<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/NCT03834870</url>
  </required_header>
  <id_info>
    <org_study_id>2000023799</org_study_id>
    <secondary_id>5R01AG060084-04</secondary_id>
    <nct_id>NCT03834870</nct_id>
  </id_info>
  <brief_title>Virtual cOaching in Making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES)</brief_title>
  <acronym>VOICES</acronym>
  <official_title>Virtual cOaching in Making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To develop an interactive tool to screen for Elder Mistreatment (EM) in the Emergency&#xD;
      Department (ED) to promote self-disclosure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To develop and refine the interactive VOICES tool, which will promote self-identification and&#xD;
      self-disclosure to increase reporting of EM at point-of-care in the Emergency Department (ED)&#xD;
      setting. Prior to conducting a feasibility study, focus groups will be conducted to inform&#xD;
      the process and to develop a tool to evaluate the use of VOICES.&#xD;
&#xD;
      Feasibility Study: To conduct a feasibility study (N= 800) examining the use of VOICES in a&#xD;
      busy ED.&#xD;
&#xD;
      Exploratory Aim: To perform a preliminary evaluation of the accuracy of VOICES as a screening&#xD;
      tool in correctly classifying EM cases that were referred to Adult Protective Services (APS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Actual">March 1, 2022</completion_date>
  <primary_completion_date type="Actual">December 1, 2021</primary_completion_date>
  <phase>Early Phase 1</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Implementation in Terms of Participation</measure>
    <time_frame>up to 16 months</time_frame>
    <description>Participation will be determined by the ratio of participants who are successfully enrolled to the total number of eligible patients. The numerator, denominator, frequencies and 95% confidence intervals will be reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Implementation in Terms of Usage</measure>
    <time_frame>up to 16 months</time_frame>
    <description>Usage will be determined by the number of consented participants enrolled in the study who used VOICES to completion.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Acceptability</measure>
    <time_frame>up to 16 months</time_frame>
    <description>Participant satisfaction will be measured along multiple dimensions using post-use satisfaction survey with two 5-point Likert response set scales, developed by the research team.&#xD;
Scale 1: Likert scale 1-5, where 1= Very Dissatisfied, and 5= Very Satisfied Scale 2: Likert scale 1-5, where 1= Strongly Disagree, and 5= Strongly Agree</description>
  </other_outcome>
  <other_outcome>
    <measure>Demand</measure>
    <time_frame>up to 16 months</time_frame>
    <description>Demand will be assessed through examining how likely will VOICES be used by patients. To do this, the size of target population of EM victims in the ED will be measured by the % of the patients who self-identified with elder mistreatment and the % who receive the Brief Negotiation Interview (BNI) portion of VOICES.</description>
  </other_outcome>
  <other_outcome>
    <measure>Practicality</measure>
    <time_frame>up to 16 months</time_frame>
    <description>Practicality will be assessed by observing the ease of VOICES use by patients. To do this, a series of steps will be watched to determine the efficiency of implementation measured by the average time (1) to consent &amp; orient participants to the tool and (2) needed to complete VOICES documented by the Research Assistant; and (3) patients perceived time of VOICES as measured on post-survey. Each of these will be reported as part of the overall outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Efficacy of the Educational Material</measure>
    <time_frame>up to 16 months</time_frame>
    <description>To understand the efficacy of VOICES in this pilot, we will look at how many participants changed their self-identification response after completing the educational component.</description>
  </other_outcome>
  <other_outcome>
    <measure>Efficacy of the Brief Negotiation Interview</measure>
    <time_frame>up to 16 months</time_frame>
    <description>We will look at how many patients changed their readiness to disclose after completing the Brief Negotiation Interview (BNI).</description>
  </other_outcome>
  <other_outcome>
    <measure>Efficacy of Self-Identification on Self-Disclosure</measure>
    <time_frame>up to 16 months</time_frame>
    <description>We will explore whether self-identification impacts likelihood of self-disclosure.&#xD;
Effect-size estimation measured by change in the % of patients who disclose among those who self-identified.</description>
  </other_outcome>
  <other_outcome>
    <measure>Accuracy</measure>
    <time_frame>up to 16 months</time_frame>
    <description>To understand the accuracy of the VOICES tool, a preliminary evaluation of the accuracy of VOICES as a screening tool in correctly classifying EM cases that were positive based on social worker assessment, and those referred to Adult Protective Services (APS). The percent correct classification will be reported.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1012</enrollment>
  <condition>Elder Abuse</condition>
  <arm_group>
    <arm_group_label>Elder adults in emergency department setting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Elder mistreatment in an Emergency Department setting.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES)</intervention_name>
    <description>Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) screening tool.</description>
    <arm_group_label>Elder adults in emergency department setting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 60 years or older&#xD;
&#xD;
          -  Non-full trauma track&#xD;
&#xD;
          -  Alert and oriented to person and place&#xD;
&#xD;
          -  AMT-4 score of 4&#xD;
&#xD;
          -  Able to consent and communicate in English&#xD;
&#xD;
          -  Agrees and able to use the iPad&#xD;
&#xD;
          -  Not in police custody&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects who live in nursing homes or other long-term care sitting and do not reside&#xD;
             in community setting&#xD;
&#xD;
          -  patients will be excluded if they cannot safely undergo the studies required for&#xD;
             participation&#xD;
&#xD;
          -  subjects with clear signs of EM&#xD;
&#xD;
          -  Patient or clinician refusal to participate&#xD;
