Remote Ambulatory Management of Veterans with Sleep Apnea

 描述(由申请人提供)： 背景：通过VHA创新计划颁发的临床奖，我们的研究团队创建了远程退伍军人呼吸暂停管理门户(REVAMP)，这是一个基于网络的个性化互动平台，使退伍军人无需前往睡眠中心即可接受阻塞性睡眠呼吸暂停(OSA)的全面管理。REVAMP(1)允许退伍军人在网站上回答摄入量和后续调查问卷；(2)显示从患者自动调整气道正压(APAP)装置传输到网站的无线数据；(3)使退伍军人能够自我监控其APAP的使用和有效性；以及(4)将患者问卷和PAP结果自动填写为可以导出到CPRS的进度记录。目的：对患有阻塞性睡眠呼吸暂停综合征的退伍军人进行前瞻性、随机干预，将改良式管理与面对面护理进行比较。目标1将确定改良管理在功能改善和客观监测的APAP依从性方面是否在临床上不逊于亲身护理。目标2将比较两种型号在成本和质量调整后的寿命年方面的差异。在目标3中，以患者和实践者为中心的形成性评估将评估改革广泛实施的潜在障碍。方法：被推荐进行OSA评估的退伍军人将被随机分配到改良管理或亲自护理。被随机安排进行管理改革的退伍军人将(1)完成调查问卷，并可以在网站上访问有关OSA和家庭睡眠测试的视频；(2)通过邮寄便携式监视器进行家庭睡眠测试，并通过邮件返回；(3)由睡眠从业者通过家庭视频电话会议(HVT)或电话采访进行评估，以审查问卷和睡眠研究结果；(4)如果被诊断为OSA，将向APAP单元开具无线调制解调器，用于依从性跟踪；(5)能够与他们的从业者一起查看他们在改造中使用APAP的情况，以及他们根据网站上的后续问卷对治疗的反应，以及(6)接受HVT或电话跟踪评估。随机接受面对面治疗的退伍军人将：(1)接受初步的面对面临床评估和如何进行家庭睡眠测试的面对面指导；(2)在网站上完成问卷，以标准化数据收集；(3)如果被诊断为OSA，则开APAP处方，并进行面对面的临床随访；以及(4)由查看APAP制造商网站上的无线数据的从业者监测他们对APAP的遵守情况。目的1 S的主要结局是APAP治疗3个月后睡眠功能问卷(FOSQ-10)评分的变化。客观监测APAP的使用将是次要结果。非劣势分析将比较这两种武器的有效性。我们假设，改进管理后FOSQ-10评分的变化在临床上不会逊于亲身护理。在目标2中，将收集VA和非VA总医疗成本，以测试改造后的平均成本是否低于面对面护理。偏好将通过SF-6D和EQ-5D进行评估。我们将估计在改造与亲自管理之间节省的增量成本与增量质量调整寿命年的比率。以测试改革管理是否会有更低的成本和同等的结果。AIM 3中的形成性评估将使用定性(有针对性的电话采访)和定量(自然减员、工作联盟和患者满意度)来指导未来的实施。对退伍军人医疗保健的预期影响：据估计，OSA是退伍军人中第三种最常见的慢性病，它与高血压、心脏病发作、中风、抑郁和驾驶事故的风险增加有关。目前睡眠中心的面对面管理限制了获得护理的机会，并导致患者等待时间较长。这项提案将评估一种基于网站的创新临床路径，该路径将改善患有阻塞性睡眠呼吸暂停综合征的退伍军人的护理机会。该项目可以作为退伍军人其他常见的慢性疾病的长期护理管理的模式，包括糖尿病、肥胖症和高血压。

 DESCRIPTION (provided by applicant): Background: Through a clinical award from the VHA Innovation Program, our research team has created the Remote Veterans Apnea Management Portal (REVAMP), a personalized, interactive web-based platform that allows Veterans to receive comprehensive management of obstructive sleep apnea (OSA) without traveling to a sleep center. REVAMP (1) allows Veterans to respond to intake and follow-up questionnaires on the website; (2) displays wireless data transmitted from the patient's automatically-adjusting positive airway pressure (APAP) unit to the website; (3) enables Veterans to self-monitor their APAP use and effectiveness; and (4) auto-populates the patient questionnaire and PAP results into progress notes that can be exported to CPRS. Objectives: This prospective, randomized intervention in Veterans with OSA will compare REVAMP manage- ment to in-person care. Aim 1 will determine if REVAMP management is not clinically inferior to in-person care in terms of functional improvement and objectively monitored APAP adherence. Aim 2 will compare differences in cost and quality-adjusted life years between the two models. In Aim 3, patient- and practitioner-centered formative evaluations will assess potential barriers to REVAMP's widespread implementation. Methods: Veterans referred for OSA evaluation will be randomized to either REVAMP management or in- person care. Veterans randomized to REVAMP management will (1) complete questionnaires and have access to videos about OSA and home sleep testing on the website; (2) be mailed a portable monitor to perform the home sleep test and return it by mail; (3) be evaluated by a sleep practitioner via home video teleconferencing (HVT) or phone interview to review the questionnaire and sleep study results; (4) if diagnosed with OSA, be prescribed an APAP unit with wireless modem for adherence tracking; (5) be able to view, along with their practitioners, their APAP use on REVAMP and their response to treatment based on follow-up questionnaires on the website, and (6) receive HVT or phone follow-up evaluations. Veterans randomized to the in-person pathway will: (1) receive an initial in-person clinic evaluation and in-person instructions on how to perform the home sleep test; (2) complete questionnaires on the website to standardize data collection; (3) if diagnosed with OSA, be prescribed APAP and have in-person follow-up clinic visits; and (4) have their APAP adherence monitored by practitioners reviewing the wireless data on the APAP manufacturer's website. Aim 1's primary outcome will be the change in Functional Outcomes of Sleep Questionnaire (FOSQ-10) score following 3 months of APAP treatment. Objectively monitored APAP use will be a secondary outcome. Non- inferiority analyses will compare the effectiveness of the two arms. We hypothesize that the change in FOSQ- 10 score with REVAMP management will not be clinically inferior to that with in-person care. In Aim 2, VA and non-VA total healthcare costs will be collected to test whether average cost is lower with REVAMP versus in- person care. Preference will be assessed by the SF-6D and EQ-5D. We will estimate the ratio of incremental costs to incremental quality-adjusted life years saved between REVAMP versus in-person management. to test whether REVAMP management will have lower cost and equivalent outcomes. Formative evaluation in Aim 3 will use qualitative (targeted phone interviews) and quantitative measures (attrition, work alliance, and patient satisfaction) to guide future implementation. Anticipated Impact on Veteran's Healthcare: Estimated to be the third most common chronic disease in Veterans, OSA is associated with an increased risk of hypertension, heart attacks, strokes, depression, and driving accidents. Current in-person management at a sleep center is limiting access to care and has resulted in long patient wait times. This proposal will evaluate an innovative website-based clinical pathway that will improve access to care of Veterans with OSA. The project may serve as the model for long-term care management for other common, chronic conditions in Veterans, including diabetes, obesity and hypertension.