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，患者经常受教育程度不足，并且在支持的情况下接受了不足的支持。 其正气道（PAP）设备的特征。最参与的患者是了解 他们的设备细节并更改功能设置，以便可以最大程度地提高治疗的好处。 功能设置包括加湿水平，呼气压力缓解，压力升压，面具警报，自动 压力启动，除其他重要的舒适特征外。从历史上看，尚未提供患者 访问更改或修改治疗压力设置，这需要医生处方。盟军的医务人员 可以进行随后的压力设置更改。显然，医疗保健系统很难 从事最佳慢性疾病管理，并在早期适应睡眠呼吸暂停患者的需求 治疗初始化过程需要多次访问/接触以确保患者是 最大化治疗的使用。 目标和目标：拟议项目的总体目的是检查提供的效果 具有在治疗依从性和结果上调整子宫颈羊压力水平的能力的患者。回答 这些研究问题，拟议的随机，对照的睡眠呼吸暂停的两组试验 管理程序（SM）和SM加上个性化压力调整（IPA）具有以下特定 与APAP依从性和功效有关的目的，患者报告的结果和利用：（1）检查 设置个性化压力调节（IPA）对治疗依从性和疗效的影响（即掩模 泄漏和残留呼吸暂停指数）； （2）检查SM+IPA与SM对患者自我的影响 报告的治疗结果； （3）描述SM-IPA和SM组对利用的影响。 意义：睡眠呼吸暂停是VA中最常见的慢性条件之一。正气道压力 （PAP）治疗是用于睡眠呼吸暂停的金色标准疗法，但与PAP的依从性是次优的。 VA睡眠 相对于教育和支持的临床需求，计划人员不足。同时适应帕普 传统上，通过依次访问和压力变化来实现治疗 在基于办公室的护理期间，自我监控和个性化压力调整是一个重要策略 将使退伍军人能够更好地控制其OSA。该项目的关键影响很大 对于两名患者（改善结果）和VA（提高员工效率）。 创新：虽然患者可以控制其子宫颈设备的各种舒适功能，但 从历史上看，他们没有得到正式教育和支持以调整压力设置。独特 这项研究的方面是重点放在个性化压力设置上，以允许最大化治疗 好处，包括提高的子宫颈钉依从性。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，受控，非盲人，单中心研究 将睡眠呼吸暂停自我管理程序（SM）与SM加上个性化压力调整进行比较 （IPA）。两组将收到SM协议，以确保他们接受相同的OSA和PAP教育 和支持。干预部门的参与者将获得其他教育和支持 允许他们调整子宫颈盘压力。 预期结果：这项研究的积极发现将导致工具包可以通过 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 改善OSA临床管理所需的知识。