First AidReFANCT05312931
Retention of Knowledge and Skills of First Aid After Change in Concept of Teaching First Aid
An observational study of First Aid, run by Brno University Hospital.
Trial summary
The investigators will evaluate the effect of simulation-based education in First Aid practice on knowledge and skills retention. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- First Aid
- What is being tested?
- OSCE
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 30 Apr 2023
- Phase
- Observational
- 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 18 to 30 years
- All sexes
- Adult
Study population: Students of General medicine and Dentistry of the Faculty of Medicine of Masaryk University who underwent FAT in autumn semester 2020 and 2021 and have not been involved in Student as Teacher programme.
Who may be able to join
- Students of General medicine and Dentistry of the Faculty of Medicine of Masaryk University who underwent FAT in autumn semester 2020 and 2021 and have not been involved in Student as Teacher programme.
Who cannot join
- Students of General medicine and Dentistry of the Faculty of Medicine of Masaryk University who underwent FAT in different time intervals or who underwent FAT in autumn semester 2020 and 2021 and also have been involved in Student as Teacher programme.
Trial locations and contacts
No sites are listed yet.
About this study
The investigators will evaluate the effect of simulation-based education in First Aid practice on knowledge and skills retention.
Read the detailed description
In autumn semester 2020 a new concept of the subject First aid for the students of General medicine and Dentistry at Faculty of Medicine of Masaryk University was introduced. This concept based on evidence-based medical education puts different principles such as simulation-based education, learner-centred learning, peer learning and outcome-based education into practice.
First aid training (FAT) is indispensable part of the curriculum and knowledge of the first year medical students. The investigator´s aim is to evaluate if the new concept of the first aid training led to improvement in knowledge and mainly in skills of the students. Investigator´s null hypothesis is that the new concept does not lead to improvement in the long-term retention of the knowledge and the skills than the original concept. The investigators will compare tested knowledge and skills of the students who underwent FAT in autumn semester 2019 (original concept, group A) and the students who underwent FAT in autumn semester 2020 (new concept, group B).
The evaluation of the two groups will happen in the interval of 20-24 months after the completion of the FAT. Group A will be evaluated in autumn semester 2021, group B in autumn semester 2022. The evaluation method will be based on a knowledge test and a OSCE (objective structured clinical examination) stations.
Applying principles of evidence-based medical education into practice and designing FAT according to simulation-based education could lead better long-term retention of knowledge and skills of the students.
- Conditions
- First Aid
- Being tested
- OSCE
- Keywords
- retention of knowledge, retention of skills, First Aid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSCEOther
Students undergo OSCE (objective structured clinical exams). It means students will perform CPR for 2 min and their success rate will be monitored.
| Study group | Role | What they receive |
|---|---|---|
| Group A | students who underwent original concept of First Aid Receives: Other: OSCE | |
| Group B | student who underwent new concept of First Aid Receives: Other: OSCE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of CPR quality - chest compression/ventilation ratio
CPR quality will be measured with CPR monitoring (qCPR Anne - compression/ventilation feedback software). Attributes of CPR and a method of measurement:
chest compression/ventilation ratio - investigator will count the number of chest compressions and a number of ventilation in each cycle in 2 min CPR. It will be statistically analyzed.
Measured: Up to 36 months
Measurement of CPR quality - percentage of adequate depth of chest compressions
CPR quality will be measured with CPR monitoring (qCPR Anne - compression/ventilation feedback software). Attributes of CPR and a method of measurement:
percentage of adequate depth of chest compressions (%) in 2 min CPR. Adequate depth of chest compression (5 - 6 cm).
Method of mesurement: (qCPR Anne - compression/ventilation feedback software).
Measured: Up to 36 months
Measurement of CPR quality - the longest pause in chest compressions (s)
CPR quality will be measured with CPR monitoring (qCPR Anne - compression/ventilation feedback software). Attributes of CPR and a method of measurement:
the longest pause in chest compressions (s) in 2 min CPR. Method of mesurement: (qCPR Anne - compression/ventilation feedback software).
Measured: Up to 36 months
Measurement of CPR quality - percentage of chest compression when thorax was adequately released
CPR quality will be measured with CPR monitoring (qCPR Anne - compression/ventilation feedback software). Attributes of CPR and a method of measurement:
percentage of chest compression when thorax was adequately released (%) in 2 min CPR.
