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

NCT06721819 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 2024-P-000520
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 3

Brief Summary

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 developing confusion, hallucinations, or delirium after surgery? How can I best prepare before surgery to improve my long-term health and avoid disability? Are there exercises I can participate in that improve my sleep, pain, and mood after surgery? Intellectual pursuits, physical activity, and social interactions support cognitive reserve, while poor health, poor sleep hygiene, poor nutrition, and mental health disease can diminish reserve. Various interventions with different intensities and timing to augment cognitive reserve have been associated with positive outcomes on neuropsychological testing. Adaptive video gaming for as little as 10 hours leads to the maintenance of independence in activities of daily living and sustained improvements in speed of processing, attention, and working memory in older people. Likely through the increased cognitive reserve, perioperative brain exercise aims to protect against morbid cognitive recovery after surgery. Sleep is vital for memory and cognitive function. Poor sleep traits in older adults that are potentially modifiable, including short/long duration, daytime napping, and associated sleepiness, led to an almost 2-fold increase in delirium risk. Patients will complete an evidence-based course on healthy sleep habits and will complete guided exercises designed to restructure behaviors and thinking. They are encouraged to follow a set of recommendations to improve their sleep (e.g., optimal sleep duration, advice for habits such as daytime napping, maintaining a regular sleep schedule, avoiding caffeine, regular daylight exposure, dimming lights or electronics and relaxation and thought exercises for optimal sleep); many of these sleep behaviors have been strongly linked to increased risk for cognitive decline. Investigators propose that sleep optimization before AND after (an established best practice sleep bundle) surgical insult will contribute to cognitive reserve leading to decreased delirium risk and key patient-centered outcomes (postoperative sleep, pain, cognition, mood, and survival). Inadequate pain relief and opioids are both risk factors for delirium. Surgery on the chest is a significant pain source. Approximately 30-75% of patients suffer from moderate to severe pain in the postoperative period. Almost half of the patients have severe pain at rest, and three-quarters have severe pain during coughing and movement. Pain and inflammation are closely biochemically linked. Sleep, brain exercise, and adequate pain control with opioid-sparing can be additive or synergistic interventions to prevent delirium following heart surgery. Investigators propose three specific aims by conducting a 1:1 randomized controlled trial in 406 heart surgery patients 60 or older undergoing heart surgery. They will be administered perioperative sleep optimization, brain exercise training, and intravenous acetaminophen over 48 hours. A trained expert will administer the sleep and cognitive exercise protocols at least two weeks before surgery. This expert will handhold the patients for two weeks until the surgery. Thus, the gains made before surgery with better sleep quality and improved brain reserve will be sustained with postoperative pain control to lower the ongoing inflammation. Through this trial, investigators will evaluate if the SCOPE bundle can reduce 1) in-hospital delirium, 2) long-term (one, six, and twelve months) cognitive, physical, and self-care function, and 3) barriers to implementation of this bundle. Currently, no options are routinely available to patients to optimize their sleep and cognition before cardiac surgery. The proposed research is significant because it will be the first to test the bundled behavioral intervention approach (sleep optimization, brain exercise) before surgery with extended, scheduled pain management with non-opioids following surgery. The SCOPE trial will yield relevant and immediately actionable data to improve care for over 900,000 adults in the U.S. each year.

Conditions

Delirium, Postoperative; Delirium in Old Age

Keywords

Delirium; PostOperative; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Delirium Incidence

  Positive CAM (Confusion Assessment Method) evaluation. : The Confusion Assessment Method (CAM) is a standardized evidence-based tool that enables non-psychiatrically trained clinicians to identify and recognize delirium quickly and accurately in both clinical and research settings. The CAM includes four features found to have the greatest ability to distinguish delirium from other types of cognitive impairment. Each feature is scored as present or absent. Delirium is considered present based on the CAM diagnostic algorithm: presence of (acute onset or fluctuating course -AND- inattention) -AND EITHER- (disorganized thinking or altered level of consciousness)

  Seven days following cardiac surgery or until discharge of patient from the hospital. This can be anywhere from 3-7 days post operatively

Secondary Outcomes (2)

• Severity of Delirium

  Seven days following cardiac surgery or until discharge of patient from the hospital. This can be anywhere from 3-7 days post operatively

• Duration of Delirium

  Seven days following cardiac surgery or until discharge of patient from the hospital. This can be anywhere from 3-7 days post operatively

Other Outcomes (9)

• Incidence of delirium in patients with active alcohol and drug abuse

  Seven days following cardiac surgery or until discharge of patient from the hospital. This can be anywhere from 3-7 days post operatively

• Incidence of delirium in patients with preoperative neurocognitive impairment, Parkinson's and Alzheimer's disease Incidence of delirium in patients with preoperative neurocognitive impairment, Parkinson's and Alzheimer's disease

  Seven days following cardiac surgery or until discharge of patient from the hospital. This can be anywhere from 3-7 days post operatively

• Intraoperative hypotension

  Seven days following cardiac surgery or until discharge of patient from the hospital. This can be anywhere from 3-7 days post operatively

Study Arms (2)

Sleep Hygiene, brain games, and IV Acetaminophen bundle intervention

EXPERIMENTAL

Preoperative Intervention: Ten days of following a sleep hygiene protocol and 10 hours minimum of playing brain games. Cognitive Exercise: Patients will be given an iPad, which will be pre-installed with access to Lumosity, a cognitive exercise software application. Participants will be instructed to try and complete 1 hour of Lumosity exercise daily prior to surgery, with a pre-operative cognitive exercise goal of 10 hours. Sleep Hygiene: Preoperatively, investigators will deliver the digital CBT-I, (Cognitive Behavioral Therapy- Insomnia) over 10 days before surgery and in parallel to cognitive exercise. Postoperative Intervention: Eight doses of IV acetaminophen at 1000g each dose delivered every 6 hours for the first 48 hours within 1 hour of admission to CVICU. Acetaminophen administration in any form other than the study medication during this time will not be allowed.

Combination Product: Sleep Hygiene, Brain Game, and IV Acetaminophen Intervention

ERAS Protocol with three doses IV Acetaminophen

ACTIVE COMPARATOR

No preoperative intervention and three doses of IV acetaminophen (as following ERAS protocol) at 1000mg per dose within 48 hours post operatively. Control patients will be on intravenous acetaminophen for the first 24 hours (three doses at 8 hourly intervals).

Drug: Control

Interventions

Control DRUG

Three doses of IV acetaminophen (as following ERAS protocol) at 1000mg per dose within 48 hours post operatively.

ERAS Protocol with three doses IV Acetaminophen

Sleep Hygiene, Brain Game, and IV Acetaminophen Intervention COMBINATION_PRODUCT

Preoperative Sleep Hygiene and Brain game followed by post operative IV acetaminophen administration

Also known as: CBT-I, Lumosity, IV-Acetaminophen

Sleep Hygiene, brain games, and IV Acetaminophen bundle intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned cardiac surgery \[CABG with or without valve, isolated valve surgery\] requiring median sternotomy and full CPB at least 10 days in the future.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Massachusetts General Hospital: collaborator
• Ohio State University: collaborator
• Columbia University: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114-2696, United States

RECRUITING

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Emergence Delirium; Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Balachundhar Subramaniam, MD/MPH

CONTACT

7814750572; bsubrama@bidmc.harvard.edu

Priyam Mathur, MS

CONTACT

3176035545; pmathur@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anaesthesia

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 6, 2024
• Study Start: June 6, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): March 31, 2030
• Last Updated: April 15, 2026

Record last verified: 2026-03

Locations

US (3)