Clinical trial NCT03608982: The Use of Simulated Patients During Basic-first Aid Courses for Laypeople
Official title: Evaluating the Impact of Simulated Patients on Knowledge, Skills and Attitudes of Laypeople Following a Basic First-Aid Course: A Cluster-Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Stroke
Keywords: First aid
Simulated patient
Laypeople
Lead sponsor: Centre for Evidence-Based Practice, Belgium
Sponsor class: OTHER
Collaborators: name: Belgian Red Cross
First posted: 2018-08-01
Enrollment: 1168
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a cluster-randomized trial, in which allocation is done at the level of the companies that request a first aid course for their employees.
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 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).
measure: 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
timeFrame: 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.
measure: 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.
timeFrame: 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 outcomes:
measure: 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.
timeFrame: 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.
measure: 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.
timeFrame: 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..
measure: Participant's satisfaction with the basic first aid course provided, measured using a 10-point scale
timeFrame: 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.
measure: Costs
timeFrame: 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)
Other outcomes:
Locations:
city: Mechelen
country: Belgium
facility: Belgian Red Cross
state: Antwerpen
Study officials:
affiliation: Centre for Evidence-Based Practice, Belgium
name: Emmy De Buck, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.