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

Delirium, Postoperative Clinical Trial

— DREAMS-OT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06107517
• Other study ID #: 2022/00936
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: August 2025

Study information

• Verified date: August 2023
• Source: National University Hospital, Singapore
• Contact: Lian Ting Wong
• Phone: +65 6601 3288
• Email: lian_ting_wong[@]nuhs.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: August 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Delirium, Postoperative

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
National University Hospital, Singapore	National Medical Research Council (NMRC), Singapore, National University of Singapore

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Richmond Agitation Sedation Scale (RASS)	RASS which will be used for CAM-ICU assessment (primary outcome measure).	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)
Other	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	3-months post-CABG (+/- 1 month)
Other	Charlson Comobility Index (CCI)	Predicts mortality for participant before CABG surgery	3-months post-CABG (+/- 1 month)
Other	Clinical Frailty Index (CFI)	Measure health status of participant before surgery	3-months post-CABG (+/- 1 month)
Other	ICU Mobility Score	Measure ICU mobility during ICU stay	Day 1 of post-CABG, Day 3 of post-CABG, Day 4 of post-CABG (+/- 1 day, or until day of ICU discharge)
Other	Pain Score	Measure pain score of participant	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)
Other	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)
Other	30-day readmission and mortality	Incidence of readmission or death within 30 days after CABG	3-months post-CABG (+/- 1 month)
Other	Short Form (36) Health Survey (SF-36)	Measure quality of life	2 weeks prior to operation (Baseline measurement, +/- 2 weeks), 3-months post-CABG (+/- 1 month)
Primary	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	Length of Stay	Length of stay in ICU and hospital in days	3-months post-CABG (+/- 1 month)
Secondary	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)
Secondary	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)
Secondary	Functional Status	Function status using Acute Care Index of Function (ACIF)	Day 5 of post-CABG (+/- 1 day)
Secondary	Physical Status	Physical status measurement using Functional Independence Measure (FIM)	Day 5 of post-CABG (+/- 1 day), 3 months post-CABG (+/- 1 month)
Secondary	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)
Secondary	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)
Secondary	Cognitive status	Weekly Calendar Planning Activity (WCPA)	3-months post-CABG (+/- 1 month)