Summative Assessment of the BurntOut 3D Simulation With Medical Students

NCT04494633 | Completed Results

• 2 other identifiers: 271330R44AA026474
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Alcohol Use Change

  1 months

• Depression Change

  1 months

• Resilience Change

  1 months

• Drug Use Change

  1 months

• Happiness and Exhaustion (Quality of Life)

  2 weeks- 1 month

Study Arms (2)

Intervention

EXPERIMENTAL

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

Wait Group

NO INTERVENTION

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

Interventions

Clinical Encounters Medical School 3D Simulation OTHER

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Self report of active symptoms of major depression

Sponsors & Collaborators

• Clinical Tools, Inc.: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Clinical Tools, Inc.

Chapel Hill, North Carolina, 27516, United States

Location

MeSH Terms

Conditions

Burnout, Psychological; Depression; Burnout, Professional

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Occupational Stress; Occupational Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Mary Metcalf, PhD, MPH
• Organization: Clinical Tools, Inc.

metcalf@clinicaltools.com

(919) 960-8118

Study Officials

• Mary P Metcalf, PhD

  Clinical Tools, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 31, 2020
• Study Start: May 11, 2022
• Primary Completion: July 1, 2022
• Study Completion: July 31, 2022
• Last Updated: December 15, 2023
• Results First Posted: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)