Summative Assessment of the BurntOut 3D Simulation With Medical Students

NCT ID: NCT04494633

Last Updated: 2023-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-11
• Study Completion Date: 2022-07-31

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.

Conditions

Burnout, Student; Alcohol; Harmful Use; Quality of Life; Depression; Resilience; Drug Use; Burnout, Professional

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

Participants completed the pre-assessments, used the intervention, waited 2-4 weeks, and then completed the assessments again.

Group Type: EXPERIMENTAL

Clinical Encounters Medical School 3D Simulation

Intervention Type: OTHER

A 3D simulation related to coping with the stresses of medical school and burnout.

Wait Group

Participants completed the pre-assessments, waited 2-4 weeks, and completed the assessments again.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Clinical Encounters Medical School 3D Simulation

A 3D simulation related to coping with the stresses of medical school and burnout.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Clinical Tools, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary P Metcalf, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Tools, Inc.

Locations

Clinical Tools, Inc.

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R44AA026474

Identifier Type: NIH

Identifier Source: secondary_id

View Link

271330

Identifier Type: -

Identifier Source: org_study_id