Randomized Trial of Specialty Palliative Care Integrated with Critical Care for Critically Ill Older Adults at High Risk of Death or Severe Disability

摘要 美国国家医学科学院和美国国立卫生研究院呼吁紧急 行动，以改善提供给近100万老年美国人谁死在 重症监护室（ICU）每年，或生存与重大损害。重大问题 包括：（1）患者经常死于令人痛苦的症状，接受更具侵入性的，生命- 延长治疗时间;（2）家庭成员作为 代理决策者经历ICU经历的持久心理困扰; 以及（3）接近生命结束时的延长生命的治疗导致高的医疗保健费用。一 潜在的策略，以解决这些缺陷的老年患者在高风险的死亡或 残疾是早期整合专业姑息治疗（PC）与重症监护。 然而，还没有高质量的随机试验评估是否整合 专业姑息治疗与标准重症监护可改善预后。我们建议解决 通过进行一项混合方法、多中心随机对照试验， 在625名重症老年人中，至少有一个建议的PC咨询标准。 患者及其代理决策者将被随机分配接受早期专科治疗或 PC与标准重症监护或常规护理相结合，包括及时的临床医生-家庭 与公布的建议一致的会议。在目标1中，我们将确定 专科PC与重症监护相结合对以患者为中心的共同主要结局的影响 照顾和代理人的心理困扰。在目标2中，我们将确定专业PC的效果 与重症监护在三个次要结果领域相结合：患者的结果， 家庭的结果和卫生保健利用。在目标3中，我们将进行并行混合 方法研究，以确定影响专业PC功效的背景和机制 与老年重症患者的重症监护相结合。这项研究意义重大 因为它将决定一个务实的、广泛可用的干预措施是否能有效地对抗 每年有近一百万美国老年人在生命即将结束时面临棘手的问题。它将 为医疗保健系统和政策制定者提供重要信息， 确定如何最好地分配专业PC顾问的工作。这一建议具有创新性 因为它将提供关于特种PC影响的第一个高质量证据， 与重症监护相结合。这项工作在我们手中是可行的，因为我们的团队建立了 研究者成功地进行了多中心ICU试验， 所有网站都参与进来。

ABSTRACT The National Academy of Medicine and the National Institutes of Health have called for urgent action to improve the care delivered to the nearly 1,000,000 older Americans who die in intensive care units (ICUs) annually, or survive with substantial impairments. Major problems include: (1) patients frequently die with distressing symptoms, receiving more invasive, life- prolonging treatments than they would choose for themselves; (2) family members acting as surrogate decision makers experience lasting psychological distress from the ICU experience; and (3) life-prolonging treatments near the end of life contribute to high health care costs. One potential strategy to address these shortcoming for older patients at high risk of death or disability is the early integration of specialty palliative care (PC) alongside critical care. However, there have been no high-quality randomized trials assessing whether integrating specialty palliative care with standard critical care improves outcomes. We propose to address this evidence gap by conducting a mixed-methods, multi-center randomized controlled trial among 625 critically ill older adults with at least one suggested criteria for PC consultation. Patients and their surrogate decision makers will be randomized to receive either early specialty PC integrated with standard critical care or usual care, which includes timely clinician-family meetings consistent with published recommendations. In Aim 1, we will determine effects of specialty PC integrated with critical care on the co-primary outcomes of patient-centeredness of care and surrogates’ psychological distress. In Aim 2, we will determine effects of specialty PC integrated with critical care on three domains of secondary outcomes: patients’ outcomes, families’ outcomes, and health care utilization. In Aim 3, we will conduct a parallel mixed methods study to identify contexts and mechanisms that influence the efficacy of specialty PC integrated with critical care among older critically ill patients. The research is highly significant because it will determine whether a pragmatic, widely-available intervention is effective against intractable problems near the end of life for nearly one million older Americans annually. It will provide important information for healthcare systems and policy makers who are trying to determine how best to allocate the effort of specialty PC consultants. This proposal is innovative because it will provide the first high-quality evidence regarding the impact of specialty PC integrated with critical care. The work is feasible in our hands because our team of established investigators successfully has a proven record of success conducting multicenter ICU trials and has buy-in for participation from all sites.