BurnsNCT03608982
The Use of Simulated Patients During Basic-first Aid Courses for Laypeople
A study testing Simulated patient and No simulated patient in people with Burns and Stroke, run by Centre for Evidence-Based Practice, Belgium at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- What is being tested?
- Simulated patient and No simulated patient
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,168 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Employed in a company requesting a basic first aid course taught by the Belgian Red Cross
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Being tested
- Simulated patient, No simulated patient
- Keywords
- First aid, Simulated patient, Laypeople
- Medical subject headings
- Burns, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulated patientOther
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 patientOther
Instead of a simulated patients, participants get to watch video clips on first aid techniques.
| Study group | Role | What they receive |
|---|---|---|
| Simulated patient | Experimental | 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. Receives: Other: Simulated patient |
| No simulated patient | Active comparator | 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. Receives: Other: No simulated patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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 (4)
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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Sep 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Evidence-Based Practice, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- Belgian Red Cross
- Responsible party
- Sponsor
- Investigators
- Emmy De Buck, Phd, Principal investigator, Centre for Evidence-Based Practice, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608982
- Sponsor's protocol ID
- SIM-001
- Other IDs
- G- 2018 06 1273
- Status last verified
- May 2022
- First submitted
- 5 Jul 2018
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 35921627
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03608982
- Acronym / sponsor ID
- SIM-001
- Keywords
- First aid, Simulated patient, Laypeople
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,168 participants (actual)
- Lead sponsor
- Centre for Evidence-Based Practice, BelgiumUniversity, hospital or other
- Collaborators
- Belgian Red Cross
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Simulated patient | Experimental | Other: Simulated patientThe 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. |
| No simulated patient | Active comparator | Other: No simulated patientThe 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Employed in a company requesting a basic first aid course taught by the Belgian Red Cross
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulated patientThe 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. | Other | Simulated patient |
| No simulated patientInstead of a simulated patients, participants get to watch video clips on first aid techniques. | Other | No simulated patient |
Primary outcome
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.
Time frame: 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).
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
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
Time frame: 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.
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.
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.
Time frame: 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).
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.
4 secondary outcomes
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- BackgroundAvau 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.
- Results publication: PubMed 35921627Avau 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.
- Individual participant dataSharing planned: Undecided
Related trials for Burns
Recruiting
Efferon LPS Hemoadsorption in in Patients With Thermal Burns
Burns
Not yet recruitingObservational study
Recurrence of Extremity Joint Contracture After Z-Plasty Versus Full-Thickness Skin Graft
Joint Contracture, Contracture
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Not yet recruiting
Impact of Range of Motion Exercises on Pain and Functional Ability
Impact of ROM Exercises on Pain and Functional Ability in Patients With Second -Degree Burns
Enrolling by invitationObservational study
Evaluating the Accuracy of Multiple Blood Tests to Diagnose Sepsis in Adult Burn Patients
Sepsis - to Reduce Mortality in the Intensive Care Unit, Burns Involving 20% or More of Body Surface
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmy De Buck, Phd principal investigator
Centre for Evidence-Based Practice, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulated patient and No simulated patient in people with Burns and Stroke, run by Centre for Evidence-Based Practice, Belgium at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03608982, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.