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OpenTrials
Completed

NCT Number: NCT05317988

Online Training for the Reconstitution of Fosun/BioNTech

The COVID-19 vaccine by BioNTech requires specific, delicate storage and dilution procedures to be stringently followed for safety and effectiveness. Training should be completed prior to undertaking dilution procedures. Currently, the nursing and pharmacy curricula do not have content on specialized vaccine reconstitution techniques. E-learning has become an essential component of teaching and learning due to COVID. Yet, optimal online learning module development for clinical procedural skill acquisition and appropriate online formative assessment has not been adequately explored. To bridge this training gap for Hong Kong nurses and pharmacists, this project aims to develop a video-based online learning programme, coupled to a randomized controlled study to determine the effectiveness of online vaccine reconstitution training. The module, a supplement to the current teaching curriculum, will train students from both Nursing and Pharmacy disciplines. Outcome measures include formative assessment of student performance, which can be used to inform the design and content of experiential content in healthcare professional curriculums. If this learning platform is shown to be effective, the scope could be extended to other disciplines (not limited to healthcare) where learning complex procedural tasks are necessary for the absence of instructor-led teaching.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre of Safe Medication Practice and Research

Hong Kong

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Students currently enrolled in the Bachelor of Pharmacy and Bachelor of Nursing programmes (Years 1 to 4) at The University of Hong Kong

Exclusion criteria

  • Students not from the aforementioned programmes and years of study

Treatment and study plan

Intervention Group

Behavioral

Participants receive a step-by-step demonstration video of detailed reconstitution procedures and text-based vaccine product information

Control Group

Behavioral

Participants receive a generic video of similar duration on basic facts of COVID-19 (unrelated to reconstitution procedures) and text-based product information

Primary outcomes

  1. Factual knowledge

    Time frame: 1 week

    Students will complete a set of validated multiple-choice questions before and after the training.

Secondary outcomes

  1. Procedural knowledge

    Time frame: 1 week

    Students will complete an interactive psychomotor assessment, where they must sort out the correct sequence of reconstitution procedures using a drag-and-drop interface with instant formative feedback

  2. Self-efficacy

    Time frame: 1 week

    Students will rate their confidence on carrying out the reconstitution procedures in practice before and after the training based on a 10-point Likert scale

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Online Training for the Reconstitution of Fosun/BioNTech: a Learning Platform to Determine Readiness for Complex Medication Preparation Procedures

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 8, 2022
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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