A Novel Serious Game as an Alternative for Teaching Basic Point-of-Care Transthoracic Echocardiography Skills

Echocardiography Clinical Trial

— SLOPE  

Official title:

A Novel Serious Game as an Alternative for Teaching Basic Point-of-Care Transthoracic Echocardiography Skills

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06106178
• Other study ID #: 1289/2023
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2023
• Est. completion date: August 2024

Study information

• Verified date: November 2023
• Source: Medical University of Vienna
• Contact: Josef Michael Lintschinger, MD
• Phone: +436607702644
• Email: josef.lintschinger[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare different digital learning methods for teaching basic skills in point-of-care transthoracic echocardiography to medical students. The main question it aims to answer is: • Is a novel digital learning tool, such as a serious video game, non-inferior to traditional ultrasound simulator teaching methods in the context of basic point-of-care transthoracic echocardiography skills training? Participants will train basic point-of-care ultrasound skills using either a traditional basic ultrasound simulator course or the serious video game "Underwater". Both methods focus on training hand-eye coordination, which is particularly important in transthoracic echocardiography. To compare the performance of the participants, a baseline assessment will be performed before and a final assessment after the two-week training period.

Description:

Point-of-care ultrasound education follows non-standardized teaching and learning methods. In many cases, ultrasound is practiced directly on patients without proper training, or ultrasound simulators are used. However, these simulators are expensive to purchase and are not always readily available to students. In addition, there are a growing number of new digital tools, such as serious video games, that aim to deliver the same content in a more accessible and cost-effective manner. However, in the field of point-of-care echocardiography, there is still little scientific evidence to support their use. This single-blind, prospective, randomized, controlled, non-inferiority trial aims to demonstrate the non-inferiority of a serious video game compared to conventional simulator-based training of basic echocardiography skills to make ultrasound training more accessible to every trainee. Only medical students who already have the necessary anatomical knowledge but no experience with ultrasound diagnostics will be recruited to participate in this study. Participants will attend a 90-minute workshop to learn the basics of point-of-care echocardiography. They will then be required to perform standardized transthoracic echocardiography before and after a two-week training period, which will be scored by blinded experts. During the training phase, one group will practice the hand-eye coordination required for echocardiography using an ultrasound simulator, while the second group will practice the same content using a serious video game. In addition, questionnaires will be used to collect additional data from the participants.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

Inclusion Criteria:

• Medical student at the Medical University of Vienna (Medicine Degree Program)
• =18 years
• Basic knowledge of anatomy (completed Block 2 of the MUV curriculum)

Exclusion Criteria:

