Implementation and Outcomes of Noninvasive Ventilation in COPD

描述（由申请人提供）：慢性阻塞性肺疾病（COPD）是美国第四大死亡原因，每年有超过50万人因病情加重住院。住院患者的呼吸护理包括支气管扩张剂、皮质类固醇、抗生素和辅助供氧。从历史上看，这些治疗失败的患者被镇静，气管插管，放置在呼吸机上，并转移到重症监护室，在那里长期住院，并发症和死亡的风险很高。20世纪90年代进行的随机试验发现，无创通气（NIV）减少了对有创机械通气的需求，并将住院生存率提高了50%。十多年后，人们对NIV在临床试验环境之外的使用或结果知之甚少。如果其他生物医学创新的经验是正确的，那么NIV在常规临床实践中的扩散可能是缓慢和不均匀的。本提案的目标是在美国医院的大样本和代表性样本中检查NIV的使用和结果，并确定与其有效实施相关的背景因素和策略。 拟议的一系列调查将分两个阶段进行。第一阶段将使用一个非常大的数据集，其中包含有关美国600多家医院患者治疗和结局的详细信息，以评估NIV的使用及其有效性。这一阶段的成功完成将缩小我们对2001-2010年期间NIV在常规临床实践中的扩散理解的主要差距，将提供对影响采用的患者和医院水平因素的新见解，并将评估疗效研究中报告的NIV获益在常规实践中的实现程度。这些研究还将帮助我们确定一组高绩效的医院，为大部分COPD患者提供无创通气，并体验无创通气对患者预后的有益影响。该项目的第二阶段涉及应用定性和定量相结合的方法，以确定与有效实施NIV相关的背景因素和战略。在一个用于解释为什么复杂创新在某些组织中比在其他组织中更成功实施的成熟概念框架的指导下，我们将通过对高绩效机构样本中的不同临床医生群体的访谈来完善我们的假设。然后，我们将在剩余的网络医院中使用调查方法来测试这些假设。确定实施NIV的有效策略是改善COPD患者结局的第一步，并将有助于为未来的多中心实施试验制定干预措施。该提案高度响应了NHLBI战略计划的第三个目标，具体而言，即“提高对将研究转化为实践的过程的理解，并利用这种理解来改善公共卫生，促进进一步的科学发现。" 公共卫生相关性：对于美国每年因慢性阻塞性肺疾病加重住院的大约50万人来说，20世纪90年代无创机械通气形式的发现代表了治疗的突破，为重症监护室中放置有创机械通气提供了替代方案，其中延长住院时间，并发症和死亡的风险很大。然而，在其发现近十年后，人们对无创通气在常规临床环境中的使用或结果知之甚少，如果其他生物医学创新的经验成立，那么有理由担心这些研究结果转化为日常实践可能会缓慢而不均衡。通过对来自600多家美国医院的代表性样本的记录进行统计分析，并通过对不同医院人员的访谈和调查，我们将缩小对美国采用无创通气的理解方面的差距，并将确定有助于加快实施过程的有效策略。

DESCRIPTION (provided by applicant): Chronic obstructive pulmonary disease (COPD) is the nation's 4th leading cause of death and exacerbations result in more than 500,000 annual hospital admissions. Usual care for hospitalized patients consists of bronchodilators, corticosteroids, antibiotics, and supplemental oxygen. Historically, patients who failed these treatments have been sedated, endotracheally intubated, placed on a ventilator, and transferred to an intensive care unit, where the risk of a prolonged stay, complications and death has been high. Randomized trials conducted in the 1990s found that noninvasive ventilation (NIV) reduced the need for invasive mechanical ventilation and improved hospital survival by 50%. More than a decade later, little is known about the use or outcomes of NIV outside of the clinical trial environment. If the experience of other biomedical innovations holds true, then the diffusion of NIV into routine clinical practice is likely occurring slowly and unevenly. The goal of this proposal is to examine the use and outcomes of NIV in a large and representative sample of US hospitals, and to identify contextual factors and strategies associated with its effective implementation. The proposed series of investigations will be carried out in two phases. The first phase will employ an extremely large dataset containing detailed information about the treatment and outcomes of patients at over 600 US hospitals to assess the use of NIV and its effectiveness. Successful completion of this phase will close major gaps in our understanding of the diffusion of NIV into routine clinical practice over the period 2001-2010, will offer novel insights into the patient and hospital level factors influencing adoption, and will assess the degree to which the benefits of NIV reported in efficacy studies are being achieved in routine practice. These investigations will also help us identify a group of high performing hospitals-that deliver noninvasive ventilation to a large proportion of COPD patients and that experience a beneficial effect of noninvasive ventilation on patient outcomes. The second phase of the project involves the application of mixed qualitative and quantitative methods to identify the contextual factors and strategies associated with effective implementation of NIV. Guided by a well-established conceptual framework used to explain why complex innovations are more successfully implemented in some organizations than in others, we will refine our hypotheses through interviews with a diverse group of clinicians at a sample of high performing institutions. We will then test these hypotheses using survey methods within the remaining network hospitals. The identification of effective strategies for implementing NIV is the first step toward improving the outcomes of COPD patients and will help shape the intervention for a future multi-center implementation trial. This proposal is highly responsive to the 3rd goal of the NHLBI's Strategic Plan, specifically to "To generate an improved understanding of the processes involved in translating research into practice and [to] use that understanding to enable improvements in public health and to stimulate further scientific discovery." PUBLIC HEALTH RELEVANCE: For the roughly 500,000 individuals hospitalized each year in the US for exacerbations of chronic obstructive pulmonary disease, the discovery of noninvasive forms of mechanical ventilation in the 1990s represented a treatment breakthrough that offered an alternative to being placed on an invasive mechanical ventilator in the intensive care unit, where the risks of prolonged hospitalization, complications, and death are substantial. Yet nearly a decade after its discovery, little is known about the use or outcomes of noninvasive ventilation in routine clinical setting, and if the experience of other biomedical innovations holds true, there are reasons to be concerned that translation of these research findings into day-to-day practice may be occurring slowly and unevenly. Through statistical analyses of records from a representative sample of more than 600 US hospitals, and through interviews and surveys with a diverse set of hospital personnel, we will close the gap in our understanding of the adoption of noninvasive ventilation in the US, and will identify effective strategies that can help speed the implementation process.