<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/NCT02991729</url>
  </required_header>
  <id_info>
    <org_study_id>15-1745</org_study_id>
    <nct_id>NCT02991729</nct_id>
  </id_info>
  <brief_title>Use of a Novel Computerized Decision Aid for Prenatal Aneuploidy Screening</brief_title>
  <acronym>DAAS</acronym>
  <official_title>Use of a Novel Decision Aid for Prenatal Aneuploidy Screening</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>North Carolina Translational and Clinical Sciences Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</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>
      The investigators aim to assess whether use of a novel, tablet-based computerized decision&#xD;
      aid for aneuploidy screening is similar to routine care with a brief genetic counseling visit&#xD;
      in improving patient knowledge and decreasing decisional conflict.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      184 women will be randomized in a 1:1 fashion to use of a novel computerized iPad-based&#xD;
      decision aid in addition to routine counseling or routine counseling only during a single&#xD;
      study visit. This decision aid was developed at a 10th grade literacy level using input from&#xD;
      Maternal Fetal Medicine physicians and certified genetic counselors, and piloted by 20&#xD;
      English and Spanish speaking women of varying education levels. Following completion of&#xD;
      genetic counseling, participants will complete several surveys assessing knowledge and&#xD;
      decision conflict. Data will be abstracted regarding demographics, screening and diagnostic&#xD;
      testing uptake, and testing results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 20, 2017</start_date>
  <completion_date type="Actual">January 12, 2018</completion_date>
  <primary_completion_date type="Actual">January 5, 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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Knowledge Score</measure>
    <time_frame>At completion of genetic counseling for the Routine Care Group and at completion of decision aid and genetic counseling for Experimental Group, approximately 10-60 minutes</time_frame>
    <description>All patients in the intervention arm will complete a knowledge questionnaire following completion of the decision and and again immediately following genetic counseling. The investigators will assess noninferiority of the decision aid on participant knowledge, with primary outcome comparing knowledge after completion of the decision aid in the intervention arm, to knowledge following genetic counseling only in the routine care arm. The questionnaire is a modification of the validated Maternal Serum Screening Knowledge Questionnaire. This is on a 12-point scale (values 0-12), with higher score indicating greater knowledge.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Decisional Conflict Score</measure>
    <time_frame>At completion of decision aid (Experimental group) and completion of genetic counseling (all participants), approximately 10-60 minutes</time_frame>
    <description>A low-literacy decisional conflict questionnaire will be used. This will be completed by patients in the intervention arm following use of the decision and and again following genetic counseling. It will be completed by patients in the routine care arm following genetic counseling. Decisional conflict at all time points will be compared - specifically, decisional conflict following decision aid completion in the Experimental Group will be compared to decisional conflict following genetic counseling in the Routine Care Group, and decisional conflict following both decision aid completion and genetic counseling in the Experimental Group will be compared to decisional conflict following genetic counseling in the Routine Care Group. This questionnaire is on a 40 point scale (values 0-40), with higher score indicating higher level of decisional conflict.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Test Chosen</measure>
    <time_frame>At completion of decision aid and at completion genetic counseling, approximately 10-60 minutes</time_frame>
    <description>For participants in the intervention arm, initial choice of aneuploidy screening following use of the decision aid will be compared to final test chosen following genetic counseling.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Supplementary Tests Performed</measure>
    <time_frame>22 weeks gestation</time_frame>
    <description>Use of additional aneuploidy screening or testing modalities (cell-free DNA, chorionic villus sampling, or amniocentesis in addition to initial screening test) in the current pregnancy will be assessed up to 22 weeks gestation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">197</enrollment>
  <condition>Aneuploidy</condition>
  <condition>Pregnancy Complications</condition>
  <arm_group>
    <arm_group_label>Routine care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>These patients will receive routine care at our institution for counseling on aneuploidy screening; they will be counseled by a genetic counselor on options, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey immediately following genetic counseling.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>These patients will use an iPad-based decision aid explaining options for aneuploidy screening and testing. They will then immediately be counseled by a genetic counselor on their options as is routine at our institution, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey following use of the decision aid, and again immediately following genetic counseling.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>iPad-based decision aid</intervention_name>
    <description>This is a novel decision aid developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Genetic counseling appointment</intervention_name>
    <description>All participants will undergo an approximately 15 minute educational genetic counseling appointment regarding aneuploidy screening options. Should family history concerns be identified on intake, this visit may be extended to include a discussion of additional issues.</description>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_label>Routine care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnancy at less than 22 weeks gestation&#xD;
&#xD;
          -  English or Spanish speaking&#xD;
&#xD;
          -  Undergoing genetic counseling at North Carolina Women's Hospital for aneuploidy&#xD;
             screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known fetal anomalies&#xD;
&#xD;
          -  Known multiple gestations&#xD;
&#xD;
          -  Prior genetic counseling or aneuploidy screening in current pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura M Carlson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <results_first_submitted>March 12, 2019</results_first_submitted>
  <results_first_submitted_qc>October 21, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 12, 2019</results_first_posted>
  <last_update_submitted>September 25, 2020</last_update_submitted>
  <last_update_submitted_qc>September 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Decision aid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregnancy Complications</mesh_term>
