<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/NCT02969031</url>
  </required_header>
  <id_info>
    <org_study_id>16-099</org_study_id>
    <nct_id>NCT02969031</nct_id>
  </id_info>
  <brief_title>Improving Communication Between Cancer Patients &amp; Oncologists</brief_title>
  <official_title>Improving Communication Between Cancer Patients and Oncologists Using Patient Feedback on Actual Conversations and the ABIM Maintenance of Certification Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Board of Internal Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dana-Farber Cancer Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overarching goal of this project is to improve communication between oncologists and&#xD;
      their patients by ensuring that the patient's voice is heard in the medical encounter. Thus,&#xD;
      the hope is to improve the experience for patients living with cancer. The investigators seek&#xD;
      to accomplish this goal by providing oncologists communication skills training that includes&#xD;
      feedback on their own audio-recorded conversations. The feedback will come from two sources:&#xD;
      1) Professional research assistant coders who will identify objective learning opportunities&#xD;
      based on specific coding criteria and 2) Trained patient reviewers who will listen to the&#xD;
      recordings and offer their own, subjective feedback at key moments in the encounters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of the Enhanced SCOPE program is to teach oncologists to recognize the&#xD;
      role of emotion in discussions with cancer patients, to increase their self-efficacy for&#xD;
      addressing affective concerns, and to provide them with the skills for doing so. Oncologists&#xD;
      are most likely to achieve competency in these areas when, in addition to didactic training,&#xD;
      they can also observe their own conversation and receive feedback on their interactions. The&#xD;
      Enhanced SCOPE program itself is an online web application that can be viewed from any&#xD;
      computer with internet connectivity. The investigators will be conducting a randomized&#xD;
      controlled trial to test the impact on patient satisfaction and medical visit quality of a&#xD;
      communication skills teaching intervention for oncologists that is integrated into the&#xD;
      American Board of Internal Medicine (ABIM) Maintenance Of Certification (MOC) process.&#xD;
      Oncologists who choose to enroll in this pilot Practice Improvement Module (PIM) will&#xD;
      complete a baseline questionnaire, send out satisfaction surveys to a sample of their&#xD;
      patients, and then audio record (using a smartphone application) eight clinic visits with&#xD;
      eight different patients. Oncologists who are assigned to the control arm will receive the&#xD;
      results of the patient surveys and be asked to conduct a quality improvement activity that&#xD;
      responds to the feedback (the current &quot;standard&quot; communication PIM). Oncologists assigned to&#xD;
      the intervention arm will receive the survey feedback as well as the enhanced SCOPE program&#xD;
      that provides feedback on their audio-recorded encounters via a web based interactive&#xD;
      program. The feedback will come from two sources: 1) Professional research assistant coders&#xD;
      who will identify objective learning opportunities based on specific coding criteria (e.g.,&#xD;
      empathic opportunities, use of open-ended questions) and 2) Trained patient reviewers who&#xD;
      will listen to the recordings and offer their own, subjective feedback at key moments in the&#xD;
      encounters. These patient reviewers will be drawn from our stakeholder partners and are&#xD;
      active patient advocates. They will be treated as members of the research team, paid for the&#xD;
      reviews, and are not patients of the study physicians. One month after reviewing their&#xD;
      feedback, oncologists in both arms will audio record another eight encounters and send out&#xD;
      satisfaction surveys to a new sample of patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 14, 2017</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Provider to Patient Communication Score</measure>
    <time_frame>6 months</time_frame>
    <description>The score measures the construct of patient's perception of attentive response by the medical oncologist during recalled office encounters over 12 months. Patients completed the Clinician Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS©) Version 1.0 questionnaire via computer or phone Interactive Voice Response (IVR) system.The Provider to Patient Communication Score:(1) Provider explained things in a way that was easy to understand (2) Provider listened carefully to patient (3) Provider showed respect for what patient had to say (4) Provider spent enough time with patient. Coded as 1 (Yes, definitely), 2 (Yes, somewhat), 3 (No), or 4 (I prefer not to answer).Obtained aggregate score ((1) to (3) above), calculated avg. of the scores to each question. Avgs. modeled with linear mixed-effect model. Analyzed data in both cases where a) missing responses are dropped from data and b) missing responses are kept in dataset. Lower score indicates more desirable outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Empathic Response to Patient Expressions of Negative Emotions</measure>
    <time_frame>6 months</time_frame>
    <description>What does the outcome measure? The outcome measures the construct of a physician's skill at providing appropriate empathic responses to patient's expressions of emotional concerns. The measure is the ratio of the number of empathic responses to the total empathic opportunities that occur during a provider-patient encounter.&#xD;
How is the outcome measured? The provider-patient encounters are audio recorded. Trained listeners review, score and code the physician responses from the audio-recorded conversations. This code indicates an empathic opportunity. Behaviors that represent appropriate empathic responses are also coded.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">148</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Enhanced SCOPE training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Complete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients, audio record (using a smartphone application) eight clinic visits with eight different patients. Receive survey feedback as well as the enhanced SCOPE program that provides feedback on their audio-recorded encounters via a web-based interactive program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Communication training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Complete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients. Receive the results of the patient surveys and be asked to conduct a quality improvement activity of their own design that responds to the feedback (the current &quot;standard&quot; communication PIM).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced SCOPE training</intervention_name>
    <description>Intervention is integrated into the American Board of Internal Medicine (ABIM) Maintenance Of Certification (MOC) process.</description>
    <arm_group_label>Enhanced SCOPE training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Communication training</intervention_name>
    <description>Standard Communication training</description>
    <arm_group_label>Standard Communication training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All American Board of Internal Medicine (ABIM) Board certified oncologists practicing&#xD;
             in the U. S. and enrolled in Maintenance of Certification.&#xD;
&#xD;
          -  Have a study-compatible smart phone.&#xD;
&#xD;
          -  Eligible patients will have metastatic cancer.&#xD;
&#xD;
          -  At least 18 years of age.&#xD;
&#xD;
          -  Speak and read English.&#xD;
&#xD;
          -  Receive oncology care from an enrolled oncologist.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dana Farber Cancer Institute oncologists and oncologists who do not speak English to&#xD;
             their patients.&#xD;
&#xD;
          -  Patients who do not speak English.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James A. Tulsky, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dana-Farber Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.pcori.org/research-results/2014/improving-communication-between-cancer-patients-and-oncologists-using-patient</url>
    <description>Patient-Centered Outcomes Research Institute (PCORI) Research Award Listing</description>
  </link>
  <link>
    <url>https://www.dana-farber.org/research/departments-centers-and-labs/departments-and-centers/department-of-psychosocial-oncology-and-palliative-care/research/</url>
    <description>Dana Farber Cancer Institute (DFCI), Department of Psychosocial Oncology and Palliative Care (POPC) Listing of Current Research and PCORI Award</description>
  </link>
  <link>
    <url>https://www.vitaltalk.org/</url>
    <description>Vital Talk is a non-profit whose mission is to nurture healthier connections between patients and clinicians. We are using Vital Talk intellectual property (e.g., REMAP) for the intervention</description>
  </link>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <results_first_submitted>October 30, 2019</results_first_submitted>
  <results_first_submitted_qc>December 16, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 3, 2020</results_first_posted>
  <last_update_submitted>December 16, 2019</last_update_submitted>
  <last_update_submitted_qc>December 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dana-Farber Cancer Institute</investigator_affiliation>
    <investigator_full_name>James A. Tulsky</investigator_full_name>
    <investigator_title>Chair, Department of Psychosocial Oncology and Palliative Care</investigator_title>
  </responsible_party>
  <keyword>communication</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 7, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT02969031/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Enhanced SCOPE Training</title>
          <description>Complete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients, audio record (using a smartphone application) eight clinic visits with eight different patients. Receive survey feedback as well as the enhanced SCOPE program that provides feedback on their audio-recorded encounters via a web-based interactive program.&#xD;
Enhanced SCOPE training: Intervention is integrated into the American Board of Internal Medicine (ABIM) Maintenance Of Certification (MOC) process.</description>
        </group>
        <group group_id="P2">
          <title>Standard Communication Training</title>
          <description>Complete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients. Receive the results of the patient surveys and be asked to conduct a quality improvement activity of their own design that responds to the feedback (the current &quot;standard&quot; communication PIM).&#xD;
Standard Communication training: Standard Communication training</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Enrolled and Randomized</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="73"/>
                <participants group_id="P2" count="75"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="73"/>
                <participants group_id="P2" count="75"/>
              </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>
          <title>Collection of Baseline Surveys</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="73"/>
                <participants group_id="P2" count="75"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="52"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Collection of Baseline Recordings</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Completed Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Collection of Follow-Up Surveys</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Collection of Follow-Up Recordings</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="12"/>
              </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>
          <title>Completed and Analyzed</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="12"/>
              </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>Enhanced SCOPE Training</title>
