Self-guided vs Traditional Instructor-led Learning for Medical Device Training

Study Overview
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Brief Summary
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The aim of this study project is to clarify whether defined practical application skills are learned by anesthesiology specialists through a self-directed learning program with learning videos and a hands-on exercise station (intervention group). Control group is a traditional instructor-led practical workshop classroom teaching. Hypothesis: A video-based and self-directed learning program shows no difference in the learning successes than traditional face-to-face workshops.

Detailed Description
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The Department of Anaesthesiology and Pain Medicine is going to buy and introduce a new generation of anaesthetic machines. Therefore the whole clinical staff of the department who will operate the new anaesthetic machine in the future must be educated and trained with this device before working with patients. Continuous professional training in the use of medical devices is an essential part of developing professional skills, including in anaesthesia. The professional, routine use of devices is essential to guarantee patient safety. The usual instructor-led workshop-based equipment training in face-to-face lessons is time-consuming and resource-intensive. The high work intensity and shift work in anaesthesia pose a challenge for such training courses. Video-supported learning sequences were more effective than traditional face-to-face lessons, especially for procedural - cognitive processes of complex psychomotor skills. Self-controlled practical practice is more effective than externally controlled practice conditions. The aim of this study is to clarify whether defined practical application skills (anaesthetic machine) are learned by anesthesiology specialists (nurses and physicians of the department) through a self-directed learning program with learning videos and a hands-on exercise station (intervention group). Control group is a traditional instructor-led practical workshop classroom teaching. • The null hypothesis (H0) is that a video-based and self-directed learning program shows no difference in the learning success than traditional face-to-face workshops The aim of this study is to clarify whether anesthesiologists and nurses anaesthetists can learn defined practical application skills through a self-directed learning program with learning videos and a hands-on training station. If this educational research project is able to demonstrate that self-guided learning of complex psychomotor skills needed for the handling of medical devices like respirators is non-inferior to traditional classroom teaching of such skills, this might minimize the dependence on traditional educator-driven resource-intensive workshop teaching and has the potential to change clinical teaching in the future. The educational topic of the study is device training in the hospital sector. A randomized controlled comparative study with two groups (face-to-face workshop versus video-based self-directed learning) in a non-inferiority design is planned, assuming a non-inferior success rate of the traditional face-to-face workshop of 80% and a non-inferiority range of 10%. According to a sample size calculation, 224 voluntary participants are needed.

Official Title
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Comparing Self-guided Learning (Video and hands-on Simulation) With Traditional Instructor-led Learning for Medical Device Training: a Randomized-controlled Trial

Conditions
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Professional Role, Interprofessional Education, Simulation Training, Learning Problem

Intervention / Treatment
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* Other: self-guided learning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical working anaesthesia staff of the Department of Anaesthesia and Pain Medicine, Bern University Hospital written consent Exclusion Criteria: - not fulfilling inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: self-guided learning (video and hands-on simulation)<br>video-based self-directed learning | Other: self-guided learning<br>* video-based self-directed learning for medical device training<br>|
| No Intervention: traditional instructor-led learning<br>traditional instructor-led learning in face-to-face workshop | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Application skills achieved in the context of an objective structured clinical examination (OSCE) test station per participant (yes or no) | Achieved or not achieved based on defined practical assignments and oral questioning using a defined catalogue of questions. The testing is carried out by an expert trained as a key user. The test is rated as successful if 60% or more of the questions are answered successfully. The following four criteria are checked: Working principle Security aspect Handling and operation Theory-practice transfer Each criterion is assessed with 0-3 points 0 = does not apply = rather does not apply = applies = applies very well The final evaluation of the device test is based on the following granulated scale: A - 100% of the criteria (excellent) B 90% - 99% (very good) C 80% - 89% (good) D 70% - 79% (satisfactory) E 60% - 69% (sufficient) F <60% (unsatisfactory) | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of application skills | Application skills scaled (excellent (A) to unsatisfactory (F), measured from the data from the test station. The final evaluation of the device test is based on the following granulated scale: A - 100% of the criteria (excellent) B 90% - 99% (very good) C 80% - 89% (good) D 70% - 79% (satisfactory) E 60% - 69% (sufficient) F <60% (unsatisfactory) | 10 minutes | 
| open questions after the training | Participants will report in a survey if they have any unanswered questions after the training. The number (n) of unanswered questions and percentages will be given for each arm | 1 day | 
| Time spent | Participants will report in a survey on their time spent for learning. Time will be reported in minutes for each arm per participant. | 1 day | 
| use of resources | Use of resources in both teaching formats (e.g., books, internet, other teaching material). The outcome will be reported in numbers and percentages. | 1 day | 
| cost comparison | Cost comparison between the two learning formats. For traditional learning e.g. cost for the instructor and facility. For video-guided learning e.g. costs for the production of the video. The outcome will be reported in Swiss Francs. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Teaching Methods, Learning Methods, Self-Directed Learning, Continuing Medical Education