A Randomized Controlled Trial of a Video Decision Making Aid to Obtain Informed Consent in the Surgical Intensive Care Unit
试验速览
- 阶段
- 不适用
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- knowledge of risks and benefits of procedures
研究概览
简要总结
To demonstrate that clinical surrogates of SICU patients who view a video decision aid in addition to receiving written and verbal information about procedures and life sustaining therapy in the SICU make more informed decisions than patients and clinical surrogates who receive written and verbal information alone.
详细描述
Specific Aim 1: To demonstrate that clinical surrogates of SICU patients who view a video decision aid in addition to receiving written and verbal information about procedures and life sustaining therapy in the SICU make more informed decisions than patients and clinical surrogates who receive written and verbal information alone.
Hypothesis 1: Adding a video decision aid to the current informed consent process, for procedures and life sustaining treatments in the SICU, will better inform clinical surrogates of incapacitated patients admitted to the SICU regarding decision making when providing consent for medical treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical surrogates of the following patients will be eligible to participate in this opinion survey:
- •All patients admitted to the SICU and not expected to die within 48 hours.
- •Patient has been admitted to the acute care surgical service,
- •The patient is over the age of 50 and does not have decision making capacity.
- •Subjects must be over the age of 21 and English speaking to participate in the opinion survey.
排除标准
- 未提供
研究组 & 干预措施
control group
usual care
Video Arm
干预措施: video decision aid (Behavioral)
结局指标
主要结局
knowledge of risks and benefits of procedures
时间窗: 5 minutes after survey
knowledge of risks and benefits of procedures
次要结局
未报告次要终点
研究者
Angelo E. Volandes, MD
Principal Investigator
Massachusetts General Hospital