Trial Outcomes & Findings for Summative Assessment of the BurntOut 3D Simulation With Medical Students (NCT NCT04494633)
NCT ID: NCT04494633
Last Updated: 2023-12-15
Results Overview
Burnout was measured using the Maslach Burnout Inventory (modified). This scale uses items to assess emotional exhaustion, and depersonalization, and measure the sense of personal accomplishment. Selected items were used to make it relevant to medical students experience. It was modified so that for all questions, higher scores indicate higher, and thus more problematic, levels of burnout. A decrease means an improvement; lower values mean more improvement. A positive change means worsening; higher values mean more worsening. Range: Minimum total value 0, Maximum total value 96. The Outcome Measure is the amount of Burnout Change from baseline (evaluation point #1) to evaluation point #2. Burnout Change is calculated for the intervention group pre intervention and 2 weeks post intervention (case) and pre intervention and after a 2 week waiting period for the Wait Group (Control) . See Baseline for more details.
COMPLETED
NA
73 participants
1 months
2023-12-15
Participant Flow
Recruitment was from lists of medical student emails at multiple US medical schools. Recruitment and the study started on the same date and continued until sufficient students had started plus allowance for expected dropout rate.
Participant milestones
| Measure |
Wait Group
Participants will complete the pre-assessments, wait 2-4 weeks, and complete the assessments again. They were then given the option to use the intervention.
|
Intervention
Participants will complete the pre-assessments, use the intervention, wait 2-4 weeks, and complete the assessment a 2nd time.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
38
|
|
Overall Study
COMPLETED
|
29
|
34
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
Wait Group
Participants will complete the pre-assessments, wait 2-4 weeks, and complete the assessments again. They were then given the option to use the intervention.
|
Intervention
Participants will complete the pre-assessments, use the intervention, wait 2-4 weeks, and complete the assessment a 2nd time.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
3
|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
Summative Assessment of the BurntOut 3D Simulation With Medical Students
Baseline characteristics by cohort
| Measure |
Wait Group
n=29 Participants
Participants will complete the pre-assessments, wait 2-4 weeks, complete the assessments, use the intervention, complete the assessment a 3/final time.
Clinical Encounters Medical School VR Simulation: A VR simulation related to coping with the stresses of medical school and burnout.
|
Intervention
n=34 Participants
Participants will complete the pre-assessments, use the intervention, complete the assessments, wait 2-4 weeks, and complete the assessment a 3/final time.
Clinical Encounters Medical School VR Simulation: A VR simulation related to coping with the stresses of medical school and burnout.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/PI
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than One Race
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Prefer Not To Answer
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian/White
|
10 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
34 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Maslach Burnout Inventory (MBI) (modified)
|
41.34 units on a scale
STANDARD_DEVIATION 16.09 • n=5 Participants
|
41.44 units on a scale
STANDARD_DEVIATION 15.22 • n=7 Participants
|
41.40 units on a scale
STANDARD_DEVIATION 15.5 • n=5 Participants
|
|
Alcohol Use Disorders Identification Test - Concise (AUDIT-C)
|
3.07 units on a scale
STANDARD_DEVIATION 1.79 • n=5 Participants
|
2.71 units on a scale
STANDARD_DEVIATION 1.49 • n=7 Participants
|
2.87 units on a scale
STANDARD_DEVIATION 1.63 • n=5 Participants
|
|
Patient Health Questionnaire (PHQ) - modified
|
4.55 units on a scale
STANDARD_DEVIATION 3.86 • n=5 Participants
|
3.85 units on a scale
STANDARD_DEVIATION 3.43 • n=7 Participants
|
4.17 units on a scale
STANDARD_DEVIATION 3.62 • n=5 Participants
|
|
Connor-Davidson Resilience Scale (CD-RISC)
|
5.83 units on a scale
STANDARD_DEVIATION 1.47 • n=5 Participants
|
6.27 units on a scale
STANDARD_DEVIATION 1.56 • n=7 Participants
|
6.06 units on a scale
STANDARD_DEVIATION 1.52 • n=5 Participants
|
|
National Institute on Drug Abuse (NIDA) Quick Screen
|
2.28 units on a scale
STANDARD_DEVIATION 0.88 • n=5 Participants
|
2.12 units on a scale
STANDARD_DEVIATION 0.73 • n=7 Participants
|
2.19 units on a scale
STANDARD_DEVIATION 0.80 • n=5 Participants
|
|
Medical Student Quality of Life
|
15.07 units on a scale
STANDARD_DEVIATION 3.29 • n=5 Participants
|
15.32 units on a scale
STANDARD_DEVIATION 2.68 • n=7 Participants
|
15.21 units on a scale
STANDARD_DEVIATION 2.96 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthsPopulation: Medical students in the US
Burnout was measured using the Maslach Burnout Inventory (modified). This scale uses items to assess emotional exhaustion, and depersonalization, and measure the sense of personal accomplishment. Selected items were used to make it relevant to medical students experience. It was modified so that for all questions, higher scores indicate higher, and thus more problematic, levels of burnout. A decrease means an improvement; lower values mean more improvement. A positive change means worsening; higher values mean more worsening. Range: Minimum total value 0, Maximum total value 96. The Outcome Measure is the amount of Burnout Change from baseline (evaluation point #1) to evaluation point #2. Burnout Change is calculated for the intervention group pre intervention and 2 weeks post intervention (case) and pre intervention and after a 2 week waiting period for the Wait Group (Control) . See Baseline for more details.
