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/NCT06012838</url>
    </required_header>
    <id_info>
      <org_study_id>202207125RIND</org_study_id>
      <nct_id>NCT06012838</nct_id>
    </id_info>
    <brief_title>The Systematic Approach for Identification of Cause Among Out-of-hospital Cardiac Arrest Survivors</brief_title>
    <official_title>The Systematic Approach for Identification of Cause Among Out-of-hospital Cardiac Arrest Survivors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Taiwan University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Taiwan University Hospital</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>
        The cause of cardiac arrest mostly determines outcomes of cardiac arrest survivors.&#xD;
        Identifying and treating the cause of cardiac arrest constitute a critical part in&#xD;
        post-arrest care. However, the pathophysiology of cardiac arrest often encompasses multiple&#xD;
        organ systems. Thus, forming accurate diagnosis for each case presents a daunting challenge,&#xD;
        especially for unexperienced physicians. This study aims to evaluate whether a standardized&#xD;
        protocol would improve the diagnostic proficiency for out-of-hospital cardiac arrest (OHCA)&#xD;
        patients.&#xD;
  &#xD;
        Sixteen Emergency Medicine Residents from National Taiwan University Hospital participated in&#xD;
        this study. The cause classification of OHCA (CCCA) protocol was developed by an expert&#xD;
        cardiac arrest committee, and a lecture concerning the Utstein's template, the epidemiology&#xD;
        of cardiac arrest and the CCCA protocol was addressed. Pre-/post-lecture questionnaires&#xD;
        regarding self-assessed diagnostic certainty and knowledge of cardiac arrest were obtained&#xD;
        and compared to evaluate participants' learning effectiveness. To validate the efficiency of&#xD;
        protocol, medical records of 586 non-traumatic OHCA adults with successful resuscitation and&#xD;
        ICU admission were reviewed retrospectively, and the OHCA cause of each patient was&#xD;
        identified by the trained residents following CCCA protocol. The primary outcome was the&#xD;
        diagnostic consistency between protocolized diagnosis, expert diagnosis and the discharge&#xD;
        diagnosis&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        To identify the classification of OHCA cause, the cause classification of OHCA (CCCA)&#xD;
        protocol was established based on previous studies, expert physician's experience and&#xD;
        questionnaire of young physicians.&#xD;
  &#xD;
        Residents from emergency department of National Taiwan University Hospital participated the&#xD;
        program and received the lecture concerning the Utstein's template, the epidemiology of&#xD;
        cardiac arrest, interpretation of examinations, and the CCCA protocol. To evaluate the&#xD;
        learning effect of the lecture, pre-lecture and post-lecture questionnaire were designed,&#xD;
        which included the knowledge for OHCA classification, confidence for correct diagnosis during&#xD;
        CPR and after return of spontaneous circulation (ROSC), and the mandatory examinations for&#xD;
        cause identification. Confidence level more than 50% was recognized as sufficient to make&#xD;
        proper cause identification. The enrolled residents were asked to review the medical records&#xD;
        of 3 non-traumatic adult OHCA patients before lecture and identified the OHCA cause by their&#xD;
        own without the assist of the CCCA protocol. After lecture, another 3 medical records were&#xD;
        reviewed by the participants with the use of the CCAC protocol. The consistency of OHCA cause&#xD;
        between young physicians were evaluated before and after lecture, respectively.&#xD;
  &#xD;
        To validate the efficiency of the CCCA protocol, these trained residents further identified&#xD;
        the arrest cause of 586 non-traumatic adult OHCA patients who survived to ICU admission from&#xD;
        January 2015 to July 2021 in NTUH following the established protocol.&#xD;
  &#xD;
        The primary outcome was the consistency of OHCA cause between protocolized diagnosis, expert&#xD;
        diagnosis and the discharge diagnosis. The diagnosis made by young physicians with protocol&#xD;
        defined as protocolized diagnosis. The expert physician is an experienced emergency&#xD;
        physicians specialized in both emergency and critical care, who has reviewed the medical&#xD;
        records without the assistance of the established CCCA protocol. Expert diagnosis was&#xD;
        recognized as diagnosis identified by expert physician. The discharge diagnosis is the major&#xD;
        diagnosis related to index cardiac arrest.&#xD;
  &#xD;
        Categorical variables are presented as numbers (percentages) and evaluated by the Chi-Squared&#xD;
        test. The continuous variables are presented as mean ± standard deviation. The Light's kappa&#xD;
        was used to evaluate the consistency of OHCA classification. The value ≤ 0.40 indicates&#xD;
        minimal agreement, while value ≥ 0.80 represent strong and almost perfect consistency16-17.&#xD;
        The statistical significance was set at p &lt;0.05. All statistical analyses were performed&#xD;
        using Statistical Package for Social Sciences Statistics (version 21.0; IBM, Chicago, IL,&#xD;
        USA).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 10, 2022</start_date>
    <completion_date type="Actual">November 10, 2022</completion_date>
