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国家卫生研究院呼吁紧急 采取行动改善向#年死亡的近100万美国老年人提供的护理 要么每年接受重症监护病房(ICU)治疗，要么在严重损伤的情况下存活。主要问题 包括：(1)患者经常死于令人痛苦的症状，接受更多的侵入性，生命- 延长治疗时间，超过他们自己的选择；(2)家庭成员充当 代理决策者从ICU经历中体验到持久的心理痛苦； 以及(3)在生命接近尾声时，延长生命的治疗导致了较高的医疗费用。一 针对死亡或死亡风险较高的老年患者解决这些缺陷的潜在策略 残疾是专业姑息护理(PC)与危重护理的早期整合。 然而，目前还没有高质量的随机试验评估是否将 特殊姑息治疗和标准危重护理可改善预后。我们建议解决以下问题 这一证据差距通过进行混合方法、多中心随机对照试验 在625名至少有一项建议的PC咨询标准的危重老年人中。 患者和他们的代理决策者将被随机选择接受早期专科治疗 与标准危重护理或常规护理集成的PC，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与危重护理相结合的以患者为中心的共同主要结果 照顾和代孕母亲的心理困扰。在目标2中，我们将确定专用PC的效果 在次要结果的三个领域与危重护理相结合：患者的结果， 家庭结果和卫生保健利用情况。在目标3中，我们将进行平行混合 方法研究确定影响专科PC疗效的环境和机制 与老年危重病人的危重护理相结合。这项研究具有重要的意义 因为它将决定一种务实的、广泛可用的干预措施是否对 每年有近100万美国老年人面临生命末期的棘手问题。会的 为医疗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。这个建议很有新意 因为它将为专业PC的影响提供第一个高质量的证据 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 调查人员有成功进行多中心ICU试验和 拥有来自所有站点的参与买入。

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.