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.
Adults (≥18 years) undergoing urine culture as part of routine outpatient care
Able to provide informed consent
English- and or Spanish-speaking.
Presence of a urinary catheter
Inability to read and sign the informed consent
Unable to follow study procedures (due to significant visual, auditory, physical or cognitive impairment).
Parallel
MSCC Educational Tool
BehavioralA brief educational intervention (video + flyer) designed to improve urine collection technique and reduce contamination. Delivered in the patient's preferred language (English or Spanish) immediately before urine collection.
Urine Culture Contamination
Presence of mixed flora, growth of non-uropathogens, or growth of three or more uropathogens in urine culture results.
Contaminated Urinalysis Status
Urine specimen will be considered contaminated if laboratory analysis reports 10 or more epithelial cells per high-power field.
Antibiotic Use
Antibiotic prescriptions associated with urine culture results.
Patient Understanding and Satisfaction
Exit interviews assessing comprehension of collection steps, intervention fidelity and usability, and satisfaction with instructions. This survey will be completed with patients who received the intervention.
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Baylor College of Medicine
Lead sponsor
Washington University School of Medicine
Collaborator
