About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Personalized CPC Prehabilitation
  • Cognitive Training
  • Meditation
  • Daily Exercise
  • Enhanced Social Support
  • Proactive Bundle Interventions
  • Pre-operative Standard of Care
  • Intra-operative Standard of Care

Treatment groups

1,200 Participants
are divided into 4 treatment groups

Locations

5
UPMC Mercy Hospital15219, PittsburghPennsylvania, United States
UPMC Montefiore Hospital15213, PittsburghPennsylvania, United States
UPMC Passavant Hospital15237, PittsburghPennsylvania, United States
UPMC Presbyterian Hospital15213, PittsburghPennsylvania, United States

Sponsors and collaborators

University of Pittsburgh

Lead sponsor