Understanding Patient Management of COPD Exacerbations

 描述(由申请人提供)： 及时使用口服类固醇和/或抗生素治疗慢性阻塞性肺疾病(COPD)的恶化，最好是在症状出现后3天内，可以降低恶化的严重程度和持续时间，并可能降低COPD住院的风险。实现早期治疗的一种方法是使用受支持的自我管理计划，其中包括一项行动计划，以及类固醇和/或抗生素的家庭处方。然而，最近的研究表明，支持的自我管理计划可能不适合大多数COPD患者，实际上可能是有害的。因此，需要一种不依赖患者自我管理的新方法。这项研究将审查退伍军人的寻求护理行为，重点是退伍军人感知的护理需求和获得护理的感知，以及这些因素如何推迟COPD恶化的寻求护理，增加住院风险。这项研究还将评估一种通过使用远程吸入器监测系统来识别早期恶化的新方法。关于影响患者决定寻求治疗的因素的数据很少。为了获得所需的数据，这项研究将招募410名COPD高危退伍军人，并对每个患者进行为期一年的跟踪调查。具体目标是：1)检查COPD恶化或呼吸恶化寻求治疗的障碍；2)测试实时远程吸入器监测仪的使用情况，以识别早期恶化。弗吉尼亚州普吉特湾和弗吉尼亚州东科罗拉多州的410名参与者将参加这项研究。对于目标1a和1b，大约60名报告慢性阻塞性肺疾病恶化并住院、作为门诊患者接受治疗或未寻求治疗的参与者将参加由训练有素的研究人员进行的深入半结构化访谈，以了解他们如何应对不断恶化的症状，并决定是否寻求治疗。如果可以，这些退伍军人的照顾者将接受采访，以了解他们对 恶化事件。在目标1c中，参与者将参加一次面对面的基线访问，以完成肺活量测定和基线问卷调查。参与者将在为期一年的时间里每两周使用交互式语音响应系统进行联系，该系统将通过4个是/否问题筛选COPD加重。筛查呈阳性的参与者将被研究人员召回，以获得有关病情恶化和如何治疗的更多详细信息。数据分析将审查获得护理的机会和基线因素与延误治疗的关系。在AIM 2中，来自AIM 1的200名参与者将使用带有沙丁胺醇吸入器的吸入器监视器，这将实时传输关于他们日常吸入器使用的数据。他们将在12个月的随访期内使用这款监护仪。数据分析将衡量沙丁胺醇使用变化预测患者报告的COPD恶化的能力，以确定可用于未来干预试验的适当截断值。这些目标将提供关键的详细信息，说明如何最好地进行干预，以确保在不依赖自我管理的情况下及时发现和治疗慢性阻塞性肺病的恶化。新的医疗保健提供方法将帮助退伍军人及早识别病情恶化，并提供可整合到退伍军人管理局初级保健、紧急药物和肺部专科护理环境中的早期护理。

 DESCRIPTION (provided by applicant): Prompt treatment of chronic obstructive pulmonary disease (COPD) exacerbations with oral steroids and/or antibiotics, ideally within 3 days of onset of symptoms, can decrease the severity and duration of exacerbations and may reduce the risk of COPD hospitalizations. One approach to accomplishing early treatment is to use a supported self-management program that includes an action plan with a home prescription for steroids and/or antibiotics. However, recent studies suggest that supported self-management programs may not be appropriate for the majority of COPD patients, and may in fact be harmful. Therefore, a new approach is needed that does not rely on patient self-management. This study will examine Veterans' care-seeking behaviors focusing on Veterans perceived need for care and perceived access to care and how these factors delay seeking care for COPD exacerbations, increasing the risk for hospitalizations. This study will also evaluate one novel approach of identifying early exacerbations through the use of a remote inhaler monitoring system. There is little data on the factors that influence when patients decide to seek care. To obtain this needed data, this study will enroll a cohort of 410 Veterans with COPD at high-risk for exacerbations and follow every patient for 1 year. The Specific Aims are: 1) Examine the barriers to seeking care for COPD exacerbations or worsening breathing; 2) Test the use of a real-time remote inhaler monitor to identify early exacerbations. 410 participants at VA Puget Sound and the VA Eastern Colorado will be enrolled in the study. For Aim 1a and 1b, approximately 60 participants who reported a COPD exacerbation and were either hospitalized, treated as outpatients, or did not seek treatment will participate in an in-depth semi-structured interview by a trained research staff to understand how they responded to their worsening symptoms and decided whether to seek care. When available, the caregivers for these Veterans will be interviewed to obtain their perspective on the exacerbation event. In Aim 1c, participants will attend one in-person baseline visit to complete spirometry and baseline questionnaires. Participants will be contacted every 2 weeks for 1 year using an interactive voice response system that will screen for COPD exacerbations with 4 yes/no questions. Participants with a positive screen will be called back by research staff to obtain additional detailed information on the exacerbation and how it was treated. Data analysis will examine where access to care and baseline factors are associated with a delay in treatment. In Aim 2, 200 participants from Aim 1 will use an inhaler monitor with their albuterol inhaler, which will transmit data in real-time about their daily inhaler use. They will use this monitor for the 12-month follow-up period. Data analysis will measure ability of a change in albuterol use to predict patient reported COPD exacerbations to determine the appropriate cut-offs that can be used in a future intervention trial. These aims will provide critical detailed information on how best to intervene to ensure prompt identification and treatment of COPD exacerbations without relying on self-management. New health care delivery approaches will assist Veterans in early identification of exacerbations and provide early access to care that can be integrated into the VA primary care, emergency medicine and pulmonary specialty care settings.