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| ID | Type | Description | Link |
|---|---|---|---|
| R44AA026474 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Participants completed the pre-assessments, used the intervention, waited 2-4 weeks, and then completed the assessments again. |
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| Wait Group | No Intervention | Participants completed the pre-assessments, waited 2-4 weeks, and completed the assessments again. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Encounters Medical School 3D Simulation | Other | A 3D simulation related to coping with the stresses of medical school and burnout. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) . |
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Inclusion Criteria:
Exclusion Criteria:
--Self report of active symptoms of major depression
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| Name | Affiliation | Role |
|---|---|---|
| Mary P Metcalf, PhD | Clinical Tools, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Tools, Inc. | Chapel Hill | North Carolina | 27516 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Intervention | Participants will complete the pre-assessments, use the intervention, wait 2-4 weeks, and complete the assessment a 2nd time. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Wait Group | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Medical students in the US | Posted | Mean | Standard Deviation | change in score on a scale | 1 months |
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Adverse event information was collected over the course of the study and for 1 month after, so 3 months total.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | 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. |
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The study period was brief, to stay within the timeframe of the Small Business Innovation Research (SBIR) Phase II grant. Additional follow-up time and intervention use would be needed to fully assess the impact of the intervention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Metcalf, PhD, MPH | Clinical Tools, Inc. | (919) 960-8118 | metcalf@clinicaltools.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 6, 2023 | Dec 6, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000077062 | Burnout, Psychological |
| D003863 | Depression |
| D002055 | Burnout, Professional |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000073397 | Occupational Stress |
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| 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 | 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. | 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. | 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). | 2 weeks- 1 month |
| Intervention |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Maslach Burnout Inventory (MBI) (modified) | Measure of burnout. Measure modified to eliminate questions that are not relevant for medical student burnout. Value reported is mean total score. 16 questions. Range for total score: 0 to 96. Higher score means worse outcome, greater burnout. Results modified in the analysis so that a higher score for all questions means more burnout. 7 point Likert scale: Never=0; A few times a year or less=1; Once a month or less=2; A few times a month=3; Once a week=4; A few times a week=5; Every day=6 | Mean | Standard Deviation | units on a scale |
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| Alcohol Use Disorders Identification Test - Concise (AUDIT-C) | Value reported is mean total score. 3 questions Range for total Score: 0-12. Higher score means worse outcome, greater use of alcohol. 5 point Likert scale: Question 1. 0=Never; 1=Monthly or Less; 2=2-4 times a month; 3=2-3 times a week; 4=4 or more times a week Question 2. 0=N/A; 0=1 or 2; 1=3 to 4; 2=5 to 6; 3=7 to 9; 4=10 or more Question 3. 0=Never; 1=Less than monthly; 2=Monthly; 3=Weekly; 4=Daily or almost daily | Mean | Standard Deviation | units on a scale |
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| Patient Health Questionnaire (PHQ) - modified | Patient Health Questionnaire-9 screen for depression, selected questions used. Value reported is mean total score. 6 questions Range per total score 0-24. Higher values mean more severe depression. Likert scale 1st 5 questions: Not at all (0 days)=0; Several days (1-6 days)=1; More than half the days (7+ days)=2; Nearly every day (~14 days)=3; 6th question scale: Not at all difficult=0; Not very difficult=1; Difficult=2; Very difficult=3 | Mean | Standard Deviation | units on a scale |
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| Connor-Davidson Resilience Scale (CD-RISC) | Selected questions from the Connor Davidson-Resilience scale. Value entered is mean total score. 2 questions evaluation of resiliency, Range per total survey score 0-8. Higher scores mean better outcome, greater resilience. Likert scale: Not true at all=0; Rarely true=1; Sometimes true=2; Often true=3; True nearly all the time=4. | Mean | Standard Deviation | units on a scale |
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| National Institute on Drug Abuse (NIDA) Quick Screen | Screen for use of drugs. (Modified to add "Other than cannabis to 2nd question on illegal drugs)" Value reported is mean total score. 2 questions Higher value means worse outcome, greater drug use. Range per question (1-5), per total score (1-15): Scale: Never=1; Monthly or less=2; 2-4 times a month=3; 2-3 times a week=4; 4 or more times a week=5 | Mean | Standard Deviation | units on a scale |
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| Medical Student Quality of Life | Measures exhaustion and happiness. Value reported is mean total score (SD). 5 questions (Range per total score 1-25) Modified so that higher scores mean better outcomes, for all questions, ie, more energy and happiness and less exhaustion. Scale per question: Never=1, A little of the time=2, A good bit of the time=3, Most of the time=4, All of the time=5 | Mean | Standard Deviation | units on a scale |
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| OG000 |
| Wait Group |
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. |
| OG001 | Intervention | 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. |
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| Secondary | 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) . | Medical student participants | Posted | Mean | Standard Deviation | change in score on a scale | 1 months |
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| Secondary | 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 | Medical student participants | Posted | Mean | Standard Deviation | change in score on a scale | 1 months |
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| Secondary | 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. | Medical student participants | Posted | Mean | Standard Deviation | Change in score on a scale | 1 months |
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| Secondary | 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. | Medical students | Posted | Mean | Standard Deviation | change in score on a scale | 1 months |
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| Secondary | 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). | medical students | Posted | Mean | Standard Deviation | change in score on a scale | 2 weeks- 1 month |
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| 0 |
| 34 |
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| 34 |
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| 34 |
| EG001 | Wait Group | 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. | 0 | 29 | 0 | 29 | 0 | 29 |
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| D009784 |
| Occupational Diseases |