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

针对死亡或严重残疾风险高的危重老年人的专业姑息治疗与重症监护相结合的随机试验

• 批准号: 10437935
• 负责人: Yael Schenker
• 金额: $ 60.32万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-15 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10437935
• 关键词: Academy; Address; Adopted; Advance Care Planning; American; Anxiety; Caring; Cessation of life; Coma; Consensus; Consultations; Country; Critical Care; Critical Illness; Data; Distress; Effectiveness; Elderly; Ensure; Ethnography; Family; Family health status; Family member; Fostering; Guidelines; Health Care Costs; Health Policy; Health system; Healthcare Systems; Heart Arrest; Hospitals; Impairment; Intensive Care Units; Intervention; Interview; Length of Stay; Letters; Life; Malignant Neoplasms; Measures; Medicine; Mental Depression; Methods; Monitor; Multicenter Trials; Outcome; Palliative Care; Participant; Patient-Focused Outcomes; Patients; Policy Maker; Prevalence; Prognosis; Publishing; Qualitative Methods; Randomized; Randomized Controlled Trials; Recommendation; Reproducibility; Research; Research Personnel; Site; Specialist; Symptoms; Testing; Time; Treatment Efficacy; United States National Institutes of Health; Work; advanced dementia; contextual factors; disability; end of life; experience; follow-up; health care service utilization; high risk; improved; improved outcome; innovation; medical information system; medical specialties; meetings; mortality risk; older patient; post-traumatic stress; prevent; primary outcome; psychological distress; psychological symptom; quality of death; randomized trial; secondary outcome; success; surrogate decision maker; treatment as usual; willingness

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.

抽象的 美国国家医学院和美国国立卫生研究院已呼吁紧急 采取行动改善对近 1,000,000 名死于美国老年人的护理 每年都会进入重症监护病房（ICU），或者在严重损伤的情况下生存。 包括：(1) 患者经常因痛苦的症状而死亡，接受更具侵入性、生命力的治疗。 比他们自己选择的治疗时间更长；(2) 家庭成员充当 代理决策者因入住 ICU 经历而遭受持久的心理困扰； (3)临终时的延长生命治疗会导致高昂的医疗费用。 解决死亡风险高的老年患者的这些缺点的潜在策略 残疾是专业姑息治疗 (PC) 与重症监护的早期整合。 然而，目前还没有高质量的随机试验来评估整合是否有效 我们建议采用专业姑息治疗和标准重症监护来改善治疗效果。 通过进行混合方法、多中心随机对照试验来弥补这一证据差距 625 名危重老年人中至少有一项建议的 PC 会诊标准。 患者及其代理决策者将被随机分配接受早期专业治疗 PC 与标准重症监护或常规护理集成，其中包括及时的临床医生家庭 在目标 1 中，我们将确定与已发布的建议一致的会议。 专业 PC 与重症监护相结合对以患者为中心的共同主要结果 在目标 2 中，我们将确定专业 PC 的影响。 与重症监护相结合，涉及次要结果的三个领域：患者的结果、 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，这项研究非常重要。 因为它将决定务实的、广泛可用的干预措施是否能有效地应对 每年有近一百万美国人在生命即将结束时面临棘手的问题。 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 该提案具有创新性。 因为它将提供关于特种 PC 影响的第一个高质量证据 由于我们的团队已建立，因此这项工作可以与重症监护相结合。 研究人员成功地拥有进行多中心 ICU 试验的成功记录，并且 已获得所有站点的参与参与。