Delirium, Postoperative
Conditions
Keywords
Delirium, Coronary Artery Bypass Grafting, Occupational Therapy, Intensive Care Units, Randomized Controlled Trial
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) 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.
Interventions
OTHERDREAMS-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.
Sponsors
National University Hospital, Singapore
National University of Singapore
National Medical Research Council (NMRC), Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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); (+/- 1 day for last measurement) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | 3-months post-CABG (+/- 1 month) | Length of stay in ICU and hospital in days |
| Duration of 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) | Duration of delirium in subgroup of participants who develop delirium |
| Sleep Quality | 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) | 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 |
| Functional Status | Day 5 of post-CABG (+/- 1 day) | 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. |
| Physical Status | Day 5 of post-CABG (+/- 1 day), 3 months post-CABG (+/- 1 month) | Physical status measured using Functional Independence Measure (FIM). The score ranges from 0 - 126, with higher scores indicating better physical status. |
| Cognitive status | 2 weeks prior to operation (Baseline measurement, +/- 2 weeks), Day 5 of post-CABG (+/- 1 day), 3 months post-CABG (+/- 1 month) | Cognitive status measurement using Montreal Cognitive Assessment (MoCA). The score ranges from 0 - 30, with higher scores indicating better cognitive status. |
| Psychological State | 2 weeks prior to operation (Baseline measurement, +/- 2 weeks), Day 5 of post-CABG (+/-1 day), 3 months post-CABG (+/- 1 month) | Psychological state measured using the Hospital Anxiety and Depression Scale (HADS). The score ranges from 0 - 21, with higher scores indicating worse psychological state. |
Countries
Singapore
Contacts
CONTACTMegan HL Tan
CONTACTMichell KS Low
PRINCIPAL_INVESTIGATORSu Ren Wong
National University Hospital, Singapore
Outcome results
None listed