<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/NCT03758391</url>
  </required_header>
  <id_info>
    <org_study_id>18-015235</org_study_id>
    <nct_id>NCT03758391</nct_id>
  </id_info>
  <brief_title>Comparison of Learning in Traditional Versus &quot;Flipped&quot; Classrooms</brief_title>
  <official_title>Comparison of a &quot;Flipped&quot; Classroom Methodology to Traditional Instructional Techniques for Neonatal-perinatal Medicine Fellows: A National Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Academy of Pediatrics Section of Neonatal-Perinatal Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Organization of Neonatal-Perinatal Medicine Training Program Directors</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital of Philadelphia</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>
      This is an educational research study to compare knowledge retention of neonatal-perinatal&#xD;
      medicine (NPM) fellowship trainees instructed on a subsection of the American Board of&#xD;
      Pediatrics (ABP) NPM Content Outline using traditional didactic lectures (control group)&#xD;
      versus a flipped classroom methodology (intervention group). The primary objectives are to&#xD;
      assess whether the flipped classroom provides equivalent or superior outcomes for knowledge&#xD;
      acquisition and retention compared to traditional lecture-based formats, based upon baseline&#xD;
      and serial knowledge assessments (after the educational session, and at 3- and 6- month&#xD;
      intervals). The secondary outcomes are learner and educator preference.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sixty-three ACGME-accredited NPM fellowship training programs in the United States have&#xD;
      enrolled to participate in this study. Programs have been randomized to teach a subsection of&#xD;
      neonatal physiology using the traditional didactic approach or using the &quot;flipped&quot; classroom&#xD;
      methodology.&#xD;
&#xD;
      The ACGME requires that NPM fellowship programs provide formal instruction to teach trainees&#xD;
      about key concepts in the care of neonates and infants, and most programs have traditionally&#xD;
      utilized didactic presentations to relay this information. These sessions are typically&#xD;
      instructor-centered, with little requirement for involvement or engagement on the part of the&#xD;
      learner, and are not felt to optimize long-term knowledge acquisition and retention. A newer&#xD;
      educational model, the &quot;flipped&quot; classroom, increases the opportunities for learner&#xD;
      engagement and requires investment and preparation. Using this educational structure, fellows&#xD;
      receive learning materials that need to be reviewed prior to the in-person educational&#xD;
      session. The participants will then spend the in-person session actively engaged in applying&#xD;
      the knowledge to answer questions, participate in discussions, and solve problems. Adult&#xD;
      learning theory supports this active involvement as a way to increase learner engagement,&#xD;
      improve recognition of meaning of the material, and improve knowledge acquisition and&#xD;
      long-term retention.&#xD;
&#xD;
      Fellowship Program Directors involved in the Organization of Neonatal Training Program&#xD;
      Directors (ONTPD) have been contacted about the opportunity to participate in this&#xD;
      prospective multi-center study. After enrollment, program directors will complete a brief&#xD;
      survey of their program's baseline educational methods and demographics. Fellows will be&#xD;
      contacted directly by local site PIs for individual consent to data collection. Fellows will&#xD;
      be asked to provide demographic information, assessment of learning style/ practices, time&#xD;
      devoted to educational pursuits, and perceptions of current physiology education. The fellows&#xD;
      will be asked to complete 4 knowledge assessments (baseline, at the end of the educational&#xD;
      block, 3 months, 6 months) in REDCap over the course of 6 months. All data will be&#xD;
      de-identified, and individual and programmatic data will be anonymous. The assigned ABP&#xD;
      content will be taught within the same 3-month period any time between September 2018 and&#xD;
      March 2019 via the assigned method (traditional didactic or flipped classroom). All&#xD;
      educational materials will be provided to both arms of the study. Learning objectives will be&#xD;
      based on the ABP NPM Content Outline and materials with be authored by experts in neonatal&#xD;
      physiology. Materials will undergo rigorous peer-review by an editorial board.&#xD;
      Traditional/control fellows will be instructed using the provided educational materials in an&#xD;
      instructor-led didactic slide presentation. Intervention group fellows will be required to&#xD;
      view the same educational materials in online videos prior to their assigned classroom&#xD;
      session. During the &quot;flipped&quot; classroom session, the fellows will work through a series of&#xD;
      questions based on the assigned educational materials with a local facilitator using a&#xD;
      facilitation guide who has been trained in flipped classroom facilitation. This facilitator&#xD;
      guide will present discussion points based upon the pre-learning materials and requires&#xD;
      learners to apply acquired knowledge. The facilitator guides are also peer-reviewed for&#xD;
      content and quality.&#xD;
&#xD;
      In the present study, only the ABP Content Objectives for NPM on gastroenterology and&#xD;
