xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06042413</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY22070046</org_study_id>
      <secondary_id>1R01AG081315</secondary_id>
      <nct_id>NCT06042413</nct_id>
    </id_info>
    <brief_title>Prediction and Prevention of Postoperative Mortality and Morbidity</brief_title>
    <official_title>Real-world and Innovative Multimodal Prediction and Prevention of Postoperative Mortality and Multi-morbidities</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Pittsburgh</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institutes of Health (NIH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Pittsburgh</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will contribute to creating a prospective and robust automated preoperative risk&#xD;
        assessment algorithm for 30-day mortality, major adverse cardiac and cerebrovascular events&#xD;
        (MACCE) and perioperative neurocognitive disorders (PND) outcomes following elective general,&#xD;
        orthopedic, cardiac, or vascular surgery. It will help to identify correlations between&#xD;
        perioperative factors and Alzheimer's Disease (AD) or AD-related dementias (ADRD). Lastly,&#xD;
        this study will create effective, validated multi-modal interventions to improve&#xD;
        perioperative health. This study will explore two main hypotheses: 1. Preoperative&#xD;
        prehabilitation and proactive cognitive/behavioral interventions will effectively improve&#xD;
        postoperative cognitive outcomes, morbidities, and mortality, and; 2. The proactive bundled&#xD;
        interventions are superior to current standard of care in reducing postoperative cognitive&#xD;
        outcomes, MACCE and mortality. Expected Outcome: Improved EHR algorithm will have higher&#xD;
        predictive accuracy for MACCE and mortality while predicting postoperative cognitive&#xD;
        outcomes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will cover the following two specific aims:&#xD;
  &#xD;
        Aim 1. A randomized controlled trial (RCT) to assess the effectiveness of pre-operative&#xD;
        personalized prehabilitation with proactive cognitive and behavioral interventions versus&#xD;
        standard of care on reducing postoperative cognitive outcomes (POD, POCD, dementia), MACCE,&#xD;
        and mortality in high-risk surgical elderly patients (≥65y). Our Electronic Health Record&#xD;
        (EHR)-based automated machine-learning risk prediction algorithm for postoperative mortality&#xD;
        and MACCE has been developed using &gt;1.25 million surgical patients' data and implemented with&#xD;
        superior performance to comparators. This EHR algorithm will identify 1000 patients at high&#xD;
        risk for 30-day mortality and MACCE for Aim 1. Patients will be stratified by baseline&#xD;
        cognition status and randomly assigned to standard of care (n=500) or personalized&#xD;
        preoperative prehabilitation with proactive cognitive/behavioral interventions (physical&#xD;
        exercise, cognitive training, enhanced social support, and proactive depression treatment)&#xD;
        (n=500). Cognitive assessments will be performed at baseline, at discharge, 1-, 3-, 6-, and&#xD;
        12- months.&#xD;
  &#xD;
        Aim 1 Hypothesis: Preoperative prehabilitation and proactive cognitive/behavioral&#xD;
        interventions will effectively improve postoperative cognitive outcomes, morbidities, and&#xD;
        mortality.&#xD;
  &#xD;
        Aim 2: An RCT to examine the effectiveness of proactive intra-operative bundled interventions&#xD;
        versus reactive standard of care to improve postoperative cognitive outcomes, MACCE, and&#xD;
        mortality in high-risk surgical elderly patients scheduled for cardiac surgery with IONM.&#xD;
        Intraoperative factors are associated with mortality, morbidity, and stroke. Intraoperative&#xD;
        triple-low events (mean arterial pressure &lt;75 mmHg, Bispectral Index &lt;45, and minimum&#xD;
        alveolar fraction &lt;0.8) are associated with postoperative cognitive outcomes. Eligible&#xD;
        patients scheduled for IONM from Aim 1 (n=500) will be stratified based on Aim 1 intervention&#xD;
        groups and randomized to either reactive standard of care intervention (n=250) or proactive&#xD;
        bundled interventions to determine if optimizing intraoperative physiology reduces&#xD;
        postoperative cognitive outcomes and 30-day MACCE and mortality. Both groups will receive&#xD;
        reactive response to shifts in electroencephalography (EEG) and somatosensory evoked&#xD;
        potential (SSEP). Proactive bundled interventions91 include maintaining normal blood&#xD;
        pressure, oxygen levels, opioid sparing analgesia92-94, avoiding deep anesthesia95 and&#xD;
        benzodiazepines.&#xD;
  &#xD;
        Aim 2 Hypothesis: The proactive bundled interventions are superior to current standard of&#xD;
        care in reducing postoperative cognitive outcomes, MACCE and mortality. Expected Outcome:&#xD;
        Improved EHR algorithm will have higher predictive accuracy for MACCE and mortality while&#xD;
