<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/NCT03804918</url>
  </required_header>
  <id_info>
    <org_study_id>18SM4947</org_study_id>
    <nct_id>NCT03804918</nct_id>
  </id_info>
  <brief_title>Mobile Learning to Improve Clinician's Ability to Break Bad News</brief_title>
  <official_title>Mobile Learning Resources as a Tool for Improving Clinician's Ability to Break Bad News: A Pre-post Mixed Methods Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imperial College London</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>
      Design:&#xD;
&#xD;
      A pre-post mixed methods pilot study. All participants granted access to a breaking bad news&#xD;
      mobile learning resource (VitalTips).&#xD;
&#xD;
      Baseline and post-intervention questionnaires, pre- and post-intervention simulated patient&#xD;
      encounters, and post-intervention semi-structured interviews.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To assess if a selected breaking bad news mobile learning resource can improve the ability of&#xD;
      clinicians to break bad news.&#xD;
&#xD;
      Population/Eligibility:&#xD;
&#xD;
      15-20 junior doctors and nurses working within two NHS hospitals trusts and one private&#xD;
      hospital in England.&#xD;
&#xD;
      Duration:&#xD;
&#xD;
      25th February 2019 to 8th July 2019.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose:&#xD;
&#xD;
      Digital and mobile learning is at the forefront of healthcare education. Though there is&#xD;
      evidence for the use of digital learning for practical skills acquisition, there is little&#xD;
      evidence of the use of digital learning for breaking bad news training. This pre-post mixed&#xD;
      methods pilot study aimed to address this gap in knowledge by assessing how a mobile learning&#xD;
      resource may impact the ability of clinicians to break bad news.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      The addition of a breaking bad news mobile learning resource to clinical practice improves&#xD;
      the confidence and ability of junior doctors and nurses to break bad news.&#xD;
&#xD;
      Study objective:&#xD;
&#xD;
      To assess if a breaking bad news mobile learning resource can improve the confidence and&#xD;
      ability of clinicians to break bad news.&#xD;
&#xD;
      Methodology:&#xD;
&#xD;
      Potential participants were sent an invitation and participant information sheet (PIS) via&#xD;
      e-mail. Potential participants were given up to two weeks to decide if they wanted to&#xD;
      participate, with a reminder sent after one week. Each potential participant was referenced&#xD;
      by a participant ID number for confidentiality purposes.&#xD;
&#xD;
      Once potential participants read the PIS and given consent, they were asked to complete a&#xD;
      baseline questionnaire to understand their demographics, their previous exposure to breaking&#xD;
      bad news (through formal or informal training) and their engagement with digital resources.&#xD;
&#xD;
      Following this, participants were asked to complete a baseline simulated patient encounter&#xD;
      (SPE) with a simulated patient (SP) (role-played by an actor) to assess their baseline&#xD;
      ability to break bad news. Participants were given a task sheet with a brief history of the&#xD;
      SP and what news they needed to deliver. The details and history of the SP was documented on&#xD;
      a character sheet for the actor's reference. Each participant was given 15 minutes to&#xD;
      complete the SPE which was video-recorded. The SPEs were evaluated against the validated&#xD;
      Breaking bad news Assessment Schedule (BAS) mark sheet completed by the chief investigator,&#xD;
      actor and an independent assessor (by watching the video footage).&#xD;
&#xD;
      Access to the mobile learning resource was granted following the baseline SPE. The mobile&#xD;
      learning resource was the freely available VitalTips mobile application, provided by&#xD;
      VitalTalks. Participants were expected to spend at least three hours using the mobile&#xD;
      learning resource, ensuring that this time did not impact on their clinical and academic&#xD;
      commitments.&#xD;
&#xD;
      Four to six weeks later, participants were asked to complete a second videoed SPE, which was&#xD;
      marked as described above. The participants were asked to complete a post-intervention&#xD;
      questionnaire to gauge the impact on their clinical practice and their engagement with the&#xD;
      mobile resources.&#xD;
&#xD;
      The questionnaires utilised a five-point Likert scale ranking of the user's confidence and&#xD;
      agreeability with statements. The questionnaires are novel to this study and were developed&#xD;
      using the principles of Kirkpatrick's Model of Learning Evaluation, the Theory of Planned&#xD;
      Behaviour and the Technology Acceptance Model, whilst also drawing on the most important&#xD;
      curricula competencies derived from the content analysis of a sample of medical and nursing&#xD;
      curricula followed by an expert consensus.&#xD;
&#xD;
      Soon after the completion of the post-intervention questionnaire, the participants were asked&#xD;
      to participate in a 15-30 minutes semi-structured interview with the chief investigator. The&#xD;
      participant was asked about their general impressions of the mobile learning resource, their&#xD;
      use of the resource in and outside of the clinical environment, their perception of their&#xD;
      ability to break bad news before and after the intervention, their perception of their&#xD;
      performance in the SPE and any impact on their practice.&#xD;
&#xD;
      Data handling and confidentiality:&#xD;
&#xD;
      Following consent, participants were referenced by their participant ID number (e.g. MLR001).&#xD;
