Online Training for the Reconstitution of Fosun/BioNTech
May 9, 2023 updated by: Dr. Esther Wai Yin Chan, The University of Hong Kong
Online Training for the Reconstitution of Fosun/BioNTech: a Learning Platform to Determine Readiness for Complex Medication Preparation Procedures
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
385
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hong Kong, Hong Kong
- Centre of Safe Medication Practice and Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
Participants receive a step-by-step demonstration video of detailed reconstitution procedures and text-based vaccine product information
|
Participants receive a step-by-step demonstration video of detailed reconstitution procedures and text-based vaccine product information
|
|
Placebo Comparator: 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
|
Participants receive a generic video of similar duration on basic facts of COVID-19 (unrelated to reconstitution procedures) and text-based product information
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Factual knowledge
Time Frame: 1 week
|
Students will complete a set of validated multiple-choice questions before and after the training.
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1 week
|
|
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
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 28, 2022
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
April 6, 2022
First Submitted That Met QC Criteria
April 6, 2022
First Posted (Actual)
April 8, 2022
Study Record Updates
Last Update Posted (Actual)
May 10, 2023
Last Update Submitted That Met QC Criteria
May 9, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- TDGCOVID-EWC-06-2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.