Diagnostic Stewardship Intervention to Reduce Inappropriate Antibiotic Use for Urinary Tract Infections in Primary Care

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT07246837
Status
Recruiting
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Conditions

  • Antimicrobial Stewardship
  • Primary Care
  • Urinary Tract Infection(UTI)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MSCC Educational Tool — BEHAVIORAL
    A 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.

Study Details

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.

Key Dates

Start date
Jan 22, 2026
Status verified
Feb 2026
Primary completion
Sep 1, 2026
Completion
May 31, 2028

Study Design

Enrollment
252 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • 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.

Primary Outcome Measure

Urine Culture Contamination [ Time Frame: Within 48 hours of specimen collection ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor College of MedicineHoustonTexas77098
Kiara Olmeda
[email protected]
7137983293

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By research site
Baylor College of Medicine· Houston, TX

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