      Their e-mail address was recorded next to their participant ID number, gender, role (i.e.&#xD;
      doctor or nurse) and training grade, on an Excel spreadsheet for the purpose of contacting&#xD;
      participants as the study progressed. Once their commitment to the study had ended, the&#xD;
      e-mail addresses were deleted.&#xD;
&#xD;
      Video recordings from the SPEs were transferred from the recording device to a password&#xD;
      protected USB stick referenced by the participant ID followed by SPE1 (baseline) or SPE2&#xD;
      (post-intervention), e.g. MLR001_SPE1. Once the independent reviewer had viewed the video and&#xD;
      marked the participant, the video file was destroyed.&#xD;
&#xD;
      Audio files from the interviews was transferred from the recording device onto a password&#xD;
      protected computer using a USB stick. Once the transfer was completed, the files were deleted&#xD;
      from the USB stick. The transferred files were stored on the password protected computer till&#xD;
      the returned transcriptions were checked by the chief investigator. Once the files had been&#xD;
      checked, the recordings were deleted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 25, 2019</start_date>
  <completion_date type="Actual">August 30, 2019</completion_date>
  <primary_completion_date type="Actual">August 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>A pre-post mixed methods pilot educational study</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Self-assessed Likert Scale Relating to Confidence in Breaking Bad News at Baseline and Post-intervention.</measure>
    <time_frame>Baseline questionnaire (week 0) followed by post-intervention questionnaire (weeks 4 to 6)</time_frame>
    <description>Baseline and post-intervention questionnaires utilise a five-point Likert scale ranking of the user's confidence and agreeability with statements (Scale: Not very confident at all; Not very confident; Somewhat confident; Very confident; Extremely confident). With each participant acting as their own control, comparisons were made from their own baseline and post-intervention Likert scale ratings.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Simulated Patient Encounter Marking Scores Related to Breaking Bad News at Baseline and Post-intervention.</measure>
    <time_frame>Baseline SPE (week 0) followed by post-intervention SPE (weeks 4 to 6)</time_frame>
    <description>The simulated patient encounter (SPE) was marked by three assessors using the validated Breaking bad news Assessment Schedule (BAS). The BAS comprises of five sections which group a set of skills relating to BBN. Each skill was marked on a Likert scale in the form of a numerical scale: definitely (positive) 5 _ 4 _ 3 _ 2 _ 1 not at all (negative). The five sections were: A. Setting the scene (minimum score 3; maximum score 15); B. Breaking the news (minimum score 5; maximum score 25); C. Eliciting concerns (minimum score 3; maximum score 15); D. Information giving (minimum score 4; maximum score 20); E. General considerations (minimum score 8; maximum score 40). Overall score (minimum score 23; maximum score 115). Scores from three markers were summed and a mean average was taken pre- and post-intervention for each section and overall. Paired sample t-test were used for analysis of aggregated scores s they enabled the comparison of means between pre- and post-intervention mean scores.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Education</condition>
  <arm_group>
    <arm_group_label>Interventional group: All participants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Given access to a selected breaking bad news mobile learning resource (VitalTips application).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>VitalTips mobile application</intervention_name>
    <description>VitalTips is a mobile learning application with learning on breaking bad news. Participants were expected to spend at least three hours using the mobile learning resource, ensuring that the time did not impact on their clinical and academic commitments.</description>
    <arm_group_label>Interventional group: All participants</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Working and training within NHS England and a private healthcare hospital.&#xD;
&#xD;
          -  Junior doctor, pre-certificate of completion of training (of any specialty).&#xD;
&#xD;
          -  Junior nurse band 5 to 6 (or equivalent) from any specialty.&#xD;
&#xD;
          -  Over the age of 18.&#xD;
&#xD;
          -  Able to communicate and write in English.&#xD;
&#xD;
          -  Willing to engage with mobile learning resources as an additional task to their&#xD;
             clinical role, ensuring their learning does not take time out of their clinical&#xD;
             commitments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical and nursing students.&#xD;
&#xD;
          -  Clinicians who have completed their training programmes i.e. medical or nursing&#xD;
             consultants, matrons.&#xD;
&#xD;
          -  Retired clinicians.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gehan B Soosaipillai, BM BSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Imperial College London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Barts Health NHS Trust</name>
      <address>
        <city>London</city>
        <zip>E1 2EF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bupa Cromwell Hospital</name>
      <address>
        <city>London</city>
        <zip>SW5 0TU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imperial College Healthcare NHS Trust</name>
      <address>
        <city>London</city>
        <zip>W2 1NY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <results_first_submitted>July 31, 2020</results_first_submitted>
  <results_first_submitted_qc>October 5, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 12, 2020</results_first_posted>