        predicting postoperative cognitive outcomes&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 31, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>A total of 1000 participants who are identified as higher risk (≥2.5%) for 30-day mortality and MACCE based on the risk prediction algorithm will be screened and randomized (1:1) to the intervention group (Group A, n=500). The control group (Group B) will receive standard of care (n=500). Based on the preoperative MoCA score, patients will be stratified into normal baseline cognition (MoCA score &gt;= 26) or baseline cognitive dysfunction (MoCA score of 23-25, inclusive) for randomization to balance the baseline cognitive function between the standard of care group and intervention group.&#xD;
  All patients scheduled for IONM from Aim 1 will be screened for Aim 2. Eligible participants (estimated ~50%, n=500) will be stratified according to their Aim 1 intervention groups and prospectively randomized to either standard of care intraoperative intervention (n=250) (Group C) or proactive bundled interventions (Group D, n=250).</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cognitive Outcomes - Dementia</measure>
      <time_frame>Preoperative baseline screening</time_frame>
      <description>Clinical Dementia Rating Instrument (CDR) will be used to assess dementia. Ratings are as follows: 0 = none, 0.5 = questionable, 1 = mild, 2 = moderate, 3 = severe</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognitive Outcomes - Dementia</measure>
      <time_frame>At time of hospital discharge (up to day 5)</time_frame>
      <description>Clinical Dementia Rating Instrument (CDR) will be used to assess dementia. Ratings are as follows: 0 = none, 0.5 = questionable, 1 = mild, 2 = moderate, 3 = severe</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognitive Outcomes - Dementia</measure>
      <time_frame>Postoperative 1-month</time_frame>
      <description>Clinical Dementia Rating Instrument (CDR) will be used to assess dementia. Ratings are as follows: 0 = none, 0.5 = questionable, 1 = mild, 2 = moderate, 3 = severe</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognitive Outcomes - Dementia</measure>
      <time_frame>Postoperative 3-months</time_frame>
      <description>Clinical Dementia Rating Instrument (CDR) will be used to assess dementia. Ratings are as follows: 0 = none, 0.5 = questionable, 1 = mild, 2 = moderate, 3 = severe</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognitive Outcomes - Dementia</measure>
      <time_frame>Postoperative 6-months</time_frame>
      <description>Clinical Dementia Rating Instrument (CDR) will be used to assess dementia. Ratings are as follows: 0 = none, 0.5 = questionable, 1 = mild, 2 = moderate, 3 = severe</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognitive Outcomes - Dementia</measure>
      <time_frame>Postoperative 12-months</time_frame>
      <description>Clinical Dementia Rating Instrument (CDR) will be used to assess dementia. Ratings are as follows: 0 = none, 0.5 = questionable, 1 = mild, 2 = moderate, 3 = severe</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognitive Outcomes - Delirium</measure>
      <time_frame>Preoperative baseline screening</time_frame>
      <description>The long CAM-Severity will be used to assess delirium. For a diagnosis of delirium by CAM, the subject must display: 1. Presence of acute onset and fluctuating discourse AND 2. Inattention AND EITHER 3. Disorganized thinking OR 4. Altered level of consciousness. Subjects will be reported as yes/no for delirium.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognitive Outcomes - Delirium</measure>
      <time_frame>At time of hospital discharge (up to day 5)</time_frame>
      <description>The long CAM-Severity will be used to assess delirium. For a diagnosis of delirium by CAM, the subject must display: 1. Presence of acute onset and fluctuating discourse AND 2. Inattention AND EITHER 3. Disorganized thinking OR 4. Altered level of consciousness. Subjects will be reported as yes/no for delirium.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognitive Outcomes - Delirium</measure>
      <time_frame>Postoperative 1-month</time_frame>
      <description>The long CAM-Severity will be used to assess delirium. For a diagnosis of delirium by CAM, the subject must display: 1. Presence of acute onset and fluctuating discourse AND 2. Inattention AND EITHER 3. Disorganized thinking OR 4. Altered level of consciousness. Subjects will be reported as yes/no for delirium.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognitive Outcomes - Delirium</measure>
      <time_frame>Postoperative 3-months</time_frame>
      <description>The long CAM-Severity will be used to assess delirium. For a diagnosis of delirium by CAM, the subject must display: 1. Presence of acute onset and fluctuating discourse AND 2. Inattention AND EITHER 3. Disorganized thinking OR 4. Altered level of consciousness. Subjects will be reported as yes/no for delirium.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognitive Outcomes - Delirium</measure>
      <time_frame>Postoperative 6-months</time_frame>
      <description>The long CAM-Severity will be used to assess delirium. For a diagnosis of delirium by CAM, the subject must display: 1. Presence of acute onset and fluctuating discourse AND 2. Inattention AND EITHER 3. Disorganized thinking OR 4. Altered level of consciousness. Subjects will be reported as yes/no for delirium.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognitive Outcomes - Delirium</measure>
      <time_frame>Postoperative 12-months</time_frame>
