Recruiting

Bilingual Intervention

Sponsor:

Baylor College of Medicine

Code:

NCT07246837

Conditions

Urinary Tract Infection(UTI)

Antimicrobial Stewardship

Primary Care

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MSCC Educational Tool

Study Details

Brief 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.

Conditions

Urinary Tract Infection(UTI)

Antimicrobial Stewardship

Primary Care

Study ID

NCT07246837

Start date

Jan 22, 2026

Status verified date

Feb, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults (≥18 years) undergoing urine culture as part of routine outpatient care
  • Able to provide informed consent
  • English- and or Spanish-speaking.

Exclusion Criteria:

  • 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).

Study Design

Enrollment

252 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

MSCC Educational Tool

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77098

Contacts

More Information

Sponsor

Baylor College of Medicine

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

Keywords

  • Urinary Tract Infection
  • UTI
  • Inappropriate Antibiotic Use
  • Diagnostic Stewardship
  • Antibiotic Resistance
  • Antimicrobial Stewardship
  • Primary Care
  • Randomized Controlled Trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2026-02-13.