  <last_update_submitted>October 13, 2020</last_update_submitted>
  <last_update_submitted_qc>October 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthcare education</keyword>
  <keyword>Breaking bad news</keyword>
  <keyword>Digital learning</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD was only be available on a password protected computer with sole access to the chief investigator. Only anonymised data was sent to the academic supervisor and other researchers.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT03804918/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Interventional Group: All Participants</title>
          <description>Given access to a selected breaking bad news mobile learning resource (VitalTips application).&#xD;
VitalTips mobile application: VitalTips is a mobile learning application with learning on breaking bad news. Participants were expected to spend at least three hours using the mobile learning resource, ensuring that this time does not impact on their clinical and academic commitments.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Participant did not use the app</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Interventional Group: All Participants</title>
          <description>Given access to a selected breaking bad news mobile learning resource (VitalTips application).&#xD;
VitalTips mobile application: VitalTips is a mobile learning application with learning on breaking bad news. Participants were expected to spend at least three hours using the mobile learning resource, ensuring that this time does not impact on their clinical and academic commitments.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="16"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Specialty</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Intensive care</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Medicine</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Oncology</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Paediatrics</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Surgery</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Self-assessed Likert Scale Relating to Confidence in Breaking Bad News at Baseline and Post-intervention.</title>
        <description>Baseline and post-intervention questionnaires utilise a five-point Likert scale ranking of the user's confidence and agreeability with statements (Scale: Not very confident at all; Not very confident; Somewhat confident; Very confident; Extremely confident). With each participant acting as their own control, comparisons were made from their own baseline and post-intervention Likert scale ratings.</description>
        <time_frame>Baseline questionnaire (week 0) followed by post-intervention questionnaire (weeks 4 to 6)</time_frame>
        <population>All participants (n=16) completed both the pre- and post-intervention questionnaires and there was no missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Interventional Group: All Participants</title>
            <description>Given access to a selected breaking bad news mobile learning resource (VitalTips application).&#xD;
VitalTips mobile application: VitalTips is a mobile learning application with learning on breaking bad news. Participants were expected to spend at least three hours using the mobile learning resource, ensuring that this time does not impact on their clinical and academic commitments.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Self-assessed Likert Scale Relating to Confidence in Breaking Bad News at Baseline and Post-intervention.</title>
          <description>Baseline and post-intervention questionnaires utilise a five-point Likert scale ranking of the user's confidence and agreeability with statements (Scale: Not very confident at all; Not very confident; Somewhat confident; Very confident; Extremely confident). With each participant acting as their own control, comparisons were made from their own baseline and post-intervention Likert scale ratings.</description>
          <population>All participants (n=16) completed both the pre- and post-intervention questionnaires and there was no missing 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="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-intervention: Not very confident at all</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention: Not very confident at all</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-intervention: Not very confident</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention: Not very confident</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-intervention: Somewhat confident</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention: Somewhat confident</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-intervention: Very confident</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention: Very confident</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-intervention: Extremely confident</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention: Extremely confident</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Simulated Patient Encounter Marking Scores Related to Breaking Bad News at Baseline and Post-intervention.</title>
        <description>The simulated patient encounter (SPE) was marked by three assessors using the validated Breaking bad news Assessment Schedule (BAS). The BAS comprises of five sections which group a set of skills relating to BBN. Each skill was marked on a Likert scale in the form of a numerical scale: definitely (positive) 5 _ 4 _ 3 _ 2 _ 1 not at all (negative). The five sections were: A. Setting the scene (minimum score 3; maximum score 15); B. Breaking the news (minimum score 5; maximum score 25); C. Eliciting concerns (minimum score 3; maximum score 15); D. Information giving (minimum score 4; maximum score 20); E. General considerations (minimum score 8; maximum score 40). Overall score (minimum score 23; maximum score 115). Scores from three markers were summed and a mean average was taken pre- and post-intervention for each section and overall. Paired sample t-test were used for analysis of aggregated scores s they enabled the comparison of means between pre- and post-intervention mean scores.</description>
