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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05496114
Other study ID # W22_163
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date February 2025

Study information

Verified date May 2024
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact Malu van der Capellen, MD
Phone 0031645144756
Email malucapellen@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to investigate whether the use of medical checklists in the emergency department can decrease resuscitation time in critically ill patients.


Description:

A scenario evaluating tricyclic antidepressant poisoning will be carried out with and without medical checklist access. Emergency physicians from the Netherlands who are willing to take part in the study are randomly allocated to perform the scenario with or without checklists.


Recruitment information / eligibility

Status Recruiting
Enrollment 56
Est. completion date February 2025
Est. primary completion date September 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Emergency Physicians recognised by KNMG (Koninklijke Nederlandsche Maatschappij tot bevordering van de Geneeskunst) working in the Netherlands Exclusion Criteria: - Residents (in Dutch: AIOS) Emergency Medicine - Interns (in Dutch: ANIOS) Emergency Medicine

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Checklist
A checklist is an aid that outlines assessments or actions systematically. In this study, the checklist outlines interventions to consider during management of a patient with tricyclic antidepressant poisoning. Each checklist will include indications, contra-indications and for medication, dose, route and rate of administration.

Locations

Country Name City State
Netherlands Amsterdam University Medical Center Amsterdam

Sponsors (1)

Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Dryver E, Lundager Forberg J, Hard Af Segerstad C, Dupont WD, Bergenfelz A, Ekelund U. Medical crisis checklists in the emergency department: a simulation-based multi-institutional randomised controlled trial. BMJ Qual Saf. 2021 Sep;30(9):697-705. doi: 10.1136/bmjqs-2020-012740. Epub 2021 Feb 17. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Duration of the scenario The primary outcome is the duration of primary resuscitation