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

Background and Significance: Cardiac surgery is performed on more than 900,000 adults in the U.S. each year, with significant cognitive consequences for individuals and society. Postoperative delirium (POD) is a common and costly complication after cardiac surgery. POD prevention is a priority for patients, families, and clinicians. Cognitive reserve is a significant contributor to POD risk. Despite many successes of Enhanced Recovery After Surgery (ERAS) initiatives to improve patient outcomes, incorporating cognitive-protective strategies into protocols remains limited by lack of evidence. The SCOPE Trial (Sleep, Cognition, and Pain bundle vs. ERAS-cardiac (enhanced recovery after cardiac surgery) for POD) will fill significant gaps in delirium prevention evidence by testing the value of a patient and care-provider-focused intervention that can potentially minimize POD. Study Aims: Investigators hypothesize that the intervention bundle (multicomponent combination of non-pharmacological (pre- and post-operative sleep optimization and cognitive exercise) and pharmacological (extended postoperative opiate-sparing pain control with intravenous (IV) acetaminophen for 48 hours) will decrease POD incidence and improve outcomes compared to standard ERAS protocols alone. Investigators hypothesize that the bundle increases 1) resistance to circadian disruption, 2) improved neuronal function, and 3) cognitive reserve. Investigators will determine differences in incidence, duration, and severity of POD (Specific Aim 1) and postoperative functional status, cognition, sleep, pain, and mood between study groups 1, 6, and 12 months following cardiac surgery (Specific Aim 2). Investigators will evaluate implementation barriers for our multicomponent SCOPE bundle and acceptability and feasibility (Specific Aim 3). Study Description: The SCOPE trial is a multicenter randomized, multi-component, superiority trial in older patients (at least 60 years) undergoing non-emergent coronary artery bypass grafting with or without valves or isolated valve surgery with 1:1 allocation using permuted block randomization of variable block sizes 2, 4, and 6 (406 patients equally divided at four tertiary care centers across the U.S (Beth Israel Deaconess Medical Center (n=106), Massachusetts General Hospital (n=100), Columbia University (n=100) and Ohio State University Medical Center (n=100). Patients with alcohol abuse, hypersensitivity to acetaminophen, and severely depressed left ventricular ejection fraction (<30%) will be excluded. Enrolled participants will receive either the SCOPE regimen at least 2 weeks before surgery and scheduled postoperative acetaminophen analgesia for the first 48 hours (plus ERAS)) or the standard-of-care ERAS regimen only.

Investigators will use a shorter form of our existing clinical CBT program for insomnia (4 hybrid sessions), delivered over two weeks before cardiac surgery to optimize sleep. Investigators will also check in with patients to establish sleep preferences during postoperative recovery, e.g., usual sleep schedule, noise reduction aids, temperature, light, and music preferences. Key components that can be effectively taught and implemented quickly based on our clinical experience include, stimulus control, relaxation techniques, sleep hygiene education, and cognitive restructuring to address sleep-related anxiety misconceptions and relaxation techniques. The Control group will be given a sleep hygiene education tip sheet only.

To optimize cognitive function, intervention patients will be asked to complete 10 hours of preoperative tablet-based brain exercise using gaming software focused on memory, speed, attention, flexibility, and problem-solving. This has been designed and integrated with the above sleep intervention to streamline patient experience and decrease burden and maximize retention. A prehabilitation specialist will deliver these interventions.

SCOPE-bundle patients will receive eight doses of IV acetaminophen over 48 hours (compared to standard pain management for ERAS includes three doses of IV acetaminophen over 24 hours).

The primary study outcome is POD incidence within seven days or until discharge following cardiac surgery, whichever occurs first, as determined by the Confusion Assessment Method (CAM) or CAM-ICU, supplemented with charted delirium. Secondary outcomes include POD duration (number of days), severity (CAM-Severity), length of postoperative stay (days), and mortality (30 days). Additional secondary outcomes assessed up to 12 months post-surgery include (pain (analgesia requirements, Verbal Rating Pain Scale), mood (Geriatric Depression Scale), functional recovery (Instrumental Activities of Daily Living and Medical Outcomes Study Short Form 12), and sleep quality (Pittsburgh Sleep Quality Index and objective metrics via sleep diary, and actigraphy). Secondary outcomes of determinants of bundle implementation, feasibility, and acceptability of implementation will be evaluated within the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework at the start and conclusion of the study