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Clinical Trials/NCT05438849
NCT05438849
Active, not recruiting
Not Applicable

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

University of Alabama at Birmingham2 sites in 1 country2,500 target enrollmentNovember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urinary Incontinence
Sponsor
University of Alabama at Birmingham
Enrollment
2500
Locations
2
Primary Endpoint
Urinary incontinence (UI) screening rates
Status
Active, not recruiting
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2022
End Date
June 1, 2026
Last Updated
5 months ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alayne D. Markland

Professor

University of Alabama at Birmingham

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Urinary incontinence (UI) screening rates

Time Frame: 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

Time Frame: 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 Outcomes

  • Enrollment rates of women Veterans for MyHealtheBladder(2-, 4-, and 6-months post-Baseline)
  • International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)(Baseline and 2-months post-Baseline)
  • Pelvic Floor Muscle Exercise (PFME) Adherence(2-months post-Baseline)
  • System Usability Scale(2-months post-Baseline)
  • Satisfaction and Perception of Improvement(2-months post-Baseline)

Study Sites (2)

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