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

National University Hospital, Singapore300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

300

Conditions

Delirium, Postoperative

Interventions

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 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 Outcomes

Length of Stay

Length of stay in ICU and hospital in days

Time frame: 3-months post-CABG (+/- 1 month)

Duration of Delirium

Duration of delirium in subgroup of participants who develop delirium

Time frame: 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

Time frame: 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)

Time frame: Day 5 of post-CABG (+/- 1 day)

Physical Status

Physical status measurement using Functional Independence Measure (FIM)

Time frame: Day 5 of post-CABG (+/- 1 day), 3 months post-CABG (+/- 1 month)

Cognitive status

Cognitive status measurement using Montreal Cognitive Assessment (MoCA)

Time frame: 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)

Time frame: 2 weeks prior to operation (Baseline measurement, +/- 2 weeks), Day 5 of post-CABG (+/-1 day), 3 months post-CABG (+/- 1 month)