Informing Decisions in Chronic Critical Illness: An RCT

慢性危重疾病的知情决策：随机对照试验

• 批准号: 8055052
• 负责人: Shannon S Carson
• 金额: $ 64.99万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-04-05 至 2015-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8055052
• 关键词: Acute; Address; Adverse effects; Anxiety; Caring; Chronic; Chronic Phase; Clinical Trials; Communication; Communities; Community Hospitals; Consult; Critical Care; Critical Illness; Decision Making; Dependence; Distress; Effectiveness; Elderly; Emotional; Enrollment; Expenditure; Face; Family; Family Physicians; Functional disorder; Goals; Health; Health Care Costs; Hospitals; Impairment; Institution; Intensive Care; Intervention; Interview; Lead; Length; Length of Stay; Life; Malignant Neoplasms; Mechanical ventilation; Medical; Mental Depression; Modeling; Multi-Institutional Clinical Trial; Organ; Outcome; Palliative Care; Patient Preferences; Patient-Focused Outcomes; Patients; Personal Satisfaction; Physicians; Population; Post-Traumatic Stress Disorders; Printing; Process; Randomized; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Recurrence; Research; Resources; Respiratory Failure; Schedule; Site; Specialist; Structure; Survivors; Syndrome; System; Testing; Time; aging population; base; clinical decision-making; cost; experience; family structure; human old age (65+); improved; meetings; mortality; patient population; primary outcome; programs; public health relevance; treatment as usual

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.

描述（由申请人提供）：老龄化人口越来越多地使用重症监护治疗，产生了一种新的医学综合症——“慢性危重病”——包括多系统紊乱、复发性并发症以及对机械通气和其他生命支持的长期/永久依赖。慢性危重病患者人数在任何时候都超过 100,000 人，其中老年人口不断增加，是一个严重的全国健康问题。这些患者的年度支出估计为 240 亿美元，其中大部分患者年龄为 65 岁。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，而且返回社区的情况很少见。描述性研究已经确定了一些信息领域，这些信息对于患者/家属在危重疾病慢性期继续治疗的决策非常重要，但也表明，决策通常是在没有这些信息或患者护理目标作为背景的情况下做出的。在急性危重疾病中，预定的、结构化的会议和印刷的信息辅助工具对 ICU 家庭来说是有效的，但没有研究测试过干预措施可以为慢性危重疾病的决策提供信息和支持。该 R01 申请提出了针对此类干预措施的随机、对照、多中心临床试验。具体目标是： (1) 评估由姑息治疗医生主导的协议化、跨学科、信息支持会议的主动计划以及印刷版信息援助对慢性危重患者家庭的影响，该计划对以家庭和患者为中心的结果的影响； (2) 评估该干预措施对慢性危重症患者重症监护资源利用的影响。我们假设，与常规护理加印刷援助相比，这种干预措施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。该研究将在 5 家医院（4 家学术中心/1 家社区医院）的医疗 ICU 中进行，为期 5 年，其中包括 4 年的受试者入组。慢性危重患者及其家属将在不同地点随机接受干预（由姑息治疗医生领导的支持信息团队 [SIT] 家庭会议）加印刷版援助或常规护理加印刷版援助。 SIT 和 ICU 医生之间的沟通将通过结构化和模板化的流程进行优化。 ICU 医生还可以选择参加干预家庭会议，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。 公共卫生相关性：大量且不断增长的患者在急性危重疾病中幸存下来，但长期处于危重状态，并持续依赖机械通气和其他重症监护治疗。这些患者大多是老年人，他们的健康状况不佳，情绪受到明显影响，给家庭带来其他负担，而且医疗费用高昂。这项多中心、随机、对照临床试验将测试一个可推广和可持续的模型，为面临慢性危重病治疗决策的家庭提供信息支持和其他帮助，从而改善以患者和家庭为中心的结果以及重症监护资源的利用率，而不增加患者死亡率。