      <description>The long CAM-Severity will be used to assess delirium. For a diagnosis of delirium by CAM, the subject must display: 1. Presence of acute onset and fluctuating discourse AND 2. Inattention AND EITHER 3. Disorganized thinking OR 4. Altered level of consciousness. Subjects will be reported as yes/no for delirium.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognitive Outcomes - Cognitive Function</measure>
      <time_frame>Preoperative baseline screening</time_frame>
      <description>The Montreal Cognitive Assessment (MoCA) will be used to assess cognitive functioning. A normal score is considered &gt;/= 26 out of 30 total points.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognitive Outcomes - Cognitive Function</measure>
      <time_frame>At time of hospital discharge (up to day 5)</time_frame>
      <description>The Montreal Cognitive Assessment (MoCA) will be used to assess cognitive functioning. A normal score is considered &gt;/= 26 out of 30 total points.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognitive Outcomes - Cognitive Function</measure>
      <time_frame>Postoperative 1-month</time_frame>
      <description>The Montreal Cognitive Assessment (MoCA) will be used to assess cognitive functioning. A normal score is considered &gt;/= 26 out of 30 total points.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognitive Outcomes - Cognitive Function</measure>
      <time_frame>Postoperative 3-months</time_frame>
      <description>The Montreal Cognitive Assessment (MoCA) will be used to assess cognitive functioning. A normal score is considered &gt;/= 26 out of 30 total points.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognitive Outcomes - Cognitive Function</measure>
      <time_frame>Postoperative 6-months</time_frame>
      <description>The Montreal Cognitive Assessment (MoCA) will be used to assess cognitive functioning. A normal score is considered &gt;/= 26 out of 30 total points.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognitive Outcomes - Cognitive Function</measure>
      <time_frame>Postoperative 12-months</time_frame>
      <description>The Montreal Cognitive Assessment (MoCA) will be used to assess cognitive functioning. A normal score is considered &gt;/= 26 out of 30 total points.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cognitive Outcomes - Depression</measure>
      <time_frame>Preoperative baseline screening</time_frame>
      <description>Patient Health Questionnaire (PHQ-9) will be used to assess depression. Scoring is as follows: 1-4 = minimal depression, 5-9 = mild depression, 10-14 = moderate depression, 15-19 = moderately severe depression, and 20-27 = severe depression</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive Outcomes - Depression</measure>
      <time_frame>At time of hospital discharge (up to day 5)</time_frame>
      <description>Patient Health Questionnaire (PHQ-9) will be used to assess depression. Scoring is as follows: 1-4 = minimal depression, 5-9 = mild depression, 10-14 = moderate depression, 15-19 = moderately severe depression, and 20-27 = severe depression</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive Outcomes - Depression</measure>
      <time_frame>Postoperative 1-month</time_frame>
      <description>Patient Health Questionnaire (PHQ-9) will be used to assess depression. Scoring is as follows: 1-4 = minimal depression, 5-9 = mild depression, 10-14 = moderate depression, 15-19 = moderately severe depression, and 20-27 = severe depression</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive Outcomes - Depression</measure>
      <time_frame>Postoperative 3-months</time_frame>
      <description>Patient Health Questionnaire (PHQ-9) will be used to assess depression. Scoring is as follows: 1-4 = minimal depression, 5-9 = mild depression, 10-14 = moderate depression, 15-19 = moderately severe depression, and 20-27 = severe depression</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive Outcomes - Depression</measure>
      <time_frame>Postoperative 6-months</time_frame>
      <description>Patient Health Questionnaire (PHQ-9) will be used to assess depression. Scoring is as follows: 1-4 = minimal depression, 5-9 = mild depression, 10-14 = moderate depression, 15-19 = moderately severe depression, and 20-27 = severe depression</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive Outcomes - Depression</measure>
      <time_frame>Postoperative 12-months</time_frame>
      <description>Patient Health Questionnaire (PHQ-9) will be used to assess depression. Scoring is as follows: 1-4 = minimal depression, 5-9 = mild depression, 10-14 = moderate depression, 15-19 = moderately severe depression, and 20-27 = severe depression</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">1200</enrollment>
    <condition>Alzheimer Disease</condition>
    <condition>Alzheimer Disease Related Dementias</condition>
    <arm_group>
      <arm_group_label>Group A/C (intervention)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants randomized to this intervention group will receive the following interventions:&#xD;
  Personalized CPC Prehabilitation&#xD;
  Cognitive Training&#xD;
  Meditation&#xD;
  Daily Exercise&#xD;
  Enhanced Social Support&#xD;
  Additionally, they will undergo standard of care routine intraoperative SSEP and EEG monitoring during the scheduled surgery.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B/C (SOC control)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group A/D (intervention + SOC)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants randomized to this intervention group will receive the following interventions for study Part I:&#xD;
