<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/NCT04418947</url>
  </required_header>
  <id_info>
    <org_study_id>843220</org_study_id>
    <nct_id>NCT04418947</nct_id>
  </id_info>
  <brief_title>Project Resurgence Communication Trial</brief_title>
  <official_title>Comparison of the Effectiveness of Communication Strategies on the Return to In-Person Visits to a Medical Center After the Emergence of COVID-19: A Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pennsylvania</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>
      Randomized, double-blind, of standard of care vs additional communication and factorial&#xD;
      design of intervention letter vs. control letter and EHR vs mail delivery mechanism in&#xD;
      patients who canceled visits and did not reschedule over a 90 day period starting March 9,&#xD;
      2020.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Actual">July 17, 2020</completion_date>
  <primary_completion_date type="Actual">July 17, 2020</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>Factorial Assignment</intervention_model>
    <intervention_model_description>Randomized, double-blind, factorial design</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent of Participants With Visit or Procedure With Provider</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent of Participants With Scheduled Visit or Procedure With Provider</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Participants With Completed Telemedicine Visit With Provider</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">11120</enrollment>
  <condition>Communication Research</condition>
  <arm_group>
    <arm_group_label>No intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>MPM control letter</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>MPM intervention letter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Mailed control letter</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Mailed intervention letter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Communication type</intervention_name>
    <description>Control letter vs. intervention letter</description>
    <arm_group_label>MPM control letter</arm_group_label>
    <arm_group_label>MPM intervention letter</arm_group_label>
    <arm_group_label>Mailed control letter</arm_group_label>
    <arm_group_label>Mailed intervention letter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a cancellation or failure to show for a procedure or visit from March 9,&#xD;
             2020 through June 7, 2020 (90 days) and who have not rescheduled as of the date of&#xD;
             randomization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Death&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <results_first_submitted>October 25, 2021</results_first_submitted>
  <results_first_submitted_qc>October 26, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 28, 2021</results_first_posted>
  <last_update_submitted>October 26, 2021</last_update_submitted>
  <last_update_submitted_qc>October 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
    <investigator_full_name>Anne Cappola, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </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>May 30, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/47/NCT04418947/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>No Intervention</title>
          <description>No letter sent to the patient</description>
        </group>
        <group group_id="P2">
          <title>MPM Control Letter</title>
          <description>Communication type: Control letter vs. intervention letter</description>
        </group>
        <group group_id="P3">
          <title>MPM Intervention Letter</title>
          <description>Communication type: Control letter vs. intervention letter</description>
        </group>
        <group group_id="P4">
          <title>Mailed Control Letter</title>
          <description>Communication type: Control letter vs. intervention letter</description>
        </group>
        <group group_id="P5">
          <title>Mailed Intervention Letter</title>
          <description>Communication type: Control letter vs. intervention letter</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1108"/>
                <participants group_id="P2" count="1351"/>
                <participants group_id="P3" count="1351"/>
                <participants group_id="P4" count="3655"/>
                <participants group_id="P5" count="3655"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1108"/>
                <participants group_id="P2" count="1351"/>
                <participants group_id="P3" count="1351"/>
                <participants group_id="P4" count="3655"/>
                <participants group_id="P5" count="3655"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>No Intervention</title>
          <description>No letter was sent to the patient.</description>
        </group>
        <group group_id="B2">
          <title>MPM Control Letter</title>
          <description>Communication type: Control letter vs. intervention letter</description>
        </group>
        <group group_id="B3">
          <title>MPM Intervention Letter</title>
          <description>Communication type: Control letter vs. intervention letter</description>
        </group>
        <group group_id="B4">
          <title>Mailed Control Letter</title>
          <description>Communication type: Control letter vs. intervention letter</description>
        </group>
        <group group_id="B5">
          <title>Mailed Intervention Letter</title>
          <description>Communication type: Control letter vs. intervention letter</description>
        </group>
        <group group_id="B6">
          <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="1108"/>
            <count group_id="B2" value="1351"/>
            <count group_id="B3" value="1351"/>
            <count group_id="B4" value="3655"/>
            <count group_id="B5" value="3655"/>
            <count group_id="B6" value="11120"/>
          </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="627"/>
                    <measurement group_id="B2" value="797"/>
                    <measurement group_id="B3" value="797"/>
                    <measurement group_id="B4" value="2032"/>
                    <measurement group_id="B5" value="2032"/>
                    <measurement group_id="B6" value="6285"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="481"/>
