Medical device education: study protocol for a randomised controlled trial comparing self-directed learning with traditional instructor-led learning on an anaesthesia workstation.

Gutersohn, Caterina; Schweingruber, Sandra; Haudenschild, Maximilian; Huber, Markus; Greif, Robert; Fuchs, Alexander (2023). 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, 13(9), e070261. BMJ Publishing Group 10.1136/bmjopen-2022-070261

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INTRODUCTION

Continuous professional development is essential for maintaining competencies in healthcare. This applies to medical device knowledge and safe handling, which are fundamental for patient safety. Little is known about the efficiency of self-directed learning with an integrated video in medical device education. This study investigates whether anaesthesia providers acquire their medical device competencies on an anaesthesia workstation differently via self-directed learning than traditional teacher-led workshops.

METHODS AND ANALYSIS

This single-centre, non-inferiority, randomised, controlled trial aims to enrol at least 224 anaesthesia providers (ie, certified nurses and physicians). Participants will be randomised to (1) self-directed learning with an integrated learning video (intervention) or (2) a traditional teacher-led workshop (control), for a 1-hour session on a new anaesthesia workstation. The two educational approaches and their effect on medical device competence will be assessed concerning 12 competencies in the same 10 min, objective, structured, clinical examination-like station for both groups. The primary endpoint will be an assessment score of ≥60%. Non-inferiority will be declared if the upper limit of a 90% two-sided CI excludes a difference of more than 10% in favour of the control group. Secondary endpoints will be: (1) the score achieved in the study assessment, (2) the number of open questions after the training, (3) training time in minutes, (4) use of resources and (5) costs, all of which are compared between both groups.

ETHICS AND DISSEMINATION

Study participants will provide written informed consent. All recorded data will be stored on a password-protected research server at the study site accessible only to the investigators. The Bern Cantonal Ethics Committee waived the need for ethical approval (Req-2021-00837; 25 July 2021). There are no ethical, legal or security issues regarding data collection, processing, storage or dissemination.

TRIAL REGISTRATION NUMBER

NCT05530382, 7 September 2022; ClinicalTrials.gov.

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