          <description>Complete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients, audio record (using a smartphone application) eight clinic visits with eight different patients. Receive survey feedback as well as the enhanced SCOPE program that provides feedback on their audio-recorded encounters via a web-based interactive program.&#xD;
Enhanced SCOPE training: Intervention is integrated into the American Board of Internal Medicine (ABIM) Maintenance Of Certification (MOC) process.</description>
        </group>
        <group group_id="B2">
          <title>Standard Communication Training</title>
          <description>Complete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients. Receive the results of the patient surveys and be asked to conduct a quality improvement activity of their own design that responds to the feedback (the current &quot;standard&quot; communication PIM).&#xD;
Standard Communication training: Standard Communication training</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="15"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="27"/>
          </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="53.00" spread="9.8"/>
                    <measurement group_id="B2" value="51.92" spread="9.0"/>
                    <measurement group_id="B3" value="52.52" spread="9.3"/>
                  </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="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="23"/>
                  </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="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                  </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>Religion</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Christian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Jewish</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Islamic/Muslim</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Buddhist/Hindu/Eastern</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Affiliation</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Previous Training</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Medical School</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Residency</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fellowship</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Practice Training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Previous Training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Social vs. Technical Inclination</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Social and Behavioral</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Technical and Scientific</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Provider to Patient Communication Score</title>
        <description>The score measures the construct of patient's perception of attentive response by the medical oncologist during recalled office encounters over 12 months. Patients completed the Clinician Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS©) Version 1.0 questionnaire via computer or phone Interactive Voice Response (IVR) system.The Provider to Patient Communication Score:(1) Provider explained things in a way that was easy to understand (2) Provider listened carefully to patient (3) Provider showed respect for what patient had to say (4) Provider spent enough time with patient. Coded as 1 (Yes, definitely), 2 (Yes, somewhat), 3 (No), or 4 (I prefer not to answer).Obtained aggregate score ((1) to (3) above), calculated avg. of the scores to each question. Avgs. modeled with linear mixed-effect model. Analyzed data in both cases where a) missing responses are dropped from data and b) missing responses are kept in dataset. Lower score indicates more desirable outcome.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Enhanced SCOPE Training</title>
            <description>Complete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients, audio record (using a smartphone application) eight clinic visits with eight different patients. Receive survey feedback as well as the enhanced SCOPE program that provides feedback on their audio-recorded encounters via a web-based interactive program.&#xD;
Enhanced SCOPE training: Intervention is integrated into the American Board of Internal Medicine (ABIM) Maintenance Of Certification (MOC) process.</description>
          </group>
          <group group_id="O2">
            <title>Standard Communication Training</title>
            <description>Complete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients. Receive the results of the patient surveys and be asked to conduct a quality improvement activity of their own design that responds to the feedback (the current &quot;standard&quot; communication PIM).&#xD;
Standard Communication training: Standard Communication training</description>
          </group>
        </group_list>
        <measure>
          <title>Provider to Patient Communication Score</title>
          <description>The score measures the construct of patient's perception of attentive response by the medical oncologist during recalled office encounters over 12 months. Patients completed the Clinician Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS©) Version 1.0 questionnaire via computer or phone Interactive Voice Response (IVR) system.The Provider to Patient Communication Score:(1) Provider explained things in a way that was easy to understand (2) Provider listened carefully to patient (3) Provider showed respect for what patient had to say (4) Provider spent enough time with patient. Coded as 1 (Yes, definitely), 2 (Yes, somewhat), 3 (No), or 4 (I prefer not to answer).Obtained aggregate score ((1) to (3) above), calculated avg. of the scores to each question. Avgs. modeled with linear mixed-effect model. Analyzed data in both cases where a) missing responses are dropped from data and b) missing responses are kept in dataset. Lower score indicates more desirable outcome.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0423" spread="0.1380"/>
                    <measurement group_id="O2" value="1.0723" spread="0.2049"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Empathic Response to Patient Expressions of Negative Emotions</title>
