Informing Decisions in Chronic Critical Illness: An RCT

描述（由申请人提供）：随着人口老龄化，重症监护治疗的使用越来越多，产生了一种新的医学综合征——“慢性危重疾病”——包括多系统紊乱、复发性并发症和对机械通气和其他生命支持的长期/永久性依赖。在任何时间点上，慢性危重病人的数量都达到100万，他们是老年人中不断增长的人口，是一个严重的国家健康问题。这些患者的年度支出估计为240亿美元，主要是65岁以上的患者。然而，6个月的死亡率超过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。描述性研究已经确定了对危重疾病慢性阶段患者/家属关于继续治疗的决策很重要的信息领域，但也揭示了决策通常在没有这些信息或患者护理目标的情况下做出。在急性危重症中，计划的、有组织的会议和印刷的信息辅助工具对ICU家庭是有效的，但没有研究测试了一种干预措施来告知和支持关于慢性危重症的决策。本R01申请提出了一项随机、对照、多中心的此类干预临床试验。具体目标是：(1)评估由姑息治疗医生领导的前瞻性方案对以家庭和患者为中心的信息支持会议的影响，并为慢性危重患者的家庭提供打印的信息援助；(2)评估该干预措施对慢性危重患者重症监护资源利用的影响。我们假设，与常规护理加印刷辅助工具相比，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，并优化重症护理资源利用，而不会增加患者死亡率。研究将在5家医院（4个学术中心/1个社区医院）的医学icu进行，为期5年，其中包括4年的受试者招募。慢性危重患者及其家属将被随机分配到不同的地点，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）加打印的辅助工具或常规护理加打印的辅助工具。SIT和ICU医生之间的沟通将通过结构化和模板化的过程进行优化。ICU医生也可以选择参加干预家庭会议，对所有患者来说，决策仍然是医生和家庭的责任。主要结局（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利用相关的结果，包括ICU和住院时间。

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.