xml: <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/NCT05979090</url>
    </required_header>
    <id_info>
      <org_study_id>20235952</org_study_id>
      <nct_id>NCT05979090</nct_id>
    </id_info>
    <brief_title>Mastery Learning in Communication Skills</brief_title>
    <official_title>Mastery Learning in Communication Skills to Improve Milestone Performance and Burnout</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ann &amp; Robert H Lurie Children's Hospital of Chicago</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ann &amp; Robert H Lurie Children's Hospital of Chicago</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 goal of this study is to determine whether mastery learning in communication skills can&#xD;
        improve skills in a simulated environment and have translational improvements in outcomes.&#xD;
        The main questions it aims to answer are: 1. Does mastery learning improve skills in the&#xD;
        simulation laboratory? 2. Does mastery learning improve clinical skills as seen by milestone&#xD;
        performance? and 3 Does mastery learning improve burnout levels? The study is a&#xD;
        multi-institutional randomized controlled trial of anesthesiology residents from five&#xD;
        different residency programs. Participants will be randomized to mastery training in&#xD;
        communication skills and standard of care, which is vicarious learning. Researchers will&#xD;
        compare these two groups to see if mastery learning improves skills and translational&#xD;
        outcomes.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">January 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2025</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>Other</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Communication skills</measure>
      <time_frame>one year</time_frame>
      <description>Post test checklist skills scores, a 16-item checklist was developed using the modified Delphi technique with possible scores of 0 (lowest) to 16 (highest). All items in the checklist are graded dichotomously and (1 if done correctly and 0 if not done or done incorrectly.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Milestones Performance</measure>
      <time_frame>two years</time_frame>
      <description>The ACGME interpersonal and communication core competency is subdivided into three Anesthesiology Milestones: Patient and Family-centered communication, Interprofessional and Team Communication, and Communication within Health Care Systems. Each milestone is graded on a score of 1 (novice) to 5 (expert) by each residency program's Clinical Competency Committee (CCC).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Burnout levels</measure>
      <time_frame>1.5 years</time_frame>
      <description>The Maslach Burnout Inventory Scale (MBI-9) will be used to estimate the levels of burnout prior to participation in the intervention, immediately after course completion, and at 2 and 6 months after training. The MBI is a measure of job burnout defined by three subscales: emotional exhaustion (EE) (9 items), depersonalization (DP) (5 items), and professional accomplishment (PA) (8 items), each with 7-point Likert-type, frequency response scale (0 = never, 1 = a few times a year or less, 2 = once a month or less, 3 = a few times a month, 4 = once a week, 5 = a few times a week, 6 = every day) [1, 2]. Scales are scored such that higher scores indicate more of each construct. Higher scores on the EE and DP subscales indicate a higher burnout symptom burden; lower scores on the PA subscale indicate a higher burnout symptom burden.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Communication Research</condition>
    <condition>Communication, Personal</condition>
    <condition>Burnout, Professional</condition>
    <arm_group>
      <arm_group_label>Mastery Learning Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard of Care Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mastery learning in communication skills</intervention_name>
      <description>Participants will undergo simulation-based mastery learning curriculum in difficult conversations.</description>
      <arm_group_label>Mastery Learning Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Anesthesiology residents rotating at Ann and Robert H. Lurie Children's Hospital of&#xD;
               Chicago&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participant refusal&#xD;
  &#xD;
            -  Study participants who have already undergone the mastery learning in difficult&#xD;
               conversations course.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Heather Ballard, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ann and Robert H. Lurie Children's Hospital of Chicago</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Heather Ballard, MD</last_name>
      <phone>3122275170</phone>
      <email>hballard@luriechildrens.org</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Burnout, Professional</mesh_term>
      <mesh_term>Burnout, Psychological</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>de-identified study data will be available upon request when study is completed and published</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05979090
  org study id: 20235952
  nct id: NCT05979090
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this study is to determine whether mastery learning in communication skills can
        improve skills in a simulated environment and have translational improvements in outcomes.
        The main questions it aims to answer are: 1. Does mastery learning improve skills in the
        simulation laboratory? 2. Does mastery learning improve clinical skills as seen by milestone
        performance? and 3 Does mastery learning improve burnout levels? The study is a
        multi-institutional randomized controlled trial of anesthesiology residents from five
        different residency programs. Participants will be randomized to mastery training in
        communication skills and standard of care, which is vicarious learning. Researchers will
        compare these two groups to see if mastery learning improves skills and translational
        outcomes.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Communication skills
  time frame: one year
  description: Post test checklist skills scores, a 16-item checklist was developed using the modified Delphi technique with possible scores of 0 (lowest) to 16 (highest). All items in the checklist are graded dichotomously and (1 if done correctly and 0 if not done or done incorrectly.
  measure: Milestones Performance
  time frame: two years
  description: The ACGME interpersonal and communication core competency is subdivided into three Anesthesiology Milestones: Patient and Family-centered communication, Interprofessional and Team Communication, and Communication within Health Care Systems. Each milestone is graded on a score of 1 (novice) to 5 (expert) by each residency program's Clinical Competency Committee (CCC).
  measure: Burnout levels
  time frame: 1.5 years
  description: The Maslach Burnout Inventory Scale (MBI-9) will be used to estimate the levels of burnout prior to participation in the intervention, immediately after course completion, and at 2 and 6 months after training. The MBI is a measure of job burnout defined by three subscales: emotional exhaustion (EE) (9 items), depersonalization (DP) (5 items), and professional accomplishment (PA) (8 items), each with 7-point Likert-type, frequency response scale (0 = never, 1 = a few times a year or less, 2 = once a month or less, 3 = a few times a month, 4 = once a week, 5 = a few times a week, 6 = every day) [1, 2]. Scales are scored such that higher scores indicate more of each construct. Higher scores on the EE and DP subscales indicate a higher burnout symptom burden; lower scores on the PA subscale indicate a higher burnout symptom burden.
  arm group label: Mastery Learning Group
  arm group type: Experimental
  arm group label: Standard of Care Group
  arm group type: No Intervention
  intervention type: Behavioral
  intervention name: Mastery learning in communication skills
  description: Participants will undergo simulation-based mastery learning curriculum in difficult conversations.
  arm group label: Mastery Learning Group
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Heather Ballard, MD
  role: Principal Investigator
  affiliation: Ann and Robert H. Lurie Children's Hospital of Chicago
  last name: Heather Ballard, MD
  phone: 3122275170
  email: hballard@luriechildrens.org
  responsible party type: Sponsor
  mesh term: Burnout, Professional
  mesh term: Burnout, Psychological
  sharing ipd: Yes
  ipd description: de-identified study data will be available upon request when study is completed and published