Improving Primary Care Access to Urinary Incontinence Treatment for Women Veterans

Recruiting

• Conditions: Urinary Incontinence
• Interventions: Behavioral: Mobile Health Application focused on behavioral treatments to treat urinary incontinence; Combination Product: Practice Facilitation

• Registration Number: NCT05438849
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

The PURSUIT project aims to improve access to evidence-based nonsurgical UI treatment for women Veterans in the Southeast region of the United States using the most effective remote delivery modality. Using cluster randomization, the study will compare two models at the practice level: (1) the use of a practice facilitation toolkit with a mHealth UI modality alone and (2) the practice facilitation toolkit with a mHealth UI model combined with education on clinical pathways for consultation. Patient level outcomes related to UI symptom improvement will be compared. Patient and provider perceptions of factors that could influence future remote UI treatment scalability will also be assessed. All primary care practices will receive practice facilitation with a PURSUIT toolkit that includes (1) 1-2 visits with a practice facilitator; (2) mobile-health or mHealth application training (MAT); 3) online resource hub; and (4) health information technology (HIT) assistance. PURSUIT's future goal is to disseminate the most effective modality for delivering nonsurgical UI treatment for women Veterans nationally within the VHA.

Detailed Description

PURSUIT aims to recruit 62 practices to participate in the trial implementation at 50 practices. Specifically, Community-Based Outpatient Clinics (CBOCs) from VA Integrated Service Network (VISN) 7 will be targeted, spanning the states of Alabama, Georgia, and South Carolina. The project will focus on VISN 7 CBOCs, serving at least 50 women Veterans with primary care services, will be recruited through connections with local women's health providers. The team estimates outreach to approximately 50,000 women Veterans and estimates that 30 percent (n=15,000) of these women will have UI symptoms, and, among those, 15 percent (n=2,500) will participate.

Study Timeline

• Study First Submitted: 2022-05-25
• Study First Submitted QC: 2022-06-27
• Study First Posted: 2022-06-30
• Study Start: 2022-11-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-27
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 2500

Inclusion Criteria

• Veteran
• English-speaking, community-dwelling women Veterans
• Diagnosis of UI (all types)
• Access to the internet via a mobile device or computer

Exclusion Criteria

• Women Veterans who are currently pregnant or less than 12 weeks postpartum

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women Veterans receiving primary care in VISN-7 of the VA Healthcare Administration (VHA)	Mobile Health Application focused on behavioral treatments to treat urinary incontinence	This project will include English-speaking, community-dwelling women Veterans 20 years or older with a diagnosis of UI (all types) and access to the internet via a mobile device or computer. Women Veterans who are currently pregnant or less than 12 weeks postpartum will be excluded. PURSUIT utilizes a mobile health application, called MyHealtheBladder, to connect patients with nonsurgical treatment options.
Health care providers in community-based outpatient clinics in VISN-7 of the the VHA	Practice Facilitation	Community-Based Outpatient Clinics (CBOCs) from VA Integrated Service Network (VISN) 7 will be targeted, spanning the states of Alabama, Georgia, and South Carolina. VISN 7 CBOCs, serving at least 50 women Veterans with primary care services, will be recruited.

Primary Outcome Measures

Name	Time	Method
Urinary incontinence (UI) screening rates	Baseline and 6 months post-Baseline	This will include measuring changes, over time, in UI diagnoses for women Veterans. These changes will be measured by pulling data on UI ICD-9 and ICD-10 codes collected via the program's clinical data dashboard.
Change, over time, in usage of the provider clinical data dashboard	Baseline and 6 months post-Baseline	This will include capturing the unique number of clinic site "champions" (i.e. designated women's health provider) who engage with this program's clinical data dashboard. Dashboard engagement will be measured as the number of unique site champions who use the dashboard divided by the total number of site champions involved in this program.

Secondary Outcome Measures

Name	Time	Method
Enrollment rates of women Veterans for MyHealtheBladder	2-, 4-, and 6-months post-Baseline	Women receiving behavioral urinary incontinence treatment on MyHealtheBladder
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)	Baseline and 2-months post-Baseline	4-item tool to measure UI symptoms, scored on scale from 0-21 with a higher score indicating worse symptoms
Pelvic Floor Muscle Exercise (PFME) Adherence	2-months post-Baseline	2-item questionnaire to explore adherence to completing PFMEs
System Usability Scale	2-months post-Baseline	10-item questionnaire, using 5-point Likert scale, to gauge the usability of MHB. Scoring range is 0-100 with a higher score indicating the system is more usable,
Satisfaction and Perception of Improvement	2-months post-Baseline	3-item tool for feedback on participant satisfaction and perceived symptom improvement

Trial Locations

Locations (2)

Birmingham VA Healthcare System; 🇺🇸 Birmingham, Alabama, United States

Atlanta VA Health Care System; 🇺🇸 Decatur, Georgia, United States