An interventional study of Tailored Hand Hygiene Bundle and Non-Alcohol Based Hand Sanitizer in Hand Hygiene Compliance, sponsored by VA Office of Research and Development. Recruiting at 4 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Prevention
Among 15 studies in Patient Compliance by VA Office of Research and Development — 2 open to participants now, 2 under way, 1 of them phase 3. Patient Compliance · VA Office of Research and Development.
Among the 15 studies in Patient Compliance by VA Office of Research and Development, this one is the 14th largest by planned enrollment of the 14 interventional ones that give a count, is one of 2 that started in 2026, is one of 11 with no phase, and was the 15th registered.
752 studies on the registry are indexed under Patient Compliance; 72 are open to participants now.
Browse Patient Compliance studies →2 of the 15 studies in Patient Compliance by VA Office of Research and Development are open now, in 1 country. Recruiting first, the newest first:
VA Office of Research and Development · Sites in United States
Ages 18+ · Healthy volunteers
By country, each count listing its studies:
Of the 45 Patient Compliance studies recruiting now, 25 (56%) set no upper age limit and 13 (29%) stop at 75 or younger; 11 take children under 18; 14 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
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15 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 2 · Phase 3 3
First in 2004; this study’s year is marked. 2 started in 2026.
This study's planned enrollment of 4 is below the median of 116 across 527 interventional studies indexed under Patient Compliance.
Median enrollment 245 across the 14 interventional studies, 20 across the 1 observational. Of the 13 that completed or were terminated, 12 (92%) have results posted.
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VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 15 studies in Patient Compliance by VA Office of Research and Development, from their registry updates:
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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.
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.
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Exclusion Criteria:
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.
Other: Tailored Hand Hygiene Bundle
Evaluate whether implementation of non-alcohol based hand sanitizer improves hand hygiene compliance compared to the tailored hand hygiene bundle.
Other: Non-Alcohol Based Hand Sanitizer
Adapt and develop a hand hygiene bundle for mental health care settings with evidence-based best practices. Disseminate the hand hygiene bundle.
Install non-alcohol based hand sanitizer dispensers
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.
Time frame: 3 years
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Jun 2029, 36 months after the start.
Of 224 non-industry interventional studies with no phase under Patient Compliance, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 38. This study's planned 36 months is above that.
Counting every sponsor, half of 237 studies reached it within 20 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
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