Clinical trial NCT06107517: 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Delirium, Postoperative
Keywords: Delirium
Coronary Artery Bypass Grafting
Occupational Therapy
Intensive Care Units
Randomized Controlled Trial
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: National University of Singapore
name: National Medical Research Council (NMRC), Singapore
First posted: 2023-10-30
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Delirium
timeFrame: 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:
measure: Length of Stay
timeFrame: 3-months post-CABG (+/- 1 month)
measure: Duration of Delirium
timeFrame: 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)
measure: Sleep Quality
timeFrame: 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)
measure: Functional Status
timeFrame: Day 5 of post-CABG (+/- 1 day)
measure: Physical Status
timeFrame: Day 5 of post-CABG (+/- 1 day), 3 months post-CABG (+/- 1 month)
measure: Cognitive status
timeFrame: 2 weeks prior to operation (Baseline measurement, +/- 2 weeks), Day 5 of post-CABG (+/- 1 day), 3 months post-CABG (+/- 1 month)
measure: Psychological State
timeFrame: 2 weeks prior to operation (Baseline measurement, +/- 2 weeks), Day 5 of post-CABG (+/-1 day), 3 months post-CABG (+/- 1 month)
measure: Cognitive status
timeFrame: 3-months post-CABG (+/- 1 month)
Other outcomes:
measure: Richmond Agitation Sedation Scale (RASS)
timeFrame: 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)
measure: European System for Cardiac Operative Risk Evaluation (EuroSCORE) 2
timeFrame: 3-months post-CABG (+/- 1 month)
measure: Charlson Comobility Index (CCI)
timeFrame: 3-months post-CABG (+/- 1 month)
measure: Clinical Frailty Index (CFI)
timeFrame: 3-months post-CABG (+/- 1 month)
measure: ICU Mobility Score
timeFrame: Day 1 of post-CABG, Day 3 of post-CABG, Day 4 of post-CABG (+/- 1 day, or until day of ICU discharge)
measure: Pain Score
timeFrame: 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)
measure: Time on Mechanical Ventilation and Ventilator Free Days
timeFrame: 3-months post-CABG (+/- 1 month)
measure: 30-day readmission and mortality
timeFrame: 3-months post-CABG (+/- 1 month)
measure: Short Form (36) Health Survey (SF-36)
timeFrame: 2 weeks prior to operation (Baseline measurement, +/- 2 weeks), 3-months post-CABG (+/- 1 month)
Locations:
Study officials:
affiliation: National University Hospital, Singapore
name: Su Ren Wong
role: PRINCIPAL_INVESTIGATOR
References: