Project 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. This study aims 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 postoperative delirium and improve outcomes (cognitive and 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 twofold 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. Researchers will investigate if 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 percent to 75 percent of patients experience moderate to severe pain in the postoperative period. Almost half of 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. 

This study will pursue 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, researchers will evaluate if the SCOPE bundle can:

  • Reduce in-hospital delirium 
  • Improve long-term (one, six and 12 months) cognitive, physical and self-care function 
  • Reduce barriers to implementation of this bundle 

Currently, no options are routinely available to patients to optimize their sleep and cognition before cardiac surgery. This 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 United States each year.

Project Information

Balachundhar Subramaniam, M.D., MPH
Lei Gao, MBBS
Beth Israel Deaconess Medical Center
$11,798,706 *

Key Dates

60 months *
November 2023
2023

*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.

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Last updated: January 24, 2024