- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05295485
Evaluation of the Course Format "NASIM25"
Evaluation of the Course Format "NASIM25" - Development of Skills and Professional Safety of Aspiring Prehospital Emergency Physicians by the Course NASIM25
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Ott Thomas, M.D.
- Phone Number: +496131177117
- Email: ottth@uni-mainz.de
Study Contact Backup
- Name: Tim Demare, M.D.
- Phone Number: +496131175480
- Email: demare@uni-mainz.de
Study Locations
-
-
RLP
-
Mainz, RLP, Germany, 55131
- University Hospital Centre Mainz
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- physician aspiring the qualification: "prehospital emergency physician" and participating in the course: NASIM25
Exclusion Criteria:
- not participating in the course NASIM25
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 Days
|
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 |
3 Days
|
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.
|
1 Year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ott Thomas, M.D., Johannes Gutenberg University Mainz
Publications and helpful links
General 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.
- 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 Spring;4(1):6-16. doi: 10.1097/SIH.0b013e3181880472.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-00708
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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