Outcome measures
| Measure |
Wait Group
n=29 Participants
Participants will complete the pre-assessments, wait 2-4 weeks, complete the assessments, use the intervention, complete the assessment a 3/final time.
Clinical Encounters Medical School VR Simulation: A VR simulation related to coping with the stresses of medical school and burnout.
|
Intervention
n=34 Participants
Participants will complete the pre-assessments, use the intervention, wait 2-4 weeks, and complete the assessment again.
Clinical Encounters Medical School VR Simulation: A VR simulation related to coping with the stresses of medical school and burnout.
|
|---|---|---|
|
Burnout Change
|
0.06 change in score on a scale
Standard Deviation 0.24
|
0.05 change in score on a scale
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: 1 monthsPopulation: Medical student participants
Alcohol use was measured using the Alcohol Use Disorders Identification Test - Concise, (AUDIT-C). This instrument is a screening tool to identify users who are hazardous drinkers or who have active alcohol use disorder. Higher scores= greater frequency or amount of alcohol use or misuse Range: Minimum value: 0, Maximum value 12. High scores indicate worse 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. The Outcome Measure is the amount of Alcohol Use Change from baseline (evaluation point #1) to evaluation point #2. Alcohol Use Change was calculated for the intervention group pre intervention and 2 weeks post intervention (case) and pre intervention and after a 2 week waiting period for the Wait Group (Control) .
Outcome measures
| Measure |
Wait Group
n=29 Participants
Participants will complete the pre-assessments, wait 2-4 weeks, complete the assessments, use the intervention, complete the assessment a 3/final time.
Clinical Encounters Medical School VR Simulation: A VR simulation related to coping with the stresses of medical school and burnout.
|
Intervention
n=34 Participants
Participants will complete the pre-assessments, use the intervention, wait 2-4 weeks, and complete the assessment again.
Clinical Encounters Medical School VR Simulation: A VR simulation related to coping with the stresses of medical school and burnout.
|
|---|---|---|
|
Alcohol Use Change
|
-0.03 change in score on a scale
Standard Deviation 0.78
|
0 change in score on a scale
Standard Deviation .95
|
SECONDARY outcome
Timeframe: 1 monthsPopulation: Medical student participants
Depression was measured using the Patient Health Questionaire, PHQ-9 (modified to 6 questions). The PHQ is a screen where respondents indicate how often the respondent has experienced depressed mood and anhedonia over the prior two weeks. Selected questions (6) were used. Range: Minimum score: 0, Maximum score18. High scores indicate worse outcomes. The Outcome Measure is the amount of Depression Change from baseline (evaluation point #1) to evaluation point #2. Depression Change is calculated for the intervention group pre intervention and 2 weeks post intervention (case) and pre intervention and after a 2 week waiting period for the Wait Group (Control). See Baseline for more details
Outcome measures
| Measure |
Wait Group
n=29 Participants
Participants will complete the pre-assessments, wait 2-4 weeks, complete the assessments, use the intervention, complete the assessment a 3/final time.
Clinical Encounters Medical School VR Simulation: A VR simulation related to coping with the stresses of medical school and burnout.
|
Intervention
n=34 Participants
Participants will complete the pre-assessments, use the intervention, wait 2-4 weeks, and complete the assessment again.
