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

NCT ID: NCT03608982

Last Updated: 2022-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Burns Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participants will be informed about participating in a study, evaluating the performance of basic first aid courses taught by the Belgian Red Cross, but will be blinded from the actual goal of the research, i.e. testing the added value of simulated patients.

The outcome assessors will not be aware of the allocation status of participants whose practical skills they judge.

Study Groups

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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.

Group Type EXPERIMENTAL

Simulated patient

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

No simulated patient

Intervention Type OTHER

Instead of a simulated patients, participants get to watch video clips on first aid techniques.

Interventions

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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.

Intervention Type OTHER

No simulated patient

Instead of a simulated patients, participants get to watch video clips on first aid techniques.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Belgian Red Cross

OTHER

Sponsor Role collaborator

Centre for Evidence-Based Practice, Belgium

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmy De Buck, Phd

Role: PRINCIPAL_INVESTIGATOR

Centre for Evidence-Based Practice, Belgium

Locations

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Belgian Red Cross

Mechelen, Antwerpen, Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND

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.

Reference Type RESULT
PMID: 35921627 (View on PubMed)

Other Identifiers

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G- 2018 06 1273

Identifier Type: OTHER

Identifier Source: secondary_id

SIM-001

Identifier Type: -

Identifier Source: org_study_id

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