A Training Program of Drug Allergy for Healthcare Professionals

A Training Program of Drug Allergy for Healthcare Professionals: A Randomized Controlled Trial

Drug allergy is often under-recognized, yet over- (mistakenly) diagnosed, especially in Hong Kong. There is also a dire shortage of allergy specialists and facilities to tackle the overwhelming drug allergy pandemic. Fortunately, when trained, non-specialist physicians and nurses have demonstrated comparable capabilities in drug allergy evaluation compared to specialists. To potentially promote and propagate the role of non-specialist physicians and nurses toward drug allergy care, the investigators propose a study to investigate the impact of an intensive and focused drug allergy educational course conducted at the University of Hong Kong.

Study Overview

• Status: Not yet recruiting
• Conditions: Drug Allergy
• Intervention / Treatment: Other: Drug allergy training program

Detailed Description

Two identical didactic courses on drug allergy were designed. Each course will last 12 hours and conducted over 2 consecutive days (6 hours each day). All candidates will attend physically and on-site. Various aspects of drug allergy with pre-set learning objectives will be taught in-person by instructors (physicians or nurses specializing in drug allergy nominated by the University of Hong Kong). Course materials and instructors will be identical for each course.

Aims of the study Primary objective

• Investigate the change in knowledge among participants of a 2-day drug allergy educational course
• Investigate the change in clinical practice among participants of a 2-day drug allergy educational course

Secondary objectives

• Investigate the sustained change(s) in knowledge (if any) of participants of a 2-day drug allergy educational course
• Investigate the sustained change(s) in clinical practice (if any) of participants of a 2-day drug allergy educational course

Hypothesis The investigators hypothesize that candidates (practicing physicians and nurses) of the drug allergy course will gain knowledge on drug allergy, which in turn will influence and change their clinical practice.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hei Li, MBBS; Phone Number: 2255 5995; Email: liphilip@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 000
    • School of Biomedical Science
    • Contact: Hei Li, MBBS; Phone Number: 2255 5995; Email: liphilip@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Registered nurses or doctors actively practicing in Hong Kong
• English speaking;
• Able to complete quizzes and questionnaires;
• Aged 18 or above

Exclusion Criteria:

• People who are unable to communicate in Cantonese or Mandarin
• People who are participating in other drug allergy training course

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; wo identical didactic courses on drug allergy will be delivered. Changes in knowledge and clinical practice will be measured by serial practice questionnaires and knowledge quizzes conducted before and after the course. Group 1 will undergo the course first.	Other: Drug allergy training program; Two identical didactic courses on drug allergy were designed. Each course will last 12 hours and conducted over 2 consecutive days (6 hours each day). All candidates will attend physically and on-site. Various aspects of drug allergy with pre-set learning objectives will be taught in-person by instructors (physicians or nurses specializing in drug allergy nominated by the University of Hong Kong). Course materials and instructors will be identical for each course.
Active Comparator: Control group; Group 2 will undergo an identical course one month later. By comparing any changes in knowledge or practice between groups, this ensures that any changes in knowledge or practice were solely due to the course and not other external factors.	Other: Drug allergy training program; Two identical didactic courses on drug allergy were designed. Each course will last 12 hours and conducted over 2 consecutive days (6 hours each day). All candidates will attend physically and on-site. Various aspects of drug allergy with pre-set learning objectives will be taught in-person by instructors (physicians or nurses specializing in drug allergy nominated by the University of Hong Kong). Course materials and instructors will be identical for each course.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in knowledge of drug allergy as measured by the validated drug allergy questionnaire	Knowledge includes mechanism, clinical manifestations, diagnosis and management of drug allergy. A binary variable scale were used to ascertain level of the knowledge (from 0 to 1: 0, wrong; 1, right). Answers formats consisted of 4-choice questions (total 14 questions).	After the 2-day training course

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): December 9, 2024
• Primary Completion (Estimated): December 16, 2024
• Study Completion (Estimated): December 16, 2024

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: May 2, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Drug allergy
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Immune System Diseases; Drug-Related Side Effects and Adverse Reactions; Hypersensitivity; Drug Hypersensitivity
• Other Study ID Numbers: Drugallergy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No