Method of mesurement: (qCPR Anne - compression/ventilation feedback software).
Measured: Up to 36 months
Measurement of CPR quality - rescue breaths
CPR quality will be measured with CPR monitoring (qCPR Anne - compression/ventilation feedback software). Attributes of CPR and a method of measurement:
the number of detectable rescue breaths and number of unsuccessful rescue breaths during 2 min in CPR will be recorded. Detectable rescue breath means that the software was able to detect the rescue breath. Unsuccessful rescue breath means that the student tried to deliver rescue breath but the software was not able to detect it. Method of mesurement: (qCPR Anne - compression/ventilation feedback software).
Measured: Up to 36 months
Measurement of CPR quality - frequency of chest compressions
CPR quality will be measured with CPR monitoring (qCPR Anne - compression/ventilation feedback software). Attributes of CPR and a method of measurement:
frequency of chest compressions (compressions/min) in 2 min CPR will be measured with qCPR software. Method of mesurement: (qCPR Anne - compression/ventilation feedback software).
Measured: Up to 36 months
Secondary outcomes (5)
Comparison of group A and B: Chest compressions/ventilation ratio
Statistic analysis will be used in a comparison of Chest compressions/ventilation ratio in groups A and B.
Chest compressions/ventilation ratio - good ratio 30:2 according to ERC.
Measured: up to 36 months
Comparison of group A and B: Depth of chest compressions
Statistic analysis will be used to compare the depth of chest compressions in groups A and B.
Depth of chest compressions: adequate chest compression is 5-6 cm.
Measured: up to 36 months
Comparison of group A and B: Frequency of chest compression
Statistic analysis will be used in a comparison of the frequency of chest compression in groups A and B.
Frequency of chest compression: adequate average frequency is 100-120/min.
Measured: up to 36 months
Comparison of group A and B: The longest pause in chest compressions
Statistic analysis will be used in a comparison of the longest pause in chest compressions in groups A and B.
The longest pause in chest compressions: adequate is up to 10s.
Measured: up to 36 months
Comparison of group A and B: rescue breaths
Statistic analysis will be used in a comparison of the longest pause in chest compressions in groups A and B.
The number of detectable rescue breaths and number of unsuccessful rescue breaths during 2 min in CPR will be statistically analyzed.
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First AidStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tereza Prokopova, MD, Brno University Hospital
- Investigators
- Martina Kosinová, MD, Study chair, Masaryk University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312931
- Sponsor's protocol ID
- ReFA
- Acronym
- ReFA
- Status last verified
- Mar 2022
- First submitted
- 17 Feb 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retention of Knowledge and Skills of First Aid After Change in Concept of Teaching First Aid
- ClinicalTrials.gov ID
- NCT05312931
- Acronym / sponsor ID
- ReFA / ReFA
- Conditions
- First Aid
- Keywords
- retention of knowledge, retention of skills, First Aid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 6 Apr 2022 (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.
The investigators will evaluate the effect of simulation-based education in First Aid practice on knowledge and skills retention.
Detailed description
In autumn semester 2020 a new concept of the subject First aid for the students of General medicine and Dentistry at Faculty of Medicine of Masaryk University was introduced. This concept based on evidence-based medical education puts different principles such as simulation-based education, learner-centred learning, peer learning and outcome-based education into practice.
First aid training (FAT) is indispensable part of the curriculum and knowledge of the first year medical students. The investigator´s aim is to evaluate if the new concept of the first aid training led to improvement in knowledge and mainly in skills of the students. Investigator´s null hypothesis is that the new concept does not lead to improvement in the long-term retention of the knowledge and the skills than the original concept. The investigators will compare tested knowledge and skills of the students who underwent FAT in autumn semester 2019 (original concept, group A) and the students who underwent FAT in autumn semester 2020 (new concept, group B).
The evaluation of the two groups will happen in the interval of 20-24 months after the completion of the FAT. Group A will be evaluated in autumn semester 2021, group B in autumn semester 2022. The evaluation method will be based on a knowledge test and a OSCE (objective structured clinical examination) stations.
Applying principles of evidence-based medical education into practice and designing FAT according to simulation-based education could lead better long-term retention of knowledge and skills of the students.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: OSCEstudents who underwent original concept of First Aid |
| Group B | – | Other: OSCEstudent who underwent new concept of First Aid |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Age groups
- Adult
- Study population
- Students of General medicine and Dentistry of the Faculty of Medicine of Masaryk University who underwent FAT in autumn semester 2020 and 2021 and have not been involved in Student as Teacher programme.
Key inclusion criteria (1 listed)
- Students of General medicine and Dentistry of the Faculty of Medicine of Masaryk University who underwent FAT in autumn semester 2020 and 2021 and have not been involved in Student as Teacher programme.
Key exclusion criteria (1 listed)
- Students of General medicine and Dentistry of the Faculty of Medicine of Masaryk University who underwent FAT in different time intervals or who underwent FAT in autumn semester 2020 and 2021 and also have been involved in Student as Teacher programme.
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 |
|---|---|---|
| OSCEStudents undergo OSCE (objective structured clinical exams). It means students will perform CPR for 2 min and their success rate will be monitored. | Other | Group A, Group B |
Primary outcome
Measurement of CPR quality - chest compression/ventilation ratio
Time frame: Up to 36 months
CPR quality will be measured with CPR monitoring (qCPR Anne - compression/ventilation feedback software). Attributes of CPR and a method of measurement: chest compression/ventilation ratio - investigator will count the number of chest compressions and a number of ventilation in each cycle in 2 min CPR. It will be statistically analyzed.
Measurement of CPR quality - percentage of adequate depth of chest compressions
Time frame: Up to 36 months
CPR quality will be measured with CPR monitoring (qCPR Anne - compression/ventilation feedback software). Attributes of CPR and a method of measurement: percentage of adequate depth of chest compressions (%) in 2 min CPR. Adequate depth of chest compression (5 - 6 cm). Method of mesurement: (qCPR Anne - compression/ventilation feedback software).
Measurement of CPR quality - the longest pause in chest compressions (s)
Time frame: Up to 36 months
CPR quality will be measured with CPR monitoring (qCPR Anne - compression/ventilation feedback software). Attributes of CPR and a method of measurement: the longest pause in chest compressions (s) in 2 min CPR. Method of mesurement: (qCPR Anne - compression/ventilation feedback software).
Measurement of CPR quality - percentage of chest compression when thorax was adequately released
Time frame: Up to 36 months
CPR quality will be measured with CPR monitoring (qCPR Anne - compression/ventilation feedback software). Attributes of CPR and a method of measurement: percentage of chest compression when thorax was adequately released (%) in 2 min CPR. Method of mesurement: (qCPR Anne - compression/ventilation feedback software).
Measurement of CPR quality - rescue breaths
Time frame: Up to 36 months
CPR quality will be measured with CPR monitoring (qCPR Anne - compression/ventilation feedback software). Attributes of CPR and a method of measurement: the number of detectable rescue breaths and number of unsuccessful rescue breaths during 2 min in CPR will be recorded. Detectable rescue breath means that the software was able to detect the rescue breath. Unsuccessful rescue breath means that the student tried to deliver rescue breath but the software was not able to detect it. Method of mesurement: (qCPR Anne - compression/ventilation feedback software).
Measurement of CPR quality - frequency of chest compressions
Time frame: Up to 36 months
CPR quality will be measured with CPR monitoring (qCPR Anne - compression/ventilation feedback software). Attributes of CPR and a method of measurement: frequency of chest compressions (compressions/min) in 2 min CPR will be measured with qCPR software. Method of mesurement: (qCPR Anne - compression/ventilation feedback software).
5 secondary outcomes
Comparison of group A and B: Chest compressions/ventilation ratio
Time frame: up to 36 months
Comparison of group A and B: Depth of chest compressions
Time frame: up to 36 months
Comparison of group A and B: Frequency of chest compression
Time frame: up to 36 months
Comparison of group A and B: The longest pause in chest compressions
Time frame: up to 36 months
Comparison of group A and B: rescue breaths
Time frame: up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No. The investigators do not plan to share IPD.
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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.
Martina Kosinová, MD study chair
Masaryk University Faculty of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of First Aid, run by Brno University Hospital.
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 1 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: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tereza Prokopová, MD (+420736669784, prokopova.tereza@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of CPR quality - chest compression/ventilation ratio (time frame: Up to 36 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2022.