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Computer-Assisted Treatment of Urinary Tract Infection in Emergency Departments and Community Health Centers (UTI-Kiosk)

Primary Purpose

Urinary Tract Infections

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer-assisted treatment group
Usual care group
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Urinary Tract Infections focused on measuring UTI, Kiosk, Computer Assisted Care, cystitis

Eligibility Criteria

18 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • CMC Fresno Emergency Department
  • La Clinica
  • Highland Hospital Emergency Department
  • San Francisco General Hospital - Emergency Department
  • UCSF Emergency Deparmtent

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Treatment Group 1 - uncomplicated UTI

Control Group 1

Treatment Group 2 - Complicated Cystitis

Control Group 2

Arm Description

Would receive computer-assisted treatment for a uncomplicated UTI.

Qualified for expedited treatment for uncomplicated cystitis but would receive usual care in the Emergency Department of Community Health Center.

Would receive expedited treatment for complicated cystitis with longer antibiotic course than the simple UTI patients.

Qualified for expedited treatment for complicated cystitis treatment but would receive usual care in the clinic or emergency department.

Outcomes

Primary Outcome Measures

The proportion of subjects with treatment failure or relapse

Secondary Outcome Measures

Patient acceptability of treatment by computer

Full Information

First Posted
August 5, 2008
Last Updated
March 5, 2015
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT00731315
Brief Title
Computer-Assisted Treatment of Urinary Tract Infection in Emergency Departments and Community Health Centers
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
Funding Period ended, did not reach full sample size due to limited numbers of eligible patients
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
Keywords
UTI, Kiosk, Computer Assisted Care, cystitis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group 1 - uncomplicated UTI
Arm Type
Experimental
Arm Description
Would receive computer-assisted treatment for a uncomplicated UTI.
Arm Title
Control Group 1
Arm Type
Active Comparator
Arm Description
Qualified for expedited treatment for uncomplicated cystitis but would receive usual care in the Emergency Department of Community Health Center.
Arm Title
Treatment Group 2 - Complicated Cystitis
Arm Type
Experimental
Arm Description
Would receive expedited treatment for complicated cystitis with longer antibiotic course than the simple UTI patients.
Arm Title
Control Group 2
Arm Type
Active Comparator
Arm Description
Qualified for expedited treatment for complicated cystitis treatment but would receive usual care in the clinic or emergency department.
Intervention Type
Other
Intervention Name(s)
Computer-assisted treatment group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care group
Intervention Description
This group will receive usual care for an uncomplicated UTI or complicated cystitis in the Emergency Department or Community Health Center.
Primary Outcome Measure Information:
Title
The proportion of subjects with treatment failure or relapse
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Patient acceptability of treatment by computer
Time Frame
21 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph Gonzales, MD
Organizational Affiliation
University of California, San Francsico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Stein, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bradley Frazee, MD
Organizational Affiliation
Alameda County Medical Centers, Highland Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CMC Fresno Emergency Department
City
Fresno
State/Province
California
ZIP/Postal Code
93701
Country
United States
Facility Name
La Clinica
City
Oakland
State/Province
California
ZIP/Postal Code
94601
Country
United States
Facility Name
Highland Hospital Emergency Department
City
Oakland
State/Province
California
ZIP/Postal Code
94602
Country
United States
Facility Name
San Francisco General Hospital - Emergency Department
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
UCSF Emergency Deparmtent
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

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

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