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

Sponsor

The University of Hong Kong (Other)

Overall Status

Recruiting

CT.gov ID

NCT05317988

Collaborator

(none)

1,200

Enrollment

Location

Arm

3.1

Anticipated Duration (Months)

384.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Behavioral: Intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 28, 2022

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Text-based product information, video of step-by-step demonstration of detailed reconstituion procedures	Behavioral: Intervention A step-by-step video on vaccine reconstitution

Arm

Intervention/Treatment

Experimental: Intervention

Text-based product information, video of step-by-step demonstration of detailed reconstituion procedures

Behavioral: Intervention

A step-by-step video on vaccine reconstitution

Outcome Measures

Primary Outcome Measures

Factual knowledge [1 week]
students will complete a set of validated multiple-choice questions before and after the training.

Secondary Outcome Measures

Procedural knowledge [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
Self-efficacy [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Current BPharm and BNurs students from the University of Hong Kong (Year 1-4)

Exclusion Criteria:

Students not from the aforementioned programmes and years of study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre of Safe Medication Practice and Research	Hong Kong		Hong Kong

Sponsors and Collaborators

The University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Esther Wai Yin Chan, Associate Professor, The University of Hong Kong

ClinicalTrials.gov Identifier:

NCT05317988

Other Study ID Numbers:

TDGCOVID-EWC-06-2021

First Posted:

Apr 8, 2022

Last Update Posted:

Apr 8, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 8, 2022