<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/NCT04458090</url>
  </required_header>
  <id_info>
    <org_study_id>18-1675</org_study_id>
    <secondary_id>R36AG064135</secondary_id>
    <nct_id>NCT04458090</nct_id>
  </id_info>
  <brief_title>Underutilization of Hospice in Older African Americans</brief_title>
  <official_title>Underutilization of Hospice in Older African Americans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite the documented benefits of hospice, less than 2 million people utilize hospice&#xD;
      services annually. Underuse disparities are extreme across race and ethnicity as White&#xD;
      Americans comprise 85% of all hospice enrollees. AAs account for only 8% of hospice enrollees&#xD;
      but are more likely to die from the top three hospice diagnoses (i.e. cancer, heart disease&#xD;
      and dementia) than White Americans. Even when AAs enroll in hospice, they spend less time in&#xD;
      hospice than White patients, averaging fewer than seven days in hospice care. Notably, AA&#xD;
      hospice enrollees report a higher degree of satisfaction with end of life care when hospice&#xD;
      is involved, as compared to AAs who are not enrolled in hospice care. There are several&#xD;
      potential barriers that may prevent AAs from enrolling in hospice care including lack of&#xD;
      knowledge of hospice care, mistrust in healthcare, perceived discrimination, health literacy.&#xD;
      AAs routinely report less knowledge of hospice than White Americans, and the information that&#xD;
      AA know about hospice often comes from non-medical professionals and is inaccurate. Some AA&#xD;
      have persistent mistrust in healthcare due to events such as the Tuskegee Syphilis&#xD;
      Experiments and many AA perceive discrimination when accessing healthcare. Data shows that&#xD;
      health literacy is a stronger predictor of hospice use than race and older AAs are more&#xD;
      likely to possess low health literacy. The driving hypothesis of this research is that by&#xD;
      providing clear and accurate information to older AAs will help address the underutilization&#xD;
      of hospice by clarifying misperceptions, building trust, and overcoming literacy barriers.&#xD;
      Patient decision aids (PtDAs) are an evidence-based approach to improve patient agency in&#xD;
      medical decision making. Research shows that AA report a desire for more agency and autonomy&#xD;
      in decision-making yet the use of PtDAs is understudied in AA communities. This proposal&#xD;
      offers a unique opportunity to address many of the potential barriers that may prevent older&#xD;
      AAs from enrolling in hospice, while simultaneously expanding the literature of SDM specific&#xD;
      to older AAs. The goals of this proposal are to evaluate if the relationships between health&#xD;
      literacy and hospice knowledge, attitudes, and beliefs is mediated by mistrust in healthcare&#xD;
      and perceived discrimination among AAs aged 65 or older (Aim1) and to evaluate the effect of&#xD;
      the hospice PtDA on changing hospice knowledge and attitudes and beliefs about hospice in AA&#xD;
      aged 65 and older (Aim 2).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">April 30, 2021</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hospice Knowledge Scale</measure>
    <time_frame>1 month</time_frame>
    <description>Hospice Knowledge Scale is a 23-item true/false scale. Each question is worth 1 point with 23 being the highest score. Possible scores range from 0 to 23, with higher scores indicate more hospice knowledge.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospice Attitudes and Beliefs Scale</measure>
    <time_frame>1 month</time_frame>
    <description>Hospice Attitudes and Beliefs Scale is an 8-item 5-point Likert scale (ranging from Strongly Agree to Strongly Disagree). Each question is scored based on 5 point scale. Maximum score 40 and minimum score 8. Higher scores indicate more favorable opinions of hospice.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Decision Self Efficacy Scale</measure>
    <time_frame>1 month</time_frame>
    <description>Decision Self-Efficacy Scale is an 11-item 5-point Likert scale (ranging from not at all confident to very confident). Maximum score is 100 and minimum score is 0. Higher scores indicate more self-efficacy.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">144</enrollment>
  <condition>Hospice Decision Making</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receive hospice patient decision aid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Does not receive hospice decision aid</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>A decision aid for patients considering Hospice care.</intervention_name>
    <description>A 12 page booklet and 17 min video describing hospice care</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Self identify as Black or African American&#xD;
&#xD;
          -  At least 65 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speakers.&#xD;
&#xD;
          -  Patients with cognitive Impairments preventing ability to provide informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Channing E Tate, MPH, PhD(c)</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Denver</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <results_first_submitted>July 14, 2022</results_first_submitted>
  <results_first_submitted_qc>August 8, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">August 30, 2022</results_first_posted>
  <last_update_submitted>August 8, 2022</last_update_submitted>
  <last_update_submitted_qc>August 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>January 24, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT04458090/Prot_SAP_000.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>October 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT04458090/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>Receive hospice patient decision aid&#xD;
