NCT05295485

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

March 25, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2023

Completed
Last Updated

November 15, 2023

Status Verified

November 1, 2023

Enrollment Period

12 months

First QC Date

March 6, 2022

Last Update Submit

November 14, 2023

Conditions

Keywords

emergenciestraumapediatric emergenciesprehospital emergencies

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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.

    1 Year

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

physicians that are aspiring the qualification: "prehospital emergency physician"

You may qualify if:

  • physician aspiring the qualification: "prehospital emergency physician" and participating in the course: NASIM25

You may not qualify if:

  • not participating in the course NASIM25

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Centre Mainz

Mainz, RLP, 55131, Germany

Location

Related Publications (2)

  • 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.

Related Links

MeSH Terms

Conditions

EmergenciesAccidental InjuriesWounds and Injuries

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ott Thomas, M.D.

    Johannes Gutenberg University Mainz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Thomas Ott, M.D., Principal Investigator, Department of Anesthesiology, University Hospital Center

Study Record Dates

First Submitted

March 6, 2022

First Posted

March 25, 2022

Study Start

March 25, 2022

Primary Completion

March 7, 2023

Study Completion

May 24, 2023

Last Updated

November 15, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations