<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/NCT03286179</url>
  </required_header>
  <id_info>
    <org_study_id>CN-16-2648</org_study_id>
    <nct_id>NCT03286179</nct_id>
  </id_info>
  <brief_title>Standardizing Emergency Work-ups Around Risk Data</brief_title>
  <acronym>STEWARD</acronym>
  <official_title>Standardizing Emergency Work-ups Around Risk Data (STEWARD): The CREST Network Chest Pain Project</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaiser Permanente</source>
  <oversight_info>
    <has_dmc>No</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>
      Chest pain is the second leading reason for emergency department (ED) visits in the United&#xD;
      States. Resource utilization for this ED subpopulation is particularly high, in part due to a&#xD;
      dearth of accepted standardized clinical approaches and general overestimation of risk on the&#xD;
      part of both providers and patients. This prospective observational cohort study seeks to&#xD;
      address this issue by providing externally validated risk scores for major adverse cardiac&#xD;
      events using a web-based clinical decision support platform (RISTRA) embedded within the&#xD;
      electronic health record at 13 Kaiser Permanente Northern California (KPNC) EDs over a&#xD;
      12-month period. The decision support will provide risk estimates specific to the KPNC&#xD;
      patient population. This studies hypothesis is that the provision of more accurate risk&#xD;
      estimation for major adverse cardiac events will improve informed decision making by both&#xD;
      providers and patients, resulting in less provocative testing and lower ED lengths of stay&#xD;
      amongst low risk patients, as well as improving medical management among non-low risk&#xD;
      patients and decreasing future rates of major adverse cardiac events.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Major adverse cardiac event (MACE)</measure>
    <time_frame>12 months</time_frame>
    <description>A composite outcome of either acute myocardial infarction, cardiac arrest, malignant arrhythmia, cardiac-related mortality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Provocative and anatomic cardiac testing rates</measure>
    <time_frame>12 months</time_frame>
    <description>Treadmill stress test, myocardial perfusion imaging, stress echocardiography, CT coronary angiography, catheter-based coronary angiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergency department length of stay</measure>
    <time_frame>12 months</time_frame>
    <description>Total hours spent in the emergency department among study eligible patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital admission rate</measure>
    <time_frame>12 months</time_frame>
    <description>Percentage of hospital admissions among study eligible patients</description>
  </secondary_outcome>
  <enrollment type="Actual">13419</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <condition>Chest Pain</condition>
  <condition>Risk Reduction</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>modified HEART score and/or Emergency Department Assessment of Chest pain Risk Score (EDACS)</intervention_name>
    <description>Provision of estimated risk for major cardiac events at 60 days based on the modified HEART and/or EDACS, using KPNC specific estimates derived from an internal validation study</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients presenting to KPNC emergency departments with above elgibilty criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Emergency department chief complaint of chest pain or chest discomfort&#xD;
&#xD;
          -  Clinical concern for possible cardiac ischemia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kaiser Permanente Antioch Emergency Department</name>
      <address>
        <city>Antioch</city>
        <state>California</state>
        <zip>94531</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Fremont Emergency Department</name>
      <address>
        <city>Fremont</city>
        <state>California</state>
        <zip>94538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Oakland Emergency Department</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Richmond Emergency Department</name>
      <address>
        <city>Richmond</city>
        <state>California</state>
        <zip>94801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Roseville Emergency Department</name>
      <address>
        <city>Roseville</city>
        <state>California</state>
        <zip>95661</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente South Sacramento Emergency Department</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95823</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Sacramento Emergency Department</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95825</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente San Francisco Emergency Department</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente San Leandro Emergency Department</name>
      <address>
        <city>San Leandro</city>
        <state>California</state>
        <zip>94577</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente San Rafael Emergency Department</name>
      <address>
        <city>San Rafael</city>
        <state>California</state>
        <zip>94903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente South San Francisco Emergency Department</name>
      <address>
        <city>South San Francisco</city>
        <state>California</state>
        <zip>94080</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Walnut Creek Emergency Department</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94596</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Sabbatini AK, Nallamothu BK, Kocher KE. Reducing variation in hospital admissions from the emergency department for low-mortality conditions may produce savings. Health Aff (Millwood). 2014 Sep;33(9):1655-63. doi: 10.1377/hlthaff.2013.1318.</citation>
    <PMID>25201672</PMID>
  </reference>
  <reference>
