Implementing a Mobile Health Application for Women Veterans with Urinary Incontinence (MyHealtheBladder): Function QUERI 3.0 aims to compare implementation approaches while also gathering information on clinical effects of the Evidence-Based Program (EBP) in its new context and focusing on equitable reach (extent to which the program serves all members of its intended audience). The overall goal is to implement, evaluate, and sustain MyHealtheBladder in 20 VA facilities using a type III effectiveness-implementation hybrid study framework and parallel cluster randomized trial (CRT) design.

Background/Purpose. Urinary incontinence (UI) is a highly prevalent condition among women, especially as they age, and can directly impair quality of life, daily function, and long-term independence. Evidence-based behavioral management approaches are first-line treatment for UI; these include treatments such as pelvic floor muscle training, fluid management, and bladder control and voiding strategies. Despite being prevalent and burdensome, UI is often unrecognized and undertreated.

MyHealtheBladder (MHB) is an interactive mobile health application designed to deliver evidence-based behavioral self-management instruction specifically for Women Veterans (WV). In a multi-site RCT (VA IIR HX002827) conducted in VA (n=286) comparing MHB to video visits via VA Video Connect (VVC) delivered by a trained Continence Care provider, MHB resulted in equivalent or greater improvements in UI symptoms and satisfaction compared with VVC. Engagement in MHB was high, with 70% retention and an average of 58 miles saved per Veteran. MHB does not require a clinical visit and has the potential to scale across other VA facilities and generate healthcare savings while maintaining comparable patient-level outcomes to individual clinical encounters.

Objectives. The investigators aim to develop scalable approaches for implementing and sustaining use of MyHealtheBladder in clinical settings. Additionally, they will assess the reach of MyHealtheBladder when delivered through the Foundational arm compared to an enhanced-implementation strategy, the REACH (Reach Equity And Collective Health) arm.

Key questions. How can the REACH arm be optimized to implement MHB across all patients who would benefit? What are shareholder perspectives on refinements needed for MHB foundational activities, as well as strategies to enhance equitable reach? To address the question "Are there differences in implementation outcomes (reach [primary], patient engagement, time to adoption) between arms?", the investigators will use generalized linear models to examine the effect of foundational vs. REACH on implementation outcomes of reach and patient engagement at 12 and 18 months (primary). Average time to adoption will be compared between study arms.

Methodology. To evaluate implementation, the investigators will randomize sites (n=20) 1:1 to either the foundational arm or REACH arm. The investigators will use generalized linear models to examine the effect of foundational vs. REACH on implementation outcomes of reach and patient engagement at 18 months.

Inclusion Criteria:

Site Inclusion Criteria:

• Facility is part of the U.S. Department of Veterans Affairs (VA) health system.
• Clinic serves at least 100 Women Veterans annually.
• Identified site champion (e.g., clinician or staff member) who is willing to assume required program responsibilities for implementation.

Patient Inclusion Criteria:

• Women Veterans
• Have any type of Urinary Incontinence existing for at least 3 months

Exclusion Criteria:

Site Exclusion Criteria:

• Clinic has already implemented the MyHealtheBladder program.

Patient Exclusion Criteria:

• No access to computer or mobile device
• No email account
• Institutionalized

MHB is an interactive mobile health application designed to deliver evidence-based behavioral self-management instruction specifically for women Veterans.

A de-identified, anonymized dataset will be available upon request. Prior to distribution, a local privacy officer and study statistician will certify that the dataset contains no protected health information (PHI). Data will be provided to requestor in electronic format. Sufficient data and descriptors will be made available to duplicate statistical analysis and confirm conclusions in publication. No data or statistical code that could lead to re-identification of individuals will be released. Data will be stored & maintained in an approved, secured location as described in the VA Research Data Inventory Form. The statistician will create de-identified, publication-specific datasets that includes variables from statistical models presented in publication. Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re-identify any individual whose data are included in the dataset.

Available upon request.

Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re- identify any individual whose data are included in the dataset.