Burnout, StudentNCT04494633
Summative Assessment of the BurntOut 3D Simulation With Medical Students
A study testing Clinical Encounters Medical School 3D Simulation in people with Burnout, Student and Alcohol; Harmful Use, run by Clinical Tools, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout, Student, Alcohol; Harmful Use, Quality of Life
- What is being tested?
- Clinical Encounters Medical School 3D Simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2022to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- US Medical students in years 2-4
- Has access to a computer with Internet access
Who cannot join
- --Self report of active symptoms of major depression
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Tools, Inc.
Chapel Hill, North Carolina, 27516
About this study
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.
Read the detailed description
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.
- Conditions
- Burnout, Student, Alcohol; Harmful Use, Quality of Life, Depression, Resilience, Drug Use
- Being tested
- Clinical Encounters Medical School 3D Simulation
- Medical subject headings
- Burnout, Psychological, Depression, Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Encounters Medical School 3D SimulationOther
A 3D simulation related to coping with the stresses of medical school and burnout.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants completed the pre-assessments, used the intervention, waited 2-4 weeks, and then completed the assessments again. Receives: Other: Clinical Encounters Medical School 3D Simulation |
| Wait Group | No intervention | Participants completed the pre-assessments, waited 2-4 weeks, and completed the assessments again. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 months
Secondary outcomes (5)
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) .
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 2 weeks- 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start11 May 2022
- Primary completion1 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Burnout, StudentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Tools, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Mary P Metcalf, PhD, Principal investigator, Clinical Tools, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494633
- Sponsor's protocol ID
- 271330
- Other IDs
- R44AA026474
- Status last verified
- Dec 2023
- First submitted
- 10 Jul 2020
- Last updated
- 15 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Summative Assessment of the BurntOut 3D Simulation With Medical Students
- ClinicalTrials.gov ID
- NCT04494633
- Acronym / sponsor ID
- 271330
- Conditions
- Burnout, Student, Alcohol; Harmful Use, Quality of Life, Depression, Resilience, Drug Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Clinical Tools, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 11 May 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 31 Jul 2020 (actual)
- Results
- Posted 15 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Clinical Encounters Medical School 3D SimulationParticipants completed the pre-assessments, used the intervention, waited 2-4 weeks, and then completed the assessments again. |
| Wait Group | No intervention | –Participants completed the pre-assessments, waited 2-4 weeks, and completed the assessments again. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- US Medical students in years 2-4
- Has access to a computer with Internet access
Key exclusion criteria (1 listed)
- --Self report of active symptoms of major depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Encounters Medical School 3D SimulationA 3D simulation related to coping with the stresses of medical school and burnout. | Other | Intervention |
Primary outcome
Burnout Change
Time frame: 1 months
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.
5 secondary outcomes
Alcohol Use Change
Time frame: 1 months
Depression Change
Time frame: 1 months
Resilience Change
Time frame: 1 months
Drug Use Change
Time frame: 1 months
Happiness and Exhaustion (Quality of Life)
Time frame: 2 weeks- 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary P Metcalf, PhD principal investigator
Clinical Tools, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Encounters Medical School 3D Simulation in people with Burnout, Student and Alcohol; Harmful Use, run by Clinical Tools, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burnout Change (time frame: 1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.