Delirium, PostoperativePhase 3SCOPENCT06721819
The SCOPE Trial: Sleep, Cognition, and Pain Bundle vs. ERAS-cardiac for Postoperative Delirium
A Phase 3 study testing Sleep Hygiene, Brain Game, and IV Acetaminophen Intervention in people with Delirium, Postoperative and Delirium in Old Age, run by Beth Israel Deaconess Medical Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Delirium, Postoperative, Delirium in Old Age
- What is being tested?
- Sleep Hygiene, Brain Game, and IV Acetaminophen Intervention
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Jun 2025to 31 Mar 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114-2696
Lei Gao, MD, LGAO@mgh.harvard.edu
Lei Gao, MD
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Michelle Humeidan, MD/PhD, michelle.humeidan@osumc.edu
Michelle Humeidan, MD/PhD
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Vivek Moitra, MD, vm2161@cumc.columbia.edu
Vivek Moitra, MD
About this study
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:
Read more
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.
Read the detailed description
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
- Conditions
- Delirium, Postoperative, Delirium in Old Age
- Being tested
- Sleep Hygiene, Brain Game, and IV Acetaminophen Intervention, Control
- Keywords
- Delirium, PostOperative, Cardiac Surgery
- Medical subject headings
- Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Hygiene, Brain Game, and IV Acetaminophen InterventionCombination product
Also called CBT-I, Lumosity, IV-Acetaminophen
Preoperative Sleep Hygiene and Brain game followed by post operative IV acetaminophen administration
ControlDrug
Three doses of IV acetaminophen (as following ERAS protocol) at 1000mg per dose within 48 hours post operatively.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
CAM- S (Confusion Assessment Method- Severity) score. A delirium severity rating scale based on the additive scoring of symptoms rated in the CAM long form (Confusion Assessment Method). The CAM-S is intended to be used in addition to the original CAM algorithm. The scale for CAM-S is from 0-19 with 0 being the least severe and 19 being the most severe.
Measured: 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
The total number of days patient is CAM (Confusion Assessment Method) positive following cardiac surgery
Measured: Seven days following cardiac surgery or until discharge of patient from the hospital. This can be anywhere from 3-7 days post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start6 Jun 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium, PostoperativeStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 406 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Balachundhar Subramaniam, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721819
- Sponsor's protocol ID
- 2024-P-000520
- Acronym
- SCOPE
- Status last verified
- Mar 2026
- First submitted
- 25 Nov 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SCOPE Trial: Sleep, Cognition, and Pain Bundle vs. ERAS-cardiac for Postoperative Delirium
- ClinicalTrials.gov ID
- NCT06721819
- Acronym / sponsor ID
- SCOPE / 2024-P-000520
- Conditions
- Delirium, Postoperative, Delirium in Old Age
- Keywords
- Delirium, PostOperative, Cardiac Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 406 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Ohio State University, Columbia University
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Hygiene, brain games, and IV Acetaminophen bundle intervention | Experimental | Combination Product: Sleep Hygiene, Brain Game, and IV Acetaminophen InterventionPreoperative 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. |
| ERAS Protocol with three doses IV Acetaminophen | Active comparator | Drug: ControlNo 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). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Planned cardiac surgery [CABG with or without valve, isolated valve surgery] requiring median sternotomy and full CPB at least 10 days in the future.
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Hygiene, Brain Game, and IV Acetaminophen InterventionAlso: CBT-I, Lumosity, IV-AcetaminophenPreoperative Sleep Hygiene and Brain game followed by post operative IV acetaminophen administration | Combination product | Sleep Hygiene, brain games, and IV Acetaminophen bundle intervention |
| ControlThree doses of IV acetaminophen (as following ERAS protocol) at 1000mg per dose within 48 hours post operatively. | Drug | ERAS Protocol with three doses IV Acetaminophen |
Primary outcome
Delirium Incidence
Time frame: Seven days following cardiac surgery or until discharge of patient from the hospital. This can be anywhere from 3-7 days post operatively
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)
2 secondary outcomes
Severity of Delirium
Time frame: 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
Time frame: Seven days following cardiac surgery or until discharge of patient from the hospital. This can be anywhere from 3-7 days post operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sleep Hygiene, Brain Game, and IV Acetaminophen Intervention in people with Delirium, Postoperative and Delirium in Old Age, run by Beth Israel Deaconess Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Balachundhar Subramaniam, MD/MPH (7814750572, bsubrama@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium Incidence (time frame: Seven days following cardiac surgery or until discharge of patient from the hospital. This can be anywhere from 3-7 days post operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.