Clinical Encounters Medical School VR Simulation: A VR simulation related to coping with the stresses of medical school and burnout.
|
|---|---|---|
|
Depression Change
|
-0.28 change in score on a scale
Standard Deviation 1.96
|
-0.53 change in score on a scale
Standard Deviation 2.57
|
SECONDARY outcome
Timeframe: 1 monthsPopulation: Medical student participants
Resilience was measured via the Connor-Davidson Resilience Scale - modified to use 2 questions from the scale. Range: Minimum score: 0, Maximum score: 8. An increase means an improvement and higher scores mean better outcomes. A decrease means worsening; and lower values mean worse outcomes. The Outcome Measure is the amount of Resilience Change from baseline (evaluation point #1) to evaluation point #2. Resilience Change was calculated for the intervention group pre intervention and 2 weeks post intervention (case) and pre intervention and after a 2 week waiting period for the Wait Group (Control). See Baseline for more details.
Outcome measures
| Measure |
Wait Group
n=29 Participants
Participants will complete the pre-assessments, wait 2-4 weeks, complete the assessments, use the intervention, complete the assessment a 3/final time.
Clinical Encounters Medical School VR Simulation: A VR simulation related to coping with the stresses of medical school and burnout.
|
Intervention
n=34 Participants
Participants will complete the pre-assessments, use the intervention, wait 2-4 weeks, and complete the assessment again.
Clinical Encounters Medical School VR Simulation: A VR simulation related to coping with the stresses of medical school and burnout.
|
|---|---|---|
|
Resilience Change
|
0.1 Change in score on a scale
Standard Deviation 1.21
|
6.26 Change in score on a scale
Standard Deviation 1.38
|
SECONDARY outcome
Timeframe: 1 monthsPopulation: Medical students
Drug use in the recent past was measured via the National Institute for Drug Abuse-Modified Alcohol, Smoking and Substance Involvement Screening Test (modified to use 2 questions from this scale). Range: Minimum 0, Maximum score 10. High scores indicate more drug use and an increase means worse outcomes. Low scores mean less drug use and a decrease means better outcomes. The Outcome Measure is the amount of Drug Use Change from baseline (evaluation point #1) to evaluation point #2. Drug Use Change is calculated for the intervention group pre intervention and 2 weeks post intervention (case) and pre intervention and after a 2 week waiting period for the Wait Group (Control). See Baseline for more details.
Outcome measures
| Measure |
Wait Group
n=29 Participants
Participants will complete the pre-assessments, wait 2-4 weeks, complete the assessments, use the intervention, complete the assessment a 3/final time.
Clinical Encounters Medical School VR Simulation: A VR simulation related to coping with the stresses of medical school and burnout.
|
Intervention
n=34 Participants
Participants will complete the pre-assessments, use the intervention, wait 2-4 weeks, and complete the assessment again.
Clinical Encounters Medical School VR Simulation: A VR simulation related to coping with the stresses of medical school and burnout.
|
|---|---|---|
|
Drug Use Change
|
-0.07 change in score on a scale
Standard Deviation 0.88
|
-.09 change in score on a scale
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: 2 weeks- 1 monthPopulation: medical students
Happiness and Exhaustion (Quality of Life) were measured using the Medical Student Quality of Life Questionnaire with Nine Items (MSQoL9). The MSQoL is a linear self-assessment analog scale. It was modified to use only 5 of the questions from the scale that are on the domains of exhaustion and general happiness. Range for total score on the 5 questions: 1-25 Greater increase in scores means improvement; High scores indicate better outcomes. The analysis was modified so that high scores indicate a better quality of life for all questions. The Outcome Measure is the amount of Happiness and Exhaustion (Quality of Life) Change from baseline (evaluation point #1) to evaluation point #2. Happiness and Exhaustion (Quality of Life) Change was calculated for the intervention group pre intervention and 2 weeks post intervention (case) and pre intervention and after a 2 week waiting period for the Wait Group (Control).
Outcome measures
| Measure |
Wait Group
n=29 Participants
Participants will complete the pre-assessments, wait 2-4 weeks, complete the assessments, use the intervention, complete the assessment a 3/final time.
Clinical Encounters Medical School VR Simulation: A VR simulation related to coping with the stresses of medical school and burnout.
|
Intervention
n=34 Participants
Participants will complete the pre-assessments, use the intervention, wait 2-4 weeks, and complete the assessment again.
Clinical Encounters Medical School VR Simulation: A VR simulation related to coping with the stresses of medical school and burnout.
|
|---|---|---|
|
Happiness and Exhaustion (Quality of Life)
|
-0.52 change in score on a scale
Standard Deviation 2.25
|
-0.47 change in score on a scale
Standard Deviation 2.34
|
Adverse Events
Intervention
Wait Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place