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呼吁紧急 改善交付给近1,000,000名死亡的年长美国人的照料行动 每年重症监护病房（ICU），或在大量障碍中生存。主要问题 包括：（1）患者经常死于令人痛苦的症状，获得更多侵入性，生活 - 延长治疗方法比他们自己选择的疗法； （2）充当的家庭成员 代理决策者经历了ICU经验的持久心理困扰； （3）生命末生命的养育疗法在生命即将结束时造成了高昂的医疗保健费用。一 针对高死亡风险或 残疾是特殊姑息治疗（PC）与重症监护同行的早期整合。 但是，没有评估是否整合的高质量随机试验 具有标准重症监护的专业姑息治疗可改善结果。我们建议解决 通过进行混合方法，多中心随机对照试验，这种证据差距 在625名重病的老年人中，至少有一个建议PC咨询的标准。 患者及其代理决策者将被随机分配以接受早期专业 PC与标准重症监护或常规护理集成在一起，其中包括及时的临床家庭 会议与已发表的建议一致。在AIM 1中，我们将确定 专业PC与重症监护集成在患者中心的共同结果上 照顾和代孕的心理困扰。在AIM 2中，我们将确定专业PC的影响 与重症监护的三个次要结局结合在一起：患者的结果， 家庭的结果和医疗保健利用。在AIM 3中，我们将进行平行的混合 方法研究以识别影响专业PC效率的上下文和机制 与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，广泛的干预措施是否有效 每年近一百万年长的美国人生命即将结束的棘手问题。会 为试图的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顾问的努力。该建议是创新的 因为它将提供有关专业PC影响的第一个高质量证据 与重症监护。这项工作在我们手中是可行的，因为我们的团队已建立 调查人员成功地记录了进行多中心ICU试验的成功记录和 已获得所有站点的参与。