DREAMS-OT Trial: Delirium Reduction Through Early Activation in Motivating and Sleep Promoting Routines: A Randomized Controlled Trial of Occupational Therapy for ICU Patients After Coronary Artery Bypass Graft (CABG) Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Delirium
研究概览
简要总结
The goal of this randomized-controlled trial (RCT) is to compare the effectiveness of the DREAMS-OT intervention with standard care in reducing post-Coronary Artery Bypass Graft (CABG) surgery delirium in patients undergoing CABG surgery.
The aims of the study are:
- To determine if early and intensive OT will lower the incidence of post-op delirium in CABG patients compared to standard are.
- To determine the cost effectiveness of the DREAMS-OT intervention.
The study team will compare intervention group and standard care group (control group) to see if there is a reduction in the incidence of delirium in patients 5 days post-CABG.
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 (Participant)
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients deemed medically suitable for elective CABG surgery
- •Patients aged 21 years and above
- •Patients who are English or Mandarin speaking.
- •Patients who are able to provide consent
排除标准
- •Patients who speak other languages are excluded due to the language requirements of certain outcome measures.
- •Patients with premorbid severe hearing impairment, severe cognitive impairment, progressive neurological disorders and psychological disorders will be excluded.
- •Patients with surgical complications resulting in profuse bleeding from any invasive sites, septic shock unresponsive to maximal treatment, and those who are moribund or have an expected mortality within 48 hours will be excluded.
- •Pregnant women will also be excluded from the study as well.
- •Patients who develop delirium before initiation of the treatment are also excluded from the study.
研究组 & 干预措施
DREAMS-OT Arm (Intervention Group)
Patients will receive an early and intensive occupational therapy protocol starting within the first 15 hours after extubation.
干预措施: DREAMS-OT (Other)
Standard Care Arm (Control Group)
Standard care OT as per current ICU setting
结局指标
主要结局
Delirium
时间窗: Day 1 of post-CABG (AM and PM), Day 2 of post-CABG (AM and PM), Day 3 of post-CABG (AM and PM), Day 4 of post-CABG (AM and PM), Day 5 of post-CABG (AM and PM); (+/- 1 day for last measurement)
Incidence of delirium from Day 1 to Day 5 post-CABG are measured using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) assessment tool.
次要结局
- Cognitive status(3-months post-CABG (+/- 1 month))
- Psychological State(2 weeks prior to operation (Baseline measurement, +/- 2 weeks), Day 5 of post-CABG (+/-1 day), 3 months post-CABG (+/- 1 month))
- Functional Status(Day 5 of post-CABG (+/- 1 day))
- Physical Status(Day 5 of post-CABG (+/- 1 day), 3 months post-CABG (+/- 1 month))
- Length of Stay(3-months post-CABG (+/- 1 month))
- Duration of Delirium(Day 1 of post-CABG (AM and PM), Day 2 of post-CABG (AM and PM), Day 3 of post-CABG (AM and PM), Day 4 of post-CABG (AM and PM), Day 5 of post-CABG (AM and PM))
- Sleep Quality(2 weeks prior to operation (Baseline measurement, +/- 2 weeks), Day 1 of post-CABG, Day 2 of post-CABG (+/- 1 day), 3 months post-CABG for 3 consecutive days (+/- 1 month))
- Cognitive status(2 weeks prior to operation (Baseline measurement, +/- 2 weeks), Day 5 of post-CABG (+/- 1 day), 3 months post-CABG (+/- 1 month))