<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/NCT02207270</url>
  </required_header>
  <id_info>
    <org_study_id>HSR-14-1479</org_study_id>
    <secondary_id>2033.11</secondary_id>
    <nct_id>NCT02207270</nct_id>
  </id_info>
  <brief_title>Study Of Costs Realized After Percutaneous Coronary intervenTion Employing Same Day Discharge</brief_title>
  <acronym>SOCRATES</acronym>
  <official_title>A Randomized Cost Minimization Analysis Comparing Same Day Discharge With Overnight Hospital Stay Following Elective and Low Risk Urgent Percutaneous Coronary Intervention.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saint Joseph Mercy Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Michigan Heart, PC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Blue Cross Blue Shield of Michigan Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Saint Joseph Mercy Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether the total costs of care associated with&#xD;
      uncomplicated elective or low-risk urgent percutaneous coronary intervention (PCI) through&#xD;
      30-day follow up are lower among patients who are randomly assigned to same day discharge&#xD;
      (SDD) or overnight hospital stay (ON).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective randomized clinical trial of same day discharge versus overnight stay&#xD;
      for patients undergoing uncomplicated elective or low-risk urgent PCI with uncomplicated&#xD;
      post-PCI recovery. The outcome is total cost accrued by patients from the time of index&#xD;
      hospital presentation through 30-day post-PCI follow-up.&#xD;
&#xD;
      Conduct of PCI procedures and provision of post-PCI care will be in accordance with routine&#xD;
      institutional practices and will not be protocol-driven.&#xD;
&#xD;
      Consented patients will be assigned to SDD or ON stay using a block randomization schedule.&#xD;
      Randomization will occur once the patient has completed an uncomplicated 6-hour post PCI&#xD;
      observation period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Unable to meet projected enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">August 11, 2014</start_date>
  <completion_date type="Actual">September 1, 2015</completion_date>
  <primary_completion_date type="Actual">September 1, 2015</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>Randomized clinical trail</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total costs from a modified societal perspective</measure>
    <time_frame>Index hospital admission to 30-days post-PCI</time_frame>
    <description>Costs will be determined from a modified societal perspective (physician labor, office visit and outpatient drug costs will not be included) and will be reported in 2014 dollars.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total costs from a 3rd party payer perspective</measure>
    <time_frame>Index hospital admission to 30-days post-PCI</time_frame>
    <description>Costs will be determined from a from a 3rd party payer perspective (physician labor, office visit and outpatient drug costs will also be included) and will be reported in 2014 dollars.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse clinical outcomes</measure>
    <time_frame>Index hospital admission to 30-days post-PCI</time_frame>
    <description>Includes death, myocardial infarction, stroke, unplanned cardiac catheterization or coronary revascularization, vascular or hemorrhagic complications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rehospitalization</measure>
    <time_frame>From discharge through 30-day post-PCI</time_frame>
    <description>Inclusive of rehospitalization for any reason.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Same day discharge</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who experienced uncomplicated PCI as well as an uncomplicated 6-hour observation period, will be randomly assigned to same day discharge.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Overnight stay standard care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients who experienced uncomplicated PCI, as well as an uncomplicated 6-hour observation period, will be randomly assigned to an overnight stay, generally considered standard care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Same day discharge</intervention_name>
    <description>Patients randomized to SDD will be discharged home on the day of their PCI, at least 6 hours following its completion. They will receive a follow up phone call from a study coordinator the next day and at 30 days to ascertain what costs (if any) were accrued and whether any adverse outcomes occurred.</description>
    <arm_group_label>Same day discharge</arm_group_label>
    <other_name>SOCRATES</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Overnight Stay</intervention_name>
    <description>Patients who experienced uncomplicated PCI, as well as an uncomplicated 6-hour observation period, will be randomly assigned to an overnight stay, generally considered standard or routine care. Patients randomized to overnight stay will be discharged the following morning to receive a follow up phone call at 30 days to ascertain what costs (if any) were accrued and whether any adverse outcomes occurred.</description>
    <arm_group_label>Overnight stay standard care</arm_group_label>
    <other_name>Standard Care</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consecutive patients who undergo elective or low-risk, (i.e., in the setting of&#xD;
             unstable angina but not non-ST segment elevation myocardial infarction) urgent PCI.&#xD;
&#xD;
          -  No sociodemographic factors that would preclude SDD (prohibitive factors include no&#xD;
             family member/friend available to remain with patient until nurse phone call the&#xD;
             following day, no working phone, no reliable transportation, home &gt; 60 minutes from&#xD;
             medical infrastructure, unable to obtain/pay for medications).&#xD;
&#xD;
          -  PCI procedures performed between 08/04/14 and 08/03/16.&#xD;
&#xD;
          -  Short term risk of in-hospital death, transfusion or contrast-induced nephropathy&#xD;
             during the index hospitalization at or below 1% using Blue Cross Blue Shield of&#xD;
             Michigan Cardiovascular Consortium (BMC2) PCI registry risk prediction models.&#xD;
&#xD;
          -  No in-lab complications (prolonged angina, acute closure, no reflow, significant or&#xD;
             untreated dissection, vessel perforation, side branch occlusion, rescue glycoprotein&#xD;
             IIb/IIIa inhibitor use, ventricular tachycardia or fibrillation requiring&#xD;
             cardioversion/defibrillation, tamponade, pulmonary edema, stroke or transient ischemic&#xD;
             attack, shock).&#xD;
&#xD;
          -  Contrast Volume/Calculated Creatinine Clearance ratio &lt; 3&#xD;
&#xD;
          -  No recurrent chest pain, shortness of breath, hemodynamic instability, bleeding or&#xD;
             vascular complications during 6 hours in recovery area post-PCI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of rotational atherectomy&#xD;
&#xD;
          -  Use of a glycoprotein IIb/IIIa inhibitor infusion post-PCI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Herbert D. Aronow, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Michigan Heart, PC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saint Joseph Mercy Health System, St. Joseph Mercy [Hospital] Ann Arbor, Cardiac Catheterization Laboratory</name>
      <address>
        <city>Ypsilanti</city>
        <state>Michigan</state>
        <zip>48197</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Jospeh Mercy Health System, St. Joseph Mercy [Hospital] Ann Arbor, Cardiac Catheterization Laboratory</name>
      <address>
        <city>Ypsilanti</city>
        <state>Michigan</state>
        <zip>48197</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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  <verification_date>March 2018</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>March 20, 2018</last_update_submitted>
  <last_update_submitted_qc>March 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronary artery disease</keyword>
  <keyword>Costs</keyword>
  <keyword>Cost minimization</keyword>
  <keyword>Percutaneous coronary intervention</keyword>
  <keyword>Risk score</keyword>
  <keyword>Same day discharge</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary 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>


