Urinary Incontinence
Conditions
Keywords
Veterans, Implementation Science, Functional Status, Quality of Life, Mobile Applications
Brief summary
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.
Detailed description
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.
Interventions
The Foundational Arm includes the following activities: Program sign up, toolkit, kickoff call, SharePoint, TEAMS channel, office hours calls, and site specific data reports.
The REACH Arm includes everything in the Foundational Arm, plus additional components: targeted data reports, a data dashboard, and external facilitation.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Parallel cluster-randomized trial (parallel-CRT): used in pragmatic evaluations of health program or policy interventions, where half the clusters (in this case, VA sites) are randomly assigned to two interventions: Foundational arm (active comparator) vs. REACH (Reach Equity And Collective Health) arm (experimental).
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reach | 18 months | Reach will be defined as the percentage of Women Veterans that accessed (logged into) the MHB app. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reach | 12 months | Reach will be defined as the percentage of Women Veterans that accessed (logged into) the MHB app. |
| Patient Engagement | 12 months | Patient engagement will be defined as the proportion of MyHealtheBladder sessions completed by Women Veterans at each clinic, among those who completed at least one session. |
| Time to Adoption | 18 months | Time to Adoption will be defined as the time from baseline to the time at which a site crosses the adoption threshold (5 or more Women Veterans who have accessed the app). This will be computed for each site meeting the adoption criteria. |
Countries
United States
Contacts
CONTACTCaitlin B Kappler, MSW
PRINCIPAL_INVESTIGATORKaren Goldstein, MD MSPH
Durham VA Medical Center, Durham, NC
PRINCIPAL_INVESTIGATORAlayne D Markland, DO MSc
Birmingham VA Medical Center, Birmingham, AL
Outcome results
None listed