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The SCOPE Trial: Preventing Delirium After Heart Surgery

This study is looking at ways to prevent delirium (confusion and agitation) after heart surgery. Researchers are testing a combination of interventions called the SCOPE bundle. This bundle includes sleep hygiene (good sleep habits) and brain games before surgery, followed by intravenous (IV) acetaminophen (a pain reliever) after surgery. This is compared to the standard approach of giving three doses of IV acetaminophen after surgery, as part of enhanced recovery after surgery (ERAS) protocols. You may be able to join if you are 60 years or older, planning to have certain heart surgeries, and are willing to use a tablet and wearable devices for at least an hour a day before surgery. The main goal is to see if the SCOPE bundle reduces the number of people who experience delirium within seven days of surgery or before leaving the hospital. The study plans to enroll 406 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 406 participants.
What's involved
If you join, you would need to commit at least 1 hour per day before surgery to complete interventions using a provided tablet and wearable devices.
Compensation
Not stated in the trial record.
Follow-up
Delirium incidence will be measured for up to seven days following cardiac surgery or until you are discharged from the hospital.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06721819

The SCOPE Trial: Sleep, Cognition, and Pain Bundle vs. ERAS-cardiac for Postoperative Delirium

Recruiting
PHASE3Ages 60+InterventionalPrevention
Beth Israel Deaconess Medical Center
~406 participants
Updated 2026-04-15 on ClinicalTrials.gov
What's tested:Sleep Hygiene, Brain Game, and IV Acetaminophen InterventionControl

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Delirium Incidence
Measured over Seven days following cardiac surgery or until discharge of patient from the hospital. This can be anywhere from 3-7 days post operatively

Conditions

Delirium, Postoperative
Delirium in Old Age

Explore related trials

Cardiac SurgeryDelirium

Where it's being run

3 sites across 3 states
Massachusetts1
New York1
Ohio1

Who to contact

Balachundhar Subramaniam, MD/MPH
[email protected]
7814750572
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Planned cardiac surgery \[CABG with or without valve, isolated valve surgery\] requiring median sternotomy and full CPB at least 10 days in the future.
60 years of age.

Exclusion

Pre-operative left ventricular ejection fraction (LVEF) \< than 30%

What this trial measures

  • Delirium IncidenceSeven days following cardiac surgery or until discharge of patient from the hospital. This can be anywhere from 3-7 days post operatively

    Positive CAM (Confusion Assessment Method) evaluation. : The Confusion Assessment Method (CAM) is a standardized evidence-based tool that enables non-psychiatrically trained clinicians to identify and recognize delirium quickly and accurately in both clinical and research settings. The CAM includes four features found to have the greatest ability to distinguish delirium from other types of cognitive impairment. Each feature is scored as present or absent. Delirium is considered present based on the CAM diagnostic algorithm: presence of (acute onset or fluctuating course -AND- inattention) -AND EITHER- (disorganized thinking or altered level of consciousness)