Improving decision making for patients with prolonged mechanical ventilation

描述(由申请人提供)：每年有超过300,000名美国患者在急性危重疾病中幸存下来，但未能充分恢复以允许呼吸机释放，这是一种被称为长时间机械通气(PMV)的综合征。PMV与高死亡率、长期残疾和非凡的资源利用有关。由于这些患者因病丧失能力，他们的代理人必须代表他们做出生命维持决定。然而，质量 决策过程中存在严重缺陷，可能会导致与患者偏好不一致的决定，延长生命支持的代价极其高昂和无效，以及患者代理决策者的心理困扰。为了解决这些问题，我们为PMV代理决策者开发了一种决策辅助工具，它促进了代理决策者和临床医生之间的共享决策。在最近的一项初步研究中，我们发现，与通常的护理控制相比，决策辅助改善了代孕医生与临床医生在预后、沟通质量以及临床医生和代孕医生参与生命支持讨论的可能性方面的一致性。它还改善了代孕者的决策冲突和对临床医生的信任。为了证实和推广我们有希望的结果，我们现在提出一项多中心随机对照试验(RCT)来测试PMV决策辅助与常规护理控制在改善以下方面的有效性：(1)决策质量，定义为临床医生-代理人对预后、沟通质量和医学理解的一致性；(2)代理人的心理困扰；以及(3)患者的卫生保健利用。我们的目标是注册 来自五个不同中心的PMV患者的600名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在6个月的随访期内，辅助决策组和常规护理控制组之间的结果差异。这项拟议的研究满足了NIH和医学研究所强调的决策制定方面的关键研究需求，也满足了2010年《平价医疗法案》规定的决策辅助创新的呼吁。这一务实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孕者的信息需求；(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)针对与沟通有关的心理困扰的风险因素；(D)其价格低廉的潜力 传播和适应更广泛人群的能力；(F)适应构成部分临床风险估计的最新情况的能力；(G)纳入效果的经济评估。总体而言，这项研究可能会对重症监护未来的诊所和研究方法产生重大、持续的影响。 公共卫生相关性：在临床医生和危重患者的代理决策者中，决定是否提供长期生命支持的过程严重不足。为了解决这一问题，我们提出了一项随机对照试验，以确定与常规护理控制相比，创新的基于网络的决策辅助是否可以提高决策质量，减少代理人的心理困扰，并降低患者的医疗成本。这项研究-基于强有力的前期工作-既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，也有可能增加生命支持决定与患者价值观保持一致的可能性。

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.