      bilirubin will be included. Educational materials will be reviewed and revised by a 4-member&#xD;
      editorial board to ensure accuracy, completeness, and quality. For online viewing, these&#xD;
      materials are uploaded on MedEdOnTheGo.com, an online learning management platform. Fellows&#xD;
      will be provided with additional reading materials, such as seminal articles or textbook&#xD;
      chapters, that will allow them to develop a deep understanding of the topic.&#xD;
&#xD;
      Fellows will be surveyed regarding their learning experiences at 3 different time points;&#xD;
      before the educational intervention begins, at the completion of the educational&#xD;
      intervention, and 3 months after completion of the intervention. Fellows will complete&#xD;
      anonymous surveys in REDCap regarding their learning experiences, class preparation, the&#xD;
      quality of teaching, perceived effectiveness of teaching efforts, and preferences for&#xD;
      learning. Fellows will also participate in short 15-item multiple choice quizzes to measure&#xD;
      knowledge retention. There will be 4 quizzes in total; prior to the intervention (baseline),&#xD;
      at the completion of the intervention, 3 months post, and 6 months post-intervention. These&#xD;
      quizzes will be proctored and closed book. Fellows in either randomization arm will answer&#xD;
      the same questions. The quiz questions will cover the specific content addressed in the&#xD;
      educational sessions, be created by the study team, and piloted by attending neonatologists&#xD;
      for clarity, accuracy, and relevance.&#xD;
&#xD;
      Data will be tabulated on baseline information for both program level and fellow level with&#xD;
      testing to determine if pre-intervention testing data is different between groups&#xD;
      (equivalence variance 2-tailed T-tests for continuous data and likert scores, and chi square&#xD;
      for categorical data). Knowledge retention curves will be developed by performing T-tests of&#xD;
      mean scores for each time point. Post-education surveys for program directors and fellows&#xD;
      will be evaluated to assess effect of interventions using equal variance 2-tailed T-tests for&#xD;
      continuous data and likert scores.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Prospective cohort study</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Knowledge retention</measure>
    <time_frame>9 months</time_frame>
    <description>Knowledge retention will be tested using multiple choice examinations.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Learner Preferences</measure>
    <time_frame>6 months</time_frame>
    <description>Learner preferences for how to receive education will be assessed through qualitative survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Educator Preferences</measure>
    <time_frame>6 months</time_frame>
    <description>Educator preferences for how to provide education will be assessed through qualitative survey</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">538</enrollment>
  <condition>Medical Education</condition>
  <arm_group>
    <arm_group_label>Traditional Didactic Education</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Education will be provided to fellows using the traditional didactic approach (lecture-based).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Flipped Classroom Education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Education will be provided to fellows using the flipped classroom approach.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Flipped Classroom education</intervention_name>
    <description>Fellows will receive GI/Bilirubin education in a flipped classroom format.</description>
    <arm_group_label>Flipped Classroom Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fellow or educator in an ACGME-accredited Neonatal-Perinatal Medicine Fellowship&#xD;
             program in the US.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not a fellow or educator in an ACGME-accredited Neonatal-Perinatal Medicine Fellowship&#xD;
             program in the US.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>January 27, 2020</last_update_submitted>
  <last_update_submitted_qc>January 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neonatal-Perinatal Medicine</keyword>
  <keyword>Andragogy</keyword>
  <keyword>Flipped Classroom</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03758391
org study id: 18-015235
nct id: NCT03758391
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is an educational research study to compare knowledge retention of neonatal-perinatal
      medicine (NPM) fellowship trainees instructed on a subsection of the American Board of
      Pediatrics (ABP) NPM Content Outline using traditional didactic lectures (control group)
      versus a flipped classroom methodology (intervention group). The primary objectives are to
      assess whether the flipped classroom provides equivalent or superior outcomes for knowledge
      acquisition and retention compared to traditional lecture-based formats, based upon baseline
      and serial knowledge assessments (after the educational session, and at 3- and 6- month
      intervals). The secondary outcomes are learner and educator preference.
Sixty-three ACGME-accredited NPM fellowship training programs in the United States have
      enrolled to participate in this study. Programs have been randomized to teach a subsection of
      neonatal physiology using the traditional didactic approach or using the "flipped" classroom
      methodology.