  Personalized CPC Prehabilitation&#xD;
  Cognitive Training&#xD;
  Meditation&#xD;
  Daily Exercise&#xD;
  Enhanced Social Support&#xD;
  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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B/D (SOC + proactive bundle interventions)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.&#xD;
  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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Personalized CPC Prehabilitation</intervention_name>
      <description>Patients for elective surgery randomized to the intervention group will be scheduled for a preoperative evaluation (3-6 weeks prior to the surgical date) and will receive standardized and personalized assessment and prehabilitation according to UPMC's established disease-specific algorithms.</description>
      <arm_group_label>Group A/C (intervention)</arm_group_label>
      <arm_group_label>Group A/D (intervention + SOC)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Cognitive Training</intervention_name>
      <description>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.</description>
      <arm_group_label>Group A/C (intervention)</arm_group_label>
      <arm_group_label>Group A/D (intervention + SOC)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Meditation</intervention_name>
      <description>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.</description>
      <arm_group_label>Group A/C (intervention)</arm_group_label>
      <arm_group_label>Group A/D (intervention + SOC)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Daily Exercise</intervention_name>
      <description>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.</description>
      <arm_group_label>Group A/C (intervention)</arm_group_label>
      <arm_group_label>Group A/D (intervention + SOC)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Enhanced Social Support</intervention_name>
      <description>Research coordinators and volunteers from HELP will reach out to patients daily prior to their surgery to discuss concerns they may have, provide daily social touchpoints, and remind them to perform their cognitive exercises. In addition, the importance of social support will be discussed with family members and other caregivers and they will be encouraged to participate.&#xD;
  e. Proactive depression treatment: All patients will receive preoperative interventions to manage their depression under their CPC prehabilitation program.</description>
      <arm_group_label>Group A/C (intervention)</arm_group_label>
      <arm_group_label>Group A/D (intervention + SOC)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Proactive Bundle Interventions</intervention_name>
      <description>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. For example, increasing mean arterial pressure can stabilize SSEP (Fig. 6). If persistent focal changes in SSEP and EEG, (i.e., changes in one hemisphere) occur efforts will be made to increase brain perfusion by ensuring and maintaining hematocrit &gt;30, MAP &gt;70, and anesthetic BIS &gt;50-60; soon after surgery, patients will get stroke management and thrombectomy if indicated.</description>
      <arm_group_label>Group A/D (intervention + SOC)</arm_group_label>
      <arm_group_label>Group B/D (SOC + proactive bundle interventions)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Pre-operative Standard of Care</intervention_name>
      <description>Patients in the control group will receive standard of care pre-operative treatment, which may or may not include a visit to the CPC.</description>
      <arm_group_label>Group A/C (intervention)</arm_group_label>
      <arm_group_label>Group A/D (intervention + SOC)</arm_group_label>
      <arm_group_label>Group B/C (SOC control)</arm_group_label>
      <arm_group_label>Group B/D (SOC + proactive bundle interventions)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Intra-operative Standard of Care</intervention_name>
      <description>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.</description>
      <arm_group_label>Group A/C (intervention)</arm_group_label>
      <arm_group_label>Group A/D (intervention + SOC)</arm_group_label>
      <arm_group_label>Group B/C (SOC control)</arm_group_label>
      <arm_group_label>Group B/D (SOC + proactive bundle interventions)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Part I Inclusion Criteria:&#xD;
  &#xD;
            -  65 years of age and older&#xD;
  &#xD;
            -  Identified as higher risk (≥2.5%) for 30-day mortality and MACCE based on the UPMC's&#xD;
               Perioperative Model (EHR risk prediction algorithm)&#xD;
  &#xD;
            -  Scheduled for major cardiac surgeries including coronary artery bypass and valvular&#xD;
               repair and/or vascular surgeries including carotid endarterectomy, aortic aneurysm&#xD;
               repair, and major vascular surgeries&#xD;
  &#xD;
            -  RAI score ≥ 30&#xD;
  &#xD;
            -  PHQ-9 score ≥ 5&#xD;
  &#xD;
            -  Anticipated length of stay &gt; 3 days&#xD;
  &#xD;
            -  Informed consent&#xD;
  &#xD;
            -  English speaking patients&#xD;
  &#xD;
            -  All races and ethnicities&#xD;
  &#xD;
            -  Diverse background (education, area deprivation index)&#xD;
  &#xD;
          Part II Inclusion Criteria:&#xD;
  &#xD;
            -  Patients undergoing high-risk cardiac and vascular surgery, such as intraoperative&#xD;