A decision aid for patients considering Hospice care.: A 12 page booklet and 17 min video describing hospice care</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Does not receive hospice decision aid</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="72"/>
                <participants group_id="P2" count="72"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="72"/>
                <participants group_id="P2" count="72"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>Receive hospice patient decision aid&#xD;
A decision aid for patients considering Hospice care.: A 12 page booklet and 17 min video describing hospice care</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Does not receive hospice decision aid</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="72"/>
            <count group_id="B2" value="72"/>
            <count group_id="B3" value="144"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="144"/>
                  </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="58"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="117"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="27"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="144"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="72"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hospice Knowledge Test</title>
          <description>Hospice Knowledge Scale is a 23-item true/false scale. Each question is worth 1 point with 23 being the highest score. Higher scores indicate more hospice knowledge. Absolute scores were measured at baseline and 1 month follow-up.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17" lower_limit="0" upper_limit="23"/>
                    <measurement group_id="B2" value="17" lower_limit="0" upper_limit="23"/>
                    <measurement group_id="B3" value="17" lower_limit="0" upper_limit="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hospice Beliefs and Attitudes Scale</title>
          <description>Hospice Attitudes and Beliefs Scale is an 8-item 5-point Likert scale (ranging from Strongly Agree to Strongly Disagree). Each question is scored based on 5 point scale. Maximum score 40 and minimum score 8. Higher scores indicate more favorable opinions of hospice. Absolute scores were measured at baseline and 1 month follow-up.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28" lower_limit="11" upper_limit="38"/>
                    <measurement group_id="B2" value="27" lower_limit="12" upper_limit="40"/>
                    <measurement group_id="B3" value="27.5" lower_limit="11" upper_limit="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Decision Self-Efficacy Scale</title>
          <description>Decision Self-Efficacy Scale is an 11-item 5-point Likert scale (ranging from not at all confident to very confident). Maximum score is 100 and minimum score is 0. Higher scores indicate more self-efficacy. Absolute scores were measured at baseline and 1 month follow-up.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="78" lower_limit="0" upper_limit="100"/>
                    <measurement group_id="B2" value="72" lower_limit="0" upper_limit="100"/>
                    <measurement group_id="B3" value="75" lower_limit="0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Hospice Knowledge Scale</title>
        <description>Hospice Knowledge Scale is a 23-item true/false scale. Each question is worth 1 point with 23 being the highest score. Possible scores range from 0 to 23, with higher scores indicate more hospice knowledge.</description>
        <time_frame>1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Receive hospice patient decision aid&#xD;
A decision aid for patients considering Hospice care.: A 12 page booklet and 17 min video describing hospice care</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Does not receive hospice decision aid</description>
          </group>
        </group_list>
        <measure>
          <title>Hospice Knowledge Scale</title>
          <description>Hospice Knowledge Scale is a 23-item true/false scale. Each question is worth 1 point with 23 being the highest score. Possible scores range from 0 to 23, with higher scores indicate more hospice knowledge.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17" lower_limit="0" upper_limit="23"/>
                    <measurement group_id="O2" value="17" lower_limit="0" upper_limit="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Hospice Attitudes and Beliefs Scale</title>
        <description>Hospice Attitudes and Beliefs Scale is an 8-item 5-point Likert scale (ranging from Strongly Agree to Strongly Disagree). Each question is scored based on 5 point scale. Maximum score 40 and minimum score 8. Higher scores indicate more favorable opinions of hospice.</description>
        <time_frame>1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Receive hospice patient decision aid&#xD;
A decision aid for patients considering Hospice care.: A 12 page booklet and 17 min video describing hospice care</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Does not receive hospice decision aid</description>
          </group>
        </group_list>
        <measure>
          <title>Hospice Attitudes and Beliefs Scale</title>
          <description>Hospice Attitudes and Beliefs Scale is an 8-item 5-point Likert scale (ranging from Strongly Agree to Strongly Disagree). Each question is scored based on 5 point scale. Maximum score 40 and minimum score 8. Higher scores indicate more favorable opinions of hospice.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31" lower_limit="9" upper_limit="40"/>
                    <measurement group_id="O2" value="30" lower_limit="9" upper_limit="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Decision Self Efficacy Scale</title>
        <description>Decision Self-Efficacy Scale is an 11-item 5-point Likert scale (ranging from not at all confident to very confident). Maximum score is 100 and minimum score is 0. Higher scores indicate more self-efficacy.</description>