    <citation>Venkatesh AK, Dai Y, Ross JS, Schuur JD, Capp R, Krumholz HM. Variation in US hospital emergency department admission rates by clinical condition. Med Care. 2015 Mar;53(3):237-44. doi: 10.1097/MLR.0000000000000261.</citation>
    <PMID>25397965</PMID>
  </reference>
  <reference>
    <citation>Newman DH, Ackerman B, Kraushar ML, Lederhandler MH, Masri A, Starikov A, Tsao DT, Meyers HP, Shah KH. Quantifying Patient-Physician Communication and Perceptions of Risk During Admissions for Possible Acute Coronary Syndromes. Ann Emerg Med. 2015 Jul;66(1):13-8, 18.e1. doi: 10.1016/j.annemergmed.2015.01.027. Epub 2015 Mar 4.</citation>
    <PMID>25748480</PMID>
  </reference>
  <reference>
    <citation>Than MP, Pickering JW, Aldous SJ, Cullen L, Frampton CM, Peacock WF, Jaffe AS, Goodacre SW, Richards AM, Ardagh MW, Deely JM, Florkowski CM, George P, Hamilton GJ, Jardine DL, Troughton RW, van Wyk P, Young JM, Bannister L, Lord SJ. Effectiveness of EDACS Versus ADAPT Accelerated Diagnostic Pathways for Chest Pain: A Pragmatic Randomized Controlled Trial Embedded Within Practice. Ann Emerg Med. 2016 Jul;68(1):93-102.e1. doi: 10.1016/j.annemergmed.2016.01.001.</citation>
    <PMID>26947800</PMID>
  </reference>
  <reference>
    <citation>Mahler SA, Riley RF, Hiestand BC, Russell GB, Hoekstra JW, Lefebvre CW, Nicks BA, Cline DM, Askew KL, Elliott SB, Herrington DM, Burke GL, Miller CD. The HEART Pathway randomized trial: identifying emergency department patients with acute chest pain for early discharge. Circ Cardiovasc Qual Outcomes. 2015 Mar;8(2):195-203. doi: 10.1161/CIRCOUTCOMES.114.001384. Epub 2015 Mar 3.</citation>
    <PMID>25737484</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>August 11, 2020</last_update_submitted>
  <last_update_submitted_qc>August 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Chest Pain</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/NCT03286179
org study id: CN-16-2648
nct id: NCT03286179
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chest pain is the second leading reason for emergency department (ED) visits in the United
      States. Resource utilization for this ED subpopulation is particularly high, in part due to a
      dearth of accepted standardized clinical approaches and general overestimation of risk on the
      part of both providers and patients. This prospective observational cohort study seeks to
      address this issue by providing externally validated risk scores for major adverse cardiac
      events using a web-based clinical decision support platform (RISTRA) embedded within the
      electronic health record at 13 Kaiser Permanente Northern California (KPNC) EDs over a
      12-month period. The decision support will provide risk estimates specific to the KPNC
      patient population. This studies hypothesis is that the provision of more accurate risk
      estimation for major adverse cardiac events will improve informed decision making by both
      providers and patients, resulting in less provocative testing and lower ED lengths of stay
      amongst low risk patients, as well as improving medical management among non-low risk
      patients and decreasing future rates of major adverse cardiac events.
observational model: Cohort
time perspective: Prospective
measure: Major adverse cardiac event (MACE)
time frame: 12 months
description: A composite outcome of either acute myocardial infarction, cardiac arrest, malignant arrhythmia, cardiac-related mortality
measure: Provocative and anatomic cardiac testing rates
time frame: 12 months
description: Treadmill stress test, myocardial perfusion imaging, stress echocardiography, CT coronary angiography, catheter-based coronary angiography
measure: Emergency department length of stay
time frame: 12 months
description: Total hours spent in the emergency department among study eligible patients
measure: Hospital admission rate
time frame: 12 months
description: Percentage of hospital admissions among study eligible patients
intervention type: Other
intervention name: modified HEART score and/or Emergency Department Assessment of Chest pain Risk Score (EDACS)
description: Provision of estimated risk for major cardiac events at 60 days based on the modified HEART and/or EDACS, using KPNC specific estimates derived from an internal validation study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Sabbatini AK, Nallamothu BK, Kocher KE. Reducing variation in hospital admissions from the emergency department for low-mortality conditions may produce savings. Health Aff (Millwood). 2014 Sep;33(9):1655-63. doi: 10.1377/hlthaff.2013.1318.
PMID: 25201672
citation: Venkatesh AK, Dai Y, Ross JS, Schuur JD, Capp R, Krumholz HM. Variation in US hospital emergency department admission rates by clinical condition. Med Care. 2015 Mar;53(3):237-44. doi: 10.1097/MLR.0000000000000261.
PMID: 25397965
citation: Newman DH, Ackerman B, Kraushar ML, Lederhandler MH, Masri A, Starikov A, Tsao DT, Meyers HP, Shah KH. Quantifying Patient-Physician Communication and Perceptions of Risk During Admissions for Possible Acute Coronary Syndromes. Ann Emerg Med. 2015 Jul;66(1):13-8, 18.e1. doi: 10.1016/j.annemergmed.2015.01.027. Epub 2015 Mar 4.
PMID: 25748480
citation: Than MP, Pickering JW, Aldous SJ, Cullen L, Frampton CM, Peacock WF, Jaffe AS, Goodacre SW, Richards AM, Ardagh MW, Deely JM, Florkowski CM, George P, Hamilton GJ, Jardine DL, Troughton RW, van Wyk P, Young JM, Bannister L, Lord SJ. Effectiveness of EDACS Versus ADAPT Accelerated Diagnostic Pathways for Chest Pain: A Pragmatic Randomized Controlled Trial Embedded Within Practice. Ann Emerg Med. 2016 Jul;68(1):93-102.e1. doi: 10.1016/j.annemergmed.2016.01.001.
PMID: 26947800
citation: Mahler SA, Riley RF, Hiestand BC, Russell GB, Hoekstra JW, Lefebvre CW, Nicks BA, Cline DM, Askew KL, Elliott SB, Herrington DM, Burke GL, Miller CD. The HEART Pathway randomized trial: identifying emergency department patients with acute chest pain for early discharge. Circ Cardiovasc Qual Outcomes. 2015 Mar;8(2):195-203. doi: 10.1161/CIRCOUTCOMES.114.001384. Epub 2015 Mar 3.
PMID: 25737484
responsible party type: Sponsor
mesh term: Acute Coronary Syndrome
mesh term: Emergencies
mesh term: Chest Pain
sharing ipd: No