An EHR-integrated Texting Platform to Promote Self-management in Women With Recurrent Urinary Tract Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Rate of Unnecessary Antibiotics
研究概览
简要总结
The goal of this clinical trial is to compare a texting platform to usual care for managing recurrent urinary tract infections (UTI).
The main question it aims to answer is:
• can a texting platform that integrates symptom triage and prevention education reduce the rate of unnecessary antibiotics for recurrent UTIs as compared to usual care?
Participants enrolled onto the texting platform will:
• receive evidence-based clinical guidance for the management of symptoms of UTI and receive educational videos on how to prevent UTIs. An important secondary outcome is to determine if the texting platform improves self-efficacy for the management of recurrent UTI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Research assistant extracting data on primary and secondary outcomes will be masked to randomization
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Females who currently meet the criteria for recurrent UTIs
- •Age 18 years or older
- •Owns a mobile device with text messaging capability
- •Ability to read and write English
- •Currently receiving care from a provider in Penn Urogynecology or Penn Urology
排除标准
- •History of known multidrug resistant UTIs
- •History of interstitial cystitis/bladder pain syndrome or current diagnosis of chronic pelvic pain
- •On continuous suppressive antibiotics currently
- •Currently pregnant or within 6 weeks of pregnancy
- •Transplant patient on immunosuppressive medication currently
- •Practice of chronic self-catheterization
研究组 & 干预措施
Electronic health record (EHR)-integrated texting platform
Patients will be enrolled into a texting platform for the management of recurrent UTI.
干预措施: EHR-integrated texting platform (Urotrust) (Device)
Usual care
Patients will receive usual care through their providers.
干预措施: Usual care (Other)
结局指标
主要结局
Rate of Unnecessary Antibiotics
时间窗: 3 months
Antibiotics prescribed for patients when 1) urine culture is negative and/or urine microscopy has pyuria \< 10 WBC/HPF, 2) asymptomatic bacteriuria is present, or 3) there is no urine testing and no urinary symptoms.
Rate of unnecessary antibiotics
时间窗: 3 months
Antibiotics prescribed for patients when 1) urine culture is negative and/or urine microscopy has pyuria \< 10 WBC/HPF, 2) asymptomatic bacteriuria is present, or 3) there is no urine testing and no urinary symptoms.
次要结局
- Healthcare-related quality of life: Recurrent UTI Impact Questionnaire score(3 months)
- Antibiotic prescriptions(3 months)
- Patient self-efficacy(3 months)
- Healthcare utilization(3 months)
- Patient medication compliance(3 months)
- Patient satisfaction: Patient Global Impression of Improvement score(3 months)
- Healthcare-related quality of life: EQ-5D-5L score(3 months)
- Patient Self-efficacy(3 months)
- Patient Satisfaction: Patient Global Impression of Improvement Score(3 months)
- Healthcare-related Quality of Life: EQ-5D-5L Score(3 months)
- Healthcare-related Quality of Life: Recurrent UTI Impact Questionnaire Score(3 months)
- Healthcare Utilization(3 months)
- Antibiotic Prescriptions(3 months)
- Patient Medication Compliance(3 months)
研究者
Lily Arya
Professor of OBGYN
University of Pennsylvania