                    <measurement group_id="B2" value="554"/>
                    <measurement group_id="B3" value="554"/>
                    <measurement group_id="B4" value="1623"/>
                    <measurement group_id="B5" value="1623"/>
                    <measurement group_id="B6" value="4835"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="60.0" spread="6.9"/>
                    <measurement group_id="B2" value="58.4" spread="16.0"/>
                    <measurement group_id="B3" value="58.4" spread="16.2"/>
                    <measurement group_id="B4" value="59.9" spread="17.0"/>
                    <measurement group_id="B5" value="60.4" spread="17.1"/>
                    <measurement group_id="B6" value="59.7" spread="16.8"/>
                  </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="609"/>
                    <measurement group_id="B2" value="757"/>
                    <measurement group_id="B3" value="756"/>
                    <measurement group_id="B4" value="1958"/>
                    <measurement group_id="B5" value="1994"/>
                    <measurement group_id="B6" value="6074"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="499"/>
                    <measurement group_id="B2" value="594"/>
                    <measurement group_id="B3" value="595"/>
                    <measurement group_id="B4" value="1697"/>
                    <measurement group_id="B5" value="1661"/>
                    <measurement group_id="B6" value="5046"/>
                  </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="28"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="104"/>
                    <measurement group_id="B5" value="118"/>
                    <measurement group_id="B6" value="320"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1039"/>
                    <measurement group_id="B2" value="1284"/>
                    <measurement group_id="B3" value="1298"/>
                    <measurement group_id="B4" value="3472"/>
                    <measurement group_id="B5" value="3443"/>
                    <measurement group_id="B6" value="10536"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="79"/>
                    <measurement group_id="B5" value="94"/>
                    <measurement group_id="B6" value="264"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="678"/>
                    <measurement group_id="B2" value="978"/>
                    <measurement group_id="B3" value="940"/>
                    <measurement group_id="B4" value="2145"/>
                    <measurement group_id="B5" value="2089"/>
                    <measurement group_id="B6" value="6830"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="291"/>
                    <measurement group_id="B2" value="259"/>
                    <measurement group_id="B3" value="273"/>
                    <measurement group_id="B4" value="1075"/>
                    <measurement group_id="B5" value="1087"/>
                    <measurement group_id="B6" value="2985"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian/Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="54"/>
                    <measurement group_id="B4" value="111"/>
                    <measurement group_id="B5" value="145"/>
                    <measurement group_id="B6" value="396"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="113"/>
                    <measurement group_id="B5" value="100"/>
                    <measurement group_id="B6" value="315"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="50"/>
                    <measurement group_id="B4" value="206"/>
                    <measurement group_id="B5" value="230"/>
                    <measurement group_id="B6" value="582"/>
                  </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="1108"/>
                    <measurement group_id="B2" value="1351"/>
                    <measurement group_id="B3" value="1351"/>
                    <measurement group_id="B4" value="3655"/>
                    <measurement group_id="B5" value="3655"/>
                    <measurement group_id="B6" value="11120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent of Participants With Visit or Procedure With Provider</title>
        <time_frame>1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Intervention</title>
            <description>No letter was sent to the patient.</description>
          </group>
          <group group_id="O2">
            <title>MPM Control Letter</title>
            <description>Communication type: Control letter vs. intervention letter</description>
          </group>
          <group group_id="O3">
            <title>MPM Intervention Letter</title>
            <description>Communication type: Control letter vs. intervention letter</description>
          </group>
          <group group_id="O4">
            <title>Mailed Control Letter</title>
            <description>Communication type: Control letter vs. intervention letter</description>
          </group>
          <group group_id="O5">
            <title>Mailed Intervention Letter</title>
            <description>Communication type: Control letter vs. intervention letter</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Participants With Visit or Procedure With Provider</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1108"/>
                <count group_id="O2" value="1351"/>
                <count group_id="O3" value="1351"/>
                <count group_id="O4" value="3655"/>
                <count group_id="O5" value="3655"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="64"/>
                    <measurement group_id="O3" value="63"/>
                    <measurement group_id="O4" value="176"/>
                    <measurement group_id="O5" value="200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Participants With Scheduled Visit or Procedure With Provider</title>
        <time_frame>1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Intervention</title>
            <description>No letter was sent to the patient.</description>
          </group>
          <group group_id="O2">
            <title>MPM Control Letter</title>
            <description>Communication type: Control letter vs. intervention letter</description>
          </group>
          <group group_id="O3">
            <title>MPM Intervention Letter</title>
            <description>Communication type: Control letter vs. intervention letter</description>
          </group>
          <group group_id="O4">
            <title>Mailed Control Letter</title>
            <description>Communication type: Control letter vs. intervention letter</description>
          </group>
          <group group_id="O5">
            <title>Mailed Intervention Letter</title>
            <description>Communication type: Control letter vs. intervention letter</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Participants With Scheduled Visit or Procedure With Provider</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1108"/>
                <count group_id="O2" value="1351"/>
                <count group_id="O3" value="1351"/>
                <count group_id="O4" value="3655"/>
                <count group_id="O5" value="3655"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="130"/>
                    <measurement group_id="O2" value="181"/>
                    <measurement group_id="O3" value="197"/>
                    <measurement group_id="O4" value="490"/>
                    <measurement group_id="O5" value="571"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Participants With Completed Telemedicine Visit With Provider</title>
        <time_frame>1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Intervention</title>
            <description>No letter was sent to the patient.</description>
          </group>
          <group group_id="O2">
            <title>MPM Control Letter</title>
            <description>Communication type: Control letter vs. intervention letter</description>
          </group>
          <group group_id="O3">
            <title>MPM Intervention Letter</title>
            <description>Communication type: Control letter vs. intervention letter</description>
          </group>
          <group group_id="O4">
            <title>Mailed Control Letter</title>
            <description>Communication type: Control letter vs. intervention letter</description>
          </group>
          <group group_id="O5">
            <title>Mailed Intervention Letter</title>
            <description>Communication type: Control letter vs. intervention letter</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Participants With Completed Telemedicine Visit With Provider</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1108"/>
                <count group_id="O2" value="1351"/>
                <count group_id="O3" value="1351"/>
                <count group_id="O4" value="3655"/>
                <count group_id="O5" value="3655"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="17"/>
                    <measurement group_id="O4" value="44"/>
                    <measurement group_id="O5" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 month</time_frame>
      <group_list>
        <group group_id="E1">
          <title>No Intervention</title>
          <description>No letter was sent to the patient.</description>
        </group>
        <group group_id="E2">
          <title>MPM Control Letter</title>
          <description>Communication type: Control letter vs. intervention letter</description>
        </group>
        <group group_id="E3">
          <title>MPM Intervention Letter</title>
          <description>Communication type: Control letter vs. intervention letter</description>
        </group>
        <group group_id="E4">
          <title>Mailed Control Letter</title>
          <description>Communication type: Control letter vs. intervention letter</description>
        </group>
        <group group_id="E5">
          <title>Mailed Intervention Letter</title>
          <description>Communication type: Control letter vs. intervention letter</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="1108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1351"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1351"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3655"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3655"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1351"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1351"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3655"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3655"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1108"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1351"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1351"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3655"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3655"/>
              </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. Anne Cappola</name_or_title>
      <organization>University of Pennsylvania</organization>
      <phone>2155735359</phone>
      <email>acappola@pennmedicine.upenn.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/NCT04418947
org study id: 843220
nct id: NCT04418947
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Randomized, double-blind, of standard of care vs additional communication and factorial
      design of intervention letter vs. control letter and EHR vs mail delivery mechanism in
      patients who canceled visits and did not reschedule over a 90 day period starting March 9,
      2020.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Randomized, double-blind, factorial design
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percent of Participants With Visit or Procedure With Provider
time frame: 1 month
measure: Percent of Participants With Scheduled Visit or Procedure With Provider
time frame: 1 month
measure: Percent of Participants With Completed Telemedicine Visit With Provider
time frame: 1 month
arm group label: No intervention
arm group type: No Intervention
arm group label: MPM control letter
arm group type: Active Comparator
arm group label: MPM intervention letter
arm group type: Experimental
arm group label: Mailed control letter
arm group type: Active Comparator
arm group label: Mailed intervention letter
arm group type: Experimental
intervention type: Other
intervention name: Communication type
description: Control letter vs. intervention letter
arm group label: MPM control letter
arm group label: MPM intervention letter
arm group label: Mailed control letter
arm group label: Mailed intervention letter
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pennsylvania
investigator full name: Anne Cappola, MD
investigator title: Professor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 