• Previous experience using an ultrasound device

Related Conditions & MeSH terms

• Echocardiography
• Education, Medical

Intervention

Other:
• Simulator for Basic Ultrasound Skills
Basic course of a traditional ultrasound simulator focusing on hand-eye coordination
• Serious Video Game
The serious video game "Underwater" uses a 3D-printed ultrasound probe for maneuvering. During gameplay, coins must be collected in an underwater world using the aforementioned simulated ultrasound probe. The main focus of this game is to improve hand-eye coordination while using an ultrasound probe.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in the participants' modified Objective Structured Assessment of Ultrasound Skill (OSAUS) score between the baseline and final assessment	The primary outcome measure is the difference in the participant's modified Objective Structured Assessment of Ultrasound Skill (OSAUS) score between the participants' baseline and final assessment. Possible assessment scores range from 4 to 20 points, with higher scores indicating better performance. Each participant's baseline assessment score is his or her individual baseline score, from which the difference to the respective final assessment score is calculated.	Two-week change from baseline to final assessment score
Secondary	Gender differences in modified Objective Structured Assessment of Ultrasound Skill (OSAUS) scores between the baseline and final assessment	A two-factorial analysis of variance model (including an interaction term) will be used to determine the influence of gender in the difference of the modified Objective Structured Assessment of Ultrasound Skill (OSAUS) score between the baseline and final assessment. Possible assessment scores range from 4 to 20 points, with higher scores indicating better performance. To adjust for potential imbalances between the randomized groups, the HEXACO (a measure of the six major dimensions of personality; H: Honesty-Humility; E: Emotionality; X: eXtraversion; A: Agreeableness (versus Anger); C: Conscientiousness; O: Openness to Experience) subscale of openness to experience (ranging from 1 to 5, with higher scores indicating more openness to experience) and the Technology Readiness Score (ranging from 1 to 5, with higher scores indicating more technology readiness) were included as covariates in the ANCOVA model.	evaluation within 3 weeks after study completion
Secondary	Group effects on gender differences in modified Objective Structured Assessment of Ultrasound Skill (OSAUS) scores	A two-factorial analysis of variance model (including an interaction term) will be used to determine the potential modifying effect of gender on the training effect, which is calculated as the difference in the participant's total modified Objective Structured Assessment of Ultrasound Skill (OSAUS) score between the participant's baseline assessment and final assessment. Possible assessment scores range from 4 to 20 points, with higher scores indicating better performance. To adjust for potential imbalances between the randomized groups, a scale for openness to experience (ranging from 1 to 5, with higher scores indicating more openness to experience) and the Technology Readiness Score (ranging from 1 to 5, with higher scores indicating more technology readiness) are included as covariates in the ANCOVA model.	evaluation within 3 weeks after study completion
Secondary	Time to complete the baseline assessment	The maximum time (minutes and seconds) to complete the baseline assessment is set to 10 minutes. Therefore, times between 0 and 10 minutes can be measured.	up to 10 minutes
Secondary	Time to complete the final assessment	The maximum time (minutes and seconds) to complete the final assessment is set to 10 minutes. Therefore, times between 0 and 10 minutes can be measured.	up to 10 minutes
Secondary	Spearman correlation coefficients between the time taken and the participants learning progress	Spearman correlation coefficients between the time taken for the final assessment and the difference in the participant's modified Objective Structured Assessment of Ultrasound Skill (OSAUS) score between the participant's baseline final assessment. Possible assessment scores range from 4 to 20 points, with higher scores indicating better performance. Each participant's baseline assessment score is his or her individual baseline score, from which the difference to the respective final assessment score is calculated.	evaluation within 3 weeks after study completion
Secondary	Group difference in modified Objective Structured Assessment of Ultrasound Skill (OSAUS) score points for each objective	Possible scores range from 1 to 4 points per objecitve, with higher scores indicating better performance.; Objectives are: applied knowledge of ultrasound equipment; image optimization; systematic examination; interpretation of images	Two-week change from baseline to final assessment score
Secondary	Subjective confidence of participants in the use of point-of-care ultrasound (POCUS) in the context of transthoracic echocardiography after the training period	5-point Likert Scale, with higher scores indicating greater confidence; (1: not confident; 2: rather not confident; 3: neither confident nor not confident; 4: confident; 5: very confident)	evaluation within 3 weeks after study completion