&#xD;
          -  severe hearing and vision impairment&#xD;
&#xD;
          -  presenting with active psychotic symptoms&#xD;
&#xD;
          -  presenting with acute intoxication&#xD;
&#xD;
          -  COVID-19 positive&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fuad Abujarad, PhD,MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Raphael Emergency Department</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <results_first_submitted>March 3, 2023</results_first_submitted>
  <results_first_submitted_qc>March 30, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 20, 2023</results_first_posted>
  <last_update_submitted>March 30, 2023</last_update_submitted>
  <last_update_submitted_qc>March 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 16, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/70/NCT03834870/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 1, 2023</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/70/NCT03834870/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 28, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/70/NCT03834870/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Elder Adults in Emergency Department Setting</title>
          <description>Elder mistreatment in an Emergency Department setting.&#xD;
Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES): Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) screening tool.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1012"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1002"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Elder Adults in Emergency Department Setting</title>
          <description>Elder mistreatment in an Emergency Department setting.&#xD;
Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES): Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) screening tool.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1002"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73.5" spread="9.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>60-69</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="392"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>70-79</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="370"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>80-89</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="177"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90+</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                  </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="594"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="408"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="938"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="298"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="673"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1002"/>
                  </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>Associate's Degree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Undergraduate Degree (Bachelor's program or equivalent)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Professional Degree (Master's program or equivalent)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High School Graduate or GED</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="290"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High School Not Completed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Refused/Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Some college</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="240"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Household Income</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Less than 25k</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="291"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Between 25k to 34k</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Between 35k to 49k</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Between 50k to 74k</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Between 75k to 99k</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Between 100k to 149k</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>More than 150k</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Refused/Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="204"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Single or Never Married</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="233"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Widowed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="221"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Married or Co-habituating</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="360"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Divorced</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Separated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Refused/Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Employment Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Full Time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Employed/Retired</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="840"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part Time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Refused/Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Living Arrangement</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>In Their Own Home</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="936"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>In Someone Else's Home</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Assisted Living</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Household Members</title>
          <units>persons</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Internet Usage</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Every Day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="530"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-2 Times a Week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-2 Times a Month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rarely</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="280"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Refused/Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Confidence in Using Technology</title>
          <description>Confidence in Using Technology is measured by a question that uses a scale of 1-10 (0= Not confident at all, 10= Very confident), where a higher score indicates greater confidence.</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="6.9" spread="2.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Implementation in Terms of Participation</title>
