Computer-Assisted Treatment of Urinary Tract Infection in Emergency Departments and Community Health Centers (UTI-Kiosk)

March 5, 2015 updated by: University of California, San Francisco

Computer-Assisted Treatment in the Management of Adult Female Patients With Symptoms of Urinary Tract Infection in Emergency Departments and Community Health Centers: A Randomized Trial

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fresno, California, United States, 93701
        • CMC Fresno Emergency Department
      • Oakland, California, United States, 94601
        • La Clinica
      • Oakland, California, United States, 94602
        • Highland Hospital Emergency Department
      • San Francisco, California, United States, 94110
        • San Francisco General Hospital - Emergency Department
      • San Francisco, California, United States, 94143
        • UCSF Emergency Deparmtent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group 1 - uncomplicated UTI
Would receive computer-assisted treatment for a uncomplicated UTI.
Other: 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.
Active Comparator: Control Group 1
Qualified for expedited treatment for uncomplicated cystitis but would receive usual care in the Emergency Department of Community Health Center.
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.
Experimental: Treatment Group 2 - Complicated Cystitis
Would receive expedited treatment for complicated cystitis with longer antibiotic course than the simple UTI patients.
Other: 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.
Active Comparator: Control Group 2
Qualified for expedited treatment for complicated cystitis treatment but would receive usual care in the clinic or emergency department.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of subjects with treatment failure or relapse
Time Frame: 21 days
21 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient acceptability of treatment by computer
Time Frame: 21 days
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Ralph Gonzales, MD, University of California, San Francsico
  • Principal Investigator: John Stein, MD, University of California, San Francisco
  • Principal Investigator: Bradley Frazee, MD, Alameda County Medical Centers, Highland Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

August 5, 2008

First Submitted That Met QC Criteria

August 8, 2008

First Posted (Estimate)

August 11, 2008

Study Record Updates

Last Update Posted (Estimate)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 5, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H12132-32499-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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