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

NCT ID: NCT00731315

Last Updated: 2015-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2011-07-31

Brief Summary

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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

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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.

Conditions

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Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Treatment Group 1 - uncomplicated UTI

Would receive computer-assisted treatment for a uncomplicated UTI.

Group Type EXPERIMENTAL

Computer-assisted treatment group

Intervention Type OTHER

This group will receive computer-assisted expedited treatment for uncomplicated UTI or complicated cystitis based on their symptoms and past medical history reported on the computer.

Control Group 1

Qualified for expedited treatment for uncomplicated cystitis but would receive usual care in the Emergency Department of Community Health Center.

Group Type ACTIVE_COMPARATOR

Usual care group

Intervention Type OTHER

This group will receive usual care for an uncomplicated UTI or complicated cystitis in the Emergency Department or Community Health Center.

Treatment Group 2 - Complicated Cystitis

Would receive expedited treatment for complicated cystitis with longer antibiotic course than the simple UTI patients.

Group Type EXPERIMENTAL

Computer-assisted treatment group

Intervention Type OTHER

This group will receive computer-assisted expedited treatment for uncomplicated UTI or complicated cystitis based on their symptoms and past medical history reported on the computer.

Control Group 2

Qualified for expedited treatment for complicated cystitis treatment but would receive usual care in the clinic or emergency department.

Group Type ACTIVE_COMPARATOR

Usual care group

Intervention Type OTHER

This group will receive usual care for an uncomplicated UTI or complicated cystitis in the Emergency Department or Community Health Center.

Interventions

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Computer-assisted treatment group

This group will receive computer-assisted expedited treatment for uncomplicated UTI or complicated cystitis based on their symptoms and past medical history reported on the computer.

Intervention Type OTHER

Usual care group

This group will receive usual care for an uncomplicated UTI or complicated cystitis in the Emergency Department or Community Health Center.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female
* 18-64 years old

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ralph Gonzales, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francsico

John Stein, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Bradley Frazee, MD

Role: PRINCIPAL_INVESTIGATOR

Alameda County Medical Centers, Highland Hospital

Locations

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CMC Fresno Emergency Department

Fresno, California, United States

Site Status

La Clinica

Oakland, California, United States

Site Status

Highland Hospital Emergency Department

Oakland, California, United States

Site Status

San Francisco General Hospital - Emergency Department

San Francisco, California, United States

Site Status

UCSF Emergency Deparmtent

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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H12132-32499-02

Identifier Type: -

Identifier Source: org_study_id

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