        <description>Participation will be determined by the ratio of participants who are successfully enrolled to the total number of eligible patients. The numerator, denominator, frequencies and 95% confidence intervals will be reported.</description>
        <time_frame>up to 16 months</time_frame>
        <population>The total number of eligible participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Elder Adults in Emergency Department Setting</title>
            <description>Elder mistreatment in an Emergency Department setting.&#xD;
Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES): Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) screening tool.</description>
          </group>
        </group_list>
        <measure>
          <title>Implementation in Terms of Participation</title>
          <description>Participation will be determined by the ratio of participants who are successfully enrolled to the total number of eligible patients. The numerator, denominator, frequencies and 95% confidence intervals will be reported.</description>
          <population>The total number of eligible participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1204"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1012"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Percentage of enrolled from eligible</param_type>
            <param_value>84.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>81.98</ci_lower_limit>
            <ci_upper_limit>86.10</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Implementation in Terms of Usage</title>
        <description>Usage will be determined by the number of consented participants enrolled in the study who used VOICES to completion.</description>
        <time_frame>up to 16 months</time_frame>
        <population>The number of participants who were enrolled in the study (n=1,012)/</population>
        <group_list>
          <group group_id="O1">
            <title>Elder Adults in Emergency Department Setting</title>
            <description>Elder mistreatment in an Emergency Department setting.&#xD;
Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES): Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) screening tool.</description>
          </group>
        </group_list>
        <measure>
          <title>Implementation in Terms of Usage</title>
          <description>Usage will be determined by the number of consented participants enrolled in the study who used VOICES to completion.</description>
          <population>The number of participants who were enrolled in the study (n=1,012)/</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1012"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1002"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Percentage of enrolled from eligible</param_type>
            <param_value>99.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>98.40</ci_lower_limit>
            <ci_upper_limit>99.60</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Acceptability</title>
        <description>Participant satisfaction will be measured along multiple dimensions using post-use satisfaction survey with two 5-point Likert response set scales, developed by the research team.&#xD;
Scale 1: Likert scale 1-5, where 1= Very Dissatisfied, and 5= Very Satisfied Scale 2: Likert scale 1-5, where 1= Strongly Disagree, and 5= Strongly Agree</description>
        <time_frame>up to 16 months</time_frame>
        <population>The number of participants who successfully used VOICES to completion.</population>
        <group_list>
          <group group_id="O1">
            <title>Elder Adults in Emergency Department Setting</title>
            <description>Elder mistreatment in an Emergency Department setting.&#xD;
Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES): Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) screening tool.</description>
          </group>
        </group_list>
        <measure>
          <title>Acceptability</title>
          <description>Participant satisfaction will be measured along multiple dimensions using post-use satisfaction survey with two 5-point Likert response set scales, developed by the research team.&#xD;
Scale 1: Likert scale 1-5, where 1= Very Dissatisfied, and 5= Very Satisfied Scale 2: Likert scale 1-5, where 1= Strongly Disagree, and 5= Strongly Agree</description>
          <population>The number of participants who successfully used VOICES to completion.</population>
          <units>units 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="1002"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Level of confidentiality and privacy provided while using this tool (Scale 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.57" spread="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>The time it took to complete using the VOICES tool (Scale 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.44" spread="0.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Your ability to complete the VOICES tool on your own on the iPad, without any staff (Scale 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="0.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time to complete the tool on the iPad was short (Scale 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.11" spread="0.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I felt engaged in the tool throughout the process (Scale 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.29" spread="0.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Audio and visual aids of the tool were helpful (Scale 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.41" spread="0.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I felt the fonts, size and the colors of the text in the tool were appropriate and readable (Scale2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.53" spread="0.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Using this tool on the iPad was very easy (Scale 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.53" spread="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I was comfortable answering questions on the iPad (Scale 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.56" spread="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Using the iPad and the headphones provided more privacy (Scale 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="0.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I feel comfortable discussing mistreatment with a doctor or medical professional (Scale 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" spread="0.