Urinary Tract InfectionNCT07411209
De-implementing PreOp Urine Testing
A study testing Interventional Project Site Visit in people with Urinary Tract Infection and Asymptomatic Bacteriuria, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This is a randomized study to evaluate the effectiveness and implementation of an intervention to decrease unnecessary urine testing for surgical patients (Less is More for Surgical Urine Testing) across six geographically diverse Veterans Affairs Medical Centers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infection, Asymptomatic Bacteriuria
- What is being tested?
- Interventional Project Site Visit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2026to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical Centers part of the Veterans Affairs Health Administration (VAMCs)
- VAMCs that perform standard, intermediate, or advanced surgical procedures
- VAMCs in which perioperative urine testing is performed among greater than 10% of their non-urologic, non-transplant surgery procedures
Who cannot join
- VAMCs that only perform ambulatory surgery (outpatient/day surgery only)
- VAMCs that do not perform urine testing among at least 10% of their non-urologic, non-transplant surgery procedures
- VAMCs that already have implemented interventions to reduce perioperative urine testing
- VAMCs' units performing genitourinary or transplant surgeries
- Database of patients with a diagnosis of urinary tract infection within 30 days before surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705-2254
Julie A Keating, PhD, 608-256-1901 ext. 12542, julie.keating@va.gov
Marin L. Schweizer-Looby, PhD BS
About this study
Official title: De-implementation of Unnecessary Pre-Operative Urine Testing
This is a randomized study to evaluate the effectiveness and implementation of an intervention to decrease unnecessary urine testing for surgical patients (Less is More for Surgical Urine Testing) across six geographically diverse Veterans Affairs Medical Centers. The intervention will unfold over two years, in three phases: control, intervention, and sustainability.
Read the detailed description
The purpose of this study is to implement our surgery-tailored evidence based 'Kicking CAUTI' intervention package in diverse surgical settings across the Veterans Affairs Medical Centers (VAMCs), and assess its effectiveness at de-implementing low-value perioperative urine testing and related inappropriate antibiotic prescribing. In this hybrid type 2 effectiveness-implementation study, the investigators will conduct a stepped wedge cluster randomized trial to evaluate the effectiveness, implementation, and cost of the tailored intervention at up to six VAMCs.
- Conditions
- Urinary Tract Infection, Asymptomatic Bacteriuria
- Being tested
- Interventional Project Site Visit
- Keywords
- antibiotic stewardship, kicking cauti
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional Project Site VisitBehavioural
Activities occurring during the 12-month intervention phase
- 1:1 meetings introducing the project
- Site Visit (once during intervention period)
- Interactive teaching cases and didactic sessions
- Distribution of algorithm as pocket cards
- Access to project materials on SharePoint
- Feedback reports on clinical outcomes
- Evidence-based order set templates
- Learning collaborative webinars
- Individualized coaching
| Study group | Role | What they receive |
|---|---|---|
| Intervention Site Visit | Experimental | VAMCs randomized in this arm will receive full access to our resources library, will receive invites to our monthly meetings, receive monthly feedback on clinical outcomes, access to project materials, etc. Receives: Behavioral: Interventional Project Site Visit |
| Standard of Care | No intervention | VAMCs randomized to the standard arm will proceed with normal standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Urine Testing Performed
Throughout the study period, the research team will generate monthly lists of all urinalyses and urine cultures performed within 30 days before and 30 days after included procedures. The study team will chart review theses cases and determine whether the urine test was done on an asymptomatic patient or whether the test was justified based on UTI symptoms.
Measured: up to 48 months
Secondary outcomes (2)
Number of Days of Therapy
Days of therapy is an aggregate sum of days on which an antimicrobial agent was administered to an individual patient. The investigators will include systemic antibacterial agents administered within 30 days before and 30 days after surgery. The investigators will exclude doses given as standard preoperative prophylaxis and antimicrobial agents that are not used for urinary tract infections.
