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

RecruitingPhase 3Ages 60 Years - anyAllBeth Israel Deaconess Medical Center
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In plain words

What the trial is, and whether it could suit you

Sleep disturbances, cognitive reserve, and continuing pain and inflammation are other risk factors contributing to delirium (confusion and agitation) and neurocognitive decline (in the long term) following heart surgery. Investigators aim to test a bundle of sleep optimization, cognitive exercise before surgery, and extended pain relief for 48 hours with intravenous acetaminophen combined with enhanced recovery after surgery protocols (SCOPE bundle). SCOPE will fill significant gaps in evidence by testing the value of a patient and care-provider-focused intervention that can potentially minimize POD and improve outcomes (cognitive \& physical function, sleep quality, pain, depression or anxiety, and survival) important to patients and families. The SCOPE trial will address many heart surgery outcome-related questions commonly asked by patients: What can I do to reduce my chances of dev

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 (โ‰ฅ 5 drinks/day for men or โ‰ฅ 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
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What it tests

  • Sleep Hygiene, Brain Game, and IV Acetaminophen Intervention
  • Control
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Where

3 sites
Massachusetts General Hospital
Boston, United States
Columbia University Irving Medical Center
New York, United States
The Ohio State University
Columbus, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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