Improving Decision Making for Patients With Prolonged Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 416
- 试验地点
- 8
- 主要终点
- Change in Clinician-surrogate Concordance Scale Score
研究概览
简要总结
Deciding about prolonged life support for critically ill patients can be very difficult. Therefore, the investigators are doing a study to see if an internet-based decision aid can improve the quality of decision making for substitute decision makers of patients who are in the intensive care unit (ICU).
详细描述
The process of making a decision about whether or not to provide prolonged life support is seriously deficient among clinicians and the surrogate decision makers for critically ill patients. To address this problem, we propose a randomized, controlled trial to determine if an innovative web-based decision aid compared to usual care control can improve the quality of decision making (defined as clinician-surrogate concordance for prognosis, quality of communication, and medical comprehension), reduce surrogates' psychological distress (depression, anxiety, and post-traumatic stress syndrome disorder (PTSD) symptoms), and reduce patients' health care costs over 6-month follow up. We will enroll 410 surrogate decision makers for 273 patients (expected average of 1.5 surrogates per patient). This study has the potential both to improve how clinicians and surrogates interact in intensive care units and to increase the likelihood that life support decisions are aligned with patients' values.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Decision aid
Web-based decision aid (decision support tool) provided to surrogate decision maker
干预措施: Decision aid (Behavioral)
Usual care
usual care in an intensive care unit setting
干预措施: Usual care (Other)
结局指标
主要结局
Change in Clinician-surrogate Concordance Scale Score
时间窗: ~2-7 days post-randomization
Concordance is calculated as the absolute value of the difference in prognosis for 1 year patient survival between the surrogate(s) and the clinician (ICU physician), and, therefore, can range from 0 to 100. We report pre-intervention to post-intervention difference in the CSCS. The CSCS is calculated as the absolute value of the difference between the surrogate's response and that of either the treating ICU physician (primary outcome) or the nurse (secondary outcome) to the question, "What percent chance do you think \[the patient/your loved one\] has of being alive 1 year from now if the current treatment plan is continued?" Scores can range from 0 to 100 percentage points, and higher values indicate greater discordance.
次要结局
- Post-traumatic Stress Syndrome Inventory(Pre-randomization (study day 1) and 180 days post-randomization)
- Patient-centeredness of Care Scale(Study day 1 and 180 days post-randomization)
- Quality of Communication Scale Score(Study day 1 (pre-randomization), ~2-7)
- Medical Comprehension Scale Score(Study day 1 (pre-randomization), ~2-7)
- Hospital Anxiety and Depression Scale (HADS) Total Score(Pre-randomization (study day 1) and 180 days post-randomization)
- Change in Clinical-surrogate Concordance Scale Score (Nurse)(~2-7 days post-randomization)