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: 8250848
• 负责人: Shannon S Carson
• 金额: $ 63.09万
• 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/8250848
• 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）：衰老人群对重症监护疗法的使用增加，已经创造了一种新的医疗综合征 - “慢性重症疾病” - 涵盖了多系统危险，复发并发症以及对机械通气和其他生命养育的持久/永久依赖。在任何时间点，长期危重的老年人人口越来越多，在任何时间点都有> 100,000个。这些患者的年度支出估计为240亿美元，主要是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，幸存者的障碍很严重，返回社区很少。描述性研究已经确定了对患者/家庭在慢性疾病持续治疗的决策至关重要的信息领域，但也揭示了决策通常是没有这些信息或患者护理目标的情况下做出的。在急性重症疾病中，预定的结构化会议和印刷的信息辅助工具对ICU家庭有效，但是没有研究测试干预措施，以告知和支持有关慢性重症疾病的决策。该R01应用提出了对这种干预措施的随机，受控的，多中心的临床试验。具体目的是：（1）评估对由姑息治疗医生主持的协议，跨学科，信息支持会议的积极主动计划计划的影响的影响，以及对长期严重患者的家庭的影响； （2）评估这种干预措施对重症监护资源利用的影响。我们假设，与通常的护理以及印刷援助相比，这种干预将有效地为决策提供依据，改善家庭福祉，促进讨论患者护理目标的偏好，并优化重症监护资源利用，而无需增加患者死亡率。这项研究将在5年内在5家医院（4个学术中心/1家社区医院）的医学ICU进行，包括4年的入学人数。长期患病患者及其家人的二元组将在现场随机分配，以接受干预措施（支持信息团队[SIT]由姑息治疗医生领导的家庭会议），以及印刷的援助或通常的护理以及印刷援助。 SIT和ICU医师之间的沟通将通过结构化和模板的过程进行优化。 ICU医生还可以选择参加干预家庭会议，对于所有患者，决策将仍然是该医生与家人的责任。主要结果（通过家庭访谈收集）是家庭焦虑/抑郁症，创伤后应激障碍以及对患者护理目标的偏好的讨论。我们还将评估与使用重症监护病房和住院时间在内的重症监护资源有关的结果。 公共卫生相关性：大量且不断增长的患者生存于急性危重疾病，只是在长期处于危重的基础上，继续依赖机械通气和其他重症监护疗法。这些患者主要是老年人，在明显的情绪影响和其他对家人的负担以及非凡的医疗保健费用的背景下面临健康状况不佳。这项多中心，随机，对照临床试验将测试一种可概括且可持续的模型，为面对治疗决策的家庭提供信息支持和其他援助，从而改善患者和以家庭为中心的结果，并利用重症监护资源，而无需增加患者死亡。