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

NCT07246837 | Recruiting

• 2 other identifiers: H-53559R01HS029489
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

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. 1.Does providing patients with a bilingual educational intervention reduce urine culture contamination rates?
2. 2.Does the intervention lead to fewer unnecessary urinary antibiotic prescriptions?
3. 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

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Urine Culture Contamination

  Presence of mixed flora, growth of non-uropathogens, or growth of three or more uropathogens in urine culture results.

  Within 48 hours of specimen collection

Secondary Outcomes (3)

• Contaminated Urinalysis Status

  Within 24-48 hours of specimen collection

• Antibiotic Use

  Within 7 days post-collection

• Patient Understanding and Satisfaction

  Immediately post-collection and after clinic visit.

Study Arms (2)

MSCC Educational Tool

EXPERIMENTAL

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.

Behavioral: MSCC Educational Tool

Usual Care

NO INTERVENTION

Participants receive standard clinical care without additional educational materials. Urine collection follows routine clinic procedures.

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.

MSCC Educational Tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Washington University School of Medicine: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77098, United States

RECRUITING

Related Publications (4)

• Bekeris LG, Jones BA, Walsh MK, Wagar EA. Urine culture contamination: a College of American Pathologists Q-Probes study of 127 laboratories. Arch Pathol Lab Med. 2008 Jun;132(6):913-7. doi: 10.5858/2008-132-913-UCCACO.

  PMID: 18517272 BACKGROUND

• Goebel MC, Trautner BW, Grigoryan L. The Five Ds of Outpatient Antibiotic Stewardship for Urinary Tract Infections. Clin Microbiol Rev. 2021 Dec 15;34(4):e0000320. doi: 10.1128/CMR.00003-20. Epub 2021 Aug 25.

  PMID: 34431702 BACKGROUND

• Hansen MA, Valentine-King M, Zoorob R, Schlueter M, Matas JL, Willis SE, Danek LCK, Muldrew KL, Zare M, Hudson F, Atmar RL, Chou A, Trautner BW, Grigoryan L. Prevalence and predictors of urine culture contamination in primary care: A cross-sectional study. Int J Nurs Stud. 2022 Oct;134:104325. doi: 10.1016/j.ijnurstu.2022.104325. Epub 2022 Jul 11.

  PMID: 35914376 BACKGROUND

• Gupta K, Grigoryan L, Trautner B. Urinary Tract Infection. Ann Intern Med. 2017 Oct 3;167(7):ITC49-ITC64. doi: 10.7326/AITC201710030.

  PMID: 28973215 BACKGROUND

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Larissa Grigoryan, MD, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kiara Olmeda, MS

CONTACT

7137983293; kiara.olmeda@bcm.edu

Azalia Mancera

CONTACT

7137982910; azalia.mancera@bcm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. The intervention group will receive a standardized educational tool, including a short video and flyer in English or Spanish, before urine collection to improve midstream clean-catch technique. The control group will receive usual care without additional education. All participants will collect urine samples using standard clinic materials, and samples will be processed according to routine laboratory protocols. The primary outcome is urine contamination status based on laboratory findings of epithelial cells or mixed flora. Secondary outcomes include antibiotic prescribing patterns, patient understanding of collection steps, and satisfaction with instructions. Randomization will be managed through REDCap. The study is open-label, and participation is voluntary with no impact on clinical care.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 24, 2025
• Study Start: January 22, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): May 31, 2028
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)