Implementation and Outcomes of Noninvasive Ventilation in COPD

描述(申请人提供)：慢性阻塞性肺疾病(COPD)是美国第四大死亡原因，病情恶化每年导致超过50万人入院治疗。住院病人的常规护理包括支气管扩张剂、皮质类固醇、抗生素和补充氧气。从历史上看，这些治疗失败的患者会被注射镇静剂，经气管插管，戴上呼吸机，然后被转移到重症监护病房，在那里长期住院、并发症和死亡的风险一直很高。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风的需求，并将医院存活率提高了50%。十多年后，在临床试验环境之外，人们对NIV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很可能是缓慢和不均衡的。这项建议的目标是在美国具有代表性的大样本医院中检查NIV的使用和结果，并确定与其有效实施相关的背景因素和战略。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极大的数据集，其中包含600多家美国医院患者的治疗和结果的详细信息，以评估NIV的使用及其有效性。这一阶段的成功完成将填补我们在2001年至2010年期间将NIV扩散到常规临床实践中的主要空白，将为患者和医院层面影响采用的因素提供新的见解，并将评估在常规实践中实现有效性研究中所报告的NIV益处的程度。这些调查还将帮助我们确定一组高绩效的医院-为大部分COPD患者提供无创呼吸机，并体验无创呼吸机对患者预后的有利影响。该项目的第二阶段涉及采用定性和定量相结合的方法，以确定与有效执行国家卫生规划相关的背景因素和战略。在一个用来解释为什么复杂的创新在一些组织中比在另一些组织中更成功地实施的成熟概念框架的指导下，我们将通过对高绩效机构的不同临床医生群体的采访来完善我们的假设。然后，我们将在剩余的网络医院中使用调查方法来检验这些假设。确定实施NIV的有效策略是改善COPD患者结局的第一步，并将有助于形成未来多中心实施试验的干预措施。这项建议高度响应了NHLBI战略计划的第三个目标，特别是“改善对将研究转化为实践所涉及的过程的理解，并利用这种理解来促进公共卫生的改善和进一步的科学发现。” 与公共卫生相关：对于美国每年因慢性阻塞性肺疾病恶化而住院的大约50万人来说，20世纪90年代非侵入性机械通气的发现代表着一项治疗突破，它提供了一种替代方案，可以在重症监护病房使用侵入性机械呼吸机，在重症监护病房中，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，人们对无创呼吸机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，有理由担心这些研究成果转化为日常实践的过程可能缓慢且不均衡。通过对600多家具有代表性的美国医院的记录进行统计分析，并通过对不同类型的医院人员的采访和调查，我们将弥合我们对美国采用无创通风的理解上的差距，并将确定有助于加快实施进程的有效策略。

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.