        <description>What does the outcome measure? The outcome measures the construct of a physician's skill at providing appropriate empathic responses to patient's expressions of emotional concerns. The measure is the ratio of the number of empathic responses to the total empathic opportunities that occur during a provider-patient encounter.&#xD;
How is the outcome measured? The provider-patient encounters are audio recorded. Trained listeners review, score and code the physician responses from the audio-recorded conversations. This code indicates an empathic opportunity. Behaviors that represent appropriate empathic responses are also coded.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Enhanced SCOPE Training</title>
            <description>Complete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients, audio record (using a smartphone application) eight clinic visits with eight different patients. Receive survey feedback as well as the enhanced SCOPE program that provides feedback on their audio-recorded encounters via a web-based interactive program.&#xD;
Enhanced SCOPE training: Intervention is integrated into the American Board of Internal Medicine (ABIM) Maintenance Of Certification (MOC) process.</description>
          </group>
          <group group_id="O2">
            <title>Standard Communication Training</title>
            <description>Complete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients. Receive the results of the patient surveys and be asked to conduct a quality improvement activity of their own design that responds to the feedback (the current &quot;standard&quot; communication PIM).&#xD;
Standard Communication training: Standard Communication training</description>
          </group>
        </group_list>
        <measure>
          <title>Empathic Response to Patient Expressions of Negative Emotions</title>
          <description>What does the outcome measure? The outcome measures the construct of a physician's skill at providing appropriate empathic responses to patient's expressions of emotional concerns. The measure is the ratio of the number of empathic responses to the total empathic opportunities that occur during a provider-patient encounter.&#xD;
How is the outcome measured? The provider-patient encounters are audio recorded. Trained listeners review, score and code the physician responses from the audio-recorded conversations. This code indicates an empathic opportunity. Behaviors that represent appropriate empathic responses are also coded.</description>
          <units># empathic responses/# empathic opportun</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2054" spread="0.2678"/>
                    <measurement group_id="O2" value="0.1203" spread="0.2735"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>The number of participants at risk for adverse events is 0 because this is a social/behavioral research trial, not a clinical trial, and therefore there is no medical risk to participants to 0 Total number of participants at risk- e.g. All-Cause Mortality, Serious and Other [Not Including Serious] Adverse Events were not monitored/assessed.</desc>
      <group_list>
        <group group_id="E1">
          <title>Enhanced SCOPE Training</title>
          <description>Complete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients, audio record (using a smartphone application) eight clinic visits with eight different patients. Receive survey feedback as well as the enhanced SCOPE program that provides feedback on their audio-recorded encounters via a web-based interactive program.&#xD;
Enhanced SCOPE training: Intervention is integrated into the American Board of Internal Medicine (ABIM) Maintenance Of Certification (MOC) process.</description>
        </group>
        <group group_id="E2">
          <title>Standard Communication Training</title>
          <description>Complete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients. Receive the results of the patient surveys and be asked to conduct a quality improvement activity of their own design that responds to the feedback (the current &quot;standard&quot; communication PIM).&#xD;
Standard Communication training: Standard Communication training</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>Julie Goldman</name_or_title>
      <organization>Dana-Farber Cancer Institute</organization>
      <phone>617-632-5563</phone>
      <email>Julie_Goldman@dfci.harvard.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/NCT02969031
org study id: 16-099
nct id: NCT02969031
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The overarching goal of this project is to improve communication between oncologists and
      their patients by ensuring that the patient's voice is heard in the medical encounter. Thus,
      the hope is to improve the experience for patients living with cancer. The investigators seek
      to accomplish this goal by providing oncologists communication skills training that includes
      feedback on their own audio-recorded conversations. The feedback will come from two sources:
      1) Professional research assistant coders who will identify objective learning opportunities
      based on specific coding criteria and 2) Trained patient reviewers who will listen to the
      recordings and offer their own, subjective feedback at key moments in the encounters.
The primary objective of the Enhanced SCOPE program is to teach oncologists to recognize the
      role of emotion in discussions with cancer patients, to increase their self-efficacy for
      addressing affective concerns, and to provide them with the skills for doing so. Oncologists
      are most likely to achieve competency in these areas when, in addition to didactic training,
      they can also observe their own conversation and receive feedback on their interactions. The
      Enhanced SCOPE program itself is an online web application that can be viewed from any
      computer with internet connectivity. The investigators will be conducting a randomized
      controlled trial to test the impact on patient satisfaction and medical visit quality of a
      communication skills teaching intervention for oncologists that is integrated into the
      American Board of Internal Medicine (ABIM) Maintenance Of Certification (MOC) process.