    <mesh_term>Aneuploidy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data will not be shared with other researchers.</ipd_description>
  </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 3, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/29/NCT02991729/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Routine Care</title>
          <description>These patients will receive routine care at our institution for counseling on aneuploidy screening; they will be counseled by a genetic counselor on options, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey immediately following genetic counseling.&#xD;
Genetic counseling appointment: All participants will undergo an approximately 15 minute educational genetic counseling appointment regarding aneuploidy screening options. Should family history concerns be identified on intake, this visit may be extended to include a discussion of additional issues.</description>
        </group>
        <group group_id="P2">
          <title>Experimental</title>
          <description>These patients will use an iPad-based decision aid explaining options for aneuploidy screening and testing. They will then immediately be counseled by a genetic counselor on their options as is routine at our institution, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey following use of the decision aid, and again immediately following genetic counseling.&#xD;
iPad-based decision aid: This novel decision aid was developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.&#xD;
Genetic counseling appointment: All participants will undergo an approximately 15-min educational genetic counseling appointment</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="105"/>
                <participants group_id="P2" count="92"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="105"/>
                <participants group_id="P2" count="92"/>
              </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>
      <population>Knowledge score (on 12 point scale) for each participant will be analyzed by group.</population>
      <group_list>
        <group group_id="B1">
          <title>Routine Care</title>
          <description>These patients will receive routine care at our institution for counseling on aneuploidy screening; they will be counseled by a genetic counselor on options, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey immediately following genetic counseling.&#xD;
Genetic counseling appointment: All participants will undergo an approximately 15 minute educational genetic counseling appointment regarding aneuploidy screening options. Should family history concerns be identified on intake, this visit may be extended to include a discussion of additional issues.</description>
        </group>
        <group group_id="B2">
          <title>Experimental</title>
          <description>These patients will use an iPad-based decision aid explaining options for aneuploidy screening and testing. They will then immediately be counseled by a genetic counselor on their options as is routine at our institution, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey following use of the decision aid, and again immediately following genetic counseling.&#xD;
iPad-based decision aid: This novel decision aid was developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.&#xD;
Genetic counseling appointment: All participants will undergo an approximately 15-min educational genetic counseling appointment</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="105"/>
            <count group_id="B2" value="92"/>
            <count group_id="B3" value="197"/>
          </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="32.4" spread="5.7"/>
                    <measurement group_id="B2" value="32.7" spread="5.6"/>
                    <measurement group_id="B3" value="32.6" spread="5.6"/>
                  </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="105"/>
                    <measurement group_id="B2" value="92"/>
                    <measurement group_id="B3" value="197"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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>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="63"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic/Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unspecified/other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Knowledge Score</title>
        <description>All patients in the intervention arm will complete a knowledge questionnaire following completion of the decision and and again immediately following genetic counseling. The investigators will assess noninferiority of the decision aid on participant knowledge, with primary outcome comparing knowledge after completion of the decision aid in the intervention arm, to knowledge following genetic counseling only in the routine care arm. The questionnaire is a modification of the validated Maternal Serum Screening Knowledge Questionnaire. This is on a 12-point scale (values 0-12), with higher score indicating greater knowledge.</description>
        <time_frame>At completion of genetic counseling for the Routine Care Group and at completion of decision aid and genetic counseling for Experimental Group, approximately 10-60 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Routine Care</title>
            <description>These patients will receive routine care at our institution for counseling on aneuploidy screening; they will be counseled by a genetic counselor on options, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey immediately following genetic counseling.&#xD;
Genetic counseling appointment: All participants will undergo an approximately 15 minute educational genetic counseling appointment regarding aneuploidy screening options. Should family history concerns be identified on intake, this visit may be extended to include a discussion of additional issues.</description>
          </group>
          <group group_id="O2">
            <title>Experimental</title>
            <description>These patients will use an iPad-based decision aid explaining options for aneuploidy screening and testing. They will then immediately be counseled by a genetic counselor on their options as is routine at our institution, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey following use of the decision aid, and again immediately following genetic counseling.&#xD;
iPad-based decision aid: This novel decision aid was developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.&#xD;
Genetic counseling appointment: All participants will undergo an approximately 15-min educational genetic counseling appointment</description>
          </group>
        </group_list>
        <measure>
          <title>Knowledge Score</title>
          <description>All patients in the intervention arm will complete a knowledge questionnaire following completion of the decision and and again immediately following genetic counseling. The investigators will assess noninferiority of the decision aid on participant knowledge, with primary outcome comparing knowledge after completion of the decision aid in the intervention arm, to knowledge following genetic counseling only in the routine care arm. The questionnaire is a modification of the validated Maternal Serum Screening Knowledge Questionnaire. This is on a 12-point scale (values 0-12), with higher score indicating greater knowledge.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.6" spread="1.9"/>
