Simulation Training Clinical Trial
— EVALUATINGOfficial title:
Comparing Self-guided Learning (Video and hands-on Simulation) With Traditional Instructor-led Learning for Medical Device Training: a Randomized-controlled Trial
Verified date | May 2024 |
Source | Insel Gruppe AG, University Hospital Bern |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 224 |
Est. completion date | April 1, 2024 |
Est. primary completion date | March 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland | Bern |
Lead Sponsor | Collaborator |
---|---|
Insel Gruppe AG, University Hospital Bern |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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