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: 10651594
• 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 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10651594
• 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：整个生命周期中妇女退伍军人之间的初级保健和预防研究是 VA卫生管理（VHA）内的重点增加。越来越多的女退伍军人正在使用 VA的一般和性别特定的医疗保健，在过去的十年中是两倍，其中7％ 在VHA中看到的退伍军人是女性。多达20％的退伍军人经历尿失禁 （UI），并且可能由于兵役期间的暴露，例如受限厕所通道和 重型齿轮和设备对骨盆底的影响。这些因素，以及已知风险 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：该拟议的临床试验着重于改善对一线治疗的机会 用UI的女退伍军人。 UI可以使用几种基于证据的治疗，包括行为， 医疗和手术疗法。行为自我管理治疗，包括骨盆底肌肉训练， 准则将膀胱控制策略和流体管理广泛推荐为一线治疗 选项由于其有效性和副作用的风险低而选择。接受的妇女 UI的行为疗法报告说，当提供了来自 在UI管理方面进行特定培训。为了确定VHA内UI治疗方式的差距，我们 接受调查的VA妇科医生，泌尿科医生以及一线治疗的行为和物理治疗提供者 全国VA医疗中心的选择。我们发现只有55％的设施报告提供了骨盆 地板肌肉训练（PFMT），而14％的人提到另一个VA，44％的人提到了非VA护理。十六 设施的百分比没有提供PFMT。我们的数据表明，女退伍军人获得的机会有限 可以提供这些安全有效治疗的临床医生。 创新：鉴于已确定的需要改善对UI治疗的访问的需求，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/计算机应用程序以及 临床视频远程医疗（CVT）访问。这项拟议的研究将结合创新的顺序，多个 分配，随机试验（智能）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）比较两个遥远的妇女退伍军人的有效性 基于经验的行为UI处理的交付模型，这是一种交互式MHealth智能手机/计算机 应用程序与远程CVT访问； （2）使用智能设计来优化UI症状的改善 对任何一种远程交货都不反应的妇女； （3）探索可能影响未来的关键因素 远程UI处理传播。我们的总体假设是接受 与培训相比 在远程CVT访问中提供。广泛的目标是改善获得基于经验的UI治疗的机会。 方法论：包括来自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，我们将随机分配260名妇女退伍军人（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，对非反应者的额外添加1：1 CVT访问。这 智能设计包括两个随机化阶段，并比较了3个月的1个优化因子 在基线，8周，12周评估的经过验证的UI Sym结果的干预期（主要） 结果），Durabiltiy的6个月。此外，我们将使用定性方法来识别关键因素 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 为了改善在更广泛的VHA设施中为女退伍军人提供UI护理的机会。