               bypass for cardiac surgeries and carotid endarterectomy/ aortic aneurysm vascular&#xD;
               surgeries.&#xD;
  &#xD;
            -  History of fully resolved stroke and TIA without any residual weakness&#xD;
  &#xD;
            -  Significant carotid artery stenosis (defined as &gt;70% unilateral or bilateral stenosis)&#xD;
  &#xD;
            -  Moderate and high risk for mortality based on Society of Thoracic Surgery score (score&#xD;
               &gt;4)&#xD;
  &#xD;
            -  Enrolled in Part 1, &quot;Randomized controlled clinical trial to assess the effectiveness&#xD;
               of preoperative personalized prehabilitation as well as cognitive and behavioral&#xD;
               interventions on reducing postoperative delirium (POD), postoperative cognitive&#xD;
               dysfunction (POCD), dementia, 30-day major adverse cardiac and cerebrovascular events&#xD;
               (MACCE) and mortality in high-risk surgical patients (≥65y).&quot;&#xD;
  &#xD;
          Part I Exclusion Criteria:&#xD;
  &#xD;
            -  Children (&lt;18 years)&#xD;
  &#xD;
            -  Patients unable to provide consent&#xD;
  &#xD;
            -  MoCA score &lt;23&#xD;
  &#xD;
            -  Persistent weakness from prior cerebrovascular accident&#xD;
  &#xD;
            -  Patients with severe preoperative medical diseases, blindness or significant visual&#xD;
               impairment, unresolved motor weakness, or any other perioperative events or&#xD;
               complications that would have a bearing on the patients' ability to perform study&#xD;
               tasks, neuropsychological tests and proposed interventions&#xD;
  &#xD;
          Part II Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant women&#xD;
  &#xD;
            -  Patients do not provide consent.&#xD;
  &#xD;
            -  Patients are unable to participate in cognitive and other behavioral assessment due to&#xD;
               physical limitations&#xD;
  &#xD;
            -  Patients refuse any blood transfusions during surgery&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Senthilkumar Sadhasivam, MD, MPH, MBA</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Pittsburgh</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Amy Monroe, MPH, MBA</last_name>
      <role>Study Director</role>
      <affiliation>University of Pittsburgh</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alisha Maslanka, BS, CCRC</last_name>
      <phone>4128646779</phone>
      <email>maslankaaa@upmc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Carly Riedmann, BS</last_name>
      <phone>412-623-4147</phone>
      <email>riedmannca@upmc.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>UPMC Presbyterian Hospital</name>
        <address>
          <city>Pittsburgh</city>
          <state>Pennsylvania</state>
          <zip>15213</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Senthilkumar Sadhasivam</last_name>
        <phone>317-948-3845</phone>
        <email>ssadhasivam@IUHealth.org</email>
      </contact>
      <contact_backup>
        <last_name>Alisha Maslanka, BS, CCRC</last_name>
        <phone>412-864-6779</phone>
        <email>maslankaaa@upmc.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
      <investigator_full_name>Senthil Sadhasivam</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alzheimer Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06042413
  org study id: STUDY22070046
  secondary id: 1R01AG081315
  nct id: NCT06042413
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study will contribute to creating a prospective and robust automated preoperative risk
        assessment algorithm for 30-day mortality, major adverse cardiac and cerebrovascular events
        (MACCE) and perioperative neurocognitive disorders (PND) outcomes following elective general,
        orthopedic, cardiac, or vascular surgery. It will help to identify correlations between
        perioperative factors and Alzheimer's Disease (AD) or AD-related dementias (ADRD). Lastly,
        this study will create effective, validated multi-modal interventions to improve
        perioperative health. This study will explore two main hypotheses: 1. Preoperative
        prehabilitation and proactive cognitive/behavioral interventions will effectively improve
        postoperative cognitive outcomes, morbidities, and mortality, and; 2. The proactive bundled
        interventions are superior to current 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.
  This study will cover the following two specific aims:
  
        Aim 1. A randomized controlled trial (RCT) to assess the effectiveness of pre-operative
        personalized prehabilitation with proactive cognitive and behavioral interventions versus
        standard of care on reducing postoperative cognitive outcomes (POD, POCD, dementia), MACCE,
        and mortality in high-risk surgical elderly patients (≥65y). 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 1000 patients at high
        risk for 30-day mortality and MACCE for Aim 1. Patients will be stratified by baseline
        cognition status and randomly assigned to standard of care (n=500) or personalized
        preoperative prehabilitation with proactive cognitive/behavioral interventions (physical
        exercise, cognitive training, enhanced social support, and proactive depression treatment)
        (n=500). Cognitive assessments will be performed at baseline, at discharge, 1-, 3-, 6-, and
        12- months.
