NCT07607145

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
51mo left

Started Jun 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Jun 2026Sep 2030

First Submitted

Initial submission to the registry

May 19, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2029

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2030

Last Updated

June 4, 2026

Status Verified

June 1, 2026

Enrollment Period

3.1 years

First QC Date

May 19, 2026

Last Update Submit

June 2, 2026

Conditions

Keywords

Infection Control (IC)Hospital-associated infections (HAI)Hand Hygiene (HH)ComplianceHealth Care Workers (HCWs)

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 years

Study Arms (2)

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.

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.

Other: Non-Alcohol Based Hand Sanitizer

Interventions

Adapt and develop a hand hygiene bundle for mental health care settings with evidence-based best practices. Disseminate the hand hygiene bundle.

Hand Hygiene Bundle Implementation

Install non-alcohol based hand sanitizer dispensers

Non-Alcohol Based Hand Rub Implementation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Outpatient care settings

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-3030, United States

RECRUITING

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, 52246-2292, United States

RECRUITING

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

RECRUITING

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705-2254, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Patient Compliance

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Eli N. Perencevich, MD MS BS

    Iowa City VA Health Care System, Iowa City, IA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eli N Perencevich, MD MS BS

CONTACT

Stacey M Hockett Sherlock, MA BA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Non-Randomized Quality Improvement Trial
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2026

First Posted

May 26, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

September 30, 2030

Last Updated

June 4, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations