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
  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. 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).


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: 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

Resource links provided by NLM:


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 ]

Enrollment: 200
Study Start Date: August 2008
Estimated Study Completion Date: June 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731315

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

No publications provided

Responsible Party: Ralph Gonzales/Professor of Medicine; Epidemiology and Biostatistics, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00731315     History of Changes
Other Study ID Numbers: H12132-32499-02
Study First Received: August 5, 2008
Last Updated: July 11, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Communicable Diseases
Infection
Urinary Tract Infections
Urologic Diseases

ClinicalTrials.gov processed this record on October 23, 2014