                    <measurement group_id="O2" value="10.2" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority limit was 1 point on the questionnaire scale.</non_inferiority_desc>
            <p_value>0.929</p_value>
            <p_value_desc>a priori threshold for statistical significance was p&lt;0.05.</p_value_desc>
            <method>Wilcoxon rank-sum</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Decisional Conflict Score</title>
        <description>A low-literacy decisional conflict questionnaire will be used. This will be completed by patients in the intervention arm following use of the decision and and again following genetic counseling. It will be completed by patients in the routine care arm following genetic counseling. Decisional conflict at all time points will be compared - specifically, decisional conflict following decision aid completion in the Experimental Group will be compared to decisional conflict following genetic counseling in the Routine Care Group, and decisional conflict following both decision aid completion and genetic counseling in the Experimental Group will be compared to decisional conflict following genetic counseling in the Routine Care Group. This questionnaire is on a 40 point scale (values 0-40), with higher score indicating higher level of decisional conflict.</description>
        <time_frame>At completion of decision aid (Experimental group) and completion of genetic counseling (all participants), approximately 10-60 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Routine Care</title>
            <description>These patients will receive routine care at our institution for counseling on aneuploidy screening; they will be counseled by a genetic counselor on options, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey immediately following genetic counseling.&#xD;
Genetic counseling appointment: All participants will undergo an approximately 15 minute educational genetic counseling appointment regarding aneuploidy screening options. Should family history concerns be identified on intake, this visit may be extended to include a discussion of additional issues.</description>
          </group>
          <group group_id="O2">
            <title>Experimental</title>
            <description>These patients will use an iPad-based decision aid explaining options for aneuploidy screening and testing. They will then immediately be counseled by a genetic counselor on their options as is routine at our institution, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey following use of the decision aid, and again immediately following genetic counseling.&#xD;
iPad-based decision aid: This novel decision aid was developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.&#xD;
Genetic counseling appointment: All participants will undergo an approximately 15-min educational genetic counseling appointment</description>
          </group>
        </group_list>
        <measure>
          <title>Decisional Conflict Score</title>
          <description>A low-literacy decisional conflict questionnaire will be used. This will be completed by patients in the intervention arm following use of the decision and and again following genetic counseling. It will be completed by patients in the routine care arm following genetic counseling. Decisional conflict at all time points will be compared - specifically, decisional conflict following decision aid completion in the Experimental Group will be compared to decisional conflict following genetic counseling in the Routine Care Group, and decisional conflict following both decision aid completion and genetic counseling in the Experimental Group will be compared to decisional conflict following genetic counseling in the Routine Care Group. This questionnaire is on a 40 point scale (values 0-40), with higher score indicating higher level of decisional conflict.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-genetic counseling/post-decision aid</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">This group did not complete a decisional conflict score prior to genetic counseling.</measurement>
                    <measurement group_id="O2" value="1.6" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Genetic Counseling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="4.8"/>
                    <measurement group_id="O2" value="0.2" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Decisional conflict was measured in 2 separate time points in the experimental group - both prior to and following genetic counseling. This analysis compares decisional conflict in the routine care group (after counseling only) to the experimental group following decision aid completion but prior to genetic counseling (first row, second column in above table).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.369</p_value>
            <method>Wilcoxon rank-sum</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Decisional conflict was measured in 2 separate time points in the experimental group - both prior to and following genetic counseling. This analysis compares decisional conflict in the routine care group (after counseling only) to the experimental group following decision aid completion and genetic counseling (second row, second column in above table).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.003</p_value>
            <method>Wilcoxon rank-sum</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Decisional conflict was measured in 2 separate time points in the experimental group - both prior to and following genetic counseling. This analysis compares decisional conflict pre-genetic counseling/post-decision aid to post-genetic counseling.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.003</p_value>
            <method>Wilcoxon signed-rank</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Test Chosen</title>
        <description>For participants in the intervention arm, initial choice of aneuploidy screening following use of the decision aid will be compared to final test chosen following genetic counseling.</description>
        <time_frame>At completion of decision aid and at completion genetic counseling, approximately 10-60 minutes</time_frame>
        <population>Some participants chose not to answer this question and so the numbers above reflect the number of participants for whom we have data.</population>
        <group_list>
          <group group_id="O1">
            <title>Experimental: Pre-genetic Counseling</title>
            <description>These patients will use an iPad-based decision aid explaining options for aneuploidy screening and testing. They will then immediately be counseled by a genetic counselor on their options as is routine at our institution, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey following use of the decision aid, and again immediately following genetic counseling.&#xD;
iPad-based decision aid: This novel decision aid was developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.&#xD;
Genetic counseling appointment: All participants will undergo an approximately 15-min educational genetic counseling appointment</description>
          </group>
          <group group_id="O2">
            <title>Experimental: Post-genetic Counseling</title>
            <description>These patients will use an iPad-based decision aid explaining options for aneuploidy screening and testing. They will then immediately be counseled by a genetic counselor on their options as is routine at our institution, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey following use of the decision aid, and again immediately following genetic counseling.&#xD;
iPad-based decision aid: This novel decision aid was developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.&#xD;
Genetic counseling appointment: All participants will undergo an approximately 15-min educational genetic counseling appointment</description>
          </group>
        </group_list>
        <measure>
          <title>Test Chosen</title>
          <description>For participants in the intervention arm, initial choice of aneuploidy screening following use of the decision aid will be compared to final test chosen following genetic counseling.</description>
          <population>Some participants chose not to answer this question and so the numbers above reflect the number of participants for whom we have data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>None/US only</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>First trimester screen</title>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cell free DNA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Quadruple analyte screen</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Chorionic villus sampling</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Amniocentesis</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Don't know</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Supplementary Tests Performed</title>
        <description>Use of additional aneuploidy screening or testing modalities (cell-free DNA, chorionic villus sampling, or amniocentesis in addition to initial screening test) in the current pregnancy will be assessed up to 22 weeks gestation.</description>
        <time_frame>22 weeks gestation</time_frame>
        <population>This analysis was updated to include only invasive testing - these numbers represent those women undergoing chorionic villus sampling or amniocentesis for high risk screening results.</population>
        <group_list>
          <group group_id="O1">
            <title>Routine Care</title>
            <description>These patients will receive routine care at our institution for counseling on aneuploidy screening; they will be counseled by a genetic counselor on options, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey immediately following genetic counseling.&#xD;
Genetic counseling appointment: All participants will undergo an approximately 15 minute educational genetic counseling appointment regarding aneuploidy screening options. Should family history concerns be identified on intake, this visit may be extended to include a discussion of additional issues.</description>
          </group>
          <group group_id="O2">
            <title>Experimental</title>
            <description>These patients will use an iPad-based decision aid explaining options for aneuploidy screening and testing. They will then immediately be counseled by a genetic counselor on their options as is routine at our institution, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey following use of the decision aid, and again immediately following genetic counseling.&#xD;
iPad-based decision aid: This novel decision aid was developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.&#xD;
Genetic counseling appointment: All participants will undergo an approximately 15-min educational genetic counseling appointment</description>
          </group>
        </group_list>
        <measure>
          <title>Supplementary Tests Performed</title>
          <description>Use of additional aneuploidy screening or testing modalities (cell-free DNA, chorionic villus sampling, or amniocentesis in addition to initial screening test) in the current pregnancy will be assessed up to 22 weeks gestation.</description>
          <population>This analysis was updated to include only invasive testing - these numbers represent those women undergoing chorionic villus sampling or amniocentesis for high risk screening results.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Invasive testing for high-risk results</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No invasive testing for high-risk results</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Over the course of the study visit, approximately 1 hour</time_frame>
      <desc>Patients were encouraged to contact study PI and given contact information for any questions or concerns.</desc>
      <group_list>
        <group group_id="E1">
          <title>Routine Care</title>
          <description>These patients will receive routine care at our institution for counseling on aneuploidy screening; they will be counseled by a genetic counselor on options, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey immediately following genetic counseling.&#xD;
Genetic counseling appointment: All participants will undergo an approximately 15 minute educational genetic counseling appointment regarding aneuploidy screening options. Should family history concerns be identified on intake, this visit may be extended to include a discussion of additional issues.</description>
        </group>
        <group group_id="E2">
          <title>Experimental</title>
          <description>These patients will use an iPad-based decision aid explaining options for aneuploidy screening and testing. They will then immediately be counseled by a genetic counselor on their options as is routine at our institution, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey following use of the decision aid, and again immediately following genetic counseling.&#xD;
iPad-based decision aid: This novel decision aid was developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.&#xD;
Genetic counseling appointment: All participants will undergo an approximately 15-min educational genetic counseling appointment</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="105"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="105"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="92"/>
              </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="105"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Laura Carlson, MD</name_or_title>
      <organization>UNC School of Medicine Maternal Fetal Medicine</organization>
      <phone>8643503140</phone>
      <email>lauramosbycarlson@gmail.com</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/NCT02991729
org study id: 15-1745
nct id: NCT02991729
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators aim to assess whether use of a novel, tablet-based computerized decision
      aid for aneuploidy screening is similar to routine care with a brief genetic counseling visit
      in improving patient knowledge and decreasing decisional conflict.
