Urinary Tract Infection (UTI) Clinical Trials

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A Randomized Controlled Trial of a Diagnostic Stewardship Intervention to Reduce Inappropriate Antibiotic Use for Urinary Tract Infections in Primary Care

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Urine culture is the most common microbiological test in the outpatient setting in the United States. Unfortunately, contamination during collection is prevalent and undermines test accuracy, leading to incorrect diagnosis, unnecessary treatment, wasted laboratory resources, and inflated costs. Unnecessary antibiotic treatment increases the risk of developing antimicrobial resistance, one of the most serious threats to patients and public health. The goal of this clinical trial is to test whether a bilingual (English and Spanish) educational intervention, an animated video and pictorial flyer, can reduce urine culture contamination and associated inappropriate antibiotic use in adult patients visiting safety-net primary care clinics. The main questions it aims to answer are: 1. Does providing patients with a bilingual educational intervention reduce urine culture contamination rates? 2. Does the intervention lead to fewer unnecessary urinary antibiotic prescriptions? 3. Does providing patients with a bilingual educational intervention reduce contaminated urinalyses? Researchers will compare patients randomized to receive the educational intervention (video and flyer) to those receiving usual care to see if the intervention improves urine collection accuracy and reduces inappropriate antibiotic use. Participants will watch a short, animated video with step-by-step instructions for proper midstream clean-catch urine (MSCC) collection, receive a pictorial flyer (with stills from the video) reinforcing the instructions, and provide a urine sample for culture. Hypothesis: patients who receive the educational intervention will have: lower urine culture contamination rates (primary outcome), fewer urinary antibiotic prescriptions (secondary outcome), and fewer contaminated urinalyses (secondary outcome). The objectives are to (1) develop educational tools: Create an animated video and pictorial flyer with step-by-step urine collection instructions for women and men, developed through an iterative, stakeholder-engaged process, (2) assess acceptability: Use mixed methods (quantitative surveys and qualitative interviews) to evaluate and refine the tools for usability and cultural/linguistic appropriateness, and (3) test effectiveness: Conduct a randomized controlled trial to assess the intervention's impact on urine contamination rates, antibiotic prescribing, and patient satisfaction.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults (≥18 years) undergoing urine culture as part of routine outpatient care

• Able to provide informed consent

• English- and or Spanish-speaking.

Locations
United States
Texas
Baylor College of Medicine
RECRUITING
Houston
Contact Information
Primary
Kiara Olmeda, MS
kiara.olmeda@bcm.edu
7137983293
Backup
Azalia Mancera
azalia.mancera@bcm.edu
7137982910
Time Frame
Start Date: 2026-01-22
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 252
Treatments
Experimental: MSCC Educational Tool
Participants receive a standardized educational tool prior to urine collection. This includes a short video and flyer in English or Spanish explaining proper midstream clean-catch technique. Materials are shown in the exam room before specimen collection.
No_intervention: Usual Care
Participants receive standard clinical care without additional educational materials. Urine collection follows routine clinic procedures.
Related Therapeutic Areas
Sponsors
Collaborators: Washington University School of Medicine
Leads: Baylor College of Medicine

This content was sourced from clinicaltrials.gov