Clinical trial NCT05515198: Improving Care for Women With Urinary Incontinence (EMPOWER)
Official title: Empowering Women and Providers for Improved Care of Urinary Incontinence (UI) [EMPOWER Study]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: women
female
urinary incontinence
empowering
EMPOWER
providers
bladder leakage
incontinence
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall goal is to improve diagnosis and non-operative management of urinary incontinence in women.

Detailed description: 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:

1. 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.
2. 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.
3. 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.

Eligibility criteria: Inclusion Criteria:

1. Female patient having a primary care provider visit at University Hospitals (UH) Cleveland Primary Care Institute (PCI)
2. ≥ 18 years old
3. Scores 1 or higher on the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)

Exclusion Criteria:

None

Primary outcomes:
measure: Change in patients' UI symptoms as measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
timeFrame: Baseline and Months 2 and 6 (all Waves)
measure: Patients' UI symptoms as measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
timeFrame: 12 months (Waves 1 and 2)
measure: Patients' UI symptoms as measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
timeFrame: 18 months (Wave 1)
Secondary outcomes:
measure: Change in patients' perceived self-efficacy for UI communication as measured by the PEPPI
timeFrame: Baseline and Months 2 and 6 (all Waves)
measure: Patients' perceived self-efficacy for UI communication as measured by the PEPPI
timeFrame: 12 months (Waves 1 and 2)
measure: Patients' perceived self-efficacy for UI communication as measured by the PEPPI
timeFrame: 18 months (Wave 1)
measure: Change in patient empowerment as measured by a patient survey
timeFrame: Baseline and Months 2 and 6 (all Waves)
measure: Change in overactive bladder symptom severity as measured by the OABSS
timeFrame: Baseline and Months 2 and 6 (all Waves)
measure: Overactive bladder symptom severity as measured by the OABSS
timeFrame: 12 months (Waves 1 and 2)
measure: Overactive bladder symptom severity as measured by the OABSS
timeFrame: 18 months (Wave 1)
measure: Change in urinary symptoms as measured by the UDI-6
timeFrame: Baseline and Months 2 and 6 (all Waves)
measure: Urinary symptoms as measured by the UDI-6
timeFrame: 12 months (Waves 1 and 2)
measure: Urinary symptoms as measured by the UDI-6
timeFrame: 18 months (Wave 1)
measure: Change in impact of UI on patients' quality of life as measured by the ICIQ-LUTSqol
timeFrame: Baseline and Months 2 and 6 (all Waves)
measure: Impact of UI on patients' quality of life as measured by the ICIQ-LUTSqol
timeFrame: 12 months (Waves 1 and 2)
measure: Impact of UI on patients' quality of life as measured by the ICIQ-LUTSqol
timeFrame: 18 months (Wave 1)
measure: Change in patients' perceived symptom improvement as measured by the PGI-I
timeFrame: Months 2 and 6 (all Waves)
measure: Patients' perceived symptom improvement as measured by the PGI-I
timeFrame: 12 months (Waves 1 and 2)
measure: Patients' perceived symptom improvement as measured by the PGI-I
timeFrame: 18 months (Wave 1)
measure: Number of practices that maintain a UI management intervention as measured by the practice survey
timeFrame: 1 month post completion of each Wave's enrollment period
measure: Number of practices that implement a UI point person as measured by the practice survey
timeFrame: 1 month post completion of each Wave's enrollment period
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Adonis Hijaz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals Cleveland Medical Center
name: Goutham Rao, MD
role: PRINCIPAL_INVESTIGATOR
References: