Urinary Tract InfectionsUTI-KioskNCT00731315
Computer-Assisted Treatment of Urinary Tract Infection in Emergency Departments and Community Health Centers
A study testing Computer-assisted treatment group in people with Urinary Tract Infections, run by University of California, San Francisco at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Computer-assisted treatment group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2008to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female
- 18-64 years old
Who cannot join
- Below 18 or Above 64
- Male
- New flank pain
- severe vomiting
- High blood sugar or diabetes
- surgery on kidneys
Show all 10Show fewer
- chronic kidney disease
- Previous cancer or chemotherapy
- HIV or AIDS
- pregnant or suspected pregnancy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
CMC Fresno Emergency Department
Fresno, California, 93701
La Clinica
Oakland, California, 94601
Highland Hospital Emergency Department
Oakland, California, 94602
San Francisco General Hospital - Emergency Department
San Francisco, California, 94110
UCSF Emergency Deparmtent
San Francisco, California, 94143
About this study
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
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).
Read the 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.
- Conditions
- Urinary Tract Infections
- Being tested
- Computer-assisted treatment group, Usual care group
- Keywords
- UTI, Kiosk, Computer Assisted Care, cystitis
- Medical subject headings
- Urinary Tract Infections, Cystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-assisted treatment groupOther
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 groupOther
This group will receive usual care for an uncomplicated UTI or complicated cystitis in the Emergency Department or Community Health Center.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 - uncomplicated UTI | Experimental | Would receive computer-assisted treatment for a uncomplicated UTI. Receives: Other: Computer-assisted treatment group |
| Control Group 1 | Active comparator | Qualified for expedited treatment for uncomplicated cystitis but would receive usual care in the Emergency Department of Community Health Center. Receives: Other: Usual care group |
| Treatment Group 2 - Complicated Cystitis | Experimental | Would receive expedited treatment for complicated cystitis with longer antibiotic course than the simple UTI patients. Receives: Other: Computer-assisted treatment group |
| Control Group 2 | Active comparator | Qualified for expedited treatment for complicated cystitis treatment but would receive usual care in the clinic or emergency department. Receives: Other: Usual care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with treatment failure or relapse
Measured: 21 days
Secondary outcomes (1)
Patient acceptability of treatment by computer
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: Funding Period ended, did not reach full sample size due to limited numbers of eligible patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ralph Gonzales, MD, Principal investigator, University of California, San FrancsicoJohn Stein, MD, Principal investigator, University of California, San FranciscoBradley Frazee, MD, Principal investigator, Alameda County Medical Centers, Highland Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731315
- Sponsor's protocol ID
- H12132-32499-02
- Acronym
- UTI-Kiosk
- Status last verified
- Mar 2015
- First submitted
- 5 Aug 2008
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00731315
- Acronym / sponsor ID
- UTI-Kiosk / H12132-32499-02
- Conditions
- Urinary Tract Infections
- Keywords
- UTI, Kiosk, Computer Assisted Care, cystitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding Period ended, did not reach full sample size due to limited numbers of eligible patients
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 11 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 - uncomplicated UTI | Experimental | Other: Computer-assisted treatment groupWould receive computer-assisted treatment for a uncomplicated UTI. |
| Control Group 1 | Active comparator | Other: Usual care groupQualified for expedited treatment for uncomplicated cystitis but would receive usual care in the Emergency Department of Community Health Center. |
| Treatment Group 2 - Complicated Cystitis | Experimental | Other: Computer-assisted treatment groupWould receive expedited treatment for complicated cystitis with longer antibiotic course than the simple UTI patients. |
| Control Group 2 | Active comparator | Other: Usual care groupQualified for expedited treatment for complicated cystitis treatment but would receive usual care in the clinic or emergency department. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female
- 18-64 years old
Key exclusion criteria (10 listed)
- Below 18 or Above 64
- Male
- New flank pain
- severe vomiting
- High blood sugar or diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-assisted treatment groupThis 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. | Other | Treatment Group 1 - uncomplicated UTI, Treatment Group 2 - Complicated Cystitis |
| Usual care groupThis group will receive usual care for an uncomplicated UTI or complicated cystitis in the Emergency Department or Community Health Center. | Other | Control Group 1, Control Group 2 |
Primary outcome
The proportion of subjects with treatment failure or relapse
Time frame: 21 days
1 secondary outcome
Patient acceptability of treatment by computer
Time frame: 21 days
Results and safety
The study was stopped early (reason given: Funding Period ended, did not reach full sample size due to limited numbers of eligible patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph Gonzales, MD principal investigator
University of California, San Francsico
John Stein, MD principal investigator
University of California, San Francisco
Bradley Frazee, MD principal investigator
Alameda County Medical Centers, Highland Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-assisted treatment group in people with Urinary Tract Infections, run by University of California, San Francisco at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding Period ended, did not reach full sample size due to limited numbers of eligible patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects with treatment failure or relapse (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.