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

NCT ID: NCT05530382

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-04
• Study Completion Date: 2024-04-01

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.

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.

Conditions

Professional Role; Interprofessional Education; Simulation Training; Learning Problem

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

self-guided learning (video and hands-on simulation)

video-based self-directed learning

Group Type: EXPERIMENTAL

self-guided learning

Intervention Type: OTHER

video-based self-directed learning for medical device training

traditional instructor-led learning

traditional instructor-led learning in face-to-face workshop

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

self-guided learning

video-based self-directed learning for medical device training

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Clinical working anaesthesia staff of the Department of Anaesthesia and Pain Medicine, Bern University Hospital
• written consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Greif Robert, MD, MME, Professor

Role: STUDY_DIRECTOR

University of Berne

Caterina Gutersohn, RN, NA

Role: PRINCIPAL_INVESTIGATOR

University of Berne

Locations

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

Bern, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 40410098 (View on PubMed)

Gutersohn 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.

Reference Type: DERIVED

PMID: 37666557 (View on PubMed)

Other Identifiers

Videolearning

Identifier Type: -

Identifier Source: org_study_id