Informing Decisions in Chronic Critical Illness: A Randomized Control Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 622
- 试验地点
- 7
- 主要终点
- Hospital Anxiety and Depression Scale
研究概览
简要总结
The purpose of this study is to test a communication intervention to support family decision-making for patients with chronic critical illness.
详细描述
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 ≥ 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 Intensive Care Unit (ICU) families, but no study has tested an intervention to inform and support decision-making about chronic critical illness. This study is 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mechanically ventilated ≥ 7 days
- •Mechanically ventilated without > 96 hour interruption
- •Age ≥ 21 years
- •ICU MD does not expect patient will die within 72 hours
- •ICU MD does not expect patient will be liberated from the ventilator within 72 hours.
排除标准
- •Previous admission to study ICU this hospitalization Mechanically ventilated at outside hospital for > 7 days before transfer
- •Chronic Neuromuscular (NM) Disease
- •Previous palliative care consultation in this hospitalization
- •No family or other surrogate decision-maker
- •Family not available
- •Surrogate lacks English proficiency
- •Physician refused permission for research staff to approach the family
结局指标
主要结局
Hospital Anxiety and Depression Scale
时间窗: Day 90
次要结局
- Physician-Surrogate Discordance Score(day 18-20)
- Impact of Events Scale-Revised(Day 90)
- Hospital Length of Stay(Average of 60 days)
- Mortality(Day 90)
- Discussion of Preferences for Patients Goals of Care(Day 90)
- Hospital Anxiety and Depression Scale(Day 18-20)
- Limitation of Intensive Care Unit (ICU) Therapy(Average of 60 days)
- Quality of Communication(Day 18-20)
- Family Satisfaction in the Intensive Care Unit (ICU) Survey(Day 90)
- Modified Center for Gerontology and Health Care Research (CHCR) Tool(Day 90)