NCT Number: NCT06042413
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.
Trial opening soon.
Get Notified65 year and older
All sexes
Interventional
Not applicable
UPMC Mercy Hospital, Pittsburgh, Pennsylvania, United States
This study will cover the following two specific aims:
Aim 1. A pragmatic, non-randomized study to assess the effectiveness of preoperative personalized prehabilitation with proactive cognitive and behavioral interventions versus standard of care on reducing postoperative cognitive outcomes (including postoperative delirium within 30 days, postoperative cognitive decline, and dementia), MACCE, and mortality in high-risk surgical elderly patients (≥65 years). Our Electronic Health Record (EHR)-based automated machine-learning risk prediction algorithm for postoperative mortality and MACCE has been developed using >1.25 million surgical patients' data and implemented with superior performance to comparators. This EHR algorithm will identify approximately 1,000 patients at high risk for 30-day mortality and MACCE who proceed to surgery for Aim 1. Participants will receive either standard of care (n=500) or CPC-guided personalized preoperative prehabilitation with proactive cognitive or behavioral interventions (physical exercise, cognitive training, enhanced social support, and depression support) (n=500), based on real-world clinical referral practices rather than randomization. Cognitive assessments will be performed at baseline, discharge, and at 1, 3, 6, and 12 months.
Aim 2 Hypothesis: Proactive bundled intraoperative interventions are superior to standard intraoperative care in reducing postoperative cognitive outcomes, MACCE, and mortality.
Expected Outcome: The refined EHR-based risk prediction algorithm will demonstrate improved accuracy for predicting MACCE, mortality, and postoperative cognitive outcomes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Part I Inclusion Criteria:
Part II Inclusion Criteria:
Part I Exclusion Criteria:
Part II Exclusion Criteria:
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
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.
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.
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.
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.
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
Participants will receive routine preoperative clinical care per institutional standard practice.
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.
Time frame: 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.
Time frame: at pre-operative baseline screening, and then at post-operative months of 1, 3, 6, and 12.
Patient Health Questionnaire (PHQ-9) will be used to assess depression symptoms. Scores range from 0 to 27, with higher scores indicating more severe depression. Scoring is as follows: 1 to 4 minimal, 5 to 9 mild, 10 to 14 moderate, 15 to 19 moderately severe, and 20 to 27 severe depression.
Time frame: Post-operative months 6 and 12.
Dementia severity will be assessed using the Clinical Dementia Rating scale (CDR). Scores range from 0 (none) to 3 (severe).
Time frame: Post-operative months 1, 3, 6, and 12.
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30, with higher scores indicating better cognitive function. Postoperative cognitive decline will be defined as a decline in MoCA score compared with the preoperative baseline.
Time frame: Post-operative months 1 and 3.
Postoperative neurocognitive disorder will be assessed based on changes from preoperative baseline in standardized cognitive assessments, including the Montreal Cognitive Assessment (MoCA). Declines in cognitive performance relative to baseline will be used to identify postoperative neurocognitive disorder.
Time frame: Within 30 days post-surgery.
This outcome measures whether a participant experiences any major adverse cardiac or cerebrovascular event within 30 days after surgery. Events included in this composite outcome are death from any cause, myocardial infarction (heart attack), stroke, or cardiac arrest. Participants will be counted once if they experience one or more of these events during the 30 day postoperative period.
Time frame: During index hospitalization, up to 30 days post-operatively.
Incidence of postoperative acute kidney injury based on changes in serum creatinine during the index hospitalization, consistent with standard clinical criteria.
Time frame: Post-operative months 1, 3, 6, and 12.
Incidence of major adverse limb events including surgical or catheter-based revascularization or amputation. MALE includes any open surgical revascularization procedure (i.e., femoral endarterectomy, bypass surgery, thrombectomy or embolectomy, etc), catheter directed lysis to the lower extremities, and above ankle amputation.
Time frame: Within 30 days post-surgery.
Incidence of postoperative stroke confirmed by clinical diagnosis.
Contact information is provided by the study sponsor or research team.
Alisha Maslanka, BS, CCRC
CONTACT
Dayana Alsamsam, BSPS, MSc
CONTACT
University of Pittsburgh
Other
Real-world and Innovative Multimodal Prediction and Prevention of Postoperative Mortality and Multi-morbidities
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