        <time_frame>Baseline SPE (week 0) followed by post-intervention SPE (weeks 4 to 6)</time_frame>
        <population>All participants (n=16) completed both the pre- and post-intervention SPEs and there was no missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Interventional Group: All Participants</title>
            <description>Given access to a selected breaking bad news mobile learning resource (VitalTips application).&#xD;
VitalTips mobile application: VitalTips is a mobile learning application with learning on breaking bad news. Participants were expected to spend at least three hours using the mobile learning resource, ensuring that this time does not impact on their clinical and academic commitments.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Simulated Patient Encounter Marking Scores Related to Breaking Bad News at Baseline and Post-intervention.</title>
          <description>The simulated patient encounter (SPE) was marked by three assessors using the validated Breaking bad news Assessment Schedule (BAS). The BAS comprises of five sections which group a set of skills relating to BBN. Each skill was marked on a Likert scale in the form of a numerical scale: definitely (positive) 5 _ 4 _ 3 _ 2 _ 1 not at all (negative). The five sections were: A. Setting the scene (minimum score 3; maximum score 15); B. Breaking the news (minimum score 5; maximum score 25); C. Eliciting concerns (minimum score 3; maximum score 15); D. Information giving (minimum score 4; maximum score 20); E. General considerations (minimum score 8; maximum score 40). Overall score (minimum score 23; maximum score 115). Scores from three markers were summed and a mean average was taken pre- and post-intervention for each section and overall. Paired sample t-test were used for analysis of aggregated scores s they enabled the comparison of means between pre- and post-intervention mean scores.</description>
          <population>All participants (n=16) completed both the pre- and post-intervention SPEs and there was no missing data.</population>
          <units>score on the BAS 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="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-intervention: Setting the scene</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.15" spread="2.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention: Setting the scene</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.25" spread="1.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-intervention: Breaking the news</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.31" spread="5.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention: Breaking the news</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.85" spread="2.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-intervention: Eliciting concerns</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.71" spread="2.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention: Eliciting concerns</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.77" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-intervention: Information giving</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.23" spread="2.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention: Information giving</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.46" spread="1.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-intervention: General considerations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.54" spread="6.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention: General considerations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.58" spread="3.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-intervention: Overall</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.15" spread="17.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention: Overall</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.92" spread="9.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AE data was not collected due to it being an observational study and no AE's were anticipated.</time_frame>
      <desc>No AE's were expected and AE's were not monitored for this reason.</desc>
      <group_list>
        <group group_id="E1">
          <title>Interventional Group: All Participants</title>
          <description>Given access to a selected breaking bad news mobile learning resource (VitalTips application).&#xD;
VitalTips mobile application: VitalTips is a mobile learning application with learning on breaking bad news. Participants were expected to spend at least three hours using the mobile learning resource, ensuring that this time does not impact on their clinical and academic commitments.</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"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" 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"/>
              </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>
    <limitations_and_caveats>Sample numbers were small, which affects the interpretation of the quantitative measures (BAS mark sheet). Participants learned both from the app and the SPEs. Any change in the skill set must also take into consideration the learning from the SPEs.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr Gehan Soosaipillai</name_or_title>
      <organization>Imperial College London</organization>
      <phone>+44 20 3312 6666 ext 7651</phone>
      <email>gsoosaip@ic.ac.uk</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/NCT03804918
org study id: 18SM4947
nct id: NCT03804918
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Design:

