Online Training for the Reconstitution of Fosun/BioNTech

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05317988
• Other study ID #: TDGCOVID-EWC-06-2021
• Status: Completed
• Phase: N/A
• Start date: March 28, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2023
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Behavioral:
• Intervention group
Participants receive a step-by-step demonstration video of detailed reconstitution procedures and text-based vaccine product information
• Control group
Participants receive a generic video of similar duration on basic facts of COVID-19 (unrelated to reconstitution procedures) and text-based product information

Locations

Country	Name	City	State
Hong Kong	Centre of Safe Medication Practice and Research	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Factual knowledge	Students will complete a set of validated multiple-choice questions before and after the training.	1 week
Secondary	Procedural knowledge	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	1 week
Secondary	Self-efficacy	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	1 week