  
        Aim 1 Hypothesis: Preoperative prehabilitation and proactive cognitive/behavioral
        interventions will effectively improve postoperative cognitive outcomes, morbidities, and
        mortality.
  
        Aim 2: An RCT to examine the effectiveness of proactive intra-operative bundled interventions
        versus reactive standard of care to improve postoperative cognitive outcomes, MACCE, and
        mortality in high-risk surgical elderly patients scheduled for cardiac surgery with IONM.
        Intraoperative factors are associated with mortality, morbidity, and stroke. Intraoperative
        triple-low events (mean arterial pressure <75 mmHg, Bispectral Index <45, and minimum
        alveolar fraction <0.8) are associated with postoperative cognitive outcomes. Eligible
        patients scheduled for IONM from Aim 1 (n=500) will be stratified based on Aim 1 intervention
        groups and randomized to either reactive standard of care intervention (n=250) or proactive
        bundled interventions to determine if optimizing intraoperative physiology reduces
        postoperative cognitive outcomes and 30-day MACCE and mortality. Both groups will receive
        reactive response to shifts in electroencephalography (EEG) and somatosensory evoked
        potential (SSEP). Proactive bundled interventions91 include maintaining normal blood
        pressure, oxygen levels, opioid sparing analgesia92-94, avoiding deep anesthesia95 and
        benzodiazepines.
  
        Aim 2 Hypothesis: The proactive bundled interventions are superior to current 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
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: A total of 1000 participants who are identified as higher risk (≥2.5%) for 30-day mortality and MACCE based on the risk prediction algorithm will be screened and randomized (1:1) to the intervention group (Group A, n=500). The control group (Group B) will receive standard of care (n=500). Based on the preoperative MoCA score, patients will be stratified into normal baseline cognition (MoCA score >= 26) or baseline cognitive dysfunction (MoCA score of 23-25, inclusive) for randomization to balance the baseline cognitive function between the standard of care group and intervention group.
  All patients scheduled for IONM from Aim 1 will be screened for Aim 2. Eligible participants (estimated ~50%, n=500) will be stratified according to their Aim 1 intervention groups and prospectively randomized to either standard of care intraoperative intervention (n=250) (Group C) or proactive bundled interventions (Group D, n=250).
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Cognitive Outcomes - Dementia
  time frame: Preoperative baseline screening
  description: Clinical Dementia Rating Instrument (CDR) will be used to assess dementia. Ratings are as follows: 0 = none, 0.5 = questionable, 1 = mild, 2 = moderate, 3 = severe
  measure: Cognitive Outcomes - Dementia
  time frame: At time of hospital discharge (up to day 5)
  description: Clinical Dementia Rating Instrument (CDR) will be used to assess dementia. Ratings are as follows: 0 = none, 0.5 = questionable, 1 = mild, 2 = moderate, 3 = severe
  measure: Cognitive Outcomes - Dementia
  time frame: Postoperative 1-month
  description: Clinical Dementia Rating Instrument (CDR) will be used to assess dementia. Ratings are as follows: 0 = none, 0.5 = questionable, 1 = mild, 2 = moderate, 3 = severe
  measure: Cognitive Outcomes - Dementia
  time frame: Postoperative 3-months
  description: Clinical Dementia Rating Instrument (CDR) will be used to assess dementia. Ratings are as follows: 0 = none, 0.5 = questionable, 1 = mild, 2 = moderate, 3 = severe
  measure: Cognitive Outcomes - Dementia
  time frame: Postoperative 6-months
  description: Clinical Dementia Rating Instrument (CDR) will be used to assess dementia. Ratings are as follows: 0 = none, 0.5 = questionable, 1 = mild, 2 = moderate, 3 = severe
  measure: Cognitive Outcomes - Dementia
  time frame: Postoperative 12-months
  description: Clinical Dementia Rating Instrument (CDR) will be used to assess dementia. Ratings are as follows: 0 = none, 0.5 = questionable, 1 = mild, 2 = moderate, 3 = severe
  measure: Cognitive Outcomes - Delirium
  time frame: Preoperative baseline screening
  description: The long CAM-Severity will be used to assess delirium. For a diagnosis of delirium by CAM, the subject must display: 1. Presence of acute onset and fluctuating discourse AND 2. Inattention AND EITHER 3. Disorganized thinking OR 4. Altered level of consciousness. Subjects will be reported as yes/no for delirium.