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>This tool is appropriate for learning about mistreatment (Scale 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.54" spread="0.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>This tool is appropriate to be used in the emergency department (Scale 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.41" spread="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I was able to complete VOICES on the iPad on my own (Scale 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.40" spread="0.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Using VOICES on the iPad was a frustrating experience (Scale 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.87" spread="1.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>The instructions provided by Vicky were clear and easy to follow (Scale 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.59" spread="0.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I feel more confident about understanding EM/resources in case I/someone else I know is mistreated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.50" spread="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I feel safer after using VOICES on the iPad (Scale 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.21" spread="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I learned new, useful things about elder mistreatment (Scale 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.34" spread="0.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>I would like to see this used by other older adults in the community such as the doctor's office (2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.52" spread="0.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Demand</title>
        <description>Demand will be assessed through examining how likely will VOICES be used by patients. To do this, the size of target population of EM victims in the ED will be measured by the % of the patients who self-identified with elder mistreatment and the % who receive the Brief Negotiation Interview (BNI) portion of VOICES.</description>
        <time_frame>up to 16 months</time_frame>
        <population>The number of participants who successfully used VOICES to completion.</population>
        <group_list>
          <group group_id="O1">
            <title>Elder Adults in Emergency Department Setting</title>
            <description>Elder mistreatment in an Emergency Department setting.&#xD;
Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES): Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) screening tool.</description>
          </group>
        </group_list>
        <measure>
          <title>Demand</title>
          <description>Demand will be assessed through examining how likely will VOICES be used by patients. To do this, the size of target population of EM victims in the ED will be measured by the % of the patients who self-identified with elder mistreatment and the % who receive the Brief Negotiation Interview (BNI) portion of VOICES.</description>
          <population>The number of participants who successfully used VOICES to completion.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1002"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants who received the BNI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants who self-identified with elder mistreatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Practicality</title>
        <description>Practicality will be assessed by observing the ease of VOICES use by patients. To do this, a series of steps will be watched to determine the efficiency of implementation measured by the average time (1) to consent &amp; orient participants to the tool and (2) needed to complete VOICES documented by the Research Assistant; and (3) patients perceived time of VOICES as measured on post-survey. Each of these will be reported as part of the overall outcome.</description>
        <time_frame>up to 16 months</time_frame>
        <population>The number of participants who successfully used VOICES to completion.</population>
        <group_list>
          <group group_id="O1">
            <title>Elder Adults in Emergency Department Setting</title>
            <description>Elder mistreatment in an Emergency Department setting.&#xD;
Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES): Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) screening tool.</description>
          </group>
        </group_list>
        <measure>
          <title>Practicality</title>
          <description>Practicality will be assessed by observing the ease of VOICES use by patients. To do this, a series of steps will be watched to determine the efficiency of implementation measured by the average time (1) to consent &amp; orient participants to the tool and (2) needed to complete VOICES documented by the Research Assistant; and (3) patients perceived time of VOICES as measured on post-survey. Each of these will be reported as part of the overall outcome.</description>
          <population>The number of participants who successfully used VOICES to completion.</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1002"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Actual VOICES Duration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.8" spread="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Actual Consent Duration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.9" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant Estimated Time to Completion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.2" spread="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Efficacy of the Educational Material</title>
        <description>To understand the efficacy of VOICES in this pilot, we will look at how many participants changed their self-identification response after completing the educational component.</description>
        <time_frame>up to 16 months</time_frame>
        <population>The number of participants who successfully used VOICES to completion.</population>
        <group_list>
          <group group_id="O1">
            <title>Elder Adults in Emergency Department Setting</title>
            <description>Elder mistreatment in an Emergency Department setting.&#xD;
Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES): Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) screening tool.</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy of the Educational Material</title>
