Computer-Assisted Treatment of Urinary Tract Infection in Emergency Departments and Community Health Centers (UTI-Kiosk)
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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 |
- The proportion of subjects with treatment failure or relapse [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
- 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 |
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| 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 | |
| UCSF Emergency Deparmtent | |
| San Francisco, California, United States, 94143 | |
| San Francisco General Hospital - Emergency Department | |
| San Francisco, California, United States, 94110 | |
| 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:
|
Emergencies Urinary Tract Infections Disease Attributes |
Pathologic Processes Infection Urologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013