Actively Recruiting
The SCOPE Trial: Sleep, Cognition, and Pain Bundle vs. ERAS-cardiac for Postoperative Delirium
Led by Beth Israel Deaconess Medical Center · Updated on 2026-04-15
406
Participants Needed
3
Research Sites
39 weeks
Total Duration
On this page
Sponsors
B
Beth Israel Deaconess Medical Center
Lead Sponsor
M
Massachusetts General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the impact of a combined approach called the SCOPE bundle, which includes sleep optimization, cognitive exercises before surgery, and extended pain relief using intravenous acetaminophen, on reducing delirium and improving recovery after heart surgery in people aged 60 and older. This trial aims to fill important gaps by testing a patient and care-provider-focused intervention to potentially lower confusion, cognitive decline, and other complications after cardiac surgery. The study compares this bundle to the standard enhanced recovery after surgery (ERAS) protocols currently used. Participants will be randomly assigned to either the SCOPE bundle group or the control group receiving standard care. Those in the SCOPE group will complete a two-week preoperative program involving guided sleep hygiene sessions and at least 10 hours of brain training games using a tablet. After surgery, they will receive eight doses of intravenous acetaminophen over 48 hours for pain management. The control group will receive standard ERAS care with three doses of intravenous acetaminophen over 24 hours and no preoperative interventions. Throughout the study, researchers will monitor participants for delirium during the first seven days after surgery or until discharge. Follow-up assessments will take place at one, six, and twelve months to measure cognitive function, physical abilities, pain, mood, sleep quality, and survival. Participants will complete questionnaires, use wearable devices to track sleep, and report pain and mood. The study will also explore challenges in implementing this combined approach. Overall, the trial lasts from pre-surgery through one year post-surgery to evaluate the intervention's effects comprehensively.
CONDITIONS
Brief Title
The SCOPE Trial: Sleep, Cognition, and Pain Bundle vs. ERAS-cardiac for Postoperative Delirium
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Planned cardiac surgery (coronary artery bypass grafting with or without valve, or isolated valve surgery) requiring median sternotomy and full cardiopulmonary bypass at least 10 days in the future
- 60 years of age or older
- Willingness to use a provided tablet and wearable devices
- Commitment to spend at least 1 hour per day before surgery completing interventions if assigned to the experimental group
You will not qualify if you...
- Pre-operative left ventricular ejection fraction less than 30%
- Emergent cardiac procedures
- Isolated aortic surgery
- Liver dysfunction with ALT or AST more than 4 times the upper limit of normal
- Known hypersensitivity to study drugs
- Active alcohol abuse or history of withdrawal or delirium tremens in the past year
- Delirium at baseline
- Inability to speak or understand English
- Physician refusal
- Chronic opioid use with tolerance (30 mg morphine equivalent or more for over one month in past year)
- Significant visual impairment
- Prisoner status
- Severe obstructive sleep apnea in the past year (Apnea-Hypopnea Index over 30 or Epworth Sleepiness Scale of 18 or more)
- Co-enrollment in non-approved interventional trials
- Severe cognitive impairment (MOCA score less than 10) or use of medications for cognitive decline
- Recent treatment for insomnia with cognitive behavioral therapy within last 6 months
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 10 days
Participants assigned to the intervention group complete a sleep hygiene program and cognitive exercises using a tablet for about 10 days before surgery to optimize sleep and cognitive function. Control participants receive sleep hygiene education only.
Multiple sessions over 10 days (in-person and remote)
Duration - Up to 48 hours post-surgery
Participants undergo cardiac surgery followed by postoperative care including IV acetaminophen administration. Intervention group receives eight doses over 48 hours; control group receives three doses over 24 hours as per standard ERAS protocol.
Continuous inpatient care with medication administration
Duration - Up to 12 months
Participants are monitored for delirium and other outcomes such as pain, mood, functional recovery, cognition, and sleep quality for up to 12 months after surgery.
Scheduled follow-up visits at 1, 6, and 12 months post-surgery
Trial Site Locations
Total: 3 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114-2696
Actively Recruiting
2
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
3
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
B
Balachundhar Subramaniam, MD/MPH
P
Priyam Mathur, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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