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

This study has been terminated.
(Funding Period ended, did not reach full sample size due to limited numbers of eligible patients)
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00731315
First received: August 5, 2008
Last updated: July 11, 2011
Last verified: July 2011
History of Changes

August 5, 2008
July 11, 2011
August 2008
July 2011   (final data collection date for primary outcome measure)
The proportion of subjects with treatment failure or relapse [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00731315 on ClinicalTrials.gov Archive Site
Patient acceptability of treatment by computer [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Computer-Assisted Treatment of Urinary Tract Infection in Emergency Departments and Community Health Centers
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).

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Health Services Research
Urinary Tract Infections
  • 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.
  • 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 1 - uncomplicated UTI
    Would receive computer-assisted treatment for a uncomplicated UTI.
    Intervention: Other: Computer-assisted treatment group
  • 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.
    Intervention: Other: Usual care group
  • Experimental: Treatment Group 2 - Complicated Cystitis
    Would receive expedited treatment for complicated cystitis with longer antibiotic course than the simple UTI patients.
    Intervention: Other: Computer-assisted treatment group
  • Active Comparator: Control Group 2
    Qualified for expedited treatment for complicated cystitis treatment but would receive usual care in the clinic or emergency department.
    Intervention: Other: Usual care group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
200
June 2012
July 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00731315
H12132-32499-02
Yes
Ralph Gonzales/Professor of Medicine; Epidemiology and Biostatistics, University of California, San Francisco
University of California, San Francisco
Not Provided
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
University of California, San Francisco
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP