<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/NCT04494633</url>
  </required_header>
  <id_info>
    <org_study_id>271330</org_study_id>
    <nct_id>NCT04494633</nct_id>
  </id_info>
  <brief_title>Summative Assessment of the BurntOut 3D Simulation With Medical Students</brief_title>
  <official_title>Summative Assessment of the BurntOut 3D Simulation With Medical Students</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinical Tools, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinical Tools, Inc.</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>
      Burnout is a common problem for medical students and is associated with stress-related health&#xD;
      problems and also potentially affects the quality of care delivered to their patients. Among&#xD;
      the health problems commonly associated with burnout are substance use problems, and alcohol&#xD;
      is the substance most often misused. The purpose of the evaluation is to document whether an&#xD;
      educational intervention delivered via a 3D online simulation experience prevents or improves&#xD;
      the primary endpoint of burnout and the secondary endpoints of burnout-related factors in&#xD;
      medical students. The investigators will also will evaluate student satisfaction with the&#xD;
      intervention to determine if it meets our standard of success. The hypothesis is that the&#xD;
      intervention will improve the primary clinical endpoint of burnout from pre-intervention to&#xD;
      post-intervention as measured by the Maslach Burnout Inventory, a validated inventory that is&#xD;
      widely used to measure burnout. The related factors that will be measured as secondary&#xD;
      clinical endpoints include quality of life, substance use (alcohol and drugs), depression,&#xD;
      and resilience. Due to evidence that these endpoints are linked to burnout, the investigators&#xD;
      also hypothesize that the measures will improve pre- to post-intervention. Satisfaction of&#xD;
      the target audience after completing the simulation intervention will also be evaluated. The&#xD;
      evaluation will be prior to and after use of the simulation by medical student participants,&#xD;
      using a pre-/post intervention wait-list crossover design.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will use a pre-/post-intervention design with wait-list controls who also&#xD;
      will receive the intervention. The investigators will recruit and enroll 80 medical students&#xD;
      who are in pre-clinical years of medical school. The number of participants selected is based&#xD;
      on a power analysis of the design and experience of low dropout rate with this target&#xD;
      audience; to reach a medium effect size the investigators plan for a final sample size of 68&#xD;
      medical students. During the intervention phase of the study, students will 1) Complete the&#xD;
      simulation experience: 6 to 8 tailored scenarios and resilience-building activities (taking&#xD;
      around 2 hours over a period of around 4 weeks); and 2) Complete pre-/post- assessments (each&#xD;
      taking around 1 hour) plus a follow-up survey after 3 months. The investigators will screen&#xD;
      for and exclude students with severe depression and suicidality. The primary clinical&#xD;
      endpoint will be burnout as measured by the Maslach Burnout Inventory. Secondary endpoints&#xD;
      will be measured via the following assessments: Medical Student Quality of Life, PHQ2/PHQ9 to&#xD;
      screen for depression, CD-RISC 2 for resiliency, AUDIT-C/AUDIT for alcohol use disorder and&#xD;
      two drug question screening for drug use, and CSQ8 for satisfaction plus questions adapted&#xD;
      from the Game User Experience Satisfaction survey and Intrinsic Motivation Inventory to&#xD;
      further describe the experience. After 4 weeks, the control and experimental (intervention)&#xD;
      groups will cross over to the opposite status and control participants will engage in the&#xD;
      intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 11, 2022</start_date>
  <completion_date type="Actual">July 31, 2022</completion_date>
  <primary_completion_date type="Actual">July 1, 2022</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Burnout</measure>
    <time_frame>1 months</time_frame>
    <description>Users will report decreased levels of burn out, as measured on the Maslach Burnout Inventory. This scale uses items to assess emotional exhaustion, depersonalization, and measure the sense of personal accomplishment. Higher scores indicate higher, and thus more problematic, levels of burnout.&#xD;
Selected items are used.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Alcohol misuse</measure>
    <time_frame>1 months</time_frame>
    <description>Users will have decrease scores on the Alcohol Use Disorders Identification Test, AUDIT-C, after the intervention. This instrument is a screening tool to identify users who are hazardous drinkers or who have active alcohol use disorder.&#xD;
Minimum value: 0, Maximum value 12. High scores indicate better outcomes.&#xD;