      A pre-post mixed methods pilot study. All participants granted access to a breaking bad news
      mobile learning resource (VitalTips).

      Baseline and post-intervention questionnaires, pre- and post-intervention simulated patient
      encounters, and post-intervention semi-structured interviews.

      Objective:

      To assess if a selected breaking bad news mobile learning resource can improve the ability of
      clinicians to break bad news.

      Population/Eligibility:

      15-20 junior doctors and nurses working within two NHS hospitals trusts and one private
      hospital in England.

      Duration:

      25th February 2019 to 8th July 2019.
Purpose:

      Digital and mobile learning is at the forefront of healthcare education. Though there is
      evidence for the use of digital learning for practical skills acquisition, there is little
      evidence of the use of digital learning for breaking bad news training. This pre-post mixed
      methods pilot study aimed to address this gap in knowledge by assessing how a mobile learning
      resource may impact the ability of clinicians to break bad news.

      Hypothesis:

      The addition of a breaking bad news mobile learning resource to clinical practice improves
      the confidence and ability of junior doctors and nurses to break bad news.

      Study objective:

      To assess if a breaking bad news mobile learning resource can improve the confidence and
      ability of clinicians to break bad news.

      Methodology:

      Potential participants were sent an invitation and participant information sheet (PIS) via
      e-mail. Potential participants were given up to two weeks to decide if they wanted to
      participate, with a reminder sent after one week. Each potential participant was referenced
      by a participant ID number for confidentiality purposes.

      Once potential participants read the PIS and given consent, they were asked to complete a
      baseline questionnaire to understand their demographics, their previous exposure to breaking
      bad news (through formal or informal training) and their engagement with digital resources.

      Following this, participants were asked to complete a baseline simulated patient encounter
      (SPE) with a simulated patient (SP) (role-played by an actor) to assess their baseline
      ability to break bad news. Participants were given a task sheet with a brief history of the
      SP and what news they needed to deliver. The details and history of the SP was documented on
      a character sheet for the actor's reference. Each participant was given 15 minutes to
      complete the SPE which was video-recorded. The SPEs were evaluated against the validated
      Breaking bad news Assessment Schedule (BAS) mark sheet completed by the chief investigator,
      actor and an independent assessor (by watching the video footage).

      Access to the mobile learning resource was granted following the baseline SPE. The mobile
      learning resource was the freely available VitalTips mobile application, provided by
      VitalTalks. Participants were expected to spend at least three hours using the mobile
      learning resource, ensuring that this time did not impact on their clinical and academic
      commitments.

      Four to six weeks later, participants were asked to complete a second videoed SPE, which was
      marked as described above. The participants were asked to complete a post-intervention
      questionnaire to gauge the impact on their clinical practice and their engagement with the
      mobile resources.

      The questionnaires utilised a five-point Likert scale ranking of the user's confidence and
      agreeability with statements. The questionnaires are novel to this study and were developed
      using the principles of Kirkpatrick's Model of Learning Evaluation, the Theory of Planned
      Behaviour and the Technology Acceptance Model, whilst also drawing on the most important
      curricula competencies derived from the content analysis of a sample of medical and nursing
      curricula followed by an expert consensus.

