Trial document





This trial has been registered retrospectively.
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  DRKS00024781

Trial Description

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Title

Influence of checklists on the processing of medical emergencies in simulation

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Trial Acronym

PROCESSION

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The influence of checklists on the processing of medical emergencies will be investigated during high-fidelity simulation

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Brief Summary in Scientific Language

Monocenter randomized controlled trial in postgraduate courses on emergency and critical care medicine.
The primary outcome variable was error rate reduction of critical workflows for each emergency.
Secondary endpoints included a survey of participants' perceptions of the usefulness and clinical relevance of the checklists, prior medical and emergency medicine knowledge, prior experience with checklists, error rate separated by gender of team leader, total scenario time, total time "away from patient," confidence, influence of experience and specialization, quality of checklist, quality of emergency scenarios, acceptance of checklists. In addition, the promotion of the participants' subjective sense of safety and the influence of the checklists on the interaction during the scenario were evaluated. All data are analyzed on an intention-to-treat basis.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

Yes, all after prior personal review by us (Study Board). Interested parties can contact the study board (see below). Extent and scope will then be determined in a personal interview.

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Organizational Data

  •   DRKS00024781
  •   2021/03/16
  •   [---]*
  •   yes
  •   Approved
  •   19-8966-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   I46 -  Cardiac arrest
  •   I47.2 -  Ventricular tachycardia
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Interventions/Observational Groups

  •   Course participants of postgraduate training in simulated medical emergencies WITH emergency medical checklists.
  •   Course participants of postgraduate training in simulated medical emergencies WITHOUT emergency medical checklists.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Error rate reduction of critical workflows for each simulated emergency.

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Secondary Outcome

Perception of usefulness and clinical relevance of the checklists, prior medical and emergency medical knowledge, prior experience with checklists, error rate separated by gender of the team leader, total time of the scenario, total time "away from the patient", self-confidence, influence of experience and specialization, quality of the checklist, quality of the emergency scenarios, acceptance of the checklists. In addition, the promotion of the participants' subjective sense of safety and the influence of the checklists on the interaction during the scenario were evaluated. All data are analyzed on an intention-to-treat basis.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2019/11/24
  •   640
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

Postgraduate course participant, Certified physician, Informed consent for study

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Exclusion Criteria

Non-consent, Pregnancy

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Addresses

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    • Arbeitsgemeinschaft Intensivmedizin (AIM) Arnsberg
    • Mr.  Dr. med.  Dietmar  Wetzchewald 
    • Apothekerstrasse 27
    • 59755  Arnsberg
    • Germany
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    • Klinik für Anästhesiologie und Intensivmedizin
    • Mr.  Dr. med.  Timur  Sellmann 
    • Heerstrasse 219
    • 47053  Duisburg
    • Germany
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    • Universität Duisburg-Essen
    • Mr.  Professor Dr. med.  Frank  Breuckmann 
    • Hufelandstr. 27
    • 45127  Essen
    • Germany
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    • Medizinische Klinik IHerz-Jesu-Krankenhaus
    • Mr.  Samer  Alchab 
    • Südring 8
    • 56428  Dernbach
    • Germany
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Sources of Monetary or Material Support

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    • Arbeitsgemeinschaft Intensivmedizin (AIM) Arnsberg
    • Mr.  Dr. med.  Dietmar  Wetzchewald 
    • Apothekerstrasse 27
    • 59755  Arnsberg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2020/06/25
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Trial Publications, Results and other Documents

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