Computer-Assisted Treatment of Urinary Tract Infection in Emergency Departments and Community Health Centers

Urinary Tract Infections Clinical Trial

— UTI-Kiosk  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00731315
• Other study ID #: H12132-32499-02
• Status: Terminated
• Phase: N/A
• First received: August 5, 2008
• Last updated: March 5, 2015
• Start date: August 2008
• Est. completion date: July 2011

Study information

• Verified date: March 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Infection
• Urinary Tract Infections

Intervention

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.
• Usual care group
This group will receive usual care for an uncomplicated UTI or complicated cystitis in the Emergency Department or Community Health Center.

Locations

Country	Name	City	State
United States	CMC Fresno Emergency Department	Fresno	California
United States	Highland Hospital Emergency Department	Oakland	California
United States	La Clinica	Oakland	California
United States	San Francisco General Hospital - Emergency Department	San Francisco	California
United States	UCSF Emergency Deparmtent	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects with treatment failure or relapse		21 days	Yes
Secondary	Patient acceptability of treatment by computer		21 days	No