Prediction tool to guide antibiotic decisions for urinary tract infections after ER visits
Application of a Prediction Model for Directing Antibiotic Use in the Treatment of Urinary Tract Infection in an Ambulatory Setting
This project tests whether a prediction model used at ED discharge can help doctors decide if adult women with a suspected UTI need antibiotics.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 47 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospitals Cleveland Medical Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06976125 on ClinicalTrials.gov |
What this trial studies
The trial implements a decision aid—a prediction model—at the point of emergency department discharge to guide antibiotic prescribing for suspected urinary tract infections. Eligible participants are adult women discharged from the ED with a UTI-related discharge code who were prescribed antibiotics; men, pregnant patients, catheterized patients, and high-acuity or admitted patients are excluded. The model uses clinical and laboratory features available at discharge (such as urinalysis and clinical presentation) to estimate the likelihood of true infection and inform prescribing decisions. Outcomes will focus on how the decision aid changes antibiotic use and aligns treatment with culture-confirmed infections.
Who should consider this trial
Good fit: Adult women (over 18) discharged from the emergency department with a UTI diagnosis who were prescribed an antibiotic and are not pregnant or catheter-dependent.
Not a fit: Men, pregnant people, patients with chronic urinary catheters, very high-acuity ED patients, and those being admitted are excluded and would not benefit from this intervention.
Why it matters
Potential benefit: If successful, this could reduce unnecessary antibiotic use and improve targeting of antibiotics to patients with confirmed infections.
How similar studies have performed: Similar decision-support and antibiotic stewardship approaches in outpatient and ED settings have shown promise, but prediction-model guidance for UTI discharge decisions is relatively novel with limited direct evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female sex * Age \>18 years old * Discharged from the hospital after ER visit * Discharge ICD code consistent with a UTI diagnosis * Antibiotic prescribed for UTI at the time of discharge Exclusion Criteria: * Male sex * Necessity for chronic bladder catheterization or discharge with a urinary catheter * Patients who have an Emergency Severity Index (ESI) of 1 and 2 * Patients who verbalize to the study team member that their pain is a 6 or higher * Patient set to be transferred to inpatient care * History of bladder augmentation * Pregnancy (this will be confirmed with a negative pregnancy test which is ordered in the ER)
Where this trial is running
Cleveland, Ohio
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: David Sheyn, MD — University Hospitals Cleveland Medical Center
- Study coordinator: Jessica Abou Zeki
- Email: Jessica.AbouZeki@UHhospitals.org
- Phone: 216-286-0603
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.