Educational Tool for Urinary Tract Infections

Overseen By Azalia Mancera

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Urinary catheter, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new educational tool, the MSCC Educational Tool, designed to reduce urine contamination during testing. By using a bilingual video and flyer, the tool aims to improve patient urine sample collection, potentially leading to fewer inaccurate test results and unnecessary antibiotic use. This is crucial because incorrect results can cause misdiagnoses and improper treatments, contributing to antibiotic resistance. The trial compares patients using the educational tool with those receiving usual care. Adults who speak English or Spanish and are undergoing a urine culture test at their clinic are suitable candidates for this trial. As an unphased study, this trial offers a unique opportunity to contribute to research that could enhance diagnostic accuracy and reduce antibiotic resistance.

What prior data suggests that this educational tool is safe for use in reducing urine culture contamination?

Research has shown that educational tools can improve health outcomes. This trial uses a bilingual educational tool to help reduce mistakes in urine sample collection. Although this trial does not involve a typical medical treatment, the educational materials—an animated video and a pictorial flyer—are safe as they only provide instructions.

Studies have found that educational programs can lower infection rates by increasing knowledge. For example, a program for nurses helped prevent urinary tract infections in older adults. Similar educational tools have reported no negative effects.

Since this trial focuses on education rather than medication or medical procedures, there are no safety concerns. Participants will learn how to collect urine samples more accurately, which is safe and straightforward. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it introduces the MSCC Educational Tool, a new approach to improving the collection of urine samples for diagnosing urinary tract infections (UTIs). Unlike standard procedures, which don't typically include detailed patient guidance, this tool offers a short video and flyer in both English and Spanish that explain the proper midstream clean-catch technique. By ensuring patients understand how to correctly collect urine samples, the tool aims to reduce contamination and improve test accuracy, potentially leading to better diagnosis and treatment of UTIs.

What evidence suggests that this educational tool is effective for reducing urine culture contamination?

Research has shown that teaching people how to collect urine samples can help reduce contamination. One study found that patients who received clear instructions had fewer contaminated samples. This trial will compare two approaches: participants in one arm will receive the MSCC Educational Tool, which includes a short video and flyer explaining proper midstream clean-catch technique, while participants in the other arm will receive usual care without additional educational materials. Providing simple, clear guidance on urine collection can significantly improve outcomes. Better sample collection can also lead to less unnecessary use of antibiotics. This is important because excessive antibiotic use can reduce their effectiveness, making infections harder to treat. Overall, educational tools seem promising in improving the accuracy of urine collection and reducing antibiotic misuse. ^{1 3 4 6 7}

Who Is on the Research Team?

Larissa Grigoryan, MD, PhD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

This trial is for adult patients at safety-net primary care clinics who may need a urine test. It's not specific about who can't join, but it's likely that people who don't speak English or Spanish, or those unable to follow the educational material due to cognitive impairments might be excluded.

Inclusion Criteria

Able to provide informed consent

I speak English or Spanish.

I am an adult having a urine test as part of my regular doctor visits.

Exclusion Criteria

Presence of a urinary catheter

Inability to read and sign the informed consent

I can follow study procedures without significant difficulty.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a bilingual educational intervention including an animated video and pictorial flyer for proper urine collection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for urine culture contamination and antibiotic use

1 week

1 follow-up (virtual or in-person)

What Are the Treatments Tested in This Trial?

Interventions

• MSCC Educational Tool

Trial Overview The trial tests if an animated video and flyer in English and Spanish can help patients give better urine samples for testing. By doing this right, the study hopes to cut down on wrong diagnoses and unnecessary antibiotics. Patients are randomly chosen to either get these new tools or just stick with the usual instructions.

How Is the Trial Designed?

Group I: MSCC Educational Tool Experimental Treatment 1 Intervention

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 II: Usual Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07246837?term=stem+cells

Diagnostic Stewardship Intervention to Reduce ... For our hypothesis, patients who receive the educational intervention will have: lower urine culture contamination rates (primary outcome), ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11290905/

Educational interventions to prevent urinary infections in ... The educational intervention was effective in preventing urinary tract infections in the elderly. The increased knowledge acquired by nurses and caregivers ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0196064489801088

Urine sampling in ambulatory women: Midstream clean ... We conducted a study to determine if there were any significant differences in urinalyses or urine cultures obtained by midstream clean-catch (MSCC) urine ...

4. thelancet.com thelancet.com/journals/laninf/article/PIIS1473-3099(21)00001-3/abstract

Effectiveness of a tailored intervention to reduce antibiotics ... We investigated whether a tailored intervention that improves knowledge about UTI and communication skills in nursing home staff influences antibiotic ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2827067

Use of Multiplex Molecular Panels to Diagnose Urinary ... This cohort study uses Medicare fee-for-service claims data to assess the use of multiplex molecular panels to diagnose urinary tract ...

6. ichgcp.net ichgcp.net/clinical-trials-registry/NCT07246837

MSCC Educational Tool in Urinary Tract Infection(UTI) and ... For our hypothesis, patients who receive the educational intervention will have: lower urine culture contamination rates (primary outcome), ...

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/20499361251328258

Atlas of patient-reported outcome measures, nomograms ... This atlas is the first comprehensive review of PROMs, scoring systems and nomograms in the management of UTIs.