Sleep, Cognition, and Pain Bundle versus ERAS‑cardiac to Prevent Delirium After Heart Surgery
The SCOPE Trial: Sleep, Cognition, and Pain Bundle vs. ERAS-cardiac for Postoperative Delirium
This trial will try a package of sleep improvement, pre-surgery brain exercises on a tablet, and 48 hours of IV acetaminophen alongside standard ERAS care to see if it lowers delirium in people 60 and older having planned heart surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 406 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 3 sites (Boston, Massachusetts and 2 other locations) |
| Trial ID | NCT06721819 on ClinicalTrials.gov |
What this trial studies
The SCOPE trial compares a multicomponent intervention—pre- and post-operative sleep optimization, preoperative cognitive exercises delivered via provided tablets and wearables, and 48 hours of IV acetaminophen for opioid-sparing pain control—added to standard ERAS‑cardiac versus ERAS protocols alone. Eligible participants are adults aged 60 or older scheduled for planned median sternotomy cardiac surgery (CABG with or without valve, or isolated valve surgery) with cardiopulmonary bypass, recruited at major academic centers. The study tracks postoperative delirium incidence and duration as primary outcomes and follows secondary outcomes including cognitive and physical function, sleep quality, pain, mood, and survival. Participants randomized to the intervention are asked to use the provided devices and commit about one hour per day before surgery to the cognitive and behavioral components.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults aged 60 or older with planned CABG or valve surgery via median sternotomy with cardiopulmonary bypass at least 10 days away who can use a provided tablet and wearable and commit roughly one hour per day preoperatively.
Not a fit: Patients less likely to benefit include those with preoperative delirium, LVEF under 30%, emergent or isolated aortic surgery, significant liver dysfunction, recent alcohol abuse, known hypersensitivity to study drugs, or inability to use the tablet or understand English.
Why it matters
Potential benefit: If successful, the bundle could reduce how often and how long patients experience postoperative delirium and improve recovery, cognition, sleep, pain control, and mood after heart surgery.
How similar studies have performed: Individual elements like sleep hygiene, cognitive prehabilitation, and multimodal opioid-sparing analgesia have shown benefit in other settings, but the combined SCOPE bundle specifically for preventing delirium after cardiac surgery is novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Willingness to use a provided tablet and wearable devices and commit at least 1 hour amount of time per day before surgery to complete interventions (psCBT/cognitive activity/exercise) if randomized to experimental group. Exclusion Criteria: * Pre-operative left ventricular ejection fraction (LVEF) \< than 30% Emergent procedures Isolated aortic surgery Liver dysfunction (ALT or AST \> 4 times the upper limit of local normal; all patients will have a baseline liver function test information or history and exam suggestive of jaundice or both) Known hypersensitivity to the study drugs Active (in the past year) history of alcohol abuse (≥ 5 drinks/day for men or ≥ 4 drinks/day for women) Any history of alcohol withdrawal or delirium tremens Delirium at baseline English language Limitations Physician refusal Chronic opioid use for chronic pain conditions with tolerance (total dose of an opioid at or more than 30 mg morphine equivalent for more than one month within the past year) Significant visual impairment Prisoner Severe OSA in the past year (AHI is greater than 30 (more than 30 episodes per hour)) or ESS of 18 or more Co-enrollment with non-approved interventional trial Severe cognitive impairment (MOCA \< 10) or medications for cognitive decline Recent treatment for insomnia with CBT-I within the last 6 months
Where this trial is running
Boston, Massachusetts and 2 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
- The Ohio State University — Columbus, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Balachundhar Subramaniam, MD/MPH
- Email: bsubrama@bidmc.harvard.edu
- Phone: 7814750572
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.