Secondary	Group difference in cognitive load while performing the final assessment as opposed to the respective cognitive load at the baseline assessment	Global National Aeronautics and Space Administration (NASA) Task-Load-Index ranging from 0 to 100. Each participant's baseline assessment score is his or her individual baseline score, from which the difference to the respective score of the final assessment is calculated. Higher scores are indicating higher cognitive load.	Two-week change from baseline to final assessment
Secondary	Group difference in cognitive load (per objective) while performing the final assessment as opposed to the respective cognitive load at the baseline assessment	National Aeronautics and Space Administration (NASA) Task-Load-Index per objective, ranging from 0 to 100. Each participant's baseline assessment score is his or her individual baseline score, from which the difference to the respective score of the final assessment is calculated.; Objectives are: (mental demand, physical demand, temporal demand, performance, effort, frustration). Higher scores are indicating higher mental demand/higher physical demand/ higher temporal demand/worse performance/more effort/more frustration).	Two-week change from baseline to final assessment
Secondary	Subjective desire for for more new digital tools in medical education before and after the training period	5-point Likert Scale, with higher scores indicating more desire; (1: no desire; 2: rather not a desire; 3: neither a desire nor not a desire; 4: a desire; 5: a strong desire)	evaluation within 3 weeks after study completion
Secondary	Frequency of playing video games for fun in the past 12 months before the study	5-point Likert Scale, with higher scores indicating higher frequency; (1: never; 2: less than once a week; 3: once a week; 4: more than once a week; 5: daily)	evaluation within 3 weeks after study completion
Secondary	Frequency of playing video games for educational purposes in the past 12 months before the study	5-point Likert Scale, with higher scores indicating higher frequency; (1: never; 2: less than once a week; 3: once a week; 4: more than once a week; 5: daily)	evaluation within 3 weeks after study completion
Secondary	Frequency of playing video games for fun between the ages of 6 and 18	5-point Likert Scale, with higher scores indicating higher frequency; (1: never; 2: less than once a week; 3: once a week; 4: more than once a week; 5: daily)	evaluation within 3 weeks after study completion
Secondary	Frequency of playing video games for educational purposes between the ages of 6 and 18	5-point Likert Scale, with higher scores indicating higher frequency; (1: never; 2: less than once a week; 3: once a week; 4: more than once a week; 5: daily)	evaluation within 3 weeks after study completion
Secondary	Correlation between the frequency of playing video games for fun in the past 12 months before the study and the learning progress	Spearman correlation between the frequency of playing video games, measured with a 5-point Likert Scale, with higher scores indicating higher frequency (1: never; 2: less than once a week; 3: once a week; 4: more than once a week; 5: daily) and the difference in the participants' modified Objective Structured Assessment of Ultrasound Skill (OSAUS) score between the baseline and final assessment. Possible assessment scores range from 4 to 20 points, with higher scores indicating better performance. Each participant's baseline assessment score is his or her individual baseline score, from which the difference to the respective final assessment score is calculated.	evaluation within 3 weeks after study completion
Secondary	Correlation between the frequency of playing video games for educational purposes in the past 12 months before the study and the difference in the learning progress	Spearman correlation between the frequency of playing video games, measured with a 5-point Likert Scale, with higher scores indicating higher frequency (1: never; 2: less than once a week; 3: once a week; 4: more than once a week; 5: daily) and the difference in the participants' modified Objective Structured Assessment of Ultrasound Skill (OSAUS) score between the baseline and final assessment. Possible assessment scores range from 4 to 20 points, with higher scores indicating better performance. Each participant's baseline assessment score is his or her individual baseline score, from which the difference to the respective final assessment score is calculated.	evaluation within 3 weeks after study completion
Secondary	Correlation between the frequency of playing video games for fun between the ages of 6 and 18 and the difference in the learning progress	Spearman correlation between the frequency of playing video games, measured with a 5-point Likert Scale, with higher scores indicating higher frequency (1: never; 2: less than once a week; 3: once a week; 4: more than once a week; 5: daily) and the difference in the participants' modified Objective Structured Assessment of Ultrasound Skill (OSAUS) score between the baseline and final assessment. Possible assessment scores range from 4 to 20 points, with higher scores indicating better performance. Each participant's baseline assessment score is his or her individual baseline score, from which the difference to the respective final assessment score is calculated.	evaluation within 3 weeks after study completion
