Reorientation Intervention for Delirium in ICU
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 6
- 主要终点
- Delirium-free Days
研究概览
简要总结
This randomized clinical trial tests a cognitive reorientation intervention to prevent delirium in the intensive care unit using scripted audio messages, recorded by the patient's family and played at hourly intervals during daytime hours, to provide information about the ICU environment to the patient (the Family Automated Voice Reorientation intervention, FAVoR). The investigators hypothesize that providing ongoing orientation to the ICU environment through recorded audio messages in a voice familiar to the patient will enable the patient to more accurately interpret the environment and reduce risk of delirium. Increasing awareness of daytime by cuing patients during waking hours may also improve day/night orientation, nighttime sleep/rest, and further reduce risk of delirium.
详细描述
This randomized clinical trial will test the effectiveness of a nonpharmacologic intervention to prevent delirium in the intensive care unit (ICU), which affects as many as 80% of critically ill, mechanically ventilated adults.. The Family Automated Voice Reorientation (FAVoR) intervention uses scripted audio messages, recorded by the patient's family and played at hourly intervals during daytime hours, to provide information about the ICU environment to the patient; this ongoing orientation to the ICU environment through recorded messages in a voice familiar to the patient may enable the patient to more accurately interpret the environment and thus reduce risk of delirium. Increasing awareness of daytime by cuing patients during waking hours may also improve day/night orientation and nighttime sleep, further reducing risk of delirium. The primary specific aim of the project is to test the effect of the FAVoR intervention on delirium in critically ill, mechanically ventilated adults during hospitalization in the ICU. Secondary aims are to: (1) explore if the effect of FAVoR on delirium is mediated by sleep, (2) explore if selected biobehavioral factors may potentially moderate the effects of FAVoR on delirium, and (3) examine the effects of FAVoR on short term (immediately after ICU discharge) and long term (1 and 6 months after hospital discharge) outcomes, including cognitive function and patient-reported health status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Study personnel evaluating delirium will use standardized tool (CAM-ICU) and will be blinded to subjects' group assignments.
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
- •mechanically ventilated patients
- •within 36 hours of ICU admission
- •patient or legally authorized representative (LAR) must be able to provide informed consent in English or Spanish
- •a family member able to speak English or Spanish must be available and willing to audio record scripted messages
排除标准
- •dementia (because it complicates planned longitudinal cognitive assessments)
- •anticipation by the clinical provider of imminent patient death
- •medical contraindication to the intervention (for example, psychiatric history of auditory hallucinations, or profoundly deaf)
- •inability to speak either English or Spanish
结局指标
主要结局
Delirium-free Days
时间窗: Up to 20 days in the intensive care unit (ICU)
Delirium will be assessed by study personnel, blinded to the group assignment, using Confusion Assessment Method-Intensive Care Unit (CAM-ICU)
次要结局
- Sleep(Up to 5 days in the ICU)
- Cognitive Function(At least 24 hours post ICU discharge, 1 month post hospital discharge, & 6 months post hospital discharge)
- Patient-reported Health Status(At least 24 hours post ICU discharge, 1 month post hospital discharge, & 6 months post hospital discharge)
研究者
Cindy Munro
Dean and Professor
University of Miami