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/NCT02207270
org study id: HSR-14-1479
secondary id: 2033.11
nct id: NCT02207270
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether the total costs of care associated with
      uncomplicated elective or low-risk urgent percutaneous coronary intervention (PCI) through
      30-day follow up are lower among patients who are randomly assigned to same day discharge
      (SDD) or overnight hospital stay (ON).
This is a prospective randomized clinical trial of same day discharge versus overnight stay
      for patients undergoing uncomplicated elective or low-risk urgent PCI with uncomplicated
      post-PCI recovery. The outcome is total cost accrued by patients from the time of index
      hospital presentation through 30-day post-PCI follow-up.

      Conduct of PCI procedures and provision of post-PCI care will be in accordance with routine
      institutional practices and will not be protocol-driven.

      Consented patients will be assigned to SDD or ON stay using a block randomization schedule.
      Randomization will occur once the patient has completed an uncomplicated 6-hour post PCI
      observation period.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized clinical trail
primary purpose: Health Services Research
masking: None (Open Label)
measure: Total costs from a modified societal perspective
time frame: Index hospital admission to 30-days post-PCI
description: Costs will be determined from a modified societal perspective (physician labor, office visit and outpatient drug costs will not be included) and will be reported in 2014 dollars.
measure: Total costs from a 3rd party payer perspective
time frame: Index hospital admission to 30-days post-PCI
description: Costs will be determined from a from a 3rd party payer perspective (physician labor, office visit and outpatient drug costs will also be included) and will be reported in 2014 dollars.
measure: Adverse clinical outcomes
time frame: Index hospital admission to 30-days post-PCI
description: Includes death, myocardial infarction, stroke, unplanned cardiac catheterization or coronary revascularization, vascular or hemorrhagic complications.
measure: Rehospitalization
time frame: From discharge through 30-day post-PCI
description: Inclusive of rehospitalization for any reason.
arm group label: Same day discharge
arm group type: Experimental
description: Patients who experienced uncomplicated PCI as well as an uncomplicated 6-hour observation period, will be randomly assigned to same day discharge.
arm group label: Overnight stay standard care
arm group type: Other
description: Patients who experienced uncomplicated PCI, as well as an uncomplicated 6-hour observation period, will be randomly assigned to an overnight stay, generally considered standard care.
intervention type: Behavioral
intervention name: Same day discharge
description: Patients randomized to SDD will be discharged home on the day of their PCI, at least 6 hours following its completion. They will receive a follow up phone call from a study coordinator the next day and at 30 days to ascertain what costs (if any) were accrued and whether any adverse outcomes occurred.
arm group label: Same day discharge
other name: SOCRATES
intervention type: Behavioral
intervention name: Overnight Stay
description: Patients who experienced uncomplicated PCI, as well as an uncomplicated 6-hour observation period, will be randomly assigned to an overnight stay, generally considered standard or routine care. Patients randomized to overnight stay will be discharged the following morning to receive a follow up phone call at 30 days to ascertain what costs (if any) were accrued and whether any adverse outcomes occurred.
arm group label: Overnight stay standard care
other name: Standard Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Herbert D. Aronow, MD, MPH
role: Principal Investigator
affiliation: Michigan Heart, PC
facility: 
facility: 
country: United States
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responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
sharing ipd: No