Self-guided vs Traditional Instructor-led Learning for Medical Device Training
EVALUATING
Comparing Self-guided Learning (Video and hands-on Simulation) With Traditional Instructor-led Learning for Medical Device Training: a Randomized-controlled Trial
1 other identifier
interventional
224
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2022
CompletedFirst Posted
Study publicly available on registry
September 7, 2022
CompletedStudy Start
First participant enrolled
October 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedMay 8, 2024
May 1, 2024
5 months
September 2, 2022
May 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 1. = rather does not apply 2. = applies 3. = 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 Outcomes (5)
level of application skills
10 minutes
open questions after the training
1 day
Time spent
1 day
use of resources
1 day
cost comparison
1 day
Study Arms (2)
self-guided learning (video and hands-on simulation)
EXPERIMENTALvideo-based self-directed learning
traditional instructor-led learning
NO INTERVENTIONtraditional instructor-led learning in face-to-face workshop
Interventions
video-based self-directed learning for medical device training
Eligibility Criteria
You may qualify if:
- Clinical working anaesthesia staff of the Department of Anaesthesia and Pain Medicine, Bern University Hospital
- written consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
Bern, 3010, Switzerland
Related Publications (2)
Gutersohn C, Schweingruber S, Haudenschild M, Huber M, Greif R, Fuchs A. Self-directed learning versus traditional instructor-led learning for education on a new anaesthesia workstation: a noninferiority, randomised, controlled trial. Br J Anaesth. 2025 Oct;135(4):990-996. doi: 10.1016/j.bja.2025.03.043. Epub 2025 May 22.
PMID: 40410098DERIVEDGutersohn C, Schweingruber S, Haudenschild M, Huber M, Greif R, Fuchs A. Medical device education: study protocol for a randomised controlled trial comparing self-directed learning with traditional instructor-led learning on an anaesthesia workstation. BMJ Open. 2023 Sep 4;13(9):e070261. doi: 10.1136/bmjopen-2022-070261.
PMID: 37666557DERIVED
Study Officials
- STUDY DIRECTOR
Greif Robert, MD, MME, Professor
University of Berne
- PRINCIPAL INVESTIGATOR
Caterina Gutersohn, RN, NA
University of Berne
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2022
First Posted
September 7, 2022
Study Start
October 4, 2022
Primary Completion
March 1, 2023
Study Completion
April 1, 2024
Last Updated
May 8, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share
All relevant data will be published