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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- The proportion of subjects with treatment failure or relapse
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-64 years old
排除标准
- •Below 18 or Above 64
- •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
研究组 & 干预措施
Treatment Group 1 - uncomplicated UTI
Would receive computer-assisted treatment for a uncomplicated UTI.
干预措施: Computer-assisted treatment group (Other)
Control Group 1
Qualified for expedited treatment for uncomplicated cystitis but would receive usual care in the Emergency Department of Community Health Center.
干预措施: Usual care group (Other)
Treatment Group 2 - Complicated Cystitis
Would receive expedited treatment for complicated cystitis with longer antibiotic course than the simple UTI patients.
干预措施: Computer-assisted treatment group (Other)
Control Group 2
Qualified for expedited treatment for complicated cystitis treatment but would receive usual care in the clinic or emergency department.
干预措施: Usual care group (Other)
结局指标
主要结局
The proportion of subjects with treatment failure or relapse
时间窗: 21 days
次要结局
- Patient acceptability of treatment by computer(21 days)