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：女性退伍军人整个生命周期的初级保健和预防研究是一个领域 退伍军人管理局健康管理局 (VHA) 日益关注。越来越多的女性退伍军人正在使用 VA 的一般和针对特定性别的医疗保健，在过去十年中翻了一番，占总数的 7% VHA 中出现的退伍军人都是女性。高达 20% 的女性退伍军人经历尿失禁 (UI)，并且可能由于服兵役期间的暴露而面临更大的风险，例如厕所通道受限和 重型防护装备和设备对骨盆底的影响。这些因素以及已知的风险 怀孕、分娩和更年期过渡等因素会增加女性退伍军人的 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 有 UI 的女性退伍军人。有几种基于证据的治疗方法可用于 UI，包括行为、 药物和手术治疗。行为自我管理治疗，包括盆底肌肉训练， 指南广泛推荐膀胱控制策略和液体管理作为一线治疗 选项，因为它们已被证明有效且副作用风险低。接受的女性 UI 的行为疗法报告称，当获得来自他人的输入时，他们对自我管理更有信心 接受过 UI 管理专门培训的临床医生。为了确定 VHA 内 UI 治疗方式的差距，我们 调查了 VA 妇科医生、泌尿科医生以及行为和物理治疗提供者的一线治疗 全国各地 VA 医疗中心的选择。我们发现只有 55% 的机构报告提供骨盆 地板肌肉训练 (PFMT)，14% 提到了另一个 VA，44% 提到了非 VA 护理。十六 % 的设施不提供 PFMT。我们的数据表明，女性退伍军人获得的机会有限 能够提供这些安全有效治疗的临床医生。 创新：鉴于已确定需要改善 UI 治疗的可及性，我们开发并测试了两种 远程交付模型：交互式移动医疗或 mHealth UI 智能手机/计算机应用程序和 临床视频远程医疗 (CVT) 就诊。这项拟议的研究将纳入一项创新的连续的、多重的 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性退伍军人的有效性 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女性； (3)探索影响未来的关键因素 远程 UI 治疗传播。我们的总体假设是，接受该政策的女性退伍军人 与训练相比，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。总体目标是改善获得基于证据的 UI 治疗的机会。 方法：包括来自女性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，我们将随机抽取 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 对两个随机分组中的无应答者依次进行额外的 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 干预期，在基线、8 周、12 周（主要 结果），耐用性为 6 个月。此外，我们将使用定性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 改善更多 VHA 设施中女性退伍军人获得 UI 护理的机会。