A score of over 4 for men, and over 3 for women is considered a positive screen for alcohol misuse. Higher scores suggest a higher likelihood that alcohol use is negatively impacting the person's health and safety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>1 months</time_frame>
    <description>Participants will complete the 2 item Patient Health Questionaire, PHQ-2.&#xD;
The PHQ-2 is a two-item screen where respondents indicate how often the respondent has experienced depressed mood and anhedonia over the prior two weeks.&#xD;
Minimum value: 0, Maximum value 6. High scores indicate worse outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resilience</measure>
    <time_frame>1 months</time_frame>
    <description>Improvement in this area will be measured via the Connor-Davidson Resilience Scale - a 2 item scale.&#xD;
Minimum value: 0, Maximum value 8. Low scores indicate worse outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug use</measure>
    <time_frame>1 months</time_frame>
    <description>Substance use in the past 3 months will be measured via the National Institute for Drug Abuse-Modified Alcohol, Smoking and Substance Involvement Screening Test (3 items).&#xD;
Minimum 0, Maximum value 390 High scores indicate worse outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Happiness; Exhaustion</measure>
    <time_frame>1 months</time_frame>
    <description>Users will report better Quality of Life after using the intervention for 3 months than at baseline.&#xD;
The Medical Student Quality of Life Questionnaire with Nine Items, MSQoL9. The MSQofL is a linear self-assessment analog scale. Users rate their overall quality of life focused on the two domains of exhaustion and general happiness.&#xD;
Minimum value: 0, Maximum value 10. High scores indicate better outcomes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Burnout, Student</condition>
  <condition>Alcohol; Harmful Use</condition>
  <condition>Quality of Life</condition>
  <condition>Depression</condition>
  <condition>Resilience</condition>
  <condition>Drug Use</condition>
  <condition>Burnout, Professional</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will complete the pre-assessments, use the intervention, complete the assessments, wait 2-4 weeks, and complete the assessment a 3/final time.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will complete the pre-assessments, wait 2-4 weeks, complete the assessments, use the intervention, complete the assessment a 3/final time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical Encounters Medical School VR Simulation</intervention_name>
    <description>A VR simulation related to coping with the stresses of medical school and burnout.</description>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_label>Wait Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  US Medical students in years 1-4&#xD;
&#xD;
          -  Has access to a computer with Internet access&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        --Self report of active symptoms of major depression&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mary P Metcalf, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Tools, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Tools, Inc.</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27516</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>January 17, 2023</last_update_submitted>
  <last_update_submitted_qc>January 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 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>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04494633
org study id: 271330
nct id: NCT04494633
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Burnout is a common problem for medical students and is associated with stress-related health
      problems and also potentially affects the quality of care delivered to their patients. Among
      the health problems commonly associated with burnout are substance use problems, and alcohol
      is the substance most often misused. The purpose of the evaluation is to document whether an
      educational intervention delivered via a 3D online simulation experience prevents or improves
      the primary endpoint of burnout and the secondary endpoints of burnout-related factors in
      medical students. The investigators will also will evaluate student satisfaction with the
      intervention to determine if it meets our standard of success. The hypothesis is that the
      intervention will improve the primary clinical endpoint of burnout from pre-intervention to
      post-intervention as measured by the Maslach Burnout Inventory, a validated inventory that is
      widely used to measure burnout. The related factors that will be measured as secondary
      clinical endpoints include quality of life, substance use (alcohol and drugs), depression,
      and resilience. Due to evidence that these endpoints are linked to burnout, the investigators
      also hypothesize that the measures will improve pre- to post-intervention. Satisfaction of
      the target audience after completing the simulation intervention will also be evaluated. The
      evaluation will be prior to and after use of the simulation by medical student participants,
      using a pre-/post intervention wait-list crossover design.
