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

NCT ID: NCT07246837

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2028-05-31

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.

Detailed Description

Background: Urinary tract infections (UTIs) account for more than 10 million ambulatory visits annually in the United States and are the third-leading cause of outpatient antibiotic prescriptions. Gram-negative urinary pathogens collected from outpatients across all regions of the United States now exhibit antimicrobial resistance levels that exceed thresholds recommended for empiric treatment of UTIs. Accurate urine cultures are essential for guiding antibiotic therapy. Midstream clean-catch (MSCC) urine collection is the gold standard for obtaining urine specimens, yet contamination rates in outpatient settings range from 46% to 55% in the recent studies. Contamination leads to incorrect diagnoses, unnecessary antibiotic use, increased resistance, and higher healthcare costs. Prior interventions aimed at reducing contamination have had mixed results and lacked stakeholder engagement and effective educational modalities.

Significance: This study addresses Goal 3 of the National Action Plan for Combating Antibiotic-Resistant Bacteria and CDC priorities by improving diagnostic accuracy and reducing inappropriate antibiotic use. Our approach empowers frontline staff and targets a neglected area of outpatient diagnostic stewardship. Urine culture contamination is common, wasteful, and harmful, particularly for pregnant patients who are routinely screened for bacteriuria. Contamination obscures true infection or leads to overtreatment, increasing risks for antimicrobial resistance, adverse drug reactions, and healthcare costs. Our intervention will improve patient care and reduce waste of laboratory resources.

Innovation and Impact: The proposed research is innovative because it places nurses and medical assistants at the forefront of antimicrobial stewardship in primary care. The investigators will develop a bilingual, multicultural educational intervention that includes an animated instructional video and a pictorial flyer. These materials will provide step-by-step guidance for proper MSCC urine collection and will be designed with input from patients, nurses, and medical assistants to ensure cultural competence and clarity for individuals with low literacy. This approach represents a departure from previous interventions, which lacked stakeholder engagement and failed to reduce contamination rates effectively. By incorporating stakeholder feedback and using engaging visual formats, the investigators aim to create an intervention that is acceptable, appropriate, and feasible for diverse patient populations.

Specific Aims: Aim 1: Iteratively develop a bilingual, multicultural educational intervention to reduce urine contamination, with stakeholder and expert input. The intervention will include an animated instructional video and a flyer with pictorial instructions that will provide step-by-step guidance to patients for collecting an MSCC urine sample. Aim 2: Perform a pilot study to assess and improve the intervention's acceptability, appropriateness, and feasibility using mixed methods. The investigators will use a sequential explanatory design that includes a quantitative survey and qualitative interviews with stakeholders (patients, nurses, and medical assistants). Aim 3: Test the effectiveness of the intervention at reducing urine culture contamination via a randomized controlled trial. The investigators hypothesize that patients who are randomized to receive the intervention versus usual care will have lower culture contamination rates (primary outcome), fewer urinary antibiotic prescriptions (secondary outcome), and fewer contaminated urinalyses (secondary outcome). Investigators will also study intervention fidelity, usability, and patient satisfaction using mixed methods research.

Methodology: The study will be conducted in two safety-net and one private primary care clinics. The investigators will use a randomized controlled trial with parallel groups to compare the intervention to usual care. Eligible participants will be adults aged 18 years or older who are asked to provide a urine sample for culture or urinalysis. Patients with indwelling urinary catheters or those unable to view the video or read the flyer in English or Spanish will be excluded. Randomization will occur at the patient level using a secure electronic system managed through REDCap. Participants assigned to the intervention group will view the animated video and flyer in their preferred language before urine collection. Men will receive materials tailored for men, and women will receive materials tailored for women. Participants in the control group will receive usual care without additional education. The primary outcome is the proportion of contaminated urine cultures, defined as mixed flora, growth of non-uropathogens, or growth of three or more uropathogens. Secondary outcomes include antibiotic prescribing within seven days of urine culture results and contamination of urinalyses, defined as more than ten squamous epithelial cells per microscopic field. The investigators will also assess implementation results through exit interviews and surveys. The sample size for the trial is 252 patients (126 per arm). Data will be collected from electronic medical records, patient surveys, and qualitative interviews. All data will be securely stored and de-identified for analysis.

Next Steps/Implementation: If the intervention proves effective, future work will focus on disseminating the educational tools to other settings, such as emergency departments and long-term care facilities. This project will provide a scalable, resource-efficient approach to improving diagnostic accuracy, reducing unnecessary antibiotic use, and advancing antimicrobial stewardship in outpatient care.

Conditions

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

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

MSCC Educational Tool

Intervention Type: 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.

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

LarisaGrigoryan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Larissa Grigoryan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

Central Contacts

Kiara Olmeda, MS

Role: CONTACT

Phone: 7137983293

Email: kiara.olmeda@bcm.edu

Azalia Mancera

Role: CONTACT

Phone: 7137982910

Email: azalia.mancera@bcm.edu

Facility Contacts

Kiara Olmeda

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 18517272 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34431702 (View on PubMed)

Reekie D. Ending the misery of child dental decay. Br Dent J. 1999 Aug 28;187(4):174-6. doi: 10.1038/sj.bdj.4800234.

Reference Type: BACKGROUND

PMID: 10513105 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 28973215 (View on PubMed)

Other Identifiers

R01HS029489

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

H-53559

Identifier Type: -

Identifier Source: org_study_id