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

患有睡眠呼吸暂停的退伍军人持续气道正压设置的自我管理

• 批准号: 10186528
• 负责人: Carl J. Stepnowsky
• 金额: --
• 依托单位: VA SAN DIEGO HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-05-01 至 2022-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10186528
• 关键词: Acetaminophen; Address; Adherence; Affect; American; Apnea; Behavioral; Caring; Chronic; Chronic Disease; Clinical; Clinical Management; Collaborations; Continuous Positive Airway Pressure; Control Groups; Devices; Disease Management; Drowsiness; Education; Ensure; Equipment and supply inventories; Fostering; Future; Gold; Health Services Accessibility; Healthcare Systems; Humidifier; Institute of Medicine (U.S.); Instruction; Knowledge; Lung; Masks; Measures; Medical; Medical Staff; Medical center; Methods; Monitor; Obstructive Sleep Apnea; Participant; Patient Monitoring; Patient Outcomes Assessments; Patient Self-Report; Patients; Philadelphia; Physicians; Process; Protocols documentation; Provider; Published Comment; Quality of Care; Quality of life; Ramp; Randomized; Reporting; Research; Residual state; Resources; Self Management; Services; Sleep; Sleep Apnea Syndromes; Sleep Disorders; Supervision; Surveys; Therapeutic; Time; Treatment Efficacy; Treatment outcome; Veterans; Visit; base; cost; economic cost; experience; experimental group; follow-up; improved; improved outcome; indexing; innovation; pressure; programs; self-management program; sleep quality; social; standard care; therapy adherence; therapy outcome; treatment adherence; treatment arm; web site

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.

背景：由于临床需求，患者常常得不到足够的教育和支持。 其气道正压通气 (PAP) 设备的特点。最积极参与的患者是那些理解的患者 他们的设备的详细信息并更改功能设置，以便他们可以最大限度地发挥治疗效果。 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。历史上，患者没有获得过 可以改变或修改治疗压力设置，这需要医生处方。盟军医务人员 可以进行后续的压力设定改变。显然，医疗保健系统很难 参与最佳的慢性病管理，并尽早满足睡眠呼吸暂停患者的需求 治疗初始化过程，需要多次就诊/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检查提供的效果 患者能够根据治疗依从性和结果调整 PAP 压力水平。来回答 这些研究问题，拟议的睡眠呼吸暂停自我随机对照两组试验 管理计划（SM）和SM加个性化压力调整（IPA）有以下具体内容 与 APAP 依从性和疗效、患者报告的结果和利用相关的目标：(1) 检查 个体化压力调整 (IPA) 设置对治疗依从性和疗效的影响（即面罩 漏气和残余呼吸暂停低通气指数）； (2) 考察 SM+IPA 与 SM 对患者自我感觉的影响 报告的治疗结果； (3) 描述 SM-IPA 和 SM 组对利用率的影响。 意义：睡眠呼吸暂停是退伍军人管理局最常见的慢性病之一。气道正压通气 (PAP) 疗法是治疗睡眠呼吸暂停的金标准疗法，但 PAP 的依从性并不理想。 VA睡眠 相对于教育和支持的临床需求，项目人手不足。适应PAP的同时 传统上，治疗是通过提供者发起的连续就诊和压力变化来实现的 在办公室护理期间，自我监测和个体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。本项目的主要影响重大 对于患者（改善结果）和 VA（提高员工效率）。 创新：虽然患者可以控制其 PAP 设备上的各种舒适功能， 从历史上看，他们没有接受过正式的教育和支持来调整压力设置。独特的 这项研究的重点是个性化压力设置，以最大限度地提高治疗效果 好处，包括提高 PAP 依从性。重要的是，这是在提供商监督的背景下完成的。 方法：拟议的研究是一项为期 6 个月的随机、对照、非盲、单中心研究 睡眠呼吸暂停自我管理计划 (SM) 与 SM 加个体化压力调节的比较 （国际音标）。两个群体都将接受 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，这将 允许他们调整 PAP 压力。 预期结果：这项研究的积极结果将产生一个可以通过以下方式分发的工具包： 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 改善 OSA 临床管理所需的知识。