Clinical trial NCT00731315: Computer-Assisted Treatment of Urinary Tract Infection in Emergency Departments and Community Health Centers
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urinary Tract Infections
Keywords: UTI
Kiosk
Computer Assisted Care
cystitis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2008-08-11
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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 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

Primary outcomes:
measure: The proportion of subjects with treatment failure or relapse
timeFrame: 21 days
Secondary outcomes:
measure: Patient acceptability of treatment by computer
timeFrame: 21 days
Other outcomes:
Locations:
city: Fresno
country: United States
facility: CMC Fresno Emergency Department
state: California
city: Oakland
country: United States
facility: La Clinica
state: California
city: Oakland
country: United States
facility: Highland Hospital Emergency Department
state: California
city: San Francisco
country: United States
facility: San Francisco General Hospital - Emergency Department
state: California
city: San Francisco
country: United States
facility: UCSF Emergency Deparmtent
state: California
Study officials:
affiliation: University of California, San Francsico
name: Ralph Gonzales, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: John Stein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alameda County Medical Centers, Highland Hospital
name: Bradley Frazee, MD
role: PRINCIPAL_INVESTIGATOR
References: