- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07411209
De-implementing PreOp Urine Testing
February 10, 2026 updated by: VA Office of Research and Development
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marin L Schweizer-Looby, PhD BS
- Phone Number: (608) 256-1901
- Email: Marin.Schweizer-Looby@va.gov
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53705-2254
- William S. Middleton Memorial Veterans Hospital, Madison, WI
-
Contact:
- Julie A Keating, PhD
- Phone Number: 12542 608-256-1901
- Email: julie.keating@va.gov
-
Principal Investigator:
- Marin L. Schweizer-Looby, PhD BS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Site Visit
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.
|
Activities occurring during the 12-month intervention phase
|
|
No Intervention: Standard of Care
VAMCs randomized to the standard arm will proceed with normal standard of care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
up to 48 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Days of Therapy
Time Frame: up to 48 months
|
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.
|
up to 48 months
|
|
Budget Impact Analysis
Time Frame: up to 48 months
|
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
|
up to 48 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marin L. Schweizer-Looby, PhD BS, William S. Middleton Memorial Veterans Hospital, Madison, WI
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 31, 2026
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2030
Study Registration Dates
First Submitted
February 3, 2026
First Submitted That Met QC Criteria
February 10, 2026
First Posted (Actual)
February 13, 2026
Study Record Updates
Last Update Posted (Actual)
February 13, 2026
Last Update Submitted That Met QC Criteria
February 10, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSR5-024-24W
- I01RD000425-01A2 (Other Grant/Funding Number: VA Research & Development)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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