Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach (POWER)

背景：普遍存在的肥胖相关疾病，如阻塞性睡眠呼吸暂停(OSA)，是一种重要的 退伍军人事务部改善人口健康的机会。阻塞性睡眠呼吸暂停综合症显著降低生活质量，并与 患心血管疾病的风险增加3倍。尽管肥胖是唯一最大的可逆风险因素 对于OSA，100万患有OSA和肥胖的退伍军人很少接受减肥护理来逆转OSA和其他 严重的并发症。功效试验加强了基于生活方式的时间和资源密集型减肥 这些计划改善了OSA严重程度的体重和生理指标(呼吸暂停低通气指数，AHI)。然而， 将这些发现转化为对人口健康有意义的成果存在障碍。首先，退伍军人管理局 有能力就生活方式的改变向患者提供咨询。患有阻塞性睡眠呼吸暂停综合症和肥胖症的退伍军人中，不到三分之一的人 接受减肥咨询的人更少，咨询减肥服务的人就更少了。第二，退伍军人事务部目前的权重 赔款很难获得。患有阻塞性睡眠呼吸暂停综合症和肥胖的退伍军人中只有12%使用Move！，而那些 已提交搬家！实现最小的体重减轻-一年1.2公斤。第三，之前的减肥试验主要集中在 中间措施(如AHI)，限制了对有意义成果的有效性的理解。相遇 针对这些挑战，我们提出了一项务实的试验，主动提供基于视频和自定向的远程 通过电话指导对新诊断为阻塞性睡眠呼吸暂停综合征的退伍军人进行减肥干预。我们的体重 丢失干预(D-ELITE)改编自一项已知在非退伍军人中有效的计划，占44% 24个月后≥减重5%的参与者。进一步优化覆盖范围，我们的远程干预 包括低技术选项(例如DVD视频)，以适应技术素养较低的人。 意义：我们的研究测试了一项主动为退伍军人提供OSA管理工具的计划 以一种独立于当地供应商时间和资源的方式减肥。我们的研究解决了一个关键问题 退伍军人健康方面的差距，符合退伍军人管理局的重要优先事项，包括人口健康、虚拟医疗、 可获得性和医疗保健价值。我们预计我们的干预可以有效地提高 同时减少严重并存的负担和风险。 创新和影响：我们的研究直接挑战了传统的提供者驱动的医疗保健模式 提供人员指导护理并提供旨在管理单一疾病的必要服务的交付。 相反，我们建议利用人口健康向高危人群主动提供减肥服务 接近。为此，我们将在OSA进行远程和自我定向减肥护理的第一次试验，并将 测试减肥护理是否可以改善有意义的结果，如生活质量和心血管风险。 具体目标：我们的主要目标是测试主动交付和务实的权重的有效性 减重干预改善退伍军人睡眠相关生活质量和体重的共同主要终点 阻塞性睡眠呼吸暂停综合症和肥胖症。其次，我们将比较不同组之间的其他结果：心血管风险 分数、睡眠症状和呼吸暂停。最后，我们还将对实施过程进行知情评估 通过RE-AIM框架确定广泛实施的障碍和促进者。 方法：我们计划进行一项混合型1型实用随机对照试验。我们将主动识别 全国范围内患有阻塞性睡眠呼吸暂停综合征和肥胖的退伍军人使用CDW的数据(n=696)，随机1：1到常规护理 再加上D级精英减肥干预或单独的日常护理。我们将在12个月时收集初步结果， 但我们也将收集3个月和24个月的结果，以评估一段时间内的趋势。我们将使用量化和 评估执行障碍的定性方法，包括全面预算影响分析。 下一步/实施：如果有效，我们将与我们的运营合作伙伴国家中心合作 健康促进和预防(NCP)，将D-Elite整合到NCP的减肥产品套件中。这个 国家肺/睡眠项目办公室也同意推动支持全国范围内收养的政策。

Background: Prevalent obesity related conditions like obstructive sleep apnea (OSA) represent an important opportunity for the VA to improve population health. OSA markedly reduces quality of life and is associated with 3-fold greater risk for cardiovascular disease. Although obesity is the single greatest reversible risk factor for OSA, the 1 million Veterans with OSA and obesity rarely receive weight loss care to reverse OSA and other serious comorbidities. Efficacy trials reinforce that time and resource intensive lifestyle-based weight loss programs improve weight and physiologic measures of OSA severity (apnea hypopnea index, AHI). However, there are barriers to translating these findings into meaningful gains for population health. First, VA has limited capacity to counsel patients around lifestyle change. Less than one-third of Veterans with OSA and obesity are counseled about weight loss and even fewer are referred to weight loss services. Second, VA’s current weight loss offerings are difficult to access. Only 12% of Veterans with OSA and obesity utilize MOVE!, and those referred to MOVE! achieve minimal weight loss—1.2 kg at 1 year. Third, prior weight loss trials focused on intermediate measures (e.g. AHI), limiting understanding of effectiveness for meaningful outcomes. To meet these challenges, we propose a pragmatic trial of proactively offering a remote video-based and self-directed weight loss intervention with telephone-based coaching to Veterans with newly diagnosed OSA. Our weight loss intervention (D-ELITE) is adapted from a program known to be effective in a non-VA population, with 44% of participants achieving ≥5% weight loss at 24 months. Further optimizing reach, our remote intervention includes low-technology options (e.g. DVD videos) to accommodate those with low technology literacy. Significance: Our research tests a program of proactively providing Veterans with OSA the tools to manage weight loss in a way that is independent of local provider time and resources. Our research addresses a key gap in Veteran’s health in a way that aligns with important VA priorities including population health, virtual care, access, and health care value. We anticipate our intervention can efficiently achieve improvements in quality of life while reducing the burden and risk of serious comorbidities. Innovation and Impact: Our research directly challenges the traditional provider-driven model of healthcare delivery where providers direct care and provide necessary services aimed at managing a single disease. Instead, we propose to proactively deliver weight loss services to a high-risk group using a population health approach. In doing so, we will conduct the first trial of remote and self-directed weight loss care in OSA and will test whether weight loss care can improve meaningful outcomes such as quality of life and cardiovascular risk. Specific Aims: Our primary aim is to test the effectiveness of a proactively delivered and pragmatic weight loss intervention to improve co-primary endpoints of sleep-related quality of life and weight among Veterans with OSA and obesity. Secondarily, we will compare additional outcomes between groups: cardiovascular risk scores, sleep symptoms, and AHI. Finally, we will also conduct an implementation process evaluation informed by the RE-AIM framework to identify barriers and facilitators to widespread implementation. Methodology: We plan a hybrid type 1 pragmatic randomized controlled trial. We will proactively identify Veterans with OSA and obesity nationwide using data from the CDW (n=696), randomizing 1:1 to usual care plus the D-ELITE weight loss intervention or usual care alone. We will collect primary outcomes at 12 months, but we will also collect outcomes at 3 and 24 months to assess trends over time. We will use quantitative and qualitative methods to assess barriers to implementation, including a comprehensive budget impact analysis. Next Steps/Implementation: If effective, we will work with our operational partner, the National Center for Health Promotion and Prevention (NCP), to integrate D-ELITE into NCPs suite of weight loss offerings. The National Program Office for Pulmonary/Sleep also agrees to promote policies supporting nationwide adoption.