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Computer-Aided Treatment of Urinary Tract Infection in Emergency Departments and Community Health Centers (UTI-Kiosk)
This study is not yet open for participant recruitment.
Verified by University of California, San Francisco, August 2008
Sponsored by: University of California, San Francisco
Information provided by: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00731315
  Purpose

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.


Condition Intervention
Urinary Tract Infections
Other: Computer-assisted treatment group
Other: Usual care group

MedlinePlus related topics: Urinary Tract Infections
U.S. FDA Resources
Study Type: Interventional
Study Design: Health Services Research, Randomized, Double Blind (Subject, Outcomes Assessor), Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title: Computer-Aided Treatment in the Management of Adult Female Patients With Symptoms of Urinary Tract Infection in Emergency Departments and Community Health Centers: A Randomized Trial

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • The proportion of subjects with treatment failure or relapse [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Patient acceptability of treatment by computer [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: August 2008
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Would receive computer-assisted treatment
Other: Computer-assisted treatment group
This group will receive computer-assisted treatment for UTI.
2: Active Comparator
Would receive usual care
Other: Usual care group
This group will receive usual care for a UTI.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female
  • 18-65 years old

Exclusion Criteria:

  • Below 18 or Above 65
  • Male
  • New flank pain
  • severe vomiting
  • High blood sugar or diabetes
  • surgery on kidneys
  • chronic kidney disease
  • UTI in previous month
  • Previous cancer or chemotherapy
  • HIV or AIDS
  • take antibiotics every day
  • pregnant or suspected pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731315

Contacts
Contact: Bahar K Navab, MPH 415-514-0569 bahar.navab@ucsf.edu

Locations
United States, California
Highland Hospital Emergency Department
Oakland, California, United States, 94602
Mission Neighborhood Health Center
San Francisco, California, United States, 94110
La Clinica
Oakland, California, United States, 94601
UCSF Emergency Deparmtent
San Francisco, California, United States, 94143
Sponsors and Collaborators
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
  More Information

Responsible Party: University of California, San Francisco ( Ralph Gonzales/Professor of Medicine; Epidemiology and Biostatistics )
Study ID Numbers: H12132-32499-01
Study First Received: August 5, 2008
Last Updated: August 8, 2008
ClinicalTrials.gov Identifier: NCT00731315  
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
UTI
Kiosk
Computer Assisted Care

Study placed in the following topic categories:
Urologic Diseases
Urinary Tract Infections
Emergencies

Additional relevant MeSH terms:
Communicable Diseases
Disease Attributes
Pathologic Processes
Infection

ClinicalTrials.gov processed this record on January 16, 2009