<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/NCT02971163</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 15-1016</org_study_id>
    <secondary_id>1K23HL132052-01</secondary_id>
    <nct_id>NCT02971163</nct_id>
  </id_info>
  <brief_title>Syncope Decision Aid for Emergency Care</brief_title>
  <acronym>SynDA</acronym>
  <official_title>SynDA: Syncope Decision Aid for Emergency Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</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>
      Syncope, or transient loss of consciousness/fainting, is a common emergency department (ED)&#xD;
      complaint responsible for over 1 million ED visits yearly. Potential causes include benign&#xD;
      conditions such as dehydration or vaso-vagal syncope. Rarely, syncope is the result of&#xD;
      serious cardiac conditions. In older patients without a clear cause of syncope hospital&#xD;
      admission is frequently initiated at very low risk thresholds, though there is little&#xD;
      evidence that these admissions improve patient outcomes. These decisions are often made&#xD;
      without significant patient input or discussion of reasonable alternatives. In this&#xD;
      situation, a patient's values, preferences, and particular circumstances should be taken into&#xD;
      account. This mutualistic approach to clinical management is referred to as Shared&#xD;
      Decision-Making. Shared Decision-Making (SDM) is a joint process of choice selection between&#xD;
      providers and patients in clinical scenarios where multiple reasonable management options&#xD;
      exist. To improve syncope emergency care, the researchers can leverage recent advances in&#xD;
      risk stratification to engage patients in SDM and deliver superior, patient-centered care.&#xD;
&#xD;
      This study will provide the groundwork for a larger, randomized controlled trial evaluating&#xD;
      the effects of the decision aid for management of low-risk syncope.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Setting:&#xD;
&#xD;
      Mount Sinai Hospital (MSH) has a 61-bed adult Emergency Department with a volume of over&#xD;
      100,000 patient visits/year or approximately 300 visits/day. MSH is a large academic tertiary&#xD;
      care medical center located in East Harlem and serves a large black and Hispanic community.&#xD;
&#xD;
      Projected Recruitment: There are approximately 60 MSH ED visits for syncope per month of&#xD;
      which 35 per month are by patients above age 30. Roughly half of these do not have a clear&#xD;
      etiology of their syncope discovered in the ED. The researchers project that of the 17&#xD;
      potentially eligible patients per month, three will be successfully enrolled for a projected&#xD;
      72 patient enrollees at the completion of the 24-month recruitment period. The PI, clinical&#xD;
      research coordinators, and SRAs will monitor the real-time electronic tracking system for all&#xD;
      ED patients and will identify any patient over age 30 with a chief complaint of syncope or&#xD;
      loss of consciousness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">January 9, 2019</completion_date>
  <primary_completion_date type="Actual">January 9, 2019</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants at End of Study</measure>
    <time_frame>Two years</time_frame>
    <description>Feasibility of the study will be measured by the number of participants successfully enrolled at the end of the study period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Knowledge</measure>
    <time_frame>Within 2 hours post ED disposition on Day 1</time_frame>
    <description>One brief post-encounter survey will be given to the patient to assess their knowledge surrounding syncope and their satisfaction with their care during the ED visit. Scores full range is 0-9, higher score indicates more knowledge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decisional Conflict Scale</measure>
    <time_frame>Within 2 hours post ED disposition on Day 1</time_frame>
    <description>Decisional quality will be measured by administering the Decisional Conflict Scale to all patients after disposition decision has been made. The decisional conflict scale total score range from 0 (no decisional conflict) to 10 (extremely high decisional conflict).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Utilization Outcomes</measure>
    <time_frame>Day 1 and 30 day follow up period</time_frame>
    <description>Number of patients admitted to the hospital or sent to observation unit at index visit and number of patients admitted to the hospital, or had an office visit or during 30-day follow-up period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Repeat Visits to the ED</measure>
    <time_frame>30-day follow-up period</time_frame>
    <description>Number of participants with repeat visits to the ED during 30-day follow-up period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants With New Significant Clinical Diagnosis</measure>
    <time_frame>at 30 days</time_frame>
    <description>Number of participants with clinical diagnosis at 30 days after index visit to the ED</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Diagnostic Testing</measure>
    <time_frame>Day 1</time_frame>
    <description>Number of diagnostic test (which may include but not limited to exercise stress testing, echocardiography, computed tomography scans) performed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OPTION-5 Scale</measure>
    <time_frame>up to 2 years</time_frame>
    <description>The degree of patient involvement in the disposition decision as measured by the OPTION (observing patient involvement in decision making) scale. The OPTION-5 scale is a brief, 5-item instrument used by a trained observer to measure the degree of patient involvement in clinical decision-making and has demonstrated validity and reliability. Full scores range from 0 to 100, with higher scores indicating higher levels of patient involvement.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Syncope</condition>
  <arm_group>
    <arm_group_label>SynDA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in the control arm will receive usual emergency care pertaining to syncope.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SynDA</intervention_name>
    <description>SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.</description>
    <arm_group_label>SynDA</arm_group_label>
    <other_name>Syncope Decision Aid</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Emergency Department patient&#xD;
&#xD;
          -  Age 30 years or above&#xD;
&#xD;
          -  Chief complaint of syncope&#xD;
&#xD;
          -  Capacity to make medical decisions&#xD;
&#xD;
          -  Speak and read English&#xD;
&#xD;
          -  Working phone number and fixed address&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Altered Mental Status&#xD;
&#xD;
          -  Cognitive Impairment&#xD;
&#xD;
          -  Serious acute diagnosis:&#xD;
&#xD;
             (e.g. clinically significant cardiac dysrhythmia, structural heart disease,&#xD;
             gastrointestinal hemorrhage, myocardial infarction, pulmonary embolism, pneumonia,&#xD;
             arterial dissection, serious infection, ectopic pregnancy, subarachnoid hemorrhage, or&#xD;
             stroke.)&#xD;
&#xD;
          -  Hemodynamic instability&#xD;
&#xD;
          -  Inability to read or speak English&#xD;
&#xD;
          -  Major communication barrier&#xD;
&#xD;
          -  Lack of phone number or fixed address&#xD;
&#xD;
          -  Too high risk as per physician judgment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lynne Richardson, MD</last_name>
