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
- Conditions
- Delirium, Postoperative
- Interventions
- Other: DREAMS-OT
- Registration Number
- NCT06107517
- Lead Sponsor
- National University Hospital, Singapore
- Brief Summary
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) delirium in patients undergoing CABG.
The aims of the study are:
* Conduct a prospective randomized controlled trial comparing the effectiveness of the DREAMS-OT intervention with standard care in reducing post-CABG delirium in Cardiothoracic Intensive Care Unit (CTICU)
* To conduct a nested cost-effectiveness study
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DREAMS-OT Arm (Intervention Group) DREAMS-OT Patients will receive an early and intensive occupational therapy protocol starting within the first 15 hours after extubation.
- Primary Outcome Measures
Name Time Method 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); (+/- 1 day for last measurement) Incidence of delirium within 5 days of undergoing CABG. Measured using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) assessment tool
- Secondary Outcome Measures
Name Time Method Length of Stay 3-months post-CABG (+/- 1 month) Length of stay in ICU and hospital in days
Cognitive status 3-months post-CABG (+/- 1 month) Weekly Calendar Planning Activity (WCPA)
Psychological State 2 weeks prior to operation (Baseline measurement, +/- 2 weeks), Day 5 of post-CABG (+/-1 day), 3 months post-CABG (+/- 1 month) Psychological state using the Hospital Anxiety and Depression Scale (HADS)
Physical Status Day 5 of post-CABG (+/- 1 day), 3 months post-CABG (+/- 1 month) Physical status measurement using Functional Independence Measure (FIM)
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) Duration of delirium in subgroup of participants who develop delirium
Sleep Quality 2 weeks prior to operation (Baseline measurement, +/- 2 weeks), Day 3 of post-CABG, Day 4 of post-CABG (+/- 1 day), 3 months post-CABG for 3 consecutive days (+/- 1 month) Sleep quality (Duration of Total Sleep, Light Sleep, Deep Sleep and Rapid Eye Movement (REM) Sleep in hours) as measured with Oura Ring, a wearable sleep tracking device
Functional Status Day 5 of post-CABG (+/- 1 day) Function status using Acute Care Index of Function (ACIF)