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

Simulation Training Clinical Trial

— EVALUATING  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05530382
• Other study ID #: Videolearning
• Status: Completed
• Phase: N/A
• Start date: October 4, 2022
• Est. completion date: April 1, 2024

Study information

• Verified date: May 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Interprofessional Education
• Professional Role
• Simulation Training

Intervention

Other:
• self-guided learning
video-based self-directed learning for medical device training

Locations

Country	Name	City	State
Switzerland	Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

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