    <primary_completion_date type="Actual">November 10, 2022</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>diagnostic consistency between protocolized diagnosis and the discharge diagnosis</measure>
      <time_frame>3 months</time_frame>
      <description>The diagnosis made by young physicians with protocol defined as protocolized diagnosis. Expert diagnosis was recognized as diagnosis identified by expert physician. The expert physician is an experienced emergency physicians specialized in both emergency and critical care, who has reviewed the medical records without the assistance of the established CCCA protocol. The discharge diagnosis is the major diagnosis related to index cardiac arrest. The Light's kappa was used to evaluate the consistency of OHCA classification.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>diagnostic consistency between protocolized diagnosis and the expert diagnosis</measure>
      <time_frame>3 months</time_frame>
      <description>The diagnosis made by young physicians with protocol defined as protocolized diagnosis. Expert diagnosis was recognized as diagnosis identified by expert physician. The expert physician is an experienced emergency physicians specialized in both emergency and critical care, who has reviewed the medical records without the assistance of the established CCCA protocol. The discharge diagnosis is the major diagnosis related to index cardiac arrest. The Light's kappa was used to evaluate the consistency of OHCA classification.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Portion of sufficient confidence to make proper OHCA cause identification</measure>
      <time_frame>2 months</time_frame>
      <description>To evaluate the learning effect of the lecture, pre-lecture and post-lecture questionnaire were designed. Confidence level more than 50% was recognized as sufficient to make proper cause identification. Categorical variables are presented as numbers (percentages) and evaluated by the Chi-Squared test.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the accuracy rates on the classification test of OHCA cause before and after the lecture</measure>
      <time_frame>baseline, 2 weeks</time_frame>
      <description>To evaluate the learning effect of the lecture, pre-lecture and post-lecture questionnaire were designed. The knowledge for OHCA classification was evaluated by the accuracy rates on each questionnaires. Categorical variables are presented as numbers (percentages) and evaluated by the Chi-Squared test.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>diagnostic consistency between participants before and after the lecture</measure>
      <time_frame>baseline, 2 weeks</time_frame>
      <description>To evaluate the learning effect of the lecture, pre-lecture and post-lecture questionnaire were designed. The enrolled residents were asked to review the medical records of 3 non-traumatic adult OHCA patients before lecture and identified the OHCA cause by their own without the assist of the CCCA protocol. After lecture, another 3 medical records were reviewed by the participants with the use of the CCAC protocol. The consistency of OHCA cause between young physicians were evaluated before and after lecture, respectively. The Light's kappa was used to evaluate the consistency of OHCA classification.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">16</enrollment>
    <condition>Out-Of-Hospital Cardiac Arrest</condition>
    <arm_group>
      <arm_group_label>cause classification of OHCA protocol</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The cause classification of OHCA protocol was developed by an expert cardiac arrest committee. A lecture concerning the Utstein's template, the epidemiology of cardiac arrest and the CCCA protocol was addressed to the participants.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Cause classification of OHCA protocol</intervention_name>
      <description>training program with cause classification of OHCA protocol</description>
      <arm_group_label>cause classification of OHCA protocol</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Residents of National Taiwan University Hospital&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Visiting staffs of National Taiwan University Hospital&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Min-Shan Tsai, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>National Taiwan University Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>National Taiwan University Hospital</name>
        <address>
          <city>Taipei county</city>
          <zip>100</zip>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Non-traumatic Out-Of-Hospital Cardiac Arrest</keyword>
    <keyword>training program</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Arrest</mesh_term>
      <mesh_term>Out-of-Hospital Cardiac Arrest</mesh_term>
    </condition_browse>
    <!-- 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/NCT06012838
  org study id: 202207125RIND
  nct id: NCT06012838
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The cause of cardiac arrest mostly determines outcomes of cardiac arrest survivors.
        Identifying and treating the cause of cardiac arrest constitute a critical part in
        post-arrest care. However, the pathophysiology of cardiac arrest often encompasses multiple
        organ systems. Thus, forming accurate diagnosis for each case presents a daunting challenge,
        especially for unexperienced physicians. This study aims to evaluate whether a standardized
        protocol would improve the diagnostic proficiency for out-of-hospital cardiac arrest (OHCA)
        patients.
  