The investigators will use a pre-/post-intervention design with wait-list controls who also
      will receive the intervention. The investigators will recruit and enroll 80 medical students
      who are in pre-clinical years of medical school. The number of participants selected is based
      on a power analysis of the design and experience of low dropout rate with this target
      audience; to reach a medium effect size the investigators plan for a final sample size of 68
      medical students. During the intervention phase of the study, students will 1) Complete the
      simulation experience: 6 to 8 tailored scenarios and resilience-building activities (taking
      around 2 hours over a period of around 4 weeks); and 2) Complete pre-/post- assessments (each
      taking around 1 hour) plus a follow-up survey after 3 months. The investigators will screen
      for and exclude students with severe depression and suicidality. The primary clinical
      endpoint will be burnout as measured by the Maslach Burnout Inventory. Secondary endpoints
      will be measured via the following assessments: Medical Student Quality of Life, PHQ2/PHQ9 to
      screen for depression, CD-RISC 2 for resiliency, AUDIT-C/AUDIT for alcohol use disorder and
      two drug question screening for drug use, and CSQ8 for satisfaction plus questions adapted
      from the Game User Experience Satisfaction survey and Intrinsic Motivation Inventory to
      further describe the experience. After 4 weeks, the control and experimental (intervention)
      groups will cross over to the opposite status and control participants will engage in the
      intervention.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Burnout
time frame: 1 months
description: Users will report decreased levels of burn out, as measured on the Maslach Burnout Inventory. This scale uses items to assess emotional exhaustion, depersonalization, and measure the sense of personal accomplishment. Higher scores indicate higher, and thus more problematic, levels of burnout.
Selected items are used.
measure: Alcohol misuse
time frame: 1 months
description: Users will have decrease scores on the Alcohol Use Disorders Identification Test, AUDIT-C, after the intervention. This instrument is a screening tool to identify users who are hazardous drinkers or who have active alcohol use disorder.
Minimum value: 0, Maximum value 12. High scores indicate better outcomes.
A score of over 4 for men, and over 3 for women is considered a positive screen for alcohol misuse. Higher scores suggest a higher likelihood that alcohol use is negatively impacting the person's health and safety.
measure: Depression
time frame: 1 months
description: Participants will complete the 2 item Patient Health Questionaire, PHQ-2.
The PHQ-2 is a two-item screen where respondents indicate how often the respondent has experienced depressed mood and anhedonia over the prior two weeks.
Minimum value: 0, Maximum value 6. High scores indicate worse outcomes.
measure: Resilience
time frame: 1 months
description: Improvement in this area will be measured via the Connor-Davidson Resilience Scale - a 2 item scale.
Minimum value: 0, Maximum value 8. Low scores indicate worse outcomes.
measure: Drug use
time frame: 1 months
description: Substance use in the past 3 months will be measured via the National Institute for Drug Abuse-Modified Alcohol, Smoking and Substance Involvement Screening Test (3 items).
Minimum 0, Maximum value 390 High scores indicate worse outcomes.
measure: Happiness; Exhaustion
time frame: 1 months
description: Users will report better Quality of Life after using the intervention for 3 months than at baseline.
The Medical Student Quality of Life Questionnaire with Nine Items, MSQoL9. The MSQofL is a linear self-assessment analog scale. Users rate their overall quality of life focused on the two domains of exhaustion and general happiness.
Minimum value: 0, Maximum value 10. High scores indicate better outcomes.
arm group label: Intervention
arm group type: Experimental
description: Participants will complete the pre-assessments, use the intervention, complete the assessments, wait 2-4 weeks, and complete the assessment a 3/final time.
arm group label: Wait Group
arm group type: Other
description: Participants will complete the pre-assessments, wait 2-4 weeks, complete the assessments, use the intervention, complete the assessment a 3/final time.
intervention type: Other
intervention name: Clinical Encounters Medical School VR Simulation
description: A VR simulation related to coping with the stresses of medical school and burnout.
arm group label: Intervention
arm group label: Wait Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mary P Metcalf, PhD
role: Principal Investigator
affiliation: Clinical Tools, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Burnout, Professional
mesh term: Burnout, Psychological
sharing ipd: No