Optimizing Remote Access to Urinary Incontinence Treatment for Women Veterans

背景：女性退伍军人生命周期中的初级保健和预防研究是 在退伍军人健康管理局(VHA)内日益受到关注。越来越多的女性退伍军人正在使用 在过去十年中翻了一番，占总人数的7% 在VHA中看到的退伍军人是女性。高达20%的退伍军人经历过尿失禁 (UI)，并可能因服兵役期间暴露而增加风险，如限制厕所出入和 沉重的防护装备对盆底的影响。这些因素以及已知的风险 怀孕、分娩和更年期转变等因素会增加退伍军人中发生尿失禁的风险。 意义/影响：这项拟议的临床试验侧重于改善患者获得一线治疗的机会 患有尿崩症的退伍军人。几种基于证据的治疗方法可用于治疗UI，包括行为、 内科和外科治疗。行为自我管理治疗，包括盆底肌肉训练， 膀胱控制策略和液体管理被指南广泛推荐为一线治疗。 选择，因为它们被证明是有效的和低风险的副作用。接受的女性 UI的行为疗法报告称，当提供来自 在用户界面管理方面接受过专门培训的临床医生。为了找出VHA内尿失禁治疗方式的差距，我们 接受调查的退伍军人事务部妇科医生、泌尿科医生以及行为和物理治疗提供者提供一线治疗 在全国各地的退伍军人医疗中心提供选择。我们发现，只有55%的设施报告提供骨盆 地板肌肉训练(PFMT)，14%涉及另一种VA，44%涉及非VA护理。十六 %的设施没有提供PFMT。我们的数据表明，女性退伍军人获得 能够提供这些安全有效的治疗的临床医生。 创新：鉴于已确定的改善获得UI治疗的需求，我们开发并测试了两个 远程交付模式：交互式移动健康或mHealth用户界面智能手机/计算机应用程序和 临床视频远程健康(CVT)访问。这项拟议的研究将纳入创新的顺序、多个 分配，随机试验(SMART)设计，以确定远程交付的最佳方法。 具体目标：我们的具体目标是：(1)比较两个偏远地区女退伍军人的有效性 基于证据的行为用户界面治疗的交付模型，交互式mHealth智能手机/计算机 应用程序与远程CVT访问的对比；(2)使用智能设计优化用户界面症状改善 对任何一种远程分娩都没有反应的女性；(3)探索可能影响未来的关键因素 远程UI治疗传播。我们最重要的假设是，接受 与培训相比，交互式mHealth应用程序将在更大程度上减少UI症状 在远程CVT访问中提供。广泛的目标是改善获得基于证据的用户界面治疗的机会。 方法：包括妇女健康实践研究网络的专业知识， 伯明翰VAMC、亚特兰大VAHCS和达勒姆VAMC，我们将随机选择260名女性退伍军人(86 每个站点)。我们将通过评估mHealth UI应用程序与CVT会话的有效性进行比较 在两个随机化组中为无应答者顺序增加额外的1：1 CVT访视。这 智能设计包括两个随机阶段，并在3个月内比较1个优化因素 在基线、8周、12周(主要)评估有效UI症状结果的干预期 结果)，耐受性为6个月。此外，我们将使用定性的方法来确定关键因素 影响女性退伍军人和提供者的参与和传播。 下一步/实施：我们的下一步将是测试实施最有效模式的能力 用于改善退伍军人在更广泛的VHA设施中获得尿毒症护理的机会。

Background: Primary care and prevention research among women Veterans across the life cycle is an area of increasing focus within VA Health Administration (VHA). Increasing numbers of women Veterans are using the VA for their general and gender-specific health care, representing a doubling in the past decade with 7% of all Veterans seen in the VHA being women. Up to 20 percent of women Veterans experience urinary incontinence (UI) and may be at increased risk due to exposures during military service, such as restricted toilet access and the impact of heavy protective gear and equipment on the pelvic floor. These factors, along with known risk factors such as pregnancy, childbirth, and menopausal transitions increase UI risk among women Veterans. Significance/Impact: This proposed clinical trial focuses on improving access to first-line treatments for women Veterans with UI. Several evidence-based treatments are available for UI including behavioral, medical, and surgical therapies. Behavioral self-management treatments including pelvic floor muscle training, bladder control strategies, and fluid management are widely recommended by guidelines as first-line treatment options because of their demonstrated effectiveness and low risk of side effects. Women who receive behavioral therapy for UI report greater confidence in self-management when provided with input from a clinician with specific training in UI management. To identify gaps in UI treatment modalities within VHA, we surveyed VA gynecologists, urologists, and behavioral and physical therapy providers for first-line treatment options at VA Medical Centers across the nation. We found that only 55% of facilities reported offering pelvic floor muscle training (PFMT), while 14% referred to another VA, and 44% referred to non-VA care. Sixteen percent of facilities did not provide PFMT. Our data demonstrated that women Veterans have limited access to clinicians who can provide these safe and effective treatments. Innovation: Given the identified need to improve access to UI treatments, we developed and tested two remote delivery models: an interactive mobile-health or mHealth UI smart phone/computer application and a clinical video telehealth (CVT) visit. This proposed study will incorporate an innovative sequential, multiple assignment, randomized trial (SMART) design to determine the optimal method for remote delivery. Specific Aims: Our specific aims are to: (1) compare the effectiveness among women Veterans of two remote delivery models for evidenced-based behavioral UI treatment, an interactive mHealth smart phone/computer application versus a remote CVT visit; (2) use a SMART design to optimize UI symptom improvement for women who do not respond to either type of remote delivery; (3) explore key factors that could influence future remote UI treatment dissemination. Our overarching hypothesis is that women Veterans who receive the interactive mHealth application will achieve greater reduction in UI symptoms compared to the training provided in a remote CVT visit. The broad goal is to improve access to evidenced-based UI treatments. Methodology: Including expertise from the Women’s Health Practice-Based Research Network, the Birmingham VAMC, the Atlanta VAHCS, and the Durham VAMC, we will randomize 260 women Veterans (86 per site). We will compare the effectiveness of our mHealth UI application to a CVT session by evaluating the sequential addition of an additional 1:1 CVT visit for non-responders in both randomization groups. This SMART design includes two randomization stages and compares 1 optimization factor over a 3-month intervention period with validated UI symptom outcomes assessed at baseline, 8-weeks, 12-weeks (primary outcome), and 6-months for durabiltiy. Additionally, we will use qualitative methods to identify key factors influencing participation and dissemination from women Veterans and providers. Next Steps/Implementation: Our next steps will be to test the ability to implement the most effective modality for improving access to UI care for women Veterans across a wider array of VHA facilities.