Informing Decisions in Chronic Critical Illness: An RCT

描述(申请人提供)：老龄化人口越来越多地使用重症监护治疗，创造了一种新的医学综合征--“慢性危重疾病”--包括多系统紊乱、反复出现的并发症以及对机械通风和其他生命支持的长期/永久依赖。在任何时间点，慢性危重病患者都是不断增长的老年人，是一个严重的国家健康问题。这些患者每年的支出估计为240亿美元，其中大部分是65岁的患者。然而，6个月的死亡率超过了大多数恶性肿瘤的死亡率，幸存者的损伤很严重，重返社区的情况很少见。描述性研究确定了对患者/家庭在危重疾病慢性期继续治疗的决策非常重要的信息领域，但也揭示了决策往往是在没有这些信息或患者护理目标的情况下做出的。在急性危重病中，预定的、有组织的会议和印刷的信息辅助对ICU家庭是有效的，但还没有研究测试一种干预措施，以告知和支持关于慢性危重病的决策。该R01申请提出了这样一种干预的随机、对照、多中心临床试验。具体目标是：(1)评估由一名姑息治疗医生领导的前瞻性、跨学科的信息支持会议的积极计划对以家庭和患者为中心的结果的影响；以及(2)评估这种干预措施对慢性危重患者家庭危重护理资源利用的影响。我们假设，与常规护理加上印刷辅助工具相比，这种干预将有效地为决策提供信息，改善家庭福祉，促进对患者护理目标偏好的讨论，并优化危重护理资源的利用，而不会增加患者死亡率。这项研究将在5家医院(4个学术中心/1个社区医院)的内科ICU进行，为期5年，包括4年的学科招生。慢性危重患者及其家人的二元组将在不同地点随机接受干预(由姑息治疗医生领导的支持性信息小组[SIT]家庭会议)加上打印的援助，或通常的护理加上打印的援助。SIT和ICU医生之间的沟通将通过结构化和模板化的程序进行优化。ICU医生还将有权参加干预家庭会议，对于所有患者，决策仍将由该医生与家人共同负责。主要结果(通过家庭访谈收集)是家庭焦虑/抑郁，家庭创伤后应激障碍，以及对患者护理目标偏好的讨论。我们还将评估与重症监护资源使用相关的结果，包括ICU和住院时间。 与公共卫生的相关性：大量且不断增长的患者在急性危重疾病中幸存下来，但在慢性基础上仍处于危重状态，继续依赖机械通风和其他重症监护治疗。这些患者大多是老年人，在显著的情感影响和对家庭的其他负担以及异常高昂的医疗费用的背景下，面临着糟糕的健康结果。这项多中心、随机、对照的临床试验将测试一种可推广和可持续的模式，为面临慢性危重病治疗决策的家庭提供信息支持和其他援助，从而改善以患者和家庭为重点的结果以及危重护理资源的利用，而不会增加患者死亡率。

DESCRIPTION (provided by applicant): Increasing use of intensive care therapies by an aging population has created a new medical syndrome - "chronic critical illness" - encompassing multi-system derangements, recurrent complications, and protracted/permanent dependence on mechanical ventilation and other life-supports. Numbering >100,000 at any point in time, the chronically critically ill are a growing population of older adults and a serious national health problem. Annual expenditures for these patients are estimated at $24 billion, mostly for patients e 65 years old. Yet 6-month mortality rates exceed those for most malignancies, impairments are severe among survivors, and return to the community is rare. Descriptive research has identified domains of information that are important for decision-making by patients/families about continuation of treatment in the chronic phase of critical illness, but has also revealed that decisions are often made without this information or patient goals of care as a context. In acute critical illness, scheduled, structured meetings and printed informational aids are effective for ICU families, but no study has tested an intervention to inform and support decision-making about chronic critical illness. This R01 application proposes a randomized, controlled, multi-center clinical trial of such an intervention. Specific Aims are: (1) To evaluate the impact on family- and patient-focused outcomes of a proactive program of protocolized, interdisciplinary, informational support meetings led by a palliative care physician, plus a printed informational aid, for families of chronically critically ill patients; and (2) To evaluate the impact of this intervention on utilization of critical care resources for the chronically critically ill. We hypothesize that as compared to usual care plus the printed aid, this intervention will effectively inform decision-making, improve family well-being, promote discussion of preferences for patient goals of care, and optimize critical care resource utilization, without increasing patient mortality. The research will be conducted in medical ICUs at 5 hospitals (4 academic centers/1 community hospital) over 5 years including 4 years of subject enrollment. Dyads of chronically critically ill patients and their families will be randomized within sites to receive either the intervention (Supportive Information Team [SIT] family meetings led by palliative care physician) plus the printed aid or usual care plus the printed aid. Communication between SIT and ICU physicians will be optimized through a structured and templated process. The ICU physician will also have the option to join intervention family meetings and, for all patients, decision-making will remain the responsibility of this physician with the family. Primary outcomes (collected by family interviews) are Family Anxiety/Depression, Family Post-Traumatic Stress Disorder, and Discussion of Preferences for Patient Goals of Care. We will also evaluate outcomes related to utilization of critical care resources including ICU and hospital lengths of stay. PUBLIC HEALTH RELEVANCE: A large and growing population of patients survive acute critical illness only to remain critically ill on a chronic basis, with continued dependence on mechanical ventilation and other intensive care therapies. Mostly older adults, these patients face poor health outcomes in the context of marked emotional impact and other burdens on their families as well as extraordinary health care costs. This multicenter, randomized, controlled clinical trial will test a generalizable and sustainable model to provide informational support and other assistance to families facing treatment decisions for the chronically critically ill, thereby improving patient- and family-focused outcomes as well as utilization of critical care resources, without increasing patient mortality.