      The ACGME requires that NPM fellowship programs provide formal instruction to teach trainees
      about key concepts in the care of neonates and infants, and most programs have traditionally
      utilized didactic presentations to relay this information. These sessions are typically
      instructor-centered, with little requirement for involvement or engagement on the part of the
      learner, and are not felt to optimize long-term knowledge acquisition and retention. A newer
      educational model, the "flipped" classroom, increases the opportunities for learner
      engagement and requires investment and preparation. Using this educational structure, fellows
      receive learning materials that need to be reviewed prior to the in-person educational
      session. The participants will then spend the in-person session actively engaged in applying
      the knowledge to answer questions, participate in discussions, and solve problems. Adult
      learning theory supports this active involvement as a way to increase learner engagement,
      improve recognition of meaning of the material, and improve knowledge acquisition and
      long-term retention.

      Fellowship Program Directors involved in the Organization of Neonatal Training Program
      Directors (ONTPD) have been contacted about the opportunity to participate in this
      prospective multi-center study. After enrollment, program directors will complete a brief
      survey of their program's baseline educational methods and demographics. Fellows will be
      contacted directly by local site PIs for individual consent to data collection. Fellows will
      be asked to provide demographic information, assessment of learning style/ practices, time
      devoted to educational pursuits, and perceptions of current physiology education. The fellows
      will be asked to complete 4 knowledge assessments (baseline, at the end of the educational
      block, 3 months, 6 months) in REDCap over the course of 6 months. All data will be
      de-identified, and individual and programmatic data will be anonymous. The assigned ABP
      content will be taught within the same 3-month period any time between September 2018 and
      March 2019 via the assigned method (traditional didactic or flipped classroom). All
      educational materials will be provided to both arms of the study. Learning objectives will be
      based on the ABP NPM Content Outline and materials with be authored by experts in neonatal
      physiology. Materials will undergo rigorous peer-review by an editorial board.
      Traditional/control fellows will be instructed using the provided educational materials in an
      instructor-led didactic slide presentation. Intervention group fellows will be required to
      view the same educational materials in online videos prior to their assigned classroom
      session. During the "flipped" classroom session, the fellows will work through a series of
      questions based on the assigned educational materials with a local facilitator using a
      facilitation guide who has been trained in flipped classroom facilitation. This facilitator
      guide will present discussion points based upon the pre-learning materials and requires
      learners to apply acquired knowledge. The facilitator guides are also peer-reviewed for
      content and quality.

      In the present study, only the ABP Content Objectives for NPM on gastroenterology and
      bilirubin will be included. Educational materials will be reviewed and revised by a 4-member
      editorial board to ensure accuracy, completeness, and quality. For online viewing, these
      materials are uploaded on MedEdOnTheGo.com, an online learning management platform. Fellows
      will be provided with additional reading materials, such as seminal articles or textbook
      chapters, that will allow them to develop a deep understanding of the topic.

      Fellows will be surveyed regarding their learning experiences at 3 different time points;
      before the educational intervention begins, at the completion of the educational
      intervention, and 3 months after completion of the intervention. Fellows will complete
      anonymous surveys in REDCap regarding their learning experiences, class preparation, the
      quality of teaching, perceived effectiveness of teaching efforts, and preferences for
      learning. Fellows will also participate in short 15-item multiple choice quizzes to measure
      knowledge retention. There will be 4 quizzes in total; prior to the intervention (baseline),
      at the completion of the intervention, 3 months post, and 6 months post-intervention. These
      quizzes will be proctored and closed book. Fellows in either randomization arm will answer
      the same questions. The quiz questions will cover the specific content addressed in the
      educational sessions, be created by the study team, and piloted by attending neonatologists
      for clarity, accuracy, and relevance.

      Data will be tabulated on baseline information for both program level and fellow level with
      testing to determine if pre-intervention testing data is different between groups
      (equivalence variance 2-tailed T-tests for continuous data and likert scores, and chi square
      for categorical data). Knowledge retention curves will be developed by performing T-tests of
      mean scores for each time point. Post-education surveys for program directors and fellows
      will be evaluated to assess effect of interventions using equal variance 2-tailed T-tests for
      continuous data and likert scores.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective cohort study
primary purpose: Other
masking: None (Open Label)
measure: Knowledge retention
time frame: 9 months
description: Knowledge retention will be tested using multiple choice examinations.
measure: Learner Preferences
time frame: 6 months
description: Learner preferences for how to receive education will be assessed through qualitative survey
measure: Educator Preferences
time frame: 6 months
description: Educator preferences for how to provide education will be assessed through qualitative survey
arm group label: Traditional Didactic Education
arm group type: No Intervention
description: Education will be provided to fellows using the traditional didactic approach (lecture-based).
arm group label: Flipped Classroom Education
arm group type: Experimental
description: Education will be provided to fellows using the flipped classroom approach.
intervention type: Other
intervention name: Flipped Classroom education
description: Fellows will receive GI/Bilirubin education in a flipped classroom format.
arm group label: Flipped Classroom Education
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor