Self-Management of Continuous Positive Airway Pressure Settings for Veterans with Sleep Apnea

背景：由于临床需求，患者往往缺乏相关知识和支持， 他们的气道正压通气（PAP）设备的特点。最投入的病人是那些理解 他们的设备的细节，并改变功能设置，使他们可以最大限度地发挥治疗的好处。 功能设置包括加湿水平，呼气压力释放，压力斜坡，面罩警报，自动 压力启动，以及其他重要的舒适功能。从历史上看，没有向患者提供 更改或修改治疗压力设置的权限，这需要医生处方。联合医务人员 可以进行后续的压力设定变更。很明显，医疗保健系统很难 参与最佳慢性病管理，并尽早满足睡眠呼吸暂停患者的需求 治疗初始化过程，需要多次访视/联系，以确保患者 最大限度地利用治疗。 目的和目标：拟议项目的总体目标是研究提供 患者能够根据治疗依从性和结局调整其PAP压力水平。回答 这些研究问题，建议随机，对照两组试验的睡眠呼吸暂停自我， 管理程序（SM）和SM plus个性化压力调节（IPA）具有以下特定 与APAP依从性和疗效、患者报告结局和利用率相关的目的：（1）检查 设置的个体化压力调节（IPA）对治疗依从性和功效的影响（即，掩模 （2）检查SM+IPA与SM对患者自身呼吸功能的影响， 报告治疗结果;（3）描述SM-IPA和SM组对利用的影响。 睡眠呼吸暂停是最常见的慢性疾病之一。气道正压 (PAP)治疗是睡眠呼吸暂停的金标准治疗，但坚持PAP是次优的。VA睡眠 相对于临床对教育和支持的需求，这些项目的人员配备不足。适应PAP 传统上，治疗是通过连续的访问和由提供者发起的压力变化来实现的 在办公室护理期间，自我监测和个性化压力调节是一项重要策略， 将使退伍军人能够更好地控制他们的OSA。该项目的主要影响是显著的 对于患者（改善结局）和VA（提高工作人员效率）。 创新：虽然患者可以控制PAP设备上的各种舒适功能， 在历史上，他们没有得到正式的教育和支持来调整压力设置。独特的 这项研究的一个方面是关注个性化的压力设置，以实现最大的治疗效果。 包括增加PAP依从性。重要的是，这是在供应商监督的背景下完成的。 方法：拟开展的研究是一项为期6个月的随机、对照、非盲、单中心研究 比较睡眠呼吸暂停自我管理计划（SM）与SM+个体化压力调节 （国际音标）。两组都将接受SM协议，以确保他们接受相同的OSA和PAP教育 和支持干预组的参与者将获得额外的教育和支持， 让他们调整自己的PAP压力。 预期成果：这项研究的积极成果将产生一个工具包，可通过 VA睡眠网络和美国睡眠呼吸暂停协会为患者和提供者提供 提高OSA临床管理所需的知识。

Background: Because of clinical demands, patients are often under-educated and under-supported about the features of their positive airway pressure (PAP) devices. The most engaged patients are ones who understand the details of their device and change the feature settings so that they can maximize the benefits of therapy. Features settings include humidification level, expiratory pressure relief, pressure ramping, mask alert, auto pressure start, among other important comfort features. Historically, patients have not been provided with access to alter or modify therapy pressure settings, which requires physician prescription. Allied medical staff can carry out subsequent pressure setting changes. It is clear that it is difficult for the healthcare system to engage in optimal chronic disease management, and accommodate the needs of sleep apnea patients early in the treatment initialization process, which requires multiple visits/contacts to ensure that patients are maximizing the use of therapy. Objectives and Aims: The overarching aim of the proposed project is to examine the effect of providing patients with the ability to adjust their PAP pressure levels on therapy adherence and outcomes. To answer these research questions, the proposed randomized, controlled two-group trial of Sleep Apnea Self- Management Program (SM) and SM plus Individualized Pressure Adjustment (IPA) has the following specific aims related to APAP adherence and efficacy, patient-reported outcomes, and utilization: (1) To examine the effect of Individualized Pressure Adjustment (IPA) of settings on treatment adherence and efficacy (i.e., mask leak and residual apnea-hypopnea index); (2) To examine the effect of SM+IPA versus SM on patient self- reported treatment outcomes; and (3) To describe the effects of SM-IPA and SM groups on utilization. Significance: Sleep apnea is one of the most common chronic conditions in the VA. Positive airway pressure (PAP) therapy is the gold-standard therapy for sleep apnea, but adherence with PAP is suboptimal. VA sleep programs are understaffed relative to clinical demand for education and support. While adaption to PAP therapy has traditionally been achieved through sequential visits and pressure changes initiated by providers during office-based care, self-monitoring and individualized pressure adjustment is an important strategy that would empower Veterans to achieve better control of their OSA. The key impacts of this project are significant for both patients (improved outcomes) and the VA (improved staff efficiencies). Innovation: While patients have control over a wide range of comfort features on their PAP devices, historically they have not been formally educated and supported to adjust pressure settings. The unique aspect of this study is the focus on individualizing pressure settings to allow for the maximizing therapeutic benefit, including increased PAP adherence. Importantly, this is done within the context of provider oversight. Methods: The proposed study is a 6-month randomized, controlled, non-blinded, single-center study comparing the Sleep Apnea Self-Management Program (SM) to SM plus Individualized Pressure Adjustment (IPA). Both groups will receive the SM protocol to ensure that they receive identical OSA and PAP education and support. Participants in the intervention arm will be provided with additional education and support that will allow them to adjust their PAP pressures. Expected Results: Positive findings from this study will result in a Toolkit that can be distributed through the VA Sleep Network and the American Sleep Apnea Association to provide patients and providers with the knowledge necessary to improve the clinical management of OSA.