About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
DREAMS-OT
Other interventionPatients 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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).
Secondary outcomes
Length of Stay
Length of stay in ICU and hospital in days
Duration of Delirium
Duration of delirium in subgroup of participants who develop delirium
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
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.
Other outcomes
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.
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.
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.
Clinical Frailty Index (CFI)
Measure health status of participant before surgery. The score range from 0 - 9, with higher score indicating worse outcome.
Sponsors and contacts
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National University Hospital, Singapore
Lead sponsor
National University of Singapore
Collaborator
National Medical Research Council (NMRC), Singapore
Collaborator