          <description>To understand the efficacy of VOICES in this pilot, we will look at how many participants changed their self-identification response after completing the educational component.</description>
          <population>The number of participants who successfully used VOICES to completion.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1002"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall participants who changed their self-identification response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&quot;Yes&quot; (does self-identify) response changed to &quot;No&quot; (does not self-identify) response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&quot;No&quot; (does not self-identify) response changed to &quot;Yes&quot; (does self-identify) response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Efficacy of the Brief Negotiation Interview</title>
        <description>We will look at how many patients changed their readiness to disclose after completing the Brief Negotiation Interview (BNI).</description>
        <time_frame>up to 16 months</time_frame>
        <population>The number of participants who successfully used VOICES to completion and accessed the self-disclosure Brief Negotiation Interview (N=18).</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Who Accessed Self-disclosure Brief Negotiation Interview</title>
            <description>The group of participants who accessed the customized self-disclosure Brief Negotiation Interview pathway.</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy of the Brief Negotiation Interview</title>
          <description>We will look at how many patients changed their readiness to disclose after completing the Brief Negotiation Interview (BNI).</description>
          <population>The number of participants who successfully used VOICES to completion and accessed the self-disclosure Brief Negotiation Interview (N=18).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Efficacy of Self-Identification on Self-Disclosure</title>
        <description>We will explore whether self-identification impacts likelihood of self-disclosure.&#xD;
Effect-size estimation measured by change in the % of patients who disclose among those who self-identified.</description>
        <time_frame>up to 16 months</time_frame>
        <population>The number of participants who self-identified with elder mistreatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Elder Adults in Emergency Department Setting</title>
            <description>Elder mistreatment in an Emergency Department setting.&#xD;
Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES): Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) screening tool.</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy of Self-Identification on Self-Disclosure</title>
          <description>We will explore whether self-identification impacts likelihood of self-disclosure.&#xD;
Effect-size estimation measured by change in the % of patients who disclose among those who self-identified.</description>
          <population>The number of participants who self-identified with elder mistreatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Accuracy</title>
        <description>To understand the accuracy of the VOICES tool, a preliminary evaluation of the accuracy of VOICES as a screening tool in correctly classifying EM cases that were positive based on social worker assessment, and those referred to Adult Protective Services (APS). The percent correct classification will be reported.</description>
        <time_frame>up to 16 months</time_frame>
        <population>The number of participants who used VOICES to completion and screened positive for suspicion of elder mistreatment (n=112).</population>
        <group_list>
          <group group_id="O1">
            <title>Participant Group Who Screened Positive for Suspicion of Elder Mistreatment</title>
            <description>Participant group of overall participants who screened positive for suspicion of elder mistreatment</description>
          </group>
        </group_list>
        <measure>
          <title>Accuracy</title>
          <description>To understand the accuracy of the VOICES tool, a preliminary evaluation of the accuracy of VOICES as a screening tool in correctly classifying EM cases that were positive based on social worker assessment, and those referred to Adult Protective Services (APS). The percent correct classification will be reported.</description>
          <population>The number of participants who used VOICES to completion and screened positive for suspicion of elder mistreatment (n=112).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants substantiated for elder mistreatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Of the substantiated participants, participants referred to Adult Protective Services (APS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Referred APS cases accepted and opened by APS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 16 months</time_frame>
      <desc>Adverse event data were collected over the entire enrollment period, from 7/20/2020 to 12/01/2021.</desc>
      <group_list>
        <group group_id="E1">
          <title>Elder Adults in Emergency Department Setting</title>
          <description>Elder mistreatment in an Emergency Department setting.&#xD;
Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES): Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) screening tool.</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="1012"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1012"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="1012"/>
              </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>This study was limited to English-speaking older adults, leading to less representation with the Hispanic/Latino population.&#xD;
Providers, nurses and other clinical emergency department staff were not included in the study and outcomes only extend to older adult patients in the emergency department.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Fuad Abujarad</name_or_title>
      <organization>Yale University</organization>
      <phone>+1 (203) 737-5088</phone>
      <email>fuad.abujarad@yale.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/NCT03834870
org study id: 2000023799
secondary id: 5R01AG060084-04
nct id: NCT03834870
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
To develop an interactive tool to screen for Elder Mistreatment (EM) in the Emergency
      Department (ED) to promote self-disclosure.