Measured: up to 48 months
Budget Impact Analysis
Time spent by sites will be converted into cost by multiplying the hourly wage rate plus benefits for each type of healthcare professional involved in the intervention
Measured: up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start31 Dec 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped Wedge Cluster Randomized Trial
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Marin L. Schweizer-Looby, PhD BS, Principal investigator, William S. Middleton Memorial Veterans Hospital, Madison, WI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411209
- Sponsor's protocol ID
- HSR5-024-24W
- Other IDs
- I01RD000425-01A2
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 13 Feb 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 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- De-implementation of Unnecessary Pre-Operative Urine Testing
- ClinicalTrials.gov ID
- NCT07411209
- Acronym / sponsor ID
- HSR5-024-24W
- Conditions
- Urinary Tract Infection, Asymptomatic Bacteriuria
- Keywords
- antibiotic stewardship, kicking cauti
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 13 Feb 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.
This is a randomized study to evaluate the effectiveness and implementation of an intervention to decrease unnecessary urine testing for surgical patients (Less is More for Surgical Urine Testing) across six geographically diverse Veterans Affairs Medical Centers. The intervention will unfold over two years, in three phases: control, intervention, and sustainability.
Detailed description
The purpose of this study is to implement our surgery-tailored evidence based 'Kicking CAUTI' intervention package in diverse surgical settings across the Veterans Affairs Medical Centers (VAMCs), and assess its effectiveness at de-implementing low-value perioperative urine testing and related inappropriate antibiotic prescribing. In this hybrid type 2 effectiveness-implementation study, the investigators will conduct a stepped wedge cluster randomized trial to evaluate the effectiveness, implementation, and cost of the tailored intervention at up to six VAMCs.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped Wedge Cluster Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Site Visit | Experimental | Behavioral: Interventional Project Site VisitVAMCs randomized in this arm will receive full access to our resources library, will receive invites to our monthly meetings, receive monthly feedback on clinical outcomes, access to project materials, etc. |
| Standard of Care | No intervention | –VAMCs randomized to the standard arm will proceed with normal standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medical Centers part of the Veterans Affairs Health Administration (VAMCs)
- VAMCs that perform standard, intermediate, or advanced surgical procedures
- VAMCs in which perioperative urine testing is performed among greater than 10% of their non-urologic, non-transplant surgery procedures
Key exclusion criteria (5 listed)
- VAMCs that only perform ambulatory surgery (outpatient/day surgery only)
- VAMCs that do not perform urine testing among at least 10% of their non-urologic, non-transplant surgery procedures
- VAMCs that already have implemented interventions to reduce perioperative urine testing
- VAMCs' units performing genitourinary or transplant surgeries
- Database of patients with a diagnosis of urinary tract infection within 30 days before surgery
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 |
|---|---|---|
| Interventional Project Site VisitActivities occurring during the 12-month intervention phase * 1:1 meetings introducing the project * Site Visit (once during intervention period) * Interactive teaching cases and didactic sessions * Distribution of algorithm as pocket cards * Access to project materials on SharePoint * Feedback reports on clinical outcomes * Evidence-based order set templates * Learning collaborative webinars * Individualized coaching | Behavioural | Intervention Site Visit |
Primary outcome
Number of Urine Testing Performed
Time frame: up to 48 months
Throughout the study period, the research team will generate monthly lists of all urinalyses and urine cultures performed within 30 days before and 30 days after included procedures. The study team will chart review theses cases and determine whether the urine test was done on an asymptomatic patient or whether the test was justified based on UTI symptoms.
2 secondary outcomes
Number of Days of Therapy
Time frame: up to 48 months
Budget Impact Analysis
Time frame: up to 48 months
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 13 Feb 2026.
- Individual participant dataSharing planned: No
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Prediction and Prevention of Bloodstream Infections After Kidney Transplantation
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Enrolling by invitation
VA Quality Enhancement Research Initiative (QUERI) CARRIAGE VAST
Common Infections, Urinary Tract Infections
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.
Marin L. Schweizer-Looby, PhD BS principal investigator
William S. Middleton Memorial Veterans Hospital, Madison, WI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventional Project Site Visit in people with Urinary Tract Infection and Asymptomatic Bacteriuria, run by VA Office of Research and Development at 1 site 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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Marin L Schweizer-Looby, PhD BS ((608) 256-1901, Marin.Schweizer-Looby@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Urine Testing Performed (time frame: up to 48 months). 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 13 Feb 2026; AzTrials last refreshed its copy on 29 Oct 2026.