184 women will be randomized in a 1:1 fashion to use of a novel computerized iPad-based
      decision aid in addition to routine counseling or routine counseling only during a single
      study visit. This decision aid was developed at a 10th grade literacy level using input from
      Maternal Fetal Medicine physicians and certified genetic counselors, and piloted by 20
      English and Spanish speaking women of varying education levels. Following completion of
      genetic counseling, participants will complete several surveys assessing knowledge and
      decision conflict. Data will be abstracted regarding demographics, screening and diagnostic
      testing uptake, and testing results.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Knowledge Score
time frame: At completion of genetic counseling for the Routine Care Group and at completion of decision aid and genetic counseling for Experimental Group, approximately 10-60 minutes
description: All patients in the intervention arm will complete a knowledge questionnaire following completion of the decision and and again immediately following genetic counseling. The investigators will assess noninferiority of the decision aid on participant knowledge, with primary outcome comparing knowledge after completion of the decision aid in the intervention arm, to knowledge following genetic counseling only in the routine care arm. The questionnaire is a modification of the validated Maternal Serum Screening Knowledge Questionnaire. This is on a 12-point scale (values 0-12), with higher score indicating greater knowledge.
measure: Decisional Conflict Score
time frame: At completion of decision aid (Experimental group) and completion of genetic counseling (all participants), approximately 10-60 minutes
description: A low-literacy decisional conflict questionnaire will be used. This will be completed by patients in the intervention arm following use of the decision and and again following genetic counseling. It will be completed by patients in the routine care arm following genetic counseling. Decisional conflict at all time points will be compared - specifically, decisional conflict following decision aid completion in the Experimental Group will be compared to decisional conflict following genetic counseling in the Routine Care Group, and decisional conflict following both decision aid completion and genetic counseling in the Experimental Group will be compared to decisional conflict following genetic counseling in the Routine Care Group. This questionnaire is on a 40 point scale (values 0-40), with higher score indicating higher level of decisional conflict.
measure: Test Chosen
time frame: At completion of decision aid and at completion genetic counseling, approximately 10-60 minutes
description: For participants in the intervention arm, initial choice of aneuploidy screening following use of the decision aid will be compared to final test chosen following genetic counseling.
measure: Supplementary Tests Performed
time frame: 22 weeks gestation
description: Use of additional aneuploidy screening or testing modalities (cell-free DNA, chorionic villus sampling, or amniocentesis in addition to initial screening test) in the current pregnancy will be assessed up to 22 weeks gestation.
arm group label: Routine care
arm group type: Active Comparator
description: These patients will receive routine care at our institution for counseling on aneuploidy screening; they will be counseled by a genetic counselor on options, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey immediately following genetic counseling.
arm group label: Experimental
arm group type: Experimental
description: These patients will use an iPad-based decision aid explaining options for aneuploidy screening and testing. They will then immediately be counseled by a genetic counselor on their options as is routine at our institution, and following counseling, will select their test of choice. All patients will complete a knowledge and demographics questionnaire prior to genetic counseling. Patients in this arm will then complete a knowledge and decisional conflict survey following use of the decision aid, and again immediately following genetic counseling.
intervention type: Other
intervention name: iPad-based decision aid
description: This is a novel decision aid developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.
arm group label: Experimental
intervention type: Other
intervention name: Genetic counseling appointment
description: All participants will undergo an approximately 15 minute educational genetic counseling appointment regarding aneuploidy screening options. Should family history concerns be identified on intake, this visit may be extended to include a discussion of additional issues.
arm group label: Experimental
arm group label: Routine care
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Laura M Carlson, MD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pregnancy Complications
mesh term: Aneuploidy
sharing ipd: No
ipd description: Individual participant data will not be shared with other researchers.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 