Prediction and Prevention of Postoperative Mortality and Morbidity

Conditions

• Dementia
• Major Adverse Cardiac and Cerebrovascular Events
• Perioperative Complications
• Postoperative Cognitive Decline
• Postoperative Delirium (POD)
• Postoperative Neurocognitive Disorder

Eligibility Criteria

Sex

ALL

Age

65 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Personalized CPC Prehabilitation — OTHER
  Patients referred for elective surgery will be scheduled for a preoperative evaluation (3 to 6 weeks prior to surgery) and will receive standardized and personalized assessment and prehabilitation according to UPMC disease specific algorithms
• Cognitive Training — BEHAVIORAL
  Participants will be provided with access to the Lumosity (Lumos Labs) software for installation on a home device. They will be trained to navigate the touchscreen tablet and guided through an introductory series of brain exercise games focused on 5 main categories: memory, speed, attention, flexibility, and problem-solving. Patients will be asked to complete a cognitive exercise dosage of a minimum of 20 minutes a day for ≥5 days prior to their date of surgery. Research coordinators and volunteers from UPMC's Hospital Elder Life Program (HELP) will reach out to participants daily for a quick social check-in and to remind them to perform their training. Compliance data will be retrieved from the Lumosity app.
• Meditation — BEHAVIORAL
  A single guided meditation session with instructions will be provided using a smart device. The meditation session will last for at least 10 minutes daily starting at least 1-week prior to surgery. If the subject does not own a smart device, one will be provided or meditation will be completed in-person or over the phone.
• Daily Exercise — BEHAVIORAL
  Participants in the intervention group will meet with an occupational or physical therapist approximately 1-6 weeks before surgery who will discuss the potential benefits of exercise and give directions for an easy strength training exercise. Participants will then be provided with a video link for a guided exercise and encouraged to walk or perform a seated strength exercise for ≥ 5 minutes each day for at least 1 week before surgery and after surgery. Patient reported frequency, fitness app compliance and exercise duration with REDCap email or mobile link or over telephone will be collected before and after surgery. Patients will be cleared by an occupational or physical therapist to perform the upper-extremity exercises and will confirm the exercises are not contraindicated after surgery. An occupational or physical therapist will see subject again post-surgery to mitigate risk of injury.
• Enhanced Social Support — BEHAVIORAL
  Research coordinators and volunteers from the Hospital Elder Life Program (HELP) will contact participants prior to surgery to discuss concerns, provide regular social support, and remind participants to complete assigned cognitive exercises. The role of family members and caregivers in supporting the participant will also be discussed, and their involvement will be encouraged when appropriate. Participants in the CPC preoperative intervention group may receive preoperative interventions to address depressive symptoms as part of CPC-guided prehabilitation, when clinically indicated.
• Proactive Bundle Interventions — OTHER
  Participants randomized to the proactive bundled intervention group (Group D) will receive routine intraoperative SSEP and EEG monitoring and proactive optimization of intraoperative physiology, including maintaining mean arterial pressure ≥65 mmHg, adequate oxygenation, opioid sparing analgesia, and avoidance of deep anesthesia and benzodiazepines. If persistent focal changes in SSEP and EEG (i.e., changes in one hemisphere) occur, reactive measures will be implemented to increase cerebral perfusion, including ensuring hematocrit \>30, maintaining anesthetic BIS \>50-60, and initiating stroke management and thrombectomy if clinically indicated
• Pre-operative Standard of Care — PROCEDURE
  Participants will receive routine preoperative clinical care per institutional standard practice.
• Intra-operative Standard of Care — PROCEDURE
  This includes routine intraoperative SSEP and EEG monitoring. Physician oversight and interpretation of real-time neuromonitoring data will be performed using a combined on-site and remote model at UPMC. In the event that changes in EEG or SSEP are considered significant by the oversight neurophysiologists, the surgical team will be immediately informed so that immediate appropriate action can be taken to reverse the change.

Study Details

This study will contribute to creating a prospective and automated preoperative risk assessment algorithm for predicting 30-day mortality, major adverse cardiac and cerebrovascular events (MACCE), and postoperative neurocognitive outcomes following elective cardiac and vascular surgery in older adults. It will evaluate associations between perioperative factors and longer-term neurocognitive outcomes, including postoperative neurocognitive disorder and dementia. In addition, this study will assess scalable, multimodal preoperative and intraoperative interventions to improve perioperative outcomes. This study will explore two main hypotheses: 1. Preoperative personalized prehabilitation with proactive cognitive and behavioral interventions will improve postoperative cognitive outcomes, morbidity, and mortality in high-risk elderly surgical patients. 2. Proactive bundled intraoperative interventions are superior to reactive standard of care in reducing postoperative cognitive outcomes, MACCE, and mortality. Expected Outcome: Improved EHR algorithm will have higher predictive accuracy for MACCE and mortality while predicting postoperative cognitive outcomes.

Key Dates

Start date

Jun 30, 2026

Status verified

Jun 2026

Primary completion

May 31, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

1,200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: CPC Preoperative Intervention (Aim 1)
  Participants referred to the Center for Perioperative Care (CPC) by their surgical team will receive preoperative prehabilitation and proactive cognitive and behavioral interventions prior to surgery. Assignment to this group is not randomized and reflects real world clinical practice. Participants will receive standard intraoperative monitoring during surgery.
• Active Comparator: Preoperative Standard of Care (Aim 1)
  Participants who do not receive CPC referral will receive standard preoperative care prior to surgery. Assignment to this group is not randomized. Participants will receive standard intraoperative monitoring during surgery.
• Experimental: Proactive Bundled Intraoperative Interventions (Aim 2)
  Participants in Aim 2 are drawn from Aim 1 participants who meet IONM eligibility. Participants requiring intraoperative neurophysiological monitoring will be randomized on the day of surgery to receive proactive bundled intraoperative interventions in addition to standard intraoperative monitoring.
• Active Comparator: Reactive Intraoperative Standard of Care (Aim 2)
  Participants in Aim 2 are drawn from Aim 1 participants who meet IONM eligibility. Participants requiring intraoperative neurophysiological monitoring will be randomized on the day of surgery to receive reactive standard of care intraoperative management with routine SSEP and EEG monitoring.

Primary Outcome Measure

Postoperative Delirium (POD) [ Time Frame: At baseline screening, then up to 30 days post-operatively ]

Central Contacts

• Alisha Maslanka, BS, CCRC
  4128646779
  [email protected]
• Dayana Alsamsam, BSPS, MSc
  412-623-4147
  [email protected]

Locations (5)

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