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，其恶化导致每年超过50万人住院。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镇静、气管内插管、戴上呼吸机，并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气的需求，并将医院生存率提高了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传播可能是缓慢而不均匀的。本提案的目标是在美国医院的大量代表性样本中检查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极其庞大的数据集，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弥补我们在2001-2010年期间对无创通气在常规临床实践中推广的理解上的主要差距，将对影响采用的患者和医院层面因素提供新的见解，并将评估在疗效研究中报告的无创通气的益处在常规实践中的实现程度。这些调查还将帮助我们确定一组高绩效的医院，这些医院为很大比例的COPD患者提供无创通气，并且对患者的预后有有益的影响。计划的第二阶段涉及运用混合的定性和定量方法，以确定与有效实施NIV相关的背景因素和策略。在一个完善的概念框架的指导下，我们将通过对高绩效机构样本中不同临床医生群体的访谈来完善我们的假设，该框架用于解释为什么复杂的创新在某些组织中比在其他组织中更成功地实施。然后，我们将在剩余的网络医院中使用调查方法检验这些假设。确定实施NIV的有效策略是改善COPD患者预后的第一步，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，特别是“提高对将研究转化为实践所涉及的过程的理解，并利用这种理解来改善公共卫生并促进进一步的科学发现。”

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.