<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/NCT02205086</url>
  </required_header>
  <id_info>
    <org_study_id>SimulConsult2</org_study_id>
    <nct_id>NCT02205086</nct_id>
  </id_info>
  <brief_title>Empowering Physicians With Evidence-Based Decision Support for Pediatric Rheumatology</brief_title>
  <acronym>Rheumatology</acronym>
  <official_title>Empowering Physicians With Evidence-Based Decision Support for Pediatric Rheumatology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SimulConsult, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SimulConsult, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares the ability of clinicians to make diagnoses with or without the&#xD;
      assistance of diagnostic decision support software. The area of clinical focus is primarily&#xD;
      rheumatology.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study uses written case vignettes, not decisions about patients seeking care from the&#xD;
      study subjects (i.e., clinicians).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">October 2014</completion_date>
  <primary_completion_date type="Anticipated">September 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measures of Diagnostic effectiveness</measure>
    <time_frame>Completion of each case vignette (typically ½ hour)</time_frame>
    <description>Each clinician subject reviews each case vignette and lists their differential diagnosis (&quot;Unaided&quot;).&#xD;
Then the clinician subject uses the diagnostic decision support software and then lists a revised differential diagnosis (&quot;Aided&quot;).&#xD;
The match between the clinician subject's differential diagnosis and a Gold Standard differential diagnosis list for each case is measured, looking at rank order of correct diseases and omissions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measures of Patient workup effectiveness</measure>
    <time_frame>Completion of each case vignette (typically in the same ½ hour as measure 1)</time_frame>
    <description>Each clinician subject reviews each case vignette and lists their initial workup (&quot;Unaided&quot;).&#xD;
Then the clinician subject uses the diagnostic decision support software and then lists a revised initial workup (&quot;Aided&quot;).&#xD;
The match between the clinician subject's initial workup and a Gold Standard workup list for each case is measured, looking at rank order of correct diseases and omissions.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Rheumatology</condition>
  <arm_group>
    <arm_group_label>Diagnosis</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Test diagnostic decision support software</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diagnosis</intervention_name>
    <description>Unaided: The testers will record a differential diagnosis consisting of a list of diseases and their ranking and a prioritized list of test orders, as well as the most appropriate referral for further evaluation and treatment of the patient.&#xD;
Aided: Then testers will enter the case into diagnostic decision support software and after getting advice from the software, the testers will record the same information as in Unaided, but allowing for the possibility that responses could differ as a result of using the software.</description>
    <arm_group_label>Diagnosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria: Clinicians in various medical specialties&#xD;
&#xD;
        Exclusion criteria: Non-clinician&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael M Segal, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>SimulConsult, Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Robert M Sundel, MD</last_name>
    <phone>(617) 355-6524</phone>
    <email>robert.sundel@childrens.harvard.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lynn Feldman, MBA</last_name>
    <phone>617-879-1670</phone>
    <email>rheumatologystudy@simulconsult.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>SimulConsult</name>
      <address>
        <city>Brookline</city>
        <state>Massachusetts</state>
        <zip>02467</zip>
        <country>United States</country>
      </address>
    </facility>
    <investigator>
      <last_name>Robert M Sundel, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michael M Segal, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Segal MM, Williams MS, Gropman AL, Torres AR, Forsyth R, Connolly AM, El-Hattab AW, Perlman SJ, Samanta D, Parikh S, Pavlakis SG, Feldman LK, Betensky RA, Gospe SM Jr. Evidence-based decision support for neurological diagnosis reduces errors and unnecessary workup. J Child Neurol. 2014 Apr;29(4):487-92. doi: 10.1177/0883073813483365. Epub 2013 Apr 10.</citation>
    <PMID>23576414</PMID>
  </reference>
  <reference>
    <citation>Segal MM, Schiffmann R. Decision support for diagnosis: co-evolution of tools and resources. Neurology. 2012 May 15;78(20):1546-7. doi: 10.1212/WNL.0b013e3182563c36. Epub 2012 Apr 18. No abstract available.</citation>
    <PMID>22517101</PMID>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>July 29, 2014</last_update_submitted>
  <last_update_submitted_qc>July 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 31, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <pending_results>
    <submitted>March 16, 2021</submitted>
    <returned>April 9, 2021</returned>
  </pending_results>
  <!-- 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/NCT02205086
org study id: SimulConsult2
nct id: NCT02205086
lead sponsor: 
has dmc: No
This study compares the ability of clinicians to make diagnoses with or without the
      assistance of diagnostic decision support software. The area of clinical focus is primarily
      rheumatology.
The study uses written case vignettes, not decisions about patients seeking care from the
      study subjects (i.e., clinicians).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Measures of Diagnostic effectiveness
time frame: Completion of each case vignette (typically ½ hour)
description: Each clinician subject reviews each case vignette and lists their differential diagnosis ("Unaided").
Then the clinician subject uses the diagnostic decision support software and then lists a revised differential diagnosis ("Aided").
The match between the clinician subject's differential diagnosis and a Gold Standard differential diagnosis list for each case is measured, looking at rank order of correct diseases and omissions.
measure: Measures of Patient workup effectiveness
time frame: Completion of each case vignette (typically in the same ½ hour as measure 1)
description: Each clinician subject reviews each case vignette and lists their initial workup ("Unaided").
Then the clinician subject uses the diagnostic decision support software and then lists a revised initial workup ("Aided").
The match between the clinician subject's initial workup and a Gold Standard workup list for each case is measured, looking at rank order of correct diseases and omissions.
arm group label: Diagnosis
arm group type: Other
description: Test diagnostic decision support software
intervention type: Other
intervention name: Diagnosis
description: Unaided: The testers will record a differential diagnosis consisting of a list of diseases and their ranking and a prioritized list of test orders, as well as the most appropriate referral for further evaluation and treatment of the patient.
Aided: Then testers will enter the case into diagnostic decision support software and after getting advice from the software, the testers will record the same information as in Unaided, but allowing for the possibility that responses could differ as a result of using the software.
arm group label: Diagnosis
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michael M Segal, MD PhD
role: Principal Investigator
affiliation: SimulConsult, Inc.
last name: Robert M Sundel, MD
phone: (617) 355-6524
email: robert.sundel@childrens.harvard.edu
last name: Lynn Feldman, MBA
phone: 617-879-1670
email: rheumatologystudy@simulconsult.com
facility: 
investigator: 
investigator: 
country: United States
citation: Segal MM, Williams MS, Gropman AL, Torres AR, Forsyth R, Connolly AM, El-Hattab AW, Perlman SJ, Samanta D, Parikh S, Pavlakis SG, Feldman LK, Betensky RA, Gospe SM Jr. Evidence-based decision support for neurological diagnosis reduces errors and unnecessary workup. J Child Neurol. 2014 Apr;29(4):487-92. doi: 10.1177/0883073813483365. Epub 2013 Apr 10.
PMID: 23576414
citation: Segal MM, Schiffmann R. Decision support for diagnosis: co-evolution of tools and resources. Neurology. 2012 May 15;78(20):1546-7. doi: 10.1212/WNL.0b013e3182563c36. Epub 2012 Apr 18. No abstract available.
PMID: 22517101
responsible party type: Sponsor
submitted: March 16, 2021
returned: April 9, 2021