Reducing Delirium After CABG Surgery With Early Activation and Sleep-Promoting Routines (DREAMS-OT)

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

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:

1. To determine if early and intensive OT will lower the incidence of post-op delirium in CABG patients compared to standard are.
2. 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.

Study Overview

• Status: Recruiting
• Conditions: Delirium, Postoperative
• Intervention / Treatment: Other: DREAMS-OT

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Megan HL Tan; Phone Number: +65-96280613; Email: megan_huei_lin_tan@nuhs.edu.sg
• Study Contact Backup: Name: Michell KS Low; Phone Number: +65 83164092; Email: michell_kai_sian_low@nuhs.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore, 119074
    • Recruiting
    • National University Hospital
    • Sub-Investigator: Hui Minn Chan
    • Sub-Investigator: Lian Kah Ti
    • Contact: Su Ren Wong; Phone Number: +65-90279451; Email: su_ren_wong@nuhs.edu.sg
    • Contact: Megan HL Tan; Email: megan_huei_lin_tan@nuhs.edu.sg
    • Principal Investigator: Su Ren Wong
    • Sub-Investigator: Geetha Kayambu
    • Sub-Investigator: Graeme MacLaren
    • Sub-Investigator: Ramanathan Kollengode Ramaswamy
    • Sub-Investigator: Guohao Chang
    • Sub-Investigator: Kit Cheng Ting
    • Sub-Investigator: Bee Choo Tai
    • Sub-Investigator: Rachel Lee
    • Sub-Investigator: Hui Min Chua
    • Sub-Investigator: Ong Li Xin
    • Sub-Investigator: Najjar Raymond

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DREAMS-OT Arm (Intervention Group); Patients will receive an early and intensive occupational therapy protocol starting within the first 15 hours after extubation.	Other: DREAMS-OT; 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.
No Intervention: Standard Care Arm (Control Group); Standard care OT as per current ICU setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delirium	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.	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)
Delirium	Incidence of delirium from Day 1 to Day 5 post-CABG are measured using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM).	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 1 of post-CABG, Day 2 of post-CABG (+/- 1 day), 3 months post-CABG for 3 consecutive days (+/- 1 month)
Functional Status	Functional status measured using Acute Care Index of Function (ACIF). The score ranges from 0 - 176 (or 206 for wheelchair-bound participants), with higher scores indicating better functional performance.	Day 5 of post-CABG (+/- 1 day)
Physical Status	Physical status measured using Functional Independence Measure (FIM). The score ranges from 0 - 126, with higher scores indicating better physical status.	Day 5 of post-CABG (+/- 1 day), 3 months post-CABG (+/- 1 month)
Cognitive status	Cognitive status measurement using Montreal Cognitive Assessment (MoCA). The score ranges from 0 - 30, with higher scores indicating better cognitive status.	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 measured using the Hospital Anxiety and Depression Scale (HADS). The score ranges from 0 - 21, with higher scores indicating worse psychological state.	2 weeks prior to operation (Baseline measurement, +/- 2 weeks), Day 5 of post-CABG (+/-1 day), 3 months post-CABG (+/- 1 month)
Cognitive status	Cognitive status measured using the Weekly Calendar Planning Activity (WCPA) is assessed using an efficiency score derived from accuracy and time to completion. Higher scores indicate better performance. The score is a continuous variable without a fixed range.	3-months post-CABG (+/- 1 month)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time on Mechanical Ventilation and Ventilator Free Days	Time on Mechanical Ventilation of participant in hours and Ventilator Free Days in days during ICU stay	3-months post-CABG (+/- 1 month)
30-day readmission and mortality	Incidence of readmission or death within 30 days after CABG	3-months post-CABG (+/- 1 month)
Richmond Agitation Sedation Scale (RASS)	RASS which will be used for CAM-ICU assessment (primary outcome measure). The scores range from -5 to +4, with higher score indicating greater agitation and lower scores indicating deeper sedation.	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)
European System for Cardiac Operative Risk Evaluation (EuroSCORE) 2	EuroSCORE 2 is used to assess the risk of heart surgery of participants before their CABG surgery. The score ranges from 0% - 100%, with higher percentage indicating worse outcome or greater predicted mortality risk.	2 weeks prior to operation (Baseline measurement, +/- 2 weeks)
Charlson Comorbidity Index (CCI)	Predicts mortality for participant before CABG surgery. The score ranges from 0 - 37, with higher score indicating worse outcome or greater comorbidity burden and mortality risk.	2 weeks prior to operation (Baseline measurement, +/- 2 weeks)
Clinical Frailty Index (CFI)	Measure health status of participant before surgery. The score range from 0 - 9, with higher score indicating worse outcome.	2 weeks prior to operation (Baseline measurement, +/- 2 weeks)
ICU Mobility Score	Assesses the highest level of mobility achieved in the ICU. The score range from 0 - 10, with higher score indicating better ouctome or greater mobility.	Day 1, Day 2 and Day 3 of post-CABG (+/- 1 day, or until day of ICU discharge)
Pain Score	Measure pain score of participant. The score range from 0 - 10, with higher score indicating worse outcome or greater pain intensity.	Day 1 of post-CABG, Day 2 of post-CABG, Day 3 of post-CABG, Day 4 of post-CABG, Day 5 of post-CABG (+/- 1 day, or until day of ICU discharge)
Short Form (36) Health Survey (SF-36)	A survey that determines quality of life. The summary of the health components Physical Health Component (PCS) and Mental Health Component (MCS) are derived from eight subscales PF, RP, BP, GH, VT, SF, RE, MH), where the minimum score represents the worst health and the maximum score represents the best health. The minimum and maximum score of the subscales are as follow: PF (minimum 19.3, maximum 57.5),; RP (minimum 21.2, maximum 57.2),; BP (minimum 21.7, maximum 62.0),; GH (minimum 19.0, maximum 66.5),; VT (minimum 22.9, maximum 70.4),; SF (minimum 17.2, maximum 57.3),; RE (minimum 14.4, maximum 56.2),; MH (minimum 11.6, maximum 63.9).	2 weeks prior to operation (Baseline measurement, +/- 2 weeks), 3-months post-CABG (+/- 1 month)

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore
• Collaborators: National Medical Research Council (NMRC), Singapore; National University of Singapore
• Investigators: Principal Investigator: Su Ren Wong, National University Hospital, Singapore

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Occupational Therapy; Intensive Care Units; Delirium; Coronary Artery Bypass Grafting
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Delirium
• Other Study ID Numbers: 2022/00936

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No