Summative Assessment of the BurntOut 3D Simulation With Medical Students
Primary Purpose
Burnout, Student, Alcohol; Harmful Use, Quality of Life
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical Encounters Medical School VR Simulation
Sponsored by
About this trial
This is an interventional prevention trial for Burnout, Student
Eligibility Criteria
Inclusion Criteria:
- US Medical students in years 1-4
- Has access to a computer with Internet access
Exclusion Criteria:
--Self report of active symptoms of major depression
Sites / Locations
- Clinical Tools, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention
Wait Group
Arm 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.
Participants will complete the pre-assessments, wait 2-4 weeks, complete the assessments, use the intervention, complete the assessment a 3/final time.
Outcomes
Primary Outcome Measures
Burnout
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.
Secondary Outcome Measures
Alcohol misuse
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.
Depression
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.
Resilience
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.
Drug use
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.
Happiness; Exhaustion
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04494633
Brief Title
Summative Assessment of the BurntOut 3D Simulation With Medical Students
Official Title
Summative Assessment of the BurntOut 3D Simulation With Medical Students
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 11, 2022 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinical Tools, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Student, Alcohol; Harmful Use, Quality of Life, Depression, Resilience, Drug Use, Burnout, Professional
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm 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 Title
Wait Group
Arm Type
Other
Arm 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(s)
Clinical Encounters Medical School VR Simulation
Intervention Description
A VR simulation related to coping with the stresses of medical school and burnout.
Primary Outcome Measure Information:
Title
Burnout
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.
Time Frame
1 months
Secondary Outcome Measure Information:
Title
Alcohol misuse
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.
Time Frame
1 months
Title
Depression
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.
Time Frame
1 months
Title
Resilience
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.
Time Frame
1 months
Title
Drug use
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.
Time Frame
1 months
Title
Happiness; Exhaustion
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.
Time Frame
1 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
US Medical students in years 1-4
Has access to a computer with Internet access
Exclusion Criteria:
--Self report of active symptoms of major depression
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary P Metcalf, PhD
Organizational Affiliation
Clinical Tools, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Tools, Inc.
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Summative Assessment of the BurntOut 3D Simulation With Medical Students
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