. Thus, novel hand hygiene improvement interventions are needed in mental health settings including new hand hygiene bundles tailored to VHA mental health settings and novel alcohol-free hand rubs that are safe for installation and use in mental health settings. Non-alcohol hand rub has been approved and is currently used in some VAs, but isn't currently a standard VA-wide practice. These products can expand access to hand hygiene in locations where alcohol-based products are not allowed.
Read the detailed description
The aim of this project is to develop tailored Hand Hygiene (HH) bundles (i.e., strategies) that will streamline the implementation process of antimicrobial stewardship by assessing and addressing challenges due to structural characteristics of the mental health facilities, its perceived compatibility, and the characteristics of the healthcare workers to facilitate HH compliance to combat Healthcare Acquired Infections (HAIs). The VA standard HH bundle includes -directive 1131 requires all VA's follow the following criteria:
(1) Implementing, at a minimum, categories IA, IB and IC of the most current CDC hand hygiene guidelines: in addition, consider current recommendations from the World Health Organization (WHO). Some VA medical facilities, based on the local risk assessment, may also choose to implement some CDC category II Recommendations (e.g., if moving from a contaminated body site to another body site during care of the same patient). 2) Periodically monitoring and recording adherence as the number of hand hygiene episodes performed by personnel relative to the number of hand hygiene opportunities, by ward or unit, and providing feedback to personnel regarding their performance. (3) Establishing goals for improving adherence with hand hygiene guidelines. (4) Assuring that hand hygiene products selected by the VA medical facility have been evaluated by the Infection Prevention and Control Program and approved by the Infection Prevention and Control Committee. Local bundles may also include HH signs, HH education, etc.
More than three million illnesses and 48,000 deaths are caused by antibiotic resistant bacteria each year, in the United States (US), with an annual economic impact of $35 billion in excess health care costs. In addition, the devastation caused by the COVID-19 pandemic has revealed the urgent needs and overwhelming limits of the US public health infrastructure to engage healthcare workers to rapidly adopt best-practices and assess emerging diseases. As a result, antimicrobial resistance and HAIs are considered by experts to be the current pandemic. This study will focus on hand hygiene of acute mental health facilities.
The goals of this study are to promote effective evidence-based strategies, promote adoption of healthcare workers participation, and ensure sustainability of continued use of HH bundles. Overall, these strategies will highlight and strengthen HH compliance which will help to train health care workers and combat the spread of infectious diseases in mental healthcare facilities. There is no randomization. The investigators are trying to improve standard practice, particularly allowing HH prep to be put on the ward that is alcohol free, and therefore expanding access to hand hygiene practices. No training interventions will be completed. The investigators will implement alcohol free hand rub in the tailored bundle. Staff may receive an update to their existing/routine standard training on hand hygiene practices.
- Conditions
- Hand Hygiene Compliance
- Being tested
- Tailored Hand Hygiene Bundle, Non-Alcohol Based Hand Sanitizer
- Keywords
- Infection Control (IC), Hospital-associated infections (HAI), Hand Hygiene (HH), Compliance, Health Care Workers (HCWs)
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Hand Hygiene BundleOther
Adapt and develop a hand hygiene bundle for mental health care settings with evidence-based best practices. Disseminate the hand hygiene bundle.
Non-Alcohol Based Hand SanitizerOther
Install non-alcohol based hand sanitizer dispensers
| Study group | Role | What they receive |
|---|---|---|
| Hand Hygiene Bundle Implementation | Experimental | Adapt and develop a HH bundle for mental health care settings with evidenced-based best practices. Evaluate whether the tailored HH bundle improves HH compliance compared to the VHA standard bundle. Receives: Other: Tailored Hand Hygiene Bundle |
| Non-Alcohol Based Hand Rub Implementation | Experimental | Evaluate whether implementation of non-alcohol based hand sanitizer improves hand hygiene compliance compared to the tailored hand hygiene bundle. Receives: Other: Non-Alcohol Based Hand Sanitizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand Hygiene Compliance
The primary outcome entails direct observation of health care workers' compliance of HH to be measured as 4 hours of direct HH observations per VA facility. All data obtained from the direct observation by research staff will be entered into a structured survey form, REDCap, developed by the primary site.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Jun 2026
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand Hygiene ComplianceStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Non-Randomized Quality Improvement Trial
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Eli N. Perencevich, MD MS BS, Principal investigator, Iowa City VA Health Care System, Iowa City, IA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607145
- Sponsor's protocol ID
- QUX 26-004
- Status last verified
- Aug 2026
- First submitted
- 19 May 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailor the Evidence-based Practice Veteran Health Administration (VHA) Hand Hygiene (HH) Bundle for Acute Mental Health Care Settings and Improve Hand Hygiene Compliance (QUE 25-023)
- ClinicalTrials.gov ID
- NCT07607145
- Acronym / sponsor ID
- QUX 26-004
- Conditions
- Hand Hygiene Compliance
- Keywords
- Infection Control (IC), Hospital-associated infections (HAI), Hand Hygiene (HH), Compliance, Health Care Workers (HCWs)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 26 May 2026 (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.
Mental health settings are particularly vulnerable to outbreaks and transmission due to infectious pathogens like norovirus. This occurs since access to soap and water (sinks) is limited for safety reasons and alcohol hand rub is not available outside patient rooms because of concerns for ingestion and fire. Thus, novel hand hygiene improvement interventions are needed in mental health settings including new hand hygiene bundles tailored to VHA mental health settings and novel alcohol-free hand rubs that are safe for installation and use in mental health settings. Non-alcohol hand rub has been approved and is currently used in some VAs, but isn't currently a standard VA-wide practice. These products can expand access to hand hygiene in locations where alcohol-based products are not allowed.
Detailed description
The aim of this project is to develop tailored Hand Hygiene (HH) bundles (i.e., strategies) that will streamline the implementation process of antimicrobial stewardship by assessing and addressing challenges due to structural characteristics of the mental health facilities, its perceived compatibility, and the characteristics of the healthcare workers to facilitate HH compliance to combat Healthcare Acquired Infections (HAIs). The VA standard HH bundle includes -directive 1131 requires all VA's follow the following criteria:
(1) Implementing, at a minimum, categories IA, IB and IC of the most current CDC hand hygiene guidelines: in addition, consider current recommendations from the World Health Organization (WHO). Some VA medical facilities, based on the local risk assessment, may also choose to implement some CDC category II Recommendations (e.g., if moving from a contaminated body site to another body site during care of the same patient). 2) Periodically monitoring and recording adherence as the number of hand hygiene episodes performed by personnel relative to the number of hand hygiene opportunities, by ward or unit, and providing feedback to personnel regarding their performance. (3) Establishing goals for improving adherence with hand hygiene guidelines. (4) Assuring that hand hygiene products selected by the VA medical facility have been evaluated by the Infection Prevention and Control Program and approved by the Infection Prevention and Control Committee. Local bundles may also include HH signs, HH education, etc.
More than three million illnesses and 48,000 deaths are caused by antibiotic resistant bacteria each year, in the United States (US), with an annual economic impact of $35 billion in excess health care costs. In addition, the devastation caused by the COVID-19 pandemic has revealed the urgent needs and overwhelming limits of the US public health infrastructure to engage healthcare workers to rapidly adopt best-practices and assess emerging diseases. As a result, antimicrobial resistance and HAIs are considered by experts to be the current pandemic. This study will focus on hand hygiene of acute mental health facilities.
The goals of this study are to promote effective evidence-based strategies, promote adoption of healthcare workers participation, and ensure sustainability of continued use of HH bundles. Overall, these strategies will highlight and strengthen HH compliance which will help to train health care workers and combat the spread of infectious diseases in mental healthcare facilities. There is no randomization. The investigators are trying to improve standard practice, particularly allowing HH prep to be put on the ward that is alcohol free, and therefore expanding access to hand hygiene practices. No training interventions will be completed. The investigators will implement alcohol free hand rub in the tailored bundle. Staff may receive an update to their existing/routine standard training on hand hygiene practices.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-Randomized Quality Improvement Trial
| Arm | Type | Receives |
|---|---|---|
| Hand Hygiene Bundle Implementation | Experimental | Other: Tailored Hand Hygiene BundleAdapt and develop a HH bundle for mental health care settings with evidenced-based best practices. Evaluate whether the tailored HH bundle improves HH compliance compared to the VHA standard bundle. |
| Non-Alcohol Based Hand Rub Implementation | Experimental | Other: Non-Alcohol Based Hand SanitizerEvaluate whether implementation of non-alcohol based hand sanitizer improves hand hygiene compliance compared to the tailored hand hygiene bundle. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- VA mental health care workers on inpatient mental health units
- Quality improvement staff including infection control
Key exclusion criteria (1 listed)
- Outpatient care settings
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 |
|---|---|---|
| Tailored Hand Hygiene BundleAdapt and develop a hand hygiene bundle for mental health care settings with evidence-based best practices. Disseminate the hand hygiene bundle. | Other | Hand Hygiene Bundle Implementation |
| Non-Alcohol Based Hand SanitizerInstall non-alcohol based hand sanitizer dispensers | Other | Non-Alcohol Based Hand Rub Implementation |
Primary outcome
Hand Hygiene Compliance
Time frame: 3 years
The primary outcome entails direct observation of health care workers' compliance of HH to be measured as 4 hours of direct HH observations per VA facility. All data obtained from the direct observation by research staff will be entered into a structured survey form, REDCap, developed by the primary site.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- 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.
Eli N. Perencevich, MD MS BS principal investigator
Iowa City VA Health Care System, Iowa City, IA
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Hand Hygiene Bundle and Non-Alcohol Based Hand Sanitizer in people with Hand Hygiene Compliance, run by VA Office of Research and Development at 4 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eli N Perencevich, MD MS BS ((319) 338-0581 ext. 3535, eli.perencevich@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand Hygiene Compliance (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2026.