Remote Ambulatory Management of Veterans with Sleep Apnea

患有睡眠呼吸暂停的退伍军人的远程门诊管理

• 批准号: 9757705
• 负责人: SAMUEL T. KUNA
• 金额: --
• 依托单位: PHILADELPHIA VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-02-01 至 2021-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9757705
• 关键词: Accidents; Adherence; Administrator; Apnea; Area; Attitude; Automobile Driving; Award; Caring; Chronic; Chronic Disease; Client satisfaction; Clinic; Clinic Visits; Clinical; Clinical Pathways; Clinical effectiveness; Computerized Medical Record; Data; Data Collection; Devices; Diabetes Mellitus; Diagnosis; Disease; Disease Pathway; Effectiveness; Equipment and supply inventories; Evaluation; Future; Goals; Health Care Costs; Health Services Accessibility; Healthcare; Home environment; Hour; Hypertension; Improve Access; Inferior; Instruction; Intake; Intention; Intervention; Interview; Laboratories; Long-Term Care; Manufacturer Name; Measures; Medical; Mental Depression; Methods; Modeling; Modems; Monitor; Myocardial Infarction; Obesity; Obstructive Sleep Apnea; Online Systems; Outcome; Outcome Measure; Participant; Pathway interactions; Patient Preferences; Patients; Persons; Public Health; Quality-Adjusted Life Years; Questionnaires; Randomized; Research; Respiration Disorders; Risk; Secondary to; Self Management; Services; Sleep; Sleep Apnea Syndromes; Specialist; Stroke; Technology; Telephone; Testing; Therapeutic; Travel; Use Effectiveness; Veterans; Visit; Wait Time; Wireless Technology; Work; arm; base; comparative cost effectiveness; compare effectiveness; cost; cost effectiveness; data exchange; data standards; design; disability; follow-up; formative assessment; functional improvement; functional outcomes; group intervention; health care delivery; innovation; patient-practitioner interaction; portable monitoring; preference; pressure; prevent; primary outcome; programs; prospective; response; rural area; satisfaction; secondary outcome; telehealth; treatment arm; treatment response; web site

 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.

 描述（由申请人提供）： 背景资料：通过VHA创新计划的临床奖项，我们的研究团队创建了远程退伍军人呼吸暂停管理门户网站（REVAMP），这是一个个性化的交互式网络平台，允许退伍军人在不前往睡眠中心的情况下接受阻塞性睡眠呼吸暂停（OSA）的综合管理。REVAMP（1）允许退伍军人在网站上回答摄入和随访问卷;（2）显示从患者的自动调节气道正压（APAP）单元传输到网站的无线数据;（3）使退伍军人能够自我监测他们的APAP使用和有效性;以及（4）自动填充患者问卷和PAP结果到可以导出到CPRS的进度记录中。目的：这项对患有OSA的退伍军人的前瞻性随机干预将比较REVAMP管理与亲自护理。目标1将确定REVAMP管理在功能改善和客观监测APAP依从性方面是否在临床上不劣于亲自护理。目标2将比较两种模式在成本和质量调整寿命年方面的差异。在目标3中，以患者和康复者为中心的形成性评价将评估REVAMP广泛实施的潜在障碍。方法：被转诊进行OSA评估的退伍军人将被随机分配到REVAMP治疗组或亲自护理组。随机分配到REVAMP管理组的退伍军人将（1）完成调查问卷并在网站上访问有关阻塞性睡眠呼吸暂停综合症和家庭睡眠测试的视频;（2）邮寄便携式监测仪进行家庭睡眠测试并通过邮寄方式返回;（3）由睡眠医生通过家庭视频电话会议（HVT）或电话采访进行评估，以审查调查问卷和睡眠研究结果;（4）如果被诊断患有OSA，则开具带有无线调制解调器的APAP单元用于依从性跟踪;（5）能够与他们的医生一起沿着查看他们在REVAMP上的APAP使用以及他们基于网站上的随访问卷对治疗的响应;以及（6）接收HVT或电话随访评估。随机分配到面对面途径的退伍军人将：（1）接受初步的面对面诊所评估和关于如何进行家庭睡眠测试的面对面指导;（2）在网站上完成问卷调查，以标准化数据收集;（3）如果诊断为OSA，则开具APAP并进行面对面随访诊所访视;以及（4）通过从业者在APAP制造商的网站上查看无线数据来监控他们的APAP依从性。目标1的主要结果是APAP治疗3个月后睡眠功能结局问卷（FOSQ-10）评分的变化。客观监测APAP的使用将是次要结局。非劣效性分析将比较两组的有效性。我们假设REVAMP治疗后FOSQ- 10评分的变化在临床上不会劣于亲自护理。在目标2中，将收集VA和非VA总医疗保健成本，以检验REVAMP的平均成本是否低于亲自护理。将通过SF-6D和EQ-5D评估偏好。我们将估计REVAMP与面对面管理之间的增量成本与增量质量调整生命年的比率。测试REVAMP管理是否具有更低的成本和同等的结果。目标3中的形成性评估将使用定性（有针对性的电话访谈）和定量措施（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是退伍军人中第三大最常见的慢性疾病，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。目前睡眠中心的亲自管理限制了获得护理的机会，并导致患者等待时间过长。该提案将评估一种创新的基于网站的临床路径，该路径将改善患有OSA的退伍军人的护理。该项目可作为退伍军人其他常见慢性疾病（包括糖尿病、肥胖和高血压）的长期护理管理模式。