        <time_frame>1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Receive hospice patient decision aid&#xD;
A decision aid for patients considering Hospice care.: A 12 page booklet and 17 min video describing hospice care</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Does not receive hospice decision aid</description>
          </group>
        </group_list>
        <measure>
          <title>Decision Self Efficacy Scale</title>
          <description>Decision Self-Efficacy Scale is an 11-item 5-point Likert scale (ranging from not at all confident to very confident). Maximum score is 100 and minimum score is 0. Higher scores indicate more self-efficacy.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89" lower_limit="48" upper_limit="100"/>
                    <measurement group_id="O2" value="78" lower_limit="11" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Minimal risk study only collecting survey date and All Cause Mortality, Serious Adverse Events, and other adverse events were not monitored.</desc>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>Receive hospice patient decision aid&#xD;
A decision aid for patients considering Hospice care.: A 12 page booklet and 17 min video describing hospice care</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Does not receive hospice decision aid</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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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>
    <point_of_contact>
      <name_or_title>Dr. Channing Tate, Assistant Professor</name_or_title>
      <organization>University of Colorado Anschutz Medical Campus</organization>
      <phone>3037248985</phone>
      <email>channing.tate@cuanschutz.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/NCT04458090
org study id: 18-1675
secondary id: R36AG064135
nct id: NCT04458090
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Despite the documented benefits of hospice, less than 2 million people utilize hospice
      services annually. Underuse disparities are extreme across race and ethnicity as White
      Americans comprise 85% of all hospice enrollees. AAs account for only 8% of hospice enrollees
      but are more likely to die from the top three hospice diagnoses (i.e. cancer, heart disease
      and dementia) than White Americans. Even when AAs enroll in hospice, they spend less time in
      hospice than White patients, averaging fewer than seven days in hospice care. Notably, AA
      hospice enrollees report a higher degree of satisfaction with end of life care when hospice
      is involved, as compared to AAs who are not enrolled in hospice care. There are several
      potential barriers that may prevent AAs from enrolling in hospice care including lack of
      knowledge of hospice care, mistrust in healthcare, perceived discrimination, health literacy.
      AAs routinely report less knowledge of hospice than White Americans, and the information that
      AA know about hospice often comes from non-medical professionals and is inaccurate. Some AA
      have persistent mistrust in healthcare due to events such as the Tuskegee Syphilis
      Experiments and many AA perceive discrimination when accessing healthcare. Data shows that
      health literacy is a stronger predictor of hospice use than race and older AAs are more
      likely to possess low health literacy. The driving hypothesis of this research is that by
      providing clear and accurate information to older AAs will help address the underutilization
      of hospice by clarifying misperceptions, building trust, and overcoming literacy barriers.
      Patient decision aids (PtDAs) are an evidence-based approach to improve patient agency in
      medical decision making. Research shows that AA report a desire for more agency and autonomy
      in decision-making yet the use of PtDAs is understudied in AA communities. This proposal
      offers a unique opportunity to address many of the potential barriers that may prevent older
      AAs from enrolling in hospice, while simultaneously expanding the literature of SDM specific
      to older AAs. The goals of this proposal are to evaluate if the relationships between health
      literacy and hospice knowledge, attitudes, and beliefs is mediated by mistrust in healthcare
      and perceived discrimination among AAs aged 65 or older (Aim1) and to evaluate the effect of
      the hospice PtDA on changing hospice knowledge and attitudes and beliefs about hospice in AA
      aged 65 and older (Aim 2).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Hospice Knowledge Scale
time frame: 1 month
description: Hospice Knowledge Scale is a 23-item true/false scale. Each question is worth 1 point with 23 being the highest score. Possible scores range from 0 to 23, with higher scores indicate more hospice knowledge.
measure: Hospice Attitudes and Beliefs Scale
time frame: 1 month
description: Hospice Attitudes and Beliefs Scale is an 8-item 5-point Likert scale (ranging from Strongly Agree to Strongly Disagree). Each question is scored based on 5 point scale. Maximum score 40 and minimum score 8. Higher scores indicate more favorable opinions of hospice.
measure: Decision Self Efficacy Scale
time frame: 1 month
description: Decision Self-Efficacy Scale is an 11-item 5-point Likert scale (ranging from not at all confident to very confident). Maximum score is 100 and minimum score is 0. Higher scores indicate more self-efficacy.
arm group label: Intervention
arm group type: Experimental
description: Receive hospice patient decision aid
arm group label: Control
arm group type: No Intervention
description: Does not receive hospice decision aid
intervention type: Behavioral
intervention name: A decision aid for patients considering Hospice care.
description: A 12 page booklet and 17 min video describing hospice care
arm group label: Intervention
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Channing E Tate, MPH, PhD(c)
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 