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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Urinary Tract Infections

Intervention / Treatment
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* Other: Computer-assisted treatment group
* Other: Usual care group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group 1 - uncomplicated UTI<br>Would receive computer-assisted treatment for a uncomplicated UTI. | Other: Computer-assisted treatment group<br>* 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.<br>|
| Active Comparator: Control Group 1<br>Qualified for expedited treatment for uncomplicated cystitis but would receive usual care in the Emergency Department of Community Health Center. | Other: Usual care group<br>* This group will receive usual care for an uncomplicated UTI or complicated cystitis in the Emergency Department or Community Health Center.<br>|
| Experimental: Treatment Group 2 - Complicated Cystitis<br>Would receive expedited treatment for complicated cystitis with longer antibiotic course than the simple UTI patients. | Other: Computer-assisted treatment group<br>* 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.<br>|
| Active Comparator: Control Group 2<br>Qualified for expedited treatment for complicated cystitis treatment but would receive usual care in the clinic or emergency department. | Other: Usual care group<br>* This group will receive usual care for an uncomplicated UTI or complicated cystitis in the Emergency Department or Community Health Center.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with treatment failure or relapse |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient acceptability of treatment by computer |  | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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UTI, Kiosk, Computer Assisted Care, cystitis