      Oncologists who choose to enroll in this pilot Practice Improvement Module (PIM) will
      complete a baseline questionnaire, send out satisfaction surveys to a sample of their
      patients, and then audio record (using a smartphone application) eight clinic visits with
      eight different patients. Oncologists who are assigned to the control arm will receive the
      results of the patient surveys and be asked to conduct a quality improvement activity that
      responds to the feedback (the current "standard" communication PIM). Oncologists assigned to
      the intervention arm will receive the survey feedback as well as the enhanced SCOPE program
      that provides feedback on their audio-recorded encounters via a web based interactive
      program. The feedback will come from two sources: 1) Professional research assistant coders
      who will identify objective learning opportunities based on specific coding criteria (e.g.,
      empathic opportunities, use of open-ended questions) and 2) Trained patient reviewers who
      will listen to the recordings and offer their own, subjective feedback at key moments in the
      encounters. These patient reviewers will be drawn from our stakeholder partners and are
      active patient advocates. They will be treated as members of the research team, paid for the
      reviews, and are not patients of the study physicians. One month after reviewing their
      feedback, oncologists in both arms will audio record another eight encounters and send out
      satisfaction surveys to a new sample of patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Provider to Patient Communication Score
time frame: 6 months
description: The score measures the construct of patient's perception of attentive response by the medical oncologist during recalled office encounters over 12 months. Patients completed the Clinician Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS©) Version 1.0 questionnaire via computer or phone Interactive Voice Response (IVR) system.The Provider to Patient Communication Score:(1) Provider explained things in a way that was easy to understand (2) Provider listened carefully to patient (3) Provider showed respect for what patient had to say (4) Provider spent enough time with patient. Coded as 1 (Yes, definitely), 2 (Yes, somewhat), 3 (No), or 4 (I prefer not to answer).Obtained aggregate score ((1) to (3) above), calculated avg. of the scores to each question. Avgs. modeled with linear mixed-effect model. Analyzed data in both cases where a) missing responses are dropped from data and b) missing responses are kept in dataset. Lower score indicates more desirable outcome.
measure: Empathic Response to Patient Expressions of Negative Emotions
time frame: 6 months
description: What does the outcome measure? The outcome measures the construct of a physician's skill at providing appropriate empathic responses to patient's expressions of emotional concerns. The measure is the ratio of the number of empathic responses to the total empathic opportunities that occur during a provider-patient encounter.
How is the outcome measured? The provider-patient encounters are audio recorded. Trained listeners review, score and code the physician responses from the audio-recorded conversations. This code indicates an empathic opportunity. Behaviors that represent appropriate empathic responses are also coded.
arm group label: Enhanced SCOPE training
arm group type: Experimental
description: Complete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients, audio record (using a smartphone application) eight clinic visits with eight different patients. Receive survey feedback as well as the enhanced SCOPE program that provides feedback on their audio-recorded encounters via a web-based interactive program.
arm group label: Standard Communication training
arm group type: Active Comparator
description: Complete a baseline questionnaire, administer satisfaction surveys anonymously to a sample of their patients. Receive the results of the patient surveys and be asked to conduct a quality improvement activity of their own design that responds to the feedback (the current "standard" communication PIM).
intervention type: Behavioral
intervention name: Enhanced SCOPE training
description: Intervention is integrated into the American Board of Internal Medicine (ABIM) Maintenance Of Certification (MOC) process.
arm group label: Enhanced SCOPE training
intervention type: Behavioral
intervention name: Standard Communication training
description: Standard Communication training
arm group label: Standard Communication training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: James A. Tulsky, MD
role: Principal Investigator
affiliation: Dana-Farber Cancer Institute
facility: 
country: United States
url: http://www.pcori.org/research-results/2014/improving-communication-between-cancer-patients-and-oncologists-using-patient
description: Patient-Centered Outcomes Research Institute (PCORI) Research Award Listing
url: https://www.dana-farber.org/research/departments-centers-and-labs/departments-and-centers/department-of-psychosocial-oncology-and-palliative-care/research/
description: Dana Farber Cancer Institute (DFCI), Department of Psychosocial Oncology and Palliative Care (POPC) Listing of Current Research and PCORI Award
url: https://www.vitaltalk.org/
description: Vital Talk is a non-profit whose mission is to nurture healthier connections between patients and clinicians. We are using Vital Talk intellectual property (e.g., REMAP) for the intervention
responsible party type: Principal Investigator
investigator affiliation: Dana-Farber Cancer Institute
investigator full name: James A. Tulsky
investigator title: Chair, Department of Psychosocial Oncology and Palliative Care
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 