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）的重点增加。 VA为他们的一般和性别特定的医疗保健，代表了双十年，而Alll的7％ 在VHA中看到的退伍军人是女性。 （UI），并且可能由于兵役期间的暴露，例如受限厕所通道和 重型防护装备和设备对这些因素的影响以及已知的风险 怀孕，分娩和绝经的因素增加了女性退伍军人的UI风险。 意义/影响：该支撑临床试验的重点是改善对一线治疗的机会 使用UI的女性退伍军人可用于UI，包括行为 医学和手术疗法。 膀胱控制策略和流体管理被准则广泛推荐为ASALS-LINE特征 由于其有效性和副作用的风险低 行为疗法堡垒对自我管理的信心更大 临床医生在UI管理中接受特定的培训，以识别VHA内UI治疗方式的差距 调查的VA妇科医生，泌尿科医生以及行为和身体。 在全国范围内的VA医疗中心的选择。 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。 设施的百分比没有提供PFMT。 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）访问此支撑性研究 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； 对任何一种远程交货都不反应的妇女； 远程UI治疗传播。我们的总体假设是 与培训相比 在远程CVT访问中，广泛的目标是改善对基于经验的UI的访问。 方法论：包括基于妇女健康实践的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）。 在两个随机组中，对非反应者的额外添加1：1 CVT访问 智能设计包括两个随机阶段和指南针1优化因子，超过3个月 在基线，8周，12周（主要（主要（主要） 结果），杜比尔蒂（Durabiltiy）的6个月。 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脱落方式的能力 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。