Computer-Assisted Treatment of Urinary Tract Infection in Emergency Departments and Community Health Centers

Not Applicable

Terminated

• Conditions: Urinary Tract Infections
• Interventions: Other: Computer-assisted treatment group; Other: Usual care group

• Registration Number: NCT00731315
• Lead Sponsor: University of California, San Francisco

Brief Summary

Our study aims to test the utility of computer-assisted treatment for uncomplicated, recurrent urinary tract infections (UTIs) for women receiving care in safety net health care facilities. As of November 2009, we are also testing the utility of computer-assisted treatment for certain types of complicated cystitis (i.e. women with voiding symptoms and one of the following complicating symptoms: fever, flank pain, or symptoms greater than 7 days).

Detailed Description

An English version of the UTI Kiosk module was validated at UCSF urgent care clinic in 2005, and has been successfully integrated into the clinical work flow at this clinic for over 2 years. The computer-based module is housed in a freestanding kiosk with a touch-screen monitor and audio handset to allow patients with low literacy and minimum computer skills to complete the module. A printer in the kiosk provides a summary of the patient's responses to each question in the module, as well as a prescription for the clinic physician to sign and return to the patient.

It's important to emphasize that the computer only "fast-tracks" women who will be treated with antibiotics. All other women see the provider as usual. Also, all women who are eligible for computer treatment may opt to see a provider instead.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-05
• Study First Submitted QC: 2008-08-08
• Study First Posted: 2008-08-11
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-05
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Female
• 18-64 years old

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Exclusion Criteria

• Below 18 or Above 64
• Male
• New flank pain
• severe vomiting
• High blood sugar or diabetes
• surgery on kidneys
• chronic kidney disease
• Previous cancer or chemotherapy
• HIV or AIDS
• pregnant or suspected pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group 1 - uncomplicated UTI	Computer-assisted treatment group	Would receive computer-assisted treatment for a uncomplicated UTI.
Control Group 1	Usual care group	Qualified for expedited treatment for uncomplicated cystitis but would receive usual care in the Emergency Department of Community Health Center.
Treatment Group 2 - Complicated Cystitis	Computer-assisted treatment group	Would receive expedited treatment for complicated cystitis with longer antibiotic course than the simple UTI patients.
Control Group 2	Usual care group	Qualified for expedited treatment for complicated cystitis treatment but would receive usual care in the clinic or emergency department.

Primary Outcome Measures

Name	Time	Method
The proportion of subjects with treatment failure or relapse	21 days

Secondary Outcome Measures

Name	Time	Method
Patient acceptability of treatment by computer	21 days

Trial Locations

Locations (5)

San Francisco General Hospital - Emergency Department; 🇺🇸 San Francisco, California, United States

CMC Fresno Emergency Department; 🇺🇸 Fresno, California, United States

UCSF Emergency Deparmtent; 🇺🇸 San Francisco, California, United States

La Clinica; 🇺🇸 Oakland, California, United States

Highland Hospital Emergency Department; 🇺🇸 Oakland, California, United States