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

Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · Dec 3, 2024

Keywords

ClinConnect Summary

The SCOPE Trial is a research study designed to help prevent confusion and agitation, known as delirium, in older patients after heart surgery. It focuses on improving sleep, mental exercises, and pain management to enhance recovery. Participants aged 60 and older who are scheduled for heart surgery may be eligible. They will take part in activities that promote better sleep habits and cognitive exercises for at least two weeks before their surgery. After surgery, they will receive pain relief through a safe medication for 48 hours to reduce discomfort and inflammation.

If you join this study, you can expect to learn helpful techniques for improving your sleep and mental sharpness, which can lead to better outcomes after surgery. The SCOPE Trial is significant because it is one of the first to combine these approaches before and after surgery, aiming to improve health and quality of life for many older adults undergoing heart procedures. If you meet the criteria, including having a planned heart surgery and being able to engage in the study activities, this could be a valuable opportunity to enhance your recovery experience.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Planned cardiac surgery \[CABG with or without valve, isolated valve surgery\] requiring median sternotomy and full CPB at least two weeks 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