Clinical trial NCT04494633: 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
Overall status: COMPLETED
Phase: NA
Conditions: Burnout, Student
Alcohol; Harmful Use
Quality of Life
Depression
Resilience
Drug Use
Burnout, Professional
Lead sponsor: Clinical Tools, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2020-07-31
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Eligibility criteria: Inclusion Criteria:

* US Medical students in years 2-4
* Has access to a computer with Internet access

Exclusion Criteria:

--Self report of active symptoms of major depression

Primary outcomes:
measure: Burnout Change
timeFrame: 1 months
Secondary outcomes:
measure: Alcohol Use Change
timeFrame: 1 months
measure: Depression Change
timeFrame: 1 months
measure: Resilience Change
timeFrame: 1 months
measure: Drug Use Change
timeFrame: 1 months
measure: Happiness and Exhaustion (Quality of Life)
timeFrame: 2 weeks- 1 month
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Clinical Tools, Inc.
state: North Carolina
Study officials:
affiliation: Clinical Tools, Inc.
name: Mary P Metcalf, PhD
role: PRINCIPAL_INVESTIGATOR
References: