Improving Primary Care Access to Urinary Incontinence Treatment for Women Veterans

Study Overview
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Brief Summary
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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 clinician expertise delivered via clinical video telehealth to improve normalization of the toolkit use. 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
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PURSUIT aims to recruit 62 practices to participate in the trial implementation. 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, 50 percent (n=7,500) will participate.

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

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Behavioral: Mobile Health Application focused on behavioral treatments to treat urinary incontinence
* Combination Product: Practice Facilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women Veterans receiving primary care in VISN-7 of the VA Healthcare Administration (VHA)<br>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. | Behavioral: Mobile Health Application focused on behavioral treatments to treat urinary incontinence<br>* Mobile health application for cell phones and computers that delivers evidence-based behavioral treatment for urinary incontinence, specifically tailored to women Veterans<br>* Other names: MyHealtheBladder;|
| Health care providers in community-based outpatient clinics in VISN-7 of the the VHA<br>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. | Combination Product: Practice Facilitation<br>* 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.<br>* Other names: Practice facilitation toolkit;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment rates of women Veterans for MyHealtheBladder | Women receiving behavioral urinary incontinence treatment on MyHealtheBladder | 2-, 4-, and 6-months post-Baseline | 
| 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 | 
| Pelvic Floor Muscle Exercise (PFME) Adherence | 2-item questionnaire to explore adherence to completing PFMEs | 2-months post-Baseline | 
| 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 | 
| Satisfaction and Perception of Improvement | 3-item tool for feedback on participant satisfaction and perceived symptom improvement | 2-months post-Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Veterans, women, behavioral treatment, primary care