Clinical trial NCT05438849: Improving Primary Care Access to Urinary Incontinence Treatment for Women Veterans
Official title: Improving Primary Care Understanding of Resources and Screening for Urinary Incontinence to Enhance Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urinary Incontinence
Keywords: women
Veterans
behavioral treatment
primary care
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2022-06-30
Enrollment: 2500
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Urinary incontinence (UI) screening rates
timeFrame: Baseline and 6 months post-Baseline
measure: Change, over time, in usage of the provider clinical data dashboard
timeFrame: Baseline and 6 months post-Baseline
Secondary outcomes:
measure: Enrollment rates of women Veterans for MyHealtheBladder
timeFrame: 2-, 4-, and 6-months post-Baseline
measure: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
timeFrame: Baseline and 2-months post-Baseline
measure: Pelvic Floor Muscle Exercise (PFME) Adherence
timeFrame: 2-months post-Baseline
measure: System Usability Scale
timeFrame: 2-months post-Baseline
measure: Satisfaction and Perception of Improvement
timeFrame: 2-months post-Baseline
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham VA Healthcare System
state: Alabama
city: Decatur
country: United States
facility: Atlanta VA Health Care System
state: Georgia
Study officials:
affiliation: UNIVERSITY OF ALABAMA AT BIRMINGHAM, BIRMINGHAM , AL
name: Alayne D Markland, DO, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.