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NCT Number: NCT07607145

Tailor VHA HH Bundle for Acute Mental Health Care

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.

Recruiting

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Edward Hines Jr. VA Hospital, Hines, IL, Hines, Illinois, United States

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About this study

The aim of this project is to develop tailored 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • VA mental health care workers on inpatient mental health units
  • Quality improvement staff including infection control

Exclusion criteria

  • Outpatient care settings

Treatment and study plan

Tailored Hand Hygiene Bundle

Other

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 Sanitizer

Other

Install non-alcohol based hand sanitizer dispensers

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eli N Perencevich, MD MS BS

CONTACT

[email protected]

(319) 338-0581 ext. 3535

Stacey M Hockett Sherlock, MA BA

CONTACT

[email protected]

(319) 338-0581 ext. 7659

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
May 26, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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