    <role>Study Director</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <results_first_submitted>May 1, 2020</results_first_submitted>
  <results_first_submitted_qc>May 21, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">May 26, 2020</results_first_posted>
  <last_update_submitted>May 21, 2020</last_update_submitted>
  <last_update_submitted_qc>May 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Syncope</keyword>
  <keyword>Shared Decision-Making</keyword>
  <keyword>Emergency Medicine</keyword>
  <keyword>Decision Aid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syncope</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT02971163/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>After screening 351 patients, 51 randomized, one was excluded because not syncope, resulting in 50 participants enrolled with unexplained syncope from January 2017 to January 2019.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>SynDA</title>
          <description>The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.&#xD;
SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Patients in the control arm will receive usual emergency care pertaining to syncope.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>SynDA</title>
          <description>The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.&#xD;
SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Patients in the control arm will receive usual emergency care pertaining to syncope.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="24"/>
            <count group_id="B2" value="26"/>
            <count group_id="B3" value="50"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.5" lower_limit="45.3" upper_limit="70"/>
                    <measurement group_id="B2" value="60" lower_limit="47.8" upper_limit="73"/>
                    <measurement group_id="B3" value="58.5" lower_limit="46.3" upper_limit="71.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Black/African-American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic/Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Control Preferences Scale</title>
          <description>A validated single question measure of patient's desire for involvement in medical decisions that ranges from 1 (active) to 3 (collaborative) to 5 (passive).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing data</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Subjective Numeracy Score (SNS)</title>
          <description>The SNS consists of three questions summed to give a min and max score of 3-18 with higher scores indicating higher subjective numeracy skills.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.2" spread="2.6"/>
                    <measurement group_id="B2" value="12.6" spread="2.6"/>
                    <measurement group_id="B3" value="12.9" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Short Literacy Survey (SLS)</title>
          <description>The SLS consists of three questions summed to give a score of 3-15 with higher scores indicating greater subjective health literacy.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.2" spread="2.6"/>
                    <measurement group_id="B2" value="12.6" spread="2.6"/>
                    <measurement group_id="B3" value="12.9" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Some High School</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High School Graduate/GED</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Some College</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>College Graduate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Graduate School</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Income</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Less than $20,000</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>$20,000 to $29,999</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>$30,000 to $39,999</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>$40,000 to $59,999</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>$60,000 to $79,999</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>$80,000 to $99,999</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>$100,000 or more</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rather Not Say</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Canadian Syncope Risk Score</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Low: 0 (≈2% risk)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medium: 1 (≈3% risk)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medium: 2 (≈5% risk)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants at End of Study</title>
        <description>Feasibility of the study will be measured by the number of participants successfully enrolled at the end of the study period.</description>
        <time_frame>Two years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SynDA</title>
            <description>The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.&#xD;
SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients in the control arm will receive usual emergency care pertaining to syncope.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants at End of Study</title>
          <description>Feasibility of the study will be measured by the number of participants successfully enrolled at the end of the study period.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Knowledge</title>
        <description>One brief post-encounter survey will be given to the patient to assess their knowledge surrounding syncope and their satisfaction with their care during the ED visit. Scores full range is 0-9, higher score indicates more knowledge</description>
        <time_frame>Within 2 hours post ED disposition on Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SynDA</title>
            <description>The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.&#xD;
SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients in the control arm will receive usual emergency care pertaining to syncope.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Knowledge</title>
          <description>One brief post-encounter survey will be given to the patient to assess their knowledge surrounding syncope and their satisfaction with their care during the ED visit. Scores full range is 0-9, higher score indicates more knowledge</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" spread="1.8"/>
                    <measurement group_id="O2" value="5.3" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Decisional Conflict Scale</title>
        <description>Decisional quality will be measured by administering the Decisional Conflict Scale to all patients after disposition decision has been made. The decisional conflict scale total score range from 0 (no decisional conflict) to 10 (extremely high decisional conflict).</description>
        <time_frame>Within 2 hours post ED disposition on Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SynDA</title>
            <description>The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.&#xD;
SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients in the control arm will receive usual emergency care pertaining to syncope.</description>
          </group>
        </group_list>
        <measure>
          <title>Decisional Conflict Scale</title>
          <description>Decisional quality will be measured by administering the Decisional Conflict Scale to all patients after disposition decision has been made. The decisional conflict scale total score range from 0 (no decisional conflict) to 10 (extremely high decisional conflict).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9" spread="1.5"/>
                    <measurement group_id="O2" value="9" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Utilization Outcomes</title>
        <description>Number of patients admitted to the hospital or sent to observation unit at index visit and number of patients admitted to the hospital, or had an office visit or during 30-day follow-up period</description>
        <time_frame>Day 1 and 30 day follow up period</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SynDA</title>
            <description>The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.&#xD;
SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients in the control arm will receive usual emergency care pertaining to syncope.</description>
          </group>
        </group_list>
        <measure>
          <title>Utilization Outcomes</title>
          <description>Number of patients admitted to the hospital or sent to observation unit at index visit and number of patients admitted to the hospital, or had an office visit or during 30-day follow-up period</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Admitted to hospital Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sent to observation unit Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Admitted to hospital 30 day follow up period</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Office visit 30 day follow up period</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Repeat Visits to the ED</title>
        <description>Number of participants with repeat visits to the ED during 30-day follow-up period</description>
        <time_frame>30-day follow-up period</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SynDA</title>
            <description>The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.&#xD;
SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients in the control arm will receive usual emergency care pertaining to syncope.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Repeat Visits to the ED</title>
          <description>Number of participants with repeat visits to the ED during 30-day follow-up period</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants With New Significant Clinical Diagnosis</title>
        <description>Number of participants with clinical diagnosis at 30 days after index visit to the ED</description>
        <time_frame>at 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SynDA</title>
            <description>The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.&#xD;
SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients in the control arm will receive usual emergency care pertaining to syncope.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants With New Significant Clinical Diagnosis</title>
          <description>Number of participants with clinical diagnosis at 30 days after index visit to the ED</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Acute Stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heart Failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cardiac Arrhythmia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Large Pericardial Effusion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Diagnostic Testing</title>
        <description>Number of diagnostic test (which may include but not limited to exercise stress testing, echocardiography, computed tomography scans) performed</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SynDA</title>
            <description>The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.&#xD;
SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients in the control arm will receive usual emergency care pertaining to syncope.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Diagnostic Testing</title>
          <description>Number of diagnostic test (which may include but not limited to exercise stress testing, echocardiography, computed tomography scans) performed</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>OPTION-5 Scale</title>
        <description>The degree of patient involvement in the disposition decision as measured by the OPTION (observing patient involvement in decision making) scale. The OPTION-5 scale is a brief, 5-item instrument used by a trained observer to measure the degree of patient involvement in clinical decision-making and has demonstrated validity and reliability. Full scores range from 0 to 100, with higher scores indicating higher levels of patient involvement.</description>
        <time_frame>up to 2 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SynDA</title>
            <description>The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.&#xD;
SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients in the control arm will receive usual emergency care pertaining to syncope.</description>
          </group>
        </group_list>
        <measure>
          <title>OPTION-5 Scale</title>
          <description>The degree of patient involvement in the disposition decision as measured by the OPTION (observing patient involvement in decision making) scale. The OPTION-5 scale is a brief, 5-item instrument used by a trained observer to measure the degree of patient involvement in clinical decision-making and has demonstrated validity and reliability. Full scores range from 0 to 100, with higher scores indicating higher levels of patient involvement.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.0" spread="18"/>
                    <measurement group_id="O2" value="26.6" spread="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>30 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>SynDA</title>
          <description>The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.&#xD;
SynDA: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Patients in the control arm will receive usual emergency care pertaining to syncope.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Small sample size of only English-speaking patients from a single, busy, urban, academic center.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Marc A. Probst</name_or_title>
      <organization>Mount Sinai Medical Center</organization>
      <phone>212-824-8094</phone>
      <email>marc.probst@mssm.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02971163
org study id: GCO 15-1016
secondary id: 1K23HL132052-01
nct id: NCT02971163
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Syncope, or transient loss of consciousness/fainting, is a common emergency department (ED)
      complaint responsible for over 1 million ED visits yearly. Potential causes include benign
      conditions such as dehydration or vaso-vagal syncope. Rarely, syncope is the result of
      serious cardiac conditions. In older patients without a clear cause of syncope hospital
      admission is frequently initiated at very low risk thresholds, though there is little
      evidence that these admissions improve patient outcomes. These decisions are often made
      without significant patient input or discussion of reasonable alternatives. In this
      situation, a patient's values, preferences, and particular circumstances should be taken into
      account. This mutualistic approach to clinical management is referred to as Shared
      Decision-Making. Shared Decision-Making (SDM) is a joint process of choice selection between
      providers and patients in clinical scenarios where multiple reasonable management options
      exist. To improve syncope emergency care, the researchers can leverage recent advances in
      risk stratification to engage patients in SDM and deliver superior, patient-centered care.