Secondary	Correlation between the frequency of playing video games for educational purposes between the ages of 6 and 18 and the difference in the learning progress	Spearman correlation between the frequency of playing video games, measured with a 5-point Likert Scale, with higher scores indicating higher frequency (1: never; 2: less than once a week; 3: once a week; 4: more than once a week; 5: daily) and the difference in the participants' modified Objective Structured Assessment of Ultrasound Skill (OSAUS) score between the baseline and final assessment. Possible assessment scores range from 4 to 20 points, with higher scores indicating better performance. Each participant's baseline assessment score is his or her individual baseline score, from which the difference to the respective final assessment score is calculated.	evaluation within 3 weeks after study completion
Secondary	Correlation between the frequency of playing video games for fun in the past 12 months before the study and the desire for more digital tools in medical education before and after the training period within the study	Spearman correlation between the frequency of playing video games, measured with a 5-point Likert Scale, with higher scores indicating higher frequency (1: never; 2: less than once a week; 3: once a week; 4: more than once a week; 5: daily) and the desire for more digital tools in medical education before and after the training period of this study. This desire will be measured with a 5-point Likert Scale, with higher scores indicating more desire (1: no desire; 2: rather not a desire; 3: neither a desire nor a desire; 4: a desire; 5: a strong desire)	evaluation within 3 weeks after study completion
Secondary	Correlation between the frequency of playing video games for educational purposes in the past 12 months before the study and the desire for more digital tools in medical education before and after the training period within the study	Spearman correlation between the frequency of playing video games, measured with a 5-point Likert Scale, with higher scores indicating higher frequency (1: never; 2: less than once a week; 3: once a week; 4: more than once a week; 5: daily) and the desire for more digital tools in medical education before and after the training period of this study. This desire will be measured with a 5-point Likert Scale, with higher scores indicating more desire (1: no desire; 2: rather not a desire; 3: neither a desire nor a desire; 4: a desire; 5: a strong desire)	evaluation within 3 weeks after study completion
Secondary	Correlation between the frequency of playing video games for fun between the ages of 6 and 18 and the desire for more digital tools in medical education before and after the training period within the study.	Spearman correlation between the frequency of playing video games, measured with a 5-point Likert Scale, with higher scores indicating higher frequency (1: never; 2: less than once a week; 3: once a week; 4: more than once a week; 5: daily) and the desire for more digital tools in medical education before and after the training period of this study. This desire will be measured with a 5-point Likert Scale, with higher scores indicating more desire (1: no desire; 2: rather not a desire; 3: neither a desire nor a desire; 4: a desire; 5: a strong desire)	evaluation within 3 weeks after study completion
Secondary	Correlation between the frequency of playing video games for educational purposes between the ages of 6 and 18 and the desire for more digital tools in medical education before and after the training period within the study.	Spearman correlation between the frequency of playing video games, measured with a 5-point Likert Scale, with higher scores indicating higher frequency (1: never; 2: less than once a week; 3: once a week; 4: more than once a week; 5: daily) and the desire for more digital tools in medical education before and after the training period of this study. This desire will be measured with a 5-point Likert Scale, with higher scores indicating more desire (1: no desire; 2: rather not a desire; 3: neither a desire nor a desire; 4: a desire; 5: a strong desire)	evaluation within 3 weeks after study completion
Secondary	Subjective feeling of learning progress during the training period	5-point Likert Scale measuring the subjective feeling of learning progress with the digital training tool within the randomized group; (1: not helpful; 2: rather not helpful; 3: neither helpful nor not helpful; 4: rather helpful; very helpful)	evaluation within 3 weeks after study completion
Secondary	Subjective level of frustration during the training period	5-point Likert Scale measuring the subjective feeling of frustration while using the digital training tool within the randomized group; (1: no frustration; 2: rather not frustrated; 3: neither frustrated nor not frustrated; 4: rather frustrated; 5: very frustrated)	evaluation within 3 weeks after study completion
Secondary	Subjective level of enjoyment during the training period	5-point Likert Scale measuring the subjective feeling of frustration while using the digital training tool within the randomized group; (1: no enjoyment; 2: rather no enjoyment; 3: neither enjoyment nor no enjoyment; 4: rather an enjoyment; 5: strong enjoyment)	evaluation within 3 weeks after study completion

External Links

•   Serious Video Game "Underwater"