        Sixteen Emergency Medicine Residents from National Taiwan University Hospital participated in
        this study. The cause classification of OHCA (CCCA) protocol was developed by an expert
        cardiac arrest committee, and a lecture concerning the Utstein's template, the epidemiology
        of cardiac arrest and the CCCA protocol was addressed. Pre-/post-lecture questionnaires
        regarding self-assessed diagnostic certainty and knowledge of cardiac arrest were obtained
        and compared to evaluate participants' learning effectiveness. To validate the efficiency of
        protocol, medical records of 586 non-traumatic OHCA adults with successful resuscitation and
        ICU admission were reviewed retrospectively, and the OHCA cause of each patient was
        identified by the trained residents following CCCA protocol. The primary outcome was the
        diagnostic consistency between protocolized diagnosis, expert diagnosis and the discharge
        diagnosis
  To identify the classification of OHCA cause, the cause classification of OHCA (CCCA)
        protocol was established based on previous studies, expert physician's experience and
        questionnaire of young physicians.
  
        Residents from emergency department of National Taiwan University Hospital participated the
        program and received the lecture concerning the Utstein's template, the epidemiology of
        cardiac arrest, interpretation of examinations, and the CCCA protocol. To evaluate the
        learning effect of the lecture, pre-lecture and post-lecture questionnaire were designed,
        which included the knowledge for OHCA classification, confidence for correct diagnosis during
        CPR and after return of spontaneous circulation (ROSC), and the mandatory examinations for
        cause identification. Confidence level more than 50% was recognized as sufficient to make
        proper cause identification. The enrolled residents were asked to review the medical records
        of 3 non-traumatic adult OHCA patients before lecture and identified the OHCA cause by their
        own without the assist of the CCCA protocol. After lecture, another 3 medical records were
        reviewed by the participants with the use of the CCAC protocol. The consistency of OHCA cause
        between young physicians were evaluated before and after lecture, respectively.
  
        To validate the efficiency of the CCCA protocol, these trained residents further identified
        the arrest cause of 586 non-traumatic adult OHCA patients who survived to ICU admission from
        January 2015 to July 2021 in NTUH following the established protocol.
  
        The primary outcome was the consistency of OHCA cause between protocolized diagnosis, expert
        diagnosis and the discharge diagnosis. The diagnosis made by young physicians with protocol
        defined as protocolized diagnosis. The expert physician is an experienced emergency
        physicians specialized in both emergency and critical care, who has reviewed the medical
        records without the assistance of the established CCCA protocol. Expert diagnosis was
        recognized as diagnosis identified by expert physician. The discharge diagnosis is the major
        diagnosis related to index cardiac arrest.
  
        Categorical variables are presented as numbers (percentages) and evaluated by the Chi-Squared
        test. The continuous variables are presented as mean ± standard deviation. The Light's kappa
        was used to evaluate the consistency of OHCA classification. The value ≤ 0.40 indicates
        minimal agreement, while value ≥ 0.80 represent strong and almost perfect consistency16-17.
        The statistical significance was set at p <0.05. All statistical analyses were performed
        using Statistical Package for Social Sciences Statistics (version 21.0; IBM, Chicago, IL,
        USA).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: diagnostic consistency between protocolized diagnosis and the discharge diagnosis
  time frame: 3 months
  description: The diagnosis made by young physicians with protocol defined as protocolized diagnosis. Expert diagnosis was recognized as diagnosis identified by expert physician. The expert physician is an experienced emergency physicians specialized in both emergency and critical care, who has reviewed the medical records without the assistance of the established CCCA protocol. The discharge diagnosis is the major diagnosis related to index cardiac arrest. The Light's kappa was used to evaluate the consistency of OHCA classification.
  measure: diagnostic consistency between protocolized diagnosis and the expert diagnosis
  time frame: 3 months
  description: The diagnosis made by young physicians with protocol defined as protocolized diagnosis. Expert diagnosis was recognized as diagnosis identified by expert physician. The expert physician is an experienced emergency physicians specialized in both emergency and critical care, who has reviewed the medical records without the assistance of the established CCCA protocol. The discharge diagnosis is the major diagnosis related to index cardiac arrest. The Light's kappa was used to evaluate the consistency of OHCA classification.
  measure: Portion of sufficient confidence to make proper OHCA cause identification
  time frame: 2 months
  description: To evaluate the learning effect of the lecture, pre-lecture and post-lecture questionnaire were designed. Confidence level more than 50% was recognized as sufficient to make proper cause identification. Categorical variables are presented as numbers (percentages) and evaluated by the Chi-Squared test.
  measure: the accuracy rates on the classification test of OHCA cause before and after the lecture
  time frame: baseline, 2 weeks
  description: To evaluate the learning effect of the lecture, pre-lecture and post-lecture questionnaire were designed. The knowledge for OHCA classification was evaluated by the accuracy rates on each questionnaires. Categorical variables are presented as numbers (percentages) and evaluated by the Chi-Squared test.
  measure: diagnostic consistency between participants before and after the lecture
  time frame: baseline, 2 weeks
  description: To evaluate the learning effect of the lecture, pre-lecture and post-lecture questionnaire were designed. The enrolled residents were asked to review the medical records of 3 non-traumatic adult OHCA patients before lecture and identified the OHCA cause by their own without the assist of the CCCA protocol. After lecture, another 3 medical records were reviewed by the participants with the use of the CCAC protocol. The consistency of OHCA cause between young physicians were evaluated before and after lecture, respectively. The Light's kappa was used to evaluate the consistency of OHCA classification.
  arm group label: cause classification of OHCA protocol
  arm group type: Experimental
  description: The cause classification of OHCA protocol was developed by an expert cardiac arrest committee. A lecture concerning the Utstein's template, the epidemiology of cardiac arrest and the CCCA protocol was addressed to the participants.
  intervention type: Behavioral
  intervention name: Cause classification of OHCA protocol
  description: training program with cause classification of OHCA protocol
  arm group label: cause classification of OHCA protocol
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Min-Shan Tsai, MD, PhD
  role: Principal Investigator
  affiliation: National Taiwan University Hospital
  facility: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Heart Arrest
  mesh term: Out-of-Hospital Cardiac Arrest