Improving Care for Women With Urinary Incontinence (EMPOWER)

University Hospitals (UH)

Status: Completed

Conditions: Urinary Incontinence

Treatments: Other: Patient Education; Other: Nurse Navigation; Other: ChatBot

Study type: Interventional

Funder types: Other

Identifiers

NCT05515198

20211420

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 3 patient groups

Arm 1

Experimental group

Description:

Patient Education

Treatment:

Other: Patient Education

Arm 2

Experimental group

Description:

Patient Education + Nurse Navigation

Treatment:

Other: Nurse Navigation

Other: Patient Education

Arm 3

Experimental group

Description:

Patient Education + Nurse Navigation + ChatBot

Treatment:

Other: ChatBot

Other: Nurse Navigation

Other: Patient Education