EmergenciesNCT05295485
Evaluation of the Course Format "NASIM25"
An observational study of Emergencies and Trauma Injury, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
The investigators intend to evauate the development and professional safety of aspiring prehospital emergency pyhsicians in a cross sectional and longitudinal modality. This compass objecitve and subjective evaluable professional skills essential in prehospital emergency medicine. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergencies, Trauma Injury
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 25 Mar 2022to 24 May 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: physicians that are aspiring the qualification: "prehospital emergency physician"
Who may be able to join
- physician aspiring the qualification: "prehospital emergency physician" and participating in the course: NASIM25
Who cannot join
- not participating in the course NASIM25
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Course Format "NASIM25" - Development of Skills and Professional Safety of Aspiring Prehospital Emergency Physicians by the Course NASIM25
The investigators intend to evauate the development and professional safety of aspiring prehospital emergency pyhsicians in a cross sectional and longitudinal modality. This compass objecitve and subjective evaluable professional skills essential in prehospital emergency medicine.
Read the detailed description
In the course format "NASIM25" aspiring prehospital emergency physicians are trained in 25 simulation based scenarios dealing about situations being rare on the scene having have a tremendous impact on the patients if not treated adequately.
To evaluate the impact of the course format on the skills of the participants (i.e. aspiring prehospital emergency physicians) the investigators quantify the trained skills and professional safety in three dimensions of skills and professional safety:
- The influence on applying the ABCDE-Approach using the a validated score by Peran et al 2020 (ABCDE cognitive aid tool in patient assessment -development and validation in a multicenter pilot simulation study. BMC Emerg Med. 2020;20(1)) and non technical skills using a validated score by Kim et al 2009 (Kim J, Neilipovitz D, Cardinal P, Chiu M.A comparison of global rating scale and checklist scores in the validation of an evaluation tool to assess performance in the resuscitation of critically ill patients during simulated emergencies (abbreviated as "CRM simulator study IB"). Simul Healthc. 2009;4(1):6-16)
- The influence on the cource on the self- and external assessement of the participants using school marks
- The influence on the professional safety using a web based survey in a longitudinal modality throughout the entire qualification curriculum of prehospital emergency medicine.
- Conditions
- Emergencies, Trauma Injury
- Keywords
- emergencies, trauma, pediatric emergencies, prehospital emergencies
- Medical subject headings
- Emergencies, Accidental Injuries, Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence on applying the ABCDE-Approach and non-technical skills
The investigators use a 33 item compassing checklist to quantify the ABCDE approach according to Peran et al. 2020 (Peran et al. ABCDE cognitive aid tool in patient assessment - development and validation in a multicenter pilot simulation study. BMC Emerg Med. 2020;20(1):95.) and a 7 items compassing Ottawa Global scale to quantify the non-technical skills concerning CRM according to Kim et al. 2009 (Kim et al. A comparison of global rating scale and checklist scores in the validation of an evaluation tool to assess performance in the resuscitation of critically ill patients during simulat-ed emergencies (abbreviated as "CRM simulator study IB"). Simul Healthc. 2009;4(1):6-16.). Further details are cited in the study description -> Detailed description
Measured: 3 Days
Influence on self- and external assessement
The investigators use school marks (1=best, 6=worst) to quantify the global performance of the participants to rate the performance at the end of each scenario within the course for external assessment and the same school marks as an internal self-assessment given by the participants.
Further details are cited in the study description -> Detailed description
Measured: 3 Days
Influence on the professional safety
The investigators use a self-designed questionnair compassing 25 diseases. Every participant has to self-assess the own capability to handle each of the diseases in a 10 items likert scale (1: very unsafe in handling, 10: very safe in handling) over the points in time: before the course, after the course and after an additional time frame after the course.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start25 Mar 2022
- Primary completion7 Mar 2023
- Study completion24 May 2023
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 EmergenciesStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Ott, Johannes Gutenberg University Mainz
- Investigators
- Ott Thomas, M.D., Principal investigator, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295485
- Sponsor's protocol ID
- 22-00708
- Status last verified
- Nov 2023
- First submitted
- 6 Mar 2022
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peran D, Kodet J, Pekara J, Mala L, Truhlar A, Cmorej PC, Lauridsen KG, Sari F, Sykora R. ABCDE cognitive aid tool in patient assessment - development and validation in a multicenter pilot simulation study. BMC Emerg Med. 2020 Dec 4;20(1):95. doi: 10.1186/s12873-020-00390-3.
PubMed 33276731Kim J, Neilipovitz D, Cardinal P, Chiu M. A comparison of global rating scale and checklist scores in the validation of an evaluation tool to assess performance in the resuscitation of critically ill patients during simulated emergencies (abbreviated as "CRM simulator study IB"). Simul Healthc. 2009 Spring;4(1):6-16. doi: 10.1097/SIH.0b013e3181880472.
PubMed 19212245
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Course Format "NASIM25" - Development of Skills and Professional Safety of Aspiring Prehospital Emergency Physicians by the Course NASIM25
- ClinicalTrials.gov ID
- NCT05295485
- Acronym / sponsor ID
- 22-00708
- Conditions
- Emergencies, Trauma Injury
- Keywords
- emergencies, trauma, pediatric emergencies, prehospital emergencies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 24 May 2023 (actual)
- First posted
- 25 Mar 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 intend to evauate the development and professional safety of aspiring prehospital emergency pyhsicians in a cross sectional and longitudinal modality. This compass objecitve and subjective evaluable professional skills essential in prehospital emergency medicine.
Detailed description
In the course format "NASIM25" aspiring prehospital emergency physicians are trained in 25 simulation based scenarios dealing about situations being rare on the scene having have a tremendous impact on the patients if not treated adequately.
To evaluate the impact of the course format on the skills of the participants (i.e. aspiring prehospital emergency physicians) the investigators quantify the trained skills and professional safety in three dimensions of skills and professional safety:
- The influence on applying the ABCDE-Approach using the a validated score by Peran et al 2020 (ABCDE cognitive aid tool in patient assessment -development and validation in a multicenter pilot simulation study. BMC Emerg Med. 2020;20(1)) and non technical skills using a validated score by Kim et al 2009 (Kim J, Neilipovitz D, Cardinal P, Chiu M.A comparison of global rating scale and checklist scores in the validation of an evaluation tool to assess performance in the resuscitation of critically ill patients during simulated emergencies (abbreviated as "CRM simulator study IB"). Simul Healthc. 2009;4(1):6-16)
- The influence on the cource on the self- and external assessement of the participants using school marks
- The influence on the professional safety using a web based survey in a longitudinal modality throughout the entire qualification curriculum of prehospital emergency medicine.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- physicians that are aspiring the qualification: "prehospital emergency physician"
Key inclusion criteria (1 listed)
- physician aspiring the qualification: "prehospital emergency physician" and participating in the course: NASIM25
Key exclusion criteria (1 listed)
- not participating in the course NASIM25
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Influence on applying the ABCDE-Approach and non-technical skills
Time frame: 3 Days
The investigators use a 33 item compassing checklist to quantify the ABCDE approach according to Peran et al. 2020 (Peran et al. ABCDE cognitive aid tool in patient assessment - development and validation in a multicenter pilot simulation study. BMC Emerg Med. 2020;20(1):95.) and a 7 items compassing Ottawa Global scale to quantify the non-technical skills concerning CRM according to Kim et al. 2009 (Kim et al. A comparison of global rating scale and checklist scores in the validation of an evaluation tool to assess performance in the resuscitation of critically ill patients during simulat-ed emergencies (abbreviated as "CRM simulator study IB"). Simul Healthc. 2009;4(1):6-16.). Further details are cited in the study description -> Detailed description
Influence on self- and external assessement
Time frame: 3 Days
The investigators use school marks (1=best, 6=worst) to quantify the global performance of the participants to rate the performance at the end of each scenario within the course for external assessment and the same school marks as an internal self-assessment given by the participants. Further details are cited in the study description -> Detailed description
Influence on the professional safety
Time frame: 1 Year
The investigators use a self-designed questionnair compassing 25 diseases. Every participant has to self-assess the own capability to handle each of the diseases in a 10 items likert scale (1: very unsafe in handling, 10: very safe in handling) over the points in time: before the course, after the course and after an additional time frame after the course.
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 15 Nov 2023.
- Results publication: PubMed 33276731Peran D, Kodet J, Pekara J, Mala L, Truhlar A, Cmorej PC, Lauridsen KG, Sari F, Sykora R. ABCDE cognitive aid tool in patient assessment - development and validation in a multicenter pilot simulation study. BMC Emerg Med. 2020 Dec 4;20(1):95. doi: 10.1186/s12873-020-00390-3.
- Results publication: PubMed 19212245Kim J, Neilipovitz D, Cardinal P, Chiu M. A comparison of global rating scale and checklist scores in the validation of an evaluation tool to assess performance in the resuscitation of critically ill patients during simulated emergencies (abbreviated as "CRM simulator study IB"). Simul Healthc. 2009 Spring;4(1):6-16. doi: 10.1097/SIH.0b013e3181880472.
- official website providing informations about the course NASIM25Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ott Thomas, M.D. principal investigator
Johannes Gutenberg University Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergencies and Trauma Injury, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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: finished, as of the sponsor's last update on 15 Nov 2023. 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 Germany. 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?
Influence on applying the ABCDE-Approach and non-technical skills (time frame: 3 Days). 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 NCT05295485, 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 15 Nov 2023.