Optimizing Remote Access to Urinary Incontinence Treatment for Women Veterans

优化女性退伍军人的远程尿失禁治疗

• 批准号: 10754895
• 负责人: Alayne Denise Markland
• 金额: --
• 依托单位: BIRMINGHAM VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-01-01 至 2024-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10754895
• 关键词: Address; Age; Anxiety; Area; Behavior Therapy; Behavioral; Bladder Control; Caring; Cellular Phone; Childbirth; Clinical; Clinical Trials; Computers; Consensus; Data; Discipline; Education; Effectiveness; Equipment; Evidence based treatment; Exposure to; Funding; Future; Gender; Geriatrics; Goals; Guidelines; Gynecologist; Health; Health Services Accessibility; Healthcare; Improve Access; Intervention; Interview; Life Cycle Stages; Liquid substance; Long-Term Care; Medical; Medical center; Methodology; Methods; Mobile Health Application; Modality; Modeling; Mood Disorders; Online Systems; Operative Surgical Procedures; Outcome Assessment; Patient Care; Pelvic Floor Muscle; Pelvic floor structure; Perception; Perimenopause; Persons; Physical therapy; Physicians; Positioning Attribute; Post-Traumatic Stress Disorders; Pregnancy; Prevention Research; Primary Care; Primary Prevention; Provider; Qualitative Methods; Quality of life; Randomized; Recommendation; Rehabilitation therapy; Reporting; Research; Research Priority; Risk; Risk Factors; Self Management; Sequential Multiple Assignment Randomized Trial; Severities; Site; Specialist; Surveys; Testing; Training; Update; Urinary Incontinence; Urologist; Veterans; Visit; Woman; Women' s Health; active duty; aged; care systems; clinical center; compare effectiveness; disability; effective therapy; effectiveness/implementation design; evidence base; experience; health administration; implementation science; improved; incontinence symptom; innovation; mHealth; military service; multidisciplinary; practice-based research network; primary outcome; remote delivery; response; sexual assault; side effect; symptomatic improvement; telehealth; treatment as usual; trial design; virtual healthcare

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.

背景：在女性退伍军人的整个生命周期中进行初级保健和预防研究是一个领域， 在VA卫生管理局（VHA）内增加关注。越来越多的女性退伍军人正在使用 VA的一般和性别特定的医疗保健，在过去十年中翻了一番，占所有 在VHA中看到的退伍军人是女性。多达20%的女性退伍军人经历尿失禁 (UI)并且可能由于在服兵役期间暴露而增加风险，例如限制上厕所， 沉重的保护装置和设备对骨盆底的影响。这些因素，沿着已知的风险 怀孕、分娩和绝经过渡等因素增加了女性退伍军人的UI风险。 意义/影响：这项拟议的临床试验的重点是改善一线治疗的可及性， 女性退伍军人与UI UI有几种循证治疗方法，包括行为， 内科和外科治疗。行为自我管理治疗，包括骨盆底肌肉训练， 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，因为他们证明的有效性和低风险的副作用。接受培训的妇女 UI的行为疗法报告说，当提供来自 接受过UI管理专门培训的临床医生。为了找出VHA中UI治疗方式的差距，我们 调查了VA妇科医生，泌尿科医生，行为和物理治疗提供者的一线治疗 在全国各地的VA医疗中心的选择。我们发现，只有55%的机构报告说， 地板肌肉训练（PFMT），而14%的人提到另一个VA，44%的人提到非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治疗的临床医生。 创新：鉴于确定需要改善对UI治疗的访问，我们开发并测试了两个 远程交付模型：交互式移动健康或mHealth UI智能手机/计算机应用程序和 临床视频远程保健（CVT）访问。这项拟议的研究将纳入一个创新的顺序，多个 分配，随机试验（SMART）设计，以确定远程交付的最佳方法。 具体目的：我们的具体目的是：（1）比较两个偏远地区的女退伍军人的效果。 基于证据的行为UI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;（2）使用SMART设计优化UI症状改善， 对任何一种远程分娩都没有反应的妇女;（3）探索可能影响未来分娩的关键因素。 远程UI治疗传播。我们的总体假设是，接受 与培训相比，交互式mHealth应用程序将更大程度地减少UI症状 在远程CVT访问中提供。广泛的目标是改善循证UI治疗的可及性。 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，对无应答者依次增加额外的1：1 CVT访视。这 SMART设计包括两个随机化阶段，并在3个月内比较1个优化因子 在基线、第8周、第12周（主要 结果）和6个月的耐久性。此外，我们将使用定性方法来确定关键因素 影响女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 在更广泛的VHA设施中改善女性退伍军人获得UI护理的机会。