The Use of Simulated Patients During Basic-first Aid Courses for Laypeople

Evaluating the Impact of Simulated Patients on Knowledge, Skills and Attitudes of Laypeople Following a Basic First-Aid Course: A Cluster-Randomized Controlled Trial

Background: Teaching first aid to laypeople is a cost-effective way to improve public health. However, it is currently unclear what the most effective ways are to teach first aid. It has already been shown that simulated patients have an added value in teaching emergency care to healthcare professionals.

This paper describes the protocol for a cluster-randomized controlled trial that will investigate the influence of using a simulated patient during basic first aid training for laypeople on laypeople's knowledge, skills and self-efficacy.

Hypothesis: The null hypothesis of this research is that the use of simulated patients during basic first aid training does not result in a statistically significant change in knowledge, skills and self-efficacy concerning the first aid topics for which a simulated patient is used. The alternative is that knowledge, skills and self-efficacy will be influenced by using simulated patients.

Methods: This study will be a cluster-randomized controlled trial, that will take place from September 2018 to June 2020. The study population will consist of employees taking a three day first aid certification course with the Belgian Red Cross. The employers requesting a first aid course will be randomised in receiving a course with or without simulated patient. The simulated patient will only be used for the topics first aid for burns and first aid for stroke in the intervention group. The participants will complete a questionnaire to measure their knowledge and self-efficacy before and after the course, and complete a practical skills test after the course testing these first aid topics. To test whether the retention of first aid knowledge and self-efficacy is influenced by using a simulated patient during a certification course, participants following a refresher course one year after the certification course will complete a follow-up questionnaire.

This cluster-randomized controlled trial will be, to the investigator's knowledge, the first to investigate the added value of simulated patients during first aid courses for laypeople.

Study Overview

• Status: Completed
• Conditions: Stroke; Burns
• Intervention / Treatment: Other: Simulated patient; Other: No simulated patient

• Study Type: Interventional
• Enrollment (Actual): 1168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen
    • Mechelen, Antwerpen, Belgium, 2800
      • Belgian Red Cross

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Employed in a company requesting a basic first aid course taught by the Belgian Red Cross

Exclusion Criteria:

• Employed in a company that purposefully requests a simulated patient
• Employed in a company that requests a course in a language other than Dutch (French, English)
• Participants < 16 years of age

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: Simulated patient; The materials in this course are standardized, and consist of lectures with a slide show, questions & answers conversations, and practical exercises on fellow-students. The courses are being taught by professional first aid tutors from the Belgian Red Cross. During the practical exercises, a simulated patient will unexpectedly enter the room requiring treatment.	Other: Simulated patient; The simulated patient is a professional actor and Belgian Red Cross employee, who combines acting distress and pain with moulage, to mimic the injuries as truthfully as possible. For feasibility reasons, the simulant will only be included in two sections of the course: the respective treatments of burns and stroke. The remainder of the course will be taught without simulated patient by the professional first aid tutors.
Active Comparator: No simulated patient; The course materials in the control courses are also standardized. Instead of using simulated patients, however, video clips will be shown to demonstrate the first aid techniques.	Other: No simulated patient; Instead of a simulated patients, participants get to watch video clips on first aid techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in first aid knowledge, measured as the change in average score on a questionnaire of 10 questions (multiple choice) related to first aid topics for which a simulated patient was used during the basic first aid course.	10 multiple choice questions testing knowledge concerning first aid for burns and stroke, blended in with 10 questions for other first aid topics for the purpose of blinding the participants	At the start of the basic first aid course and at one year follow-up, right before the participants follow their yearly refresher course (between 10 months and 14 months after the basic first aid course).
First aid skills, measured during a practical skills test evaluating a total of 14 skills concerning the first aid topics for which a simulated patient was used during the basic first aid course	Practical skills concerning first aid for burns and stroke, blended in with practical skills tests for cardiopulmonary resuscitation and two other first aid topics for the purpose of blinding the participants.	At the end of the basic first aid course, during the evaluation moment in the afternoon of the final day of the three-day course.
Change in first aid self-efficacy, measured as the change in average score on a questionnaire of 6 questions (5-point Likert scale), related to first aid topics for which a simulated patient was used during the basic first aid course.	6 questions to be answered on a 5-point Likert scale, testing self-efficacy concerning first aid for burns and stroke, blended in with 6 questions concerning self-efficacy for other first aid topics for the purpose of blinding the participants.	At the start of the basic first aid course and at one year follow-up, right before the participants follow their yearly refresher course (between 10 months and 14 months after the basic first aid course).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in first aid knowledge, measured as the change in average score on a questionnaire of 10 questions (multiple choice) related to first aid topics for which a simulated patient was used during the basic first aid course.	10 questions testing knowledge concerning first aid for burns and stroke, blended in with 10 questions for other first aid topics for the purpose of blinding the participants.	At the start of the basic first aid course and at the end of the basic first aid course, during the evaluation moment in the afternoon of the final day of the three-day course.
Change in first aid self-efficacy, measured as the change in average score on a questionnaire of 6 questions (5-point Likert scale), related to first aid topics for which a simulated patient was used during the basic first aid course.	6 questions to be answered on a 5-point Likert scale, testing self-efficacy concerning first aid for burns and stroke, blended in with 6 questions concerning self-efficacy for other first aid topics for the purpose of blinding the participants.	At the start of the basic first aid course and at the end of the basic first aid course, during the evaluation moment in the afternoon of the final day of the three-day course..
Participant's satisfaction with the basic first aid course provided, measured using a 10-point scale	Participant's general satisfaction concerning the basic first aid course they received will be verified using a 10-point scale (ranging from 1: not satisfied at all to 10: very satisfied).	At the end of the basic first aid course, during the evaluation moment in the afternoon of the final day of the three-day course.
Costs	Costs associated with a course, relatively to the gain in knowledge and self-efficacy	At the start of the basic first aid course, immediately after the basic first aid course, during the evaluation moment, and at one year follow-up, right before the participants follow their yearly refresher course (between 10 months and 14 months)

Collaborators and Investigators

• Sponsor: Centre for Evidence-Based Practice, Belgium
• Collaborators: Belgian Red Cross
• Investigators: Principal Investigator: Emmy De Buck, PhD, Centre for Evidence-Based Practice, Belgium

Publications and helpful links

General Publications

• Avau B, Vanhove AC, Vandenlindenloof M, Suls L, Verstraeten H, Vandekerckhove P, De Buck E. Evaluating the Impact of Simulated Patients on Knowledge, Skills and Attitudes of Laypeople Following a Basic First Aid Course: Protocol for a Cluster-Randomized Controlled Trial. International Journal of First Aid Education 2019, Vol. 2 Issue 2, Article 3.
• Avau B, Vanhove AC, Scheers H, Stroobants S, Lauwers K, Vandekerckhove P, De Buck E. Impact of the Use of Simulated Patients in Basic First Aid Training on Laypeople Knowledge, Skills, and Self-efficacy: A Controlled Experimental Study. Simul Healthc. 2022 Aug 1;17(4):213-219. doi: 10.1097/SIH.0000000000000657. Epub 2022 Apr 5.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: July 5, 2018
• First Submitted That Met QC Criteria: July 24, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: First aid; Simulated patient; Laypeople
• Other Study ID Numbers: SIM-001; G- 2018 06 1273 (Other Identifier: Social Medical Ethical Comission (SMEC) of KU Leuven)

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