Empowering Women and Providers for Improved Care of Urinary Incontinence (UI) [EMPOWER Study]
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Patients' UI symptoms as measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
研究概览
简要总结
The overall goal is to improve diagnosis and non-operative management of urinary incontinence in women.
详细描述
In the study, patients will be screened in primary care offices for symptoms of urinary incontinence. Women with positive screening results will be asked if they are interested in participating in an implementation study where women will be assigned to one of the three following groups:
- Usual Care plus Patient Educational Opportunities - The patient's urinary incontinence will be managed using standard of care treatment by the patient's primary care provider. Patients will be offered educational opportunities about urinary incontinence.
- Nurse Navigation - Along with the treatment described for "Usual Care plus Patient Educational Opportunities," a nurse navigator will work with the patient to implement behavioral changes and provide education and physical therapy options. In addition, the navigator will be available to answer the patient's questions in a timely fashion and help the patient move through the care pathway.
- Nurse Navigation and ChatBot - Along with the treatment described for "Usual Care plus Patient Educational Opportunities" and "Nurse Navigation," this group will include a ChatBot feature which will allow a patient to directly and privately communicate with an artificial intelligence-driven ChatBot, also known as a "conversational agent," that will provide education and help the patient navigate the care pathway.
All participants will complete questionnaires throughout their enrollment and data will be collected from medical records. The study team will analyze the data at six months after the original appointment/study enrollment, assess adherence to therapy and how the therapy impacted the outcomes the team hopes to improve, such as improvement in symptoms. The study will be implemented over three subsequent time periods called Wave 1, Wave 2 and Wave 3 with primary care practices from two geographic regions being involved in each wave (6 regions total). Participants in Wave 1 will be followed for a total of 18 months, while participants in Wave 2 will be followed for a total of 12 months, and participants in Wave 3 will be followed for 6 months. Primary care providers at all participating practices will be offered educational opportunities related to urinary incontinence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient having a primary care provider visit at University Hospitals (UH) Cleveland Primary Care Institute (PCI)
- •≥ 18 years old
- •Scores 1 or higher on the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)
排除标准
- 未提供
研究组 & 干预措施
Arm 1
Patient Education
干预措施: Patient Education (Other)
Arm 3
Patient Education + Nurse Navigation + ChatBot
干预措施: ChatBot (Other)
Arm 2
Patient Education + Nurse Navigation
干预措施: Patient Education (Other)
Arm 2
Patient Education + Nurse Navigation
干预措施: Nurse Navigation (Other)
Arm 3
Patient Education + Nurse Navigation + ChatBot
干预措施: Patient Education (Other)
Arm 3
Patient Education + Nurse Navigation + ChatBot
干预措施: Nurse Navigation (Other)
结局指标
主要结局
Patients' UI symptoms as measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
时间窗: 18 months (Wave 1)
The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) assess frequency, severity and impact on quality of life (QoL) of patients' urinary incontinence symptoms. The result of the ICIQ-UI SF is a composite score ranging from 0 to 21, with higher scores indicating more severe incontinence.
Change in patients' UI symptoms as measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
时间窗: Baseline and Months 2 and 6 (all Waves)
The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) assess frequency, severity and impact on quality of life (QoL) of patients' urinary incontinence symptoms. The result of the ICIQ-UI SF is a composite score ranging from 0 to 21, with higher scores indicating more severe incontinence.
次要结局
- Impact of UI on patients' quality of life as measured by the ICIQ-LUTSqol(18 months (Wave 1))
- Number of practices that implement a UI point person as measured by the practice survey(1 month post completion of each Wave's enrollment period)
- Urinary symptoms as measured by the UDI-6(18 months (Wave 1))
- Patients' perceived self-efficacy for UI communication as measured by the PEPPI(18 months (Wave 1))
- Change in patient empowerment as measured by a patient survey(Baseline and Months 2 and 6 (all Waves))
- Change in overactive bladder symptom severity as measured by the OABSS(Baseline and Months 2 and 6 (all Waves))
- Change in urinary symptoms as measured by the UDI-6(Baseline and Months 2 and 6 (all Waves))
- Change in impact of UI on patients' quality of life as measured by the ICIQ-LUTSqol(Baseline and Months 2 and 6 (all Waves))
- Patients' perceived symptom improvement as measured by the PGI-I(18 months (Wave 1))
- Change in patients' perceived self-efficacy for UI communication as measured by the PEPPI(Baseline and Months 2 and 6 (all Waves))
- Overactive bladder symptom severity as measured by the OABSS(18 months (Wave 1))
- Change in patients' perceived symptom improvement as measured by the PGI-I(Months 2 and 6 (all Waves))
- Number of practices that maintain a UI management intervention as measured by the practice survey(1 month post completion of each Wave's enrollment period)
研究者
Adonis Hijaz, MD
Vice Chair of Academics and Research for the Urology Institute
University Hospitals Cleveland Medical Center