      This study will provide the groundwork for a larger, randomized controlled trial evaluating
      the effects of the decision aid for management of low-risk syncope.
Setting:

      Mount Sinai Hospital (MSH) has a 61-bed adult Emergency Department with a volume of over
      100,000 patient visits/year or approximately 300 visits/day. MSH is a large academic tertiary
      care medical center located in East Harlem and serves a large black and Hispanic community.

      Projected Recruitment: There are approximately 60 MSH ED visits for syncope per month of
      which 35 per month are by patients above age 30. Roughly half of these do not have a clear
      etiology of their syncope discovered in the ED. The researchers project that of the 17
      potentially eligible patients per month, three will be successfully enrolled for a projected
      72 patient enrollees at the completion of the 24-month recruitment period. The PI, clinical
      research coordinators, and SRAs will monitor the real-time electronic tracking system for all
      ED patients and will identify any patient over age 30 with a chief complaint of syncope or
      loss of consciousness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Number of Participants at End of Study
time frame: Two years
description: Feasibility of the study will be measured by the number of participants successfully enrolled at the end of the study period.
measure: Patient Knowledge
time frame: Within 2 hours post ED disposition on Day 1
description: One brief post-encounter survey will be given to the patient to assess their knowledge surrounding syncope and their satisfaction with their care during the ED visit. Scores full range is 0-9, higher score indicates more knowledge
measure: Decisional Conflict Scale
time frame: Within 2 hours post ED disposition on Day 1
description: Decisional quality will be measured by administering the Decisional Conflict Scale to all patients after disposition decision has been made. The decisional conflict scale total score range from 0 (no decisional conflict) to 10 (extremely high decisional conflict).
measure: Utilization Outcomes
time frame: Day 1 and 30 day follow up period
description: Number of patients admitted to the hospital or sent to observation unit at index visit and number of patients admitted to the hospital, or had an office visit or during 30-day follow-up period
measure: Number of Participants With Repeat Visits to the ED
time frame: 30-day follow-up period
description: Number of participants with repeat visits to the ED during 30-day follow-up period
measure: Participants With New Significant Clinical Diagnosis
time frame: at 30 days
description: Number of participants with clinical diagnosis at 30 days after index visit to the ED
measure: Number of Diagnostic Testing
time frame: Day 1
description: Number of diagnostic test (which may include but not limited to exercise stress testing, echocardiography, computed tomography scans) performed
measure: OPTION-5 Scale
time frame: up to 2 years
description: The degree of patient involvement in the disposition decision as measured by the OPTION (observing patient involvement in decision making) scale. The OPTION-5 scale is a brief, 5-item instrument used by a trained observer to measure the degree of patient involvement in clinical decision-making and has demonstrated validity and reliability. Full scores range from 0 to 100, with higher scores indicating higher levels of patient involvement.
arm group label: SynDA
arm group type: Experimental
description: The research coordinator will print the appropriate version of the SynDA based on the patient's individualized risk score and the corresponding estimated probability of a serious medical event within 30 days.
arm group label: Control
arm group type: No Intervention
description: Patients in the control arm will receive usual emergency care pertaining to syncope.
intervention type: Behavioral
intervention name: SynDA
description: SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.
arm group label: SynDA
other name: Syncope Decision Aid
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
last name: Lynne Richardson, MD
role: Study Director
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
country: United States
responsible party type: Sponsor
mesh term: Syncope
mesh term: Emergencies
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Small sample size of only English-speaking patients from a single, busy, urban, academic center.
point of contact: 