An interventional study of Clinical Encounters Medical School 3D Simulation in Burnout, Student, Alcohol; Harmful Use and Quality of Life, sponsored by Clinical Tools, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-15.
Sponsored by Clinical Tools, Inc. · Not applicable, Interventional, and Prevention
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 incorporating aspects of virtual reality (VR) 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 control, parallel design.
The investigators used a pre-/post-intervention design with wait-list controls who were able to use the intervention after the study, if they chose. The investigators recruited and enrolled 73 medical students. 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 and 63 actually completed the study. During the intervention phase of the study, intervention group students 1) Completed the simulation experience: an interactive online simulation, interactive online case stories, and resilience-building activities (taking around 2 hours over a period of less than 2 weeks); and 2) Completed pre- assessments and 2-4 week post-assessments (each taking \<1 hour). Controls completing pre-assessments and repeated the pre assessments after a 2 to 4 week wait period. The investigators screened for and excluded students with severe depression and suicidality but none needed to be excluded for this reason. The primary clinical endpoint was burnout as measured by the Maslach Burnout Inventory. Secondary endpoints were measured via adaptations of the following assessments: Alcohol Use Disorders Identification Test (AUDIT-C/AUDIT) for alcohol use disorder, Patient Health Questionaire (PHQ2/PHQ9) to screen for depression, Connor-Davidson Resilience Scale © (CD-RISC 2) for resiliency, two drug question screening for drug use, and Medical Student Quality of Life (MSQoL9). Control participants were invited to engage in the intervention after completing the study, that is, after completing their 2nd set of assessments. There were no adverse events.
214 studies on the registry are indexed under Burnout, Professional; 33 are open to participants now.
This study's enrollment of 73 is close to the median of 80 across 158 interventional studies indexed under Burnout, Professional.
Browse Burnout, Professional studies →This is the only study on the registry with Clinical Tools, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
--Self report of active symptoms of major depression
Participants completed the pre-assessments, used the intervention, waited 2-4 weeks, and then completed the assessments again.
Other: Clinical Encounters Medical School 3D Simulation
Participants completed the pre-assessments, waited 2-4 weeks, and completed the assessments again.
A 3D simulation related to coping with the stresses of medical school and burnout.
Burnout Change
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.
Time frame: 1 months
Alcohol Use Change
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) .
Time frame: 1 months
Depression Change
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
Time frame: 1 months
Resilience Change
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.
Time frame: 1 months
Drug Use Change
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.
Time frame: 1 months
Happiness and Exhaustion (Quality of Life)
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).
Time frame: 2 weeks- 1 month
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.
| Milestone | Wait Group | Intervention |
|---|---|---|
| Started | 35 | 38 |
| Completed | 29 | 34 |
| Not completed | 6 | 4 |
| Withdrew: Lost to follow-up | 5 | 3 |
| Withdrew: Protocol violation | 1 | 1 |
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.
| change in score on a scale | Wait Group | Intervention |
|---|---|---|
| Burnout Change | 0.06 ± 0.24 | 0.05 ± 0.51 |
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) .
| change in score on a scale | Wait Group | Intervention |
|---|---|---|
| Alcohol Use Change | -0.03 ± 0.78 | 0 ± .95 |
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
| change in score on a scale | Wait Group | Intervention |
|---|---|---|
| Depression Change | -0.28 ± 1.96 | -0.53 ± 2.57 |
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.
| Change in score on a scale | Wait Group | Intervention |
|---|---|---|
| Resilience Change | 0.1 ± 1.21 | 6.26 ± 1.38 |
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.
| change in score on a scale | Wait Group | Intervention |
|---|---|---|
| Drug Use Change | -0.07 ± 0.88 | -.09 ± 0.38 |
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).
| change in score on a scale | Wait Group | Intervention |
|---|---|---|
| Happiness and Exhaustion (Quality of Life) | -0.52 ± 2.25 | -0.47 ± 2.34 |
Collected over Adverse event information was collected over the course of the study and for 1 month after, so 3 months total.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/34 (0%) | 0/34 (0%) | 0/34 (0%) |
| Wait Group | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Age, Categorical(Participants) | Wait Group | Intervention | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 29 | 34 | 63 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Wait Group | Intervention | Total |
|---|---|---|---|
| Female | 11 | 26 | 37 |
| Male | 18 | 8 | 26 |
| Race/Ethnicity, Customized(Participants) | Wait Group | Intervention | Total |
|---|---|---|---|
| American Indian | 0 | 0 | 0 |
| Asian/PI | 12 | 9 | 21 |
| Black or African American | 1 | 3 | 4 |
| More than One Race | 4 | 3 | 7 |
| Other | 1 | 2 | 3 |
| Prefer Not To Answer | 1 | 0 | 1 |
| Caucasian/White | 10 | 17 | 27 |
| Region of Enrollment(participants) | Wait Group | Intervention | Total |
|---|---|---|---|
| United States | 29 | 34 | 63 |
| Maslach Burnout Inventory (MBI) (modified)(units on a scale) | Wait Group | Intervention | Total |
|---|---|---|---|
| Mean | 41.34 ± 16.09 | 41.44 ± 15.22 | 41.40 ± 15.5 |
| Alcohol Use Disorders Identification Test - Concise (AUDIT-C)(units on a scale) | Wait Group | Intervention | Total |
|---|---|---|---|
| Mean | 3.07 ± 1.79 | 2.71 ± 1.49 | 2.87 ± 1.63 |
| Patient Health Questionnaire (PHQ) - modified(units on a scale) | Wait Group | Intervention | Total |
|---|---|---|---|
| Mean | 4.55 ± 3.86 | 3.85 ± 3.43 | 4.17 ± 3.62 |
| Connor-Davidson Resilience Scale (CD-RISC)(units on a scale) | Wait Group | Intervention | Total |
|---|---|---|---|
| Mean | 5.83 ± 1.47 | 6.27 ± 1.56 | 6.06 ± 1.52 |
2 further baseline measures are reported on the registry.
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