1003 The SCOPE Trial: Sleep, Cognition, and Pain Bundle vs. ERAS-Cardiac [Enhanced Recovery After Cardiac Surgery] for Postoperative Delirium (POD)

Abstract Introduction Sleep disruption is prevalent among older cardiac surgery patients and has been linked to postoperative delirium (POD) in up to a third of patients. POD is characterized by acute confusion and fluctuating attention, associated with long-term cognitive decline, dementia, prolonged hospitalization and even mortality. Despite this, perioperative interventions targeting sleep remain limited. The Sleep, Cognition, and Pain (SCOPE) bundle aims to reduce POD incidence compared to standard care of Enhanced Recovery After Surgery (ERAS)-cardiac. Methods This is a PCORI-funded randomized controlled trial at four sites (BIDMC, MGH, Columbia and OSU) targeting older patients (≥60 years) undergoing cardiac surgery. Beginning June 2025, 406 will be enrolled over 3 years. Participants are randomized to: 1) Intervention group: sleep optimization and cognitive training starting two weeks prior to surgery, plus eight doses of IV acetaminophen over 48 hours, or 2) Control group: Standard ERAS protocol with three doses over 24 hours. All participants will complete a daily sleep diary and wear an actigraphy before and after surgery. Primary outcome is POD incidence via Confusion Assessment method (CAM) within 7 days of surgery. Secondary outcomes include POD severity and duration, and cognition, functional, sleep, pain, and psychological outcomes up to 1 year after cardiac surgery. Results We will describe recruitment efforts, focus group findings and patient reception to sleep-related interventions thus far. We anticipate that the SCOPE bundle will reducePOD incidence and severity as well as improve recovery compared with standard ERAS care. Challenges are expected in recruitment and retention due to preoperative requirements and the high likelihood of postoperative complications that may affect adherence. Conclusion If effective, the SCOPE bundle will provide the first evidence-based, multimodal intervention to prevent POD in older cardiac surgery patients by optimizing sleep, cognition, and pain, while improving recovery and patient-centered outcomes. Support (if any) This work is supported by the Patient-Centered Outcomes Research Institute (PCORI).