Improving Primary Care Access to Urinary Incontinence Treatment for Women Veterans

Urinary Incontinence Clinical Trial

— PURSUIT  

Official title:

Improving Primary Care Understanding of Resources and Screening for Urinary Incontinence to Enhance Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05438849
• Other study ID #: 1658917-2
• Secondary ID: U18HS028736
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: University of Alabama at Birmingham
• Contact: Emily B Malone, MPH
• Phone: 12059338101
• Email: emilymalone[@]uabmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Behavioral:
• Mobile Health Application focused on behavioral treatments to treat urinary incontinence
Mobile health application for cell phones and computers that delivers evidence-based behavioral treatment for urinary incontinence, specifically tailored to women Veterans

Combination Product:
• Practice Facilitation
The toolkit has 4 components: (1) Practice Facilitation Visits, (2) Mobile-health or mHealth Application Training (MAT) training, (3) Access and education on the Data Dashboard, and (4) Health information technology (HIT) assistance.

Locations

Country	Name	City	State
United States	Birmingham VA Healthcare System	Birmingham	Alabama
United States	Atlanta VA Health Care System	Decatur	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Agency for Healthcare Research and Quality (AHRQ), US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

References & Publications (1)

Goode PS, Markland AD, Echt KV, Slay L, Barnacastle S, Hale G, Wright MK, Lane TR, Burgio KL. A mobile telehealth program for behavioral treatment of urinary incontinence in women veterans: Development and pilot evaluation of MyHealtheBladder. Neurourol Urodyn. 2020 Jan;39(1):432-439. doi: 10.1002/nau.24226. Epub 2019 Nov 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary incontinence (UI) screening rates	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.	Baseline and 6 months post-Baseline
Primary	Change, over time, in usage of the provider clinical data dashboard	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.	Baseline and 6 months post-Baseline
Secondary	Enrollment rates of women Veterans for MyHealtheBladder	Women receiving behavioral urinary incontinence treatment on MyHealtheBladder	2-, 4-, and 6-months post-Baseline
Secondary	International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)	4-item tool to measure UI symptoms, scored on scale from 0-21 with a higher score indicating worse symptoms	Baseline and 2-months post-Baseline
Secondary	Pelvic Floor Muscle Exercise (PFME) Adherence	2-item questionnaire to explore adherence to completing PFMEs	2-months post-Baseline
Secondary	System Usability Scale	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,	2-months post-Baseline
Secondary	Satisfaction and Perception of Improvement	3-item tool for feedback on participant satisfaction and perceived symptom improvement	2-months post-Baseline