      Soon after the completion of the post-intervention questionnaire, the participants were asked
      to participate in a 15-30 minutes semi-structured interview with the chief investigator. The
      participant was asked about their general impressions of the mobile learning resource, their
      use of the resource in and outside of the clinical environment, their perception of their
      ability to break bad news before and after the intervention, their perception of their
      performance in the SPE and any impact on their practice.

      Data handling and confidentiality:

      Following consent, participants were referenced by their participant ID number (e.g. MLR001).
      Their e-mail address was recorded next to their participant ID number, gender, role (i.e.
      doctor or nurse) and training grade, on an Excel spreadsheet for the purpose of contacting
      participants as the study progressed. Once their commitment to the study had ended, the
      e-mail addresses were deleted.

      Video recordings from the SPEs were transferred from the recording device to a password
      protected USB stick referenced by the participant ID followed by SPE1 (baseline) or SPE2
      (post-intervention), e.g. MLR001_SPE1. Once the independent reviewer had viewed the video and
      marked the participant, the video file was destroyed.

      Audio files from the interviews was transferred from the recording device onto a password
      protected computer using a USB stick. Once the transfer was completed, the files were deleted
      from the USB stick. The transferred files were stored on the password protected computer till
      the returned transcriptions were checked by the chief investigator. Once the files had been
      checked, the recordings were deleted.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A pre-post mixed methods pilot educational study
primary purpose: Other
masking: None (Open Label)
measure: Change in Self-assessed Likert Scale Relating to Confidence in Breaking Bad News at Baseline and Post-intervention.
time frame: Baseline questionnaire (week 0) followed by post-intervention questionnaire (weeks 4 to 6)
description: Baseline and post-intervention questionnaires utilise a five-point Likert scale ranking of the user's confidence and agreeability with statements (Scale: Not very confident at all; Not very confident; Somewhat confident; Very confident; Extremely confident). With each participant acting as their own control, comparisons were made from their own baseline and post-intervention Likert scale ratings.
measure: Change in Simulated Patient Encounter Marking Scores Related to Breaking Bad News at Baseline and Post-intervention.
time frame: Baseline SPE (week 0) followed by post-intervention SPE (weeks 4 to 6)
description: The simulated patient encounter (SPE) was marked by three assessors using the validated Breaking bad news Assessment Schedule (BAS). The BAS comprises of five sections which group a set of skills relating to BBN. Each skill was marked on a Likert scale in the form of a numerical scale: definitely (positive) 5 _ 4 _ 3 _ 2 _ 1 not at all (negative). The five sections were: A. Setting the scene (minimum score 3; maximum score 15); B. Breaking the news (minimum score 5; maximum score 25); C. Eliciting concerns (minimum score 3; maximum score 15); D. Information giving (minimum score 4; maximum score 20); E. General considerations (minimum score 8; maximum score 40). Overall score (minimum score 23; maximum score 115). Scores from three markers were summed and a mean average was taken pre- and post-intervention for each section and overall. Paired sample t-test were used for analysis of aggregated scores s they enabled the comparison of means between pre- and post-intervention mean scores.
arm group label: Interventional group: All participants
arm group type: Experimental
description: Given access to a selected breaking bad news mobile learning resource (VitalTips application).
intervention type: Other
intervention name: VitalTips mobile application
description: VitalTips is a mobile learning application with learning on breaking bad news. Participants were expected to spend at least three hours using the mobile learning resource, ensuring that the time did not impact on their clinical and academic commitments.
arm group label: Interventional group: All participants
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gehan B Soosaipillai, BM BSc
role: Principal Investigator
affiliation: Imperial College London
facility: 
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No
ipd description: IPD was only be available on a password protected computer with sole access to the chief investigator. Only anonymised data was sent to the academic supervisor and other researchers.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Sample numbers were small, which affects the interpretation of the quantitative measures (BAS mark sheet). Participants learned both from the app and the SPEs. Any change in the skill set must also take into consideration the learning from the SPEs.
point of contact: 