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Study on Preventing Postoperative Complications in Older Adults

This study is looking at ways to predict and prevent health problems after surgery in older adults (65 and older) who are at higher risk for complications like death, heart/brain events (Major Adverse Cardiac and Cerebrovascular Events, or MACCE), and memory issues (Postoperative Delirium and Postoperative Neurocognitive Disorder). It tests a program called Personalized CPC Prehabilitation, which includes cognitive training (using Lumosity), meditation, daily exercise, and enhanced social support. The goal is to see if these interventions can reduce these complications. The study is currently unclear on its recruitment status, but plans to enroll 1200 participants. Success will be measured by how well these interventions reduce postoperative delirium within 30 days after surgery.

Study design
This is a pragmatic, non-randomized study comparing personalized prehabilitation with standard care in 1000 high-risk surgical patients aged 65 and older. Participants will be identified using an EHR-based risk prediction algorithm.
What's involved
Participants will have a preoperative evaluation 3-6 weeks before surgery. They will engage in cognitive training, meditation, and daily exercise, and receive social support, starting at least 1 week before surgery. Cognitive assessments will be done at baseline, discharge, and at 1, 3, 6, and 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for cognitive outcomes at discharge, and at 1, 3, 6, and 12 months after surgery.

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NCT06042413

Prediction and Prevention of Postoperative Mortality and Morbidity

Not Yet Recruiting
NAAges 65+InterventionalPrevention
University of Pittsburgh
~1,200 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:Personalized CPC PrehabilitationCognitive TrainingMeditationDaily ExerciseEnhanced Social SupportProactive Bundle Interventions

At a glance

Recruiting sites
0 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Postoperative Delirium (POD)
Measured over At baseline screening, then up to 30 days post-operatively

Conditions

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

Explore related trials

DementiaMajor Adverse Cardiac and Cerebrovascular EventsPerioperative complicationPostoperative cognitive dysfunctionPostoperative deliriumPostoperative Neurocognitive Disorder

Where it's being run

5 sites across 1 states
Pennsylvania5

Study leadership

  • Senthilkumar Sadhasivam, MD, MPH, MBA · PRINCIPAL_INVESTIGATOR · University of Pittsburgh
  • Amy Monroe, MPH, MBA · STUDY_DIRECTOR · University of Pittsburgh

Who to contact

Alisha Maslanka, BS, CCRC
[email protected]
4128646779
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

65 years of age and older
Identified as higher risk (≥2.5%) for 30-day mortality and MACCE based on the UPMC's Perioperative Model (EHR risk prediction algorithm)
Scheduled for major cardiac surgeries including coronary artery bypass and valvular repair and/or vascular surgeries including carotid endarterectomy, aortic aneurysm repair, and major vascular surgeries
RAI score ≥ 30
Informed consent
English speaking patients
Enrolled in Aim 1 / Part I Preoperative Intervention Trial
Scheduled for high-risk, cardiac or vascular surgery requiring intraoperative neurophysiological monitoring (IONM)
Moderate and high risk for mortality based on Society of Thoracic Surgery score (score \>4)

Exclusion

Children (\<18 years)
Patients unable to provide consent
Participants undergoing same day procedures or operations (discharged same day)
Patients with severe preoperative medical diseases such as blindness or significant visual impairment, unresolved motor weakness, or any other perioperative events or complications that would have a bearing on the patient's ability to perform study tasks, neuropsychological tests, and proposed interventions
Pregnant women
Patients do not provide consent.
Patients are unable to participate in cognitive and other behavioral assessment due to physical limitations
Patients refuse any blood transfusions during surgery

What this trial measures

  • Postoperative Delirium (POD)At baseline screening, then up to 30 days post-operatively

    Postoperative delirium will be assessed using the Confusion Assessment Method (CAM). Participants will be classified as having delirium or not having delirium based on standard CAM criteria. A positive CAM indicates the presence of delirium.