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

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.

Study Overview

• Status: Completed
• Conditions: Professional Role; Simulation Training; Interprofessional Education; Learning Problem
• Intervention / Treatment: Other: self-guided learning

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Study Director: Greif Robert, MD, MME, Professor, University of Berne; Principal Investigator: Caterina Gutersohn, RN, NA, University of Berne

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2022
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: September 2, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Teaching Methods; Learning Methods; Self-Directed Learning; Continuing Medical Education
• Other Study ID Numbers: Videolearning

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All relevant data will be published

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No