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 Health System (NUHS)

Status: Not yet enrolling

Conditions: Delirium, Postoperative

Treatments: Other: DREAMS-OT

Study type: Interventional

Funder types: Other

Identifiers

NCT06107517

2022/00936

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 21 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

DREAMS-OT Arm (Intervention Group)

Experimental group

Description:

Patients will receive an early and intensive occupational therapy protocol starting within the first 15 hours after extubation.

Treatment:

Other: DREAMS-OT

Standard Care Arm (Control Group)

No Intervention group

Description:

Standard care OT as per current ICU setting