  measure: Cognitive Outcomes - Delirium
  time frame: At time of hospital discharge (up to day 5)
  description: The long CAM-Severity will be used to assess delirium. For a diagnosis of delirium by CAM, the subject must display: 1. Presence of acute onset and fluctuating discourse AND 2. Inattention AND EITHER 3. Disorganized thinking OR 4. Altered level of consciousness. Subjects will be reported as yes/no for delirium.
  measure: Cognitive Outcomes - Delirium
  time frame: Postoperative 1-month
  description: The long CAM-Severity will be used to assess delirium. For a diagnosis of delirium by CAM, the subject must display: 1. Presence of acute onset and fluctuating discourse AND 2. Inattention AND EITHER 3. Disorganized thinking OR 4. Altered level of consciousness. Subjects will be reported as yes/no for delirium.
  measure: Cognitive Outcomes - Delirium
  time frame: Postoperative 3-months
  description: The long CAM-Severity will be used to assess delirium. For a diagnosis of delirium by CAM, the subject must display: 1. Presence of acute onset and fluctuating discourse AND 2. Inattention AND EITHER 3. Disorganized thinking OR 4. Altered level of consciousness. Subjects will be reported as yes/no for delirium.
  measure: Cognitive Outcomes - Delirium
  time frame: Postoperative 6-months
  description: The long CAM-Severity will be used to assess delirium. For a diagnosis of delirium by CAM, the subject must display: 1. Presence of acute onset and fluctuating discourse AND 2. Inattention AND EITHER 3. Disorganized thinking OR 4. Altered level of consciousness. Subjects will be reported as yes/no for delirium.
  measure: Cognitive Outcomes - Delirium
  time frame: Postoperative 12-months
  description: The long CAM-Severity will be used to assess delirium. For a diagnosis of delirium by CAM, the subject must display: 1. Presence of acute onset and fluctuating discourse AND 2. Inattention AND EITHER 3. Disorganized thinking OR 4. Altered level of consciousness. Subjects will be reported as yes/no for delirium.
  measure: Cognitive Outcomes - Cognitive Function
  time frame: Preoperative baseline screening
  description: The Montreal Cognitive Assessment (MoCA) will be used to assess cognitive functioning. A normal score is considered >/= 26 out of 30 total points.
  measure: Cognitive Outcomes - Cognitive Function
  time frame: At time of hospital discharge (up to day 5)
  description: The Montreal Cognitive Assessment (MoCA) will be used to assess cognitive functioning. A normal score is considered >/= 26 out of 30 total points.
  measure: Cognitive Outcomes - Cognitive Function
  time frame: Postoperative 1-month
  description: The Montreal Cognitive Assessment (MoCA) will be used to assess cognitive functioning. A normal score is considered >/= 26 out of 30 total points.
  measure: Cognitive Outcomes - Cognitive Function
  time frame: Postoperative 3-months
  description: The Montreal Cognitive Assessment (MoCA) will be used to assess cognitive functioning. A normal score is considered >/= 26 out of 30 total points.
  measure: Cognitive Outcomes - Cognitive Function
  time frame: Postoperative 6-months
  description: The Montreal Cognitive Assessment (MoCA) will be used to assess cognitive functioning. A normal score is considered >/= 26 out of 30 total points.
  measure: Cognitive Outcomes - Cognitive Function
  time frame: Postoperative 12-months
  description: The Montreal Cognitive Assessment (MoCA) will be used to assess cognitive functioning. A normal score is considered >/= 26 out of 30 total points.
  measure: Cognitive Outcomes - Depression
  time frame: Preoperative baseline screening
  description: Patient Health Questionnaire (PHQ-9) will be used to assess depression. Scoring is as follows: 1-4 = minimal depression, 5-9 = mild depression, 10-14 = moderate depression, 15-19 = moderately severe depression, and 20-27 = severe depression
  measure: Cognitive Outcomes - Depression
  time frame: At time of hospital discharge (up to day 5)
  description: Patient Health Questionnaire (PHQ-9) will be used to assess depression. Scoring is as follows: 1-4 = minimal depression, 5-9 = mild depression, 10-14 = moderate depression, 15-19 = moderately severe depression, and 20-27 = severe depression
  measure: Cognitive Outcomes - Depression
  time frame: Postoperative 1-month
  description: Patient Health Questionnaire (PHQ-9) will be used to assess depression. Scoring is as follows: 1-4 = minimal depression, 5-9 = mild depression, 10-14 = moderate depression, 15-19 = moderately severe depression, and 20-27 = severe depression
  measure: Cognitive Outcomes - Depression
  time frame: Postoperative 3-months
  description: Patient Health Questionnaire (PHQ-9) will be used to assess depression. Scoring is as follows: 1-4 = minimal depression, 5-9 = mild depression, 10-14 = moderate depression, 15-19 = moderately severe depression, and 20-27 = severe depression
  measure: Cognitive Outcomes - Depression
  time frame: Postoperative 6-months
  description: Patient Health Questionnaire (PHQ-9) will be used to assess depression. Scoring is as follows: 1-4 = minimal depression, 5-9 = mild depression, 10-14 = moderate depression, 15-19 = moderately severe depression, and 20-27 = severe depression
  measure: Cognitive Outcomes - Depression
  time frame: Postoperative 12-months
  description: Patient Health Questionnaire (PHQ-9) will be used to assess depression. Scoring is as follows: 1-4 = minimal depression, 5-9 = mild depression, 10-14 = moderate depression, 15-19 = moderately severe depression, and 20-27 = severe depression
  arm group label: Group A/C (intervention)
  arm group type: Experimental
  description: 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.
