Summative Assessment of the BurntOut 3D Simulation With Medical Students

Sponsor
Clinical Tools, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04494633
Collaborator
(none)
120
1
2
2.7
45.1

Study Details

Study Description

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 delivered 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 crossover design.

Condition or Disease Intervention/Treatment Phase
  • Other: Clinical Encounters Medical School VR Simulation
N/A

Detailed Description

The investigators will use a pre-/post-intervention design with wait-list controls who also will receive the intervention. The investigators will recruit and enroll 80 medical students who are in pre-clinical years of medical school. 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. During the intervention phase of the study, students will 1) Complete the simulation experience: 6 to 8 tailored scenarios and resilience-building activities (taking around 2 hours over a period of around 4 weeks); and 2) Complete pre-/post- assessments (each taking around 1 hour) plus a follow-up survey after 3 months. The investigators will screen for and exclude students with severe depression and suicidality. The primary clinical endpoint will be burnout as measured by the Maslach Burnout Inventory. Secondary endpoints will be measured via the following assessments: Medical Student Quality of Life, PHQ2/PHQ9 to screen for depression, CD-RISC 2 for resiliency, AUDIT-C/AUDIT for alcohol use disorder and two drug question screening for drug use, and CSQ8 for satisfaction plus questions adapted from the Game User Experience Satisfaction survey and Intrinsic Motivation Inventory to further describe the experience. After 4 weeks, the control and experimental (intervention) groups will cross over to the opposite status and control participants will engage in the intervention.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Summative Assessment of the BurntOut 3D Simulation With Medical Students
Actual Study Start Date :
May 11, 2022
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Other: Clinical Encounters Medical School VR Simulation
A VR simulation related to coping with the stresses of medical school and burnout.

Other: 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.

Other: Clinical Encounters Medical School VR Simulation
A VR simulation related to coping with the stresses of medical school and burnout.

Outcome Measures

Primary Outcome Measures

  1. Burnout [1 months]

    Users will report decreased levels of burn out, as measured on the Maslach Burnout Inventory. This scale uses items to assess emotional exhaustion, depersonalization, and measure the sense of personal accomplishment. Higher scores indicate higher, and thus more problematic, levels of burnout. Selected items are used.

Secondary Outcome Measures

  1. Alcohol misuse [1 months]

    Users will have decrease scores on the Alcohol Use Disorders Identification Test, AUDIT-C, after the intervention. This instrument is a screening tool to identify users who are hazardous drinkers or who have active alcohol use disorder. Minimum value: 0, Maximum value 12. High scores indicate better 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.

  2. Depression [1 months]

    Participants will complete the 2 item Patient Health Questionaire, PHQ-2. The PHQ-2 is a two-item screen where respondents indicate how often the respondent has experienced depressed mood and anhedonia over the prior two weeks. Minimum value: 0, Maximum value 6. High scores indicate worse outcomes.

  3. Resilience [1 months]

    Improvement in this area will be measured via the Connor-Davidson Resilience Scale - a 2 item scale. Minimum value: 0, Maximum value 8. Low scores indicate worse outcomes.

  4. Drug use [1 months]

    Substance use in the past 3 months will be measured via the National Institute for Drug Abuse-Modified Alcohol, Smoking and Substance Involvement Screening Test (3 items). Minimum 0, Maximum value 390 High scores indicate worse outcomes.

  5. Happiness; Exhaustion [1 months]

    Users will report better Quality of Life after using the intervention for 3 months than at baseline. The Medical Student Quality of Life Questionnaire with Nine Items, MSQoL9. The MSQofL is a linear self-assessment analog scale. Users rate their overall quality of life focused on the two domains of exhaustion and general happiness. Minimum value: 0, Maximum value 10. High scores indicate better outcomes.

  6. Satisfaction with the intervention [2 weeks]

    Users will report a positive experience with the intervention and be willing to recommend it to others.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • US Medical students in years 1-4

  • Has access to a computer with Internet access

Exclusion Criteria:

--Self report of active symptoms of major depression

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinical Tools, Inc. Chapel Hill North Carolina United States 27516

Sponsors and Collaborators

  • Clinical Tools, Inc.

Investigators

  • Principal Investigator: Mary P Metcalf, PhD, Clinical Tools, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Clinical Tools, Inc.
ClinicalTrials.gov Identifier:
NCT04494633
Other Study ID Numbers:
  • 271330
First Posted:
Jul 31, 2020
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2022