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

Study Overview
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Brief Summary
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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.

Official Title
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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
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Delirium, Postoperative

Intervention / Treatment
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* Other: DREAMS-OT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DREAMS-OT Arm (Intervention Group)<br>Patients will receive an early and intensive occupational therapy protocol starting within the first 15 hours after extubation. | Other: DREAMS-OT<br>* Patients will receive the DREAMS-OT protocol 3 times per day, 20 minutes per therapy session. Intervention frequency will be confirmed with a feasibility trial. If not feasible to maintain 3 times per day, the intervention will still be maintained at the same intensity of 1 hour per day, with a graded approach.<br>|
| No Intervention: Standard Care Arm (Control Group)<br>Standard care OT as per current ICU setting | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium | Incidence of delirium within 5 days of undergoing CABG. Measured using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) assessment tool | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay | Length of stay in ICU and hospital in days | 3-months post-CABG (+/- 1 month) | 
| Duration of Delirium | Duration of delirium in subgroup of participants who develop 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 | 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 | 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) | 
| Functional Status | Function status using Acute Care Index of Function (ACIF) | Day 5 of post-CABG (+/- 1 day) | 
| Physical Status | Physical status measurement using Functional Independence Measure (FIM) | Day 5 of post-CABG (+/- 1 day), 3 months post-CABG (+/- 1 month) | 
| Cognitive status | Cognitive status measurement using Montreal Cognitive Assessment (MoCA) | 2 weeks prior to operation (Baseline measurement, +/- 2 weeks), Day 5 of post-CABG (+/- 1 day), 3 months post-CABG (+/- 1 month) | 
| Psychological State | Psychological state using the Hospital Anxiety and Depression Scale (HADS) | 2 weeks prior to operation (Baseline measurement, +/- 2 weeks), Day 5 of post-CABG (+/-1 day), 3 months post-CABG (+/- 1 month) | 
| Cognitive status | Weekly Calendar Planning Activity (WCPA) | 3-months post-CABG (+/- 1 month) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium, Coronary Artery Bypass Grafting, Occupational Therapy, Intensive Care Units, Randomized Controlled Trial