Prediction and Prevention of Postoperative Mortality and Morbidity
Alzheimer Disease, Alzheimer Disease Related Dementias
About this trial
This is an interventional prevention trial for Alzheimer Disease
Eligibility Criteria
Part I Inclusion Criteria: 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 PHQ-9 score ≥ 5 Anticipated length of stay > 3 days Informed consent English speaking patients All races and ethnicities Diverse background (education, area deprivation index) Part II Inclusion Criteria: Patients undergoing high-risk cardiac and vascular surgery, such as intraoperative bypass for cardiac surgeries and carotid endarterectomy/ aortic aneurysm vascular surgeries. History of fully resolved stroke and TIA without any residual weakness Significant carotid artery stenosis (defined as >70% unilateral or bilateral stenosis) Moderate and high risk for mortality based on Society of Thoracic Surgery score (score >4) Enrolled in Part 1, "Randomized controlled clinical trial to assess the effectiveness of preoperative personalized prehabilitation as well as cognitive and behavioral interventions on reducing postoperative delirium (POD), postoperative cognitive dysfunction (POCD), dementia, 30-day major adverse cardiac and cerebrovascular events (MACCE) and mortality in high-risk surgical patients (≥65y)." Part I Exclusion Criteria: Children (<18 years) Patients unable to provide consent MoCA score <23 Persistent weakness from prior cerebrovascular accident Patients with severe preoperative medical diseases, blindness or significant visual impairment, unresolved motor weakness, or any other perioperative events or complications that would have a bearing on the patients' ability to perform study tasks, neuropsychological tests and proposed interventions Part II Exclusion Criteria: 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
Sites / Locations
- UPMC Presbyterian Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Experimental
Experimental
Group A/C (intervention)
Group B/C (SOC control)
Group A/D (intervention + SOC)
Group B/D (SOC + proactive bundle interventions)
Participants randomized to this intervention group will receive the following interventions: Personalized CPC Prehabilitation Cognitive Training Meditation Daily Exercise Enhanced Social Support Additionally, they will undergo standard of care routine intraoperative SSEP and EEG monitoring during the scheduled surgery.
Participants randomized to the control group will receive standard of care pre-operative treatment, which may or may not include a visit to the CPC. Participants will receive standard of care routine intraoperative SSEP and EEG monitoring during the scheduled surgery.
Participants randomized to this intervention group will receive the following interventions for study Part I: Personalized CPC Prehabilitation Cognitive Training Meditation Daily Exercise Enhanced Social Support If eligible to continue to Study Part 2, participants who received the Part I intervention will receive standard of care monitoring that includes: Routine intraoperative SSEP and EEG monitoring.
Participants randomized to the control group in study Part I will receive standard of care pre-operative treatment, which may or may not include a visit to the CPC. If eligible to continue to Study Part 2, participants who received standard of care pre-operatively, will receive Proactive Bundle Interventions during surgery that includes: Participants randomized to the proactive bundled intervention group (Group D) will receive a routine intraoperative SSEP and EEG monitoring as well as optimization of intraoperative physiology by maintaining normal blood pressure, oxygen levels, opioid sparing analgesia, avoiding deep anesthesia and benzodiazepines.