Improving decision making for patients with prolonged mechanical ventilation

描述（由申请人提供）：每年，超过300，000名美国患者在急性危重病中存活，但未能充分恢复以允许呼吸机释放，这是一种称为延长机械通气（PMV）的综合征。PMV与高死亡率、长期残疾和过度资源利用有关。由于这些病人因病丧失能力，他们的代理人必须代表他们做出生命支持决定。然而，质量 决策过程的有效性严重不足，可能导致与患者偏好不一致的决定，延长生命支持，这是非常昂贵的无效的，以及患者代理决策者的心理困扰。为了解决这些问题，我们开发了一个决策辅助PMV代理决策者，促进代理决策者和临床医生之间的共同决策。在最近的一项试点研究中，我们发现，与通常的护理控制相比，决策辅助改善了预后的代理人-临床医生一致性，沟通质量以及临床医生和代理人参与生命支持讨论的可能性。它还改善了代理人的决策冲突和对临床医生的信任。为了证实和扩展我们有希望的结果，我们现在提出了一项多中心随机对照试验（RCT），以测试PMV决策辅助与常规护理控制在改善以下方面的疗效：（1）决策质量，定义为临床医生-代理人对预后的一致性，沟通质量和医学理解;（2）代理人的心理困扰;（3）患者的医疗保健利用。我们的目标是招收 来自五个不同中心的600名PMV患者的代理决策者以及患者的ICU医生和护士组成了现有的PMV研究网络。我们将使用广义线性模型来检验决策辅助组和常规护理对照组在6个月随访期内的结局差异。这项拟议的研究解决了NIH和医学研究所强调的决策中的关键研究需求，也满足了2010年《平价医疗法案》规定的决策辅助创新的要求。这种实用干预的创新方面包括：（a）使用基于网络的平板电脑技术来满足代理人的信息需求;（B）其作为家庭会议辅助工具的功能，以促进个性化的共同决策;（c）针对与沟通相关的心理困扰风险因素;（d）其潜在的廉价 传播和适应更广泛的人群，（f）其适应组分临床风险估计的更新的能力，以及（g）纳入效果的经济评价。总的来说，这项研究可能会对重症监护的未来临床和研究方法产生重大的，持续的影响。 公共卫生相关性：在决定是否为危重病人提供延长生命支持的过程中，临床医生和替代决策者严重不足。为了解决这个问题，我们提出了一个随机对照试验，以确定是否一个创新的基于网络的决策辅助相比，通常的护理控制，可以提高决策的质量，减少代理人的心理困扰，并降低患者的医疗保健费用。这项研究基于强有力的初步工作，有可能改善临床医生和代理人在重症监护病房的互动方式，并增加生命支持决策与患者价值观一致的可能性。

DESCRIPTION (provided by applicant): Annually, over 300,000 US patients survive an acute critical illness but fail to recover sufficiently to permit ventilator liberation, a syndrome knownas prolonged mechanical ventilation (PMV). PMV is associated with high mortality, prolonged disability, and extraordinary resource utilization. Because these patients are incapacitated due to illness, their surrogates must make life support decisions on their behalf. However, the quality of the decision making process is seriously deficient and may lead to decisions that are inconsistent with a patient's preferences, prolonged life support that is extraordinarily costly an ineffective, and psychological distress among patients' surrogate decision makers. To address these problems, we developed a decision aid for PMV surrogate decision makers that promotes shared decision making between surrogate decision makers and clinicians. In a recent pilot study, we found that compared to usual care control, the decision aid improved surrogate-clinician concordance for prognosis, the quality of communication, and the likelihood that clinicians and surrogates engaged in life support discussions. It also improved surrogates' decisional conflict and trust in clinicians. To confirm and extend our promising results, we now propose a multicenter randomized controlled trial (RCT) to test the efficacy of the PMV decision aid vs. usual care control in improving: (1) decision making quality, defined as clinician-surrogate concordance for prognosis, quality of communication, and medical comprehension; (2) surrogates' psychological distress; and (3) patients' health care utilization. We aim to enroll 600 surrogate decision makers for PMV patients, as well as patients' ICU physicians and nurses, from five diverse centers that make up an existing PMV research network. We will use generalized linear models to test for differences in outcomes between decision aid and usual care control groups over a 6-month follow up period. The proposed study addresses key research needs in decision making highlighted by the NIH and the Institute of Medicine, and also meets a call for innovation in decision aids specified by the 2010 Affordable Care Act. Innovative aspects of this pragmatic intervention include: (a) its use of web-based tablet computer technology to address surrogates' informational needs; (b) its function as a family meeting adjunct to promote individualized shared decision making, (c) the targeting of communication-associated risk factors for psychological distress, (d) its potential for inexpensive dissemination and adaptation to broader populations, (f) its ability to accommodate updates in component clinical risk estimates, and (g) the inclusion of an economic evaluation of effect. Overall, this research could have a significant, sustained impact on critical care's future clinica and research approach. PUBLIC HEALTH RELEVANCE: The process of making a decision about whether or not to provide prolonged life support is seriously deficient among clinicians and the surrogate decision makers for critically ill patients. To address this problem, we propose a randomized, controlled trial to determine if an innovative web-based decision aid compared to usual care control can improve the quality of decision making, reduce surrogates' psychological distress, and reduce patients' health care costs. This study-based on strong preliminary work-has the potential both to improve how clinicians and surrogates interact in intensive care units and to increase the likelihood that life support decisions are aligned with patients' values.