  arm group label: Group B/C (SOC control)
  arm group type: Active Comparator
  description: 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.
  arm group label: Group A/D (intervention + SOC)
  arm group type: Experimental
  description: 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.
  arm group label: Group B/D (SOC + proactive bundle interventions)
  arm group type: Experimental
  description: 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.
  intervention type: Other
  intervention name: Personalized CPC Prehabilitation
  description: Patients for elective surgery randomized to the intervention group will be scheduled for a preoperative evaluation (3-6 weeks prior to the surgical date) and will receive standardized and personalized assessment and prehabilitation according to UPMC's established disease-specific algorithms.
  arm group label: Group A/C (intervention)
  arm group label: Group A/D (intervention + SOC)
  intervention type: Behavioral
  intervention name: Cognitive Training
  description: 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.
  arm group label: Group A/C (intervention)
  arm group label: Group A/D (intervention + SOC)
  intervention type: Behavioral
  intervention name: Meditation
  description: 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.
  arm group label: Group A/C (intervention)
  arm group label: Group A/D (intervention + SOC)
  intervention type: Behavioral
  intervention name: Daily Exercise
  description: 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.
  arm group label: Group A/C (intervention)
  arm group label: Group A/D (intervention + SOC)
  intervention type: Behavioral
  intervention name: Enhanced Social Support
  description: Research coordinators and volunteers from HELP will reach out to patients daily prior to their surgery to discuss concerns they may have, provide daily social touchpoints, and remind them to perform their cognitive exercises. In addition, the importance of social support will be discussed with family members and other caregivers and they will be encouraged to participate.
  e. Proactive depression treatment: All patients will receive preoperative interventions to manage their depression under their CPC prehabilitation program.
  arm group label: Group A/C (intervention)
  arm group label: Group A/D (intervention + SOC)
  intervention type: Other
  intervention name: Proactive Bundle Interventions
  description: 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. For example, increasing mean arterial pressure can stabilize SSEP (Fig. 6). If persistent focal changes in SSEP and EEG, (i.e., changes in one hemisphere) occur efforts will be made to increase brain perfusion by ensuring and maintaining hematocrit >30, MAP >70, and anesthetic BIS >50-60; soon after surgery, patients will get stroke management and thrombectomy if indicated.
  arm group label: Group A/D (intervention + SOC)
  arm group label: Group B/D (SOC + proactive bundle interventions)
  intervention type: Procedure
  intervention name: Pre-operative Standard of Care
  description: Patients in the control group will receive standard of care pre-operative treatment, which may or may not include a visit to the CPC.
  arm group label: Group A/C (intervention)
  arm group label: Group A/D (intervention + SOC)
  arm group label: Group B/C (SOC control)
  arm group label: Group B/D (SOC + proactive bundle interventions)
  intervention type: Procedure
  intervention name: Intra-operative Standard of Care
  description: 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.
  arm group label: Group A/C (intervention)
  arm group label: Group A/D (intervention + SOC)
  arm group label: Group B/C (SOC control)
  arm group label: Group B/D (SOC + proactive bundle interventions)
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Senthilkumar Sadhasivam, MD, MPH, MBA
  role: Principal Investigator
  affiliation: University of Pittsburgh
  last name: Amy Monroe, MPH, MBA
  role: Study Director
  affiliation: University of Pittsburgh
  last name: Alisha Maslanka, BS, CCRC
  phone: 4128646779
  email: maslankaaa@upmc.edu
  last name: Carly Riedmann, BS
  phone: 412-623-4147
  email: riedmannca@upmc.edu
  facility: 
  contact: 
  contact backup: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Pittsburgh
  investigator full name: Senthil Sadhasivam
  investigator title: Professor
  mesh term: Alzheimer Disease
  sharing ipd: No