To develop and refine the interactive VOICES tool, which will promote self-identification and
      self-disclosure to increase reporting of EM at point-of-care in the Emergency Department (ED)
      setting. Prior to conducting a feasibility study, focus groups will be conducted to inform
      the process and to develop a tool to evaluate the use of VOICES.

      Feasibility Study: To conduct a feasibility study (N= 800) examining the use of VOICES in a
      busy ED.

      Exploratory Aim: To perform a preliminary evaluation of the accuracy of VOICES as a screening
      tool in correctly classifying EM cases that were referred to Adult Protective Services (APS).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Implementation in Terms of Participation
time frame: up to 16 months
description: Participation will be determined by the ratio of participants who are successfully enrolled to the total number of eligible patients. The numerator, denominator, frequencies and 95% confidence intervals will be reported.
measure: Implementation in Terms of Usage
time frame: up to 16 months
description: Usage will be determined by the number of consented participants enrolled in the study who used VOICES to completion.
measure: Acceptability
time frame: up to 16 months
description: Participant satisfaction will be measured along multiple dimensions using post-use satisfaction survey with two 5-point Likert response set scales, developed by the research team.
Scale 1: Likert scale 1-5, where 1= Very Dissatisfied, and 5= Very Satisfied Scale 2: Likert scale 1-5, where 1= Strongly Disagree, and 5= Strongly Agree
measure: Demand
time frame: up to 16 months
description: Demand will be assessed through examining how likely will VOICES be used by patients. To do this, the size of target population of EM victims in the ED will be measured by the % of the patients who self-identified with elder mistreatment and the % who receive the Brief Negotiation Interview (BNI) portion of VOICES.
measure: Practicality
time frame: up to 16 months
description: Practicality will be assessed by observing the ease of VOICES use by patients. To do this, a series of steps will be watched to determine the efficiency of implementation measured by the average time (1) to consent & orient participants to the tool and (2) needed to complete VOICES documented by the Research Assistant; and (3) patients perceived time of VOICES as measured on post-survey. Each of these will be reported as part of the overall outcome.
measure: Efficacy of the Educational Material
time frame: up to 16 months
description: To understand the efficacy of VOICES in this pilot, we will look at how many participants changed their self-identification response after completing the educational component.
measure: Efficacy of the Brief Negotiation Interview
time frame: up to 16 months
description: We will look at how many patients changed their readiness to disclose after completing the Brief Negotiation Interview (BNI).
measure: Efficacy of Self-Identification on Self-Disclosure
time frame: up to 16 months
description: We will explore whether self-identification impacts likelihood of self-disclosure.
Effect-size estimation measured by change in the % of patients who disclose among those who self-identified.
measure: Accuracy
time frame: up to 16 months
description: To understand the accuracy of the VOICES tool, a preliminary evaluation of the accuracy of VOICES as a screening tool in correctly classifying EM cases that were positive based on social worker assessment, and those referred to Adult Protective Services (APS). The percent correct classification will be reported.
arm group label: Elder adults in emergency department setting
arm group type: Experimental
description: Elder mistreatment in an Emergency Department setting.
intervention type: Behavioral
intervention name: Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES)
description: Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) screening tool.
arm group label: Elder adults in emergency department setting
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Fuad Abujarad, PhD,MSc
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study was limited to English-speaking older adults, leading to less representation with the Hispanic/Latino population.
Providers, nurses and other clinical emergency department staff were not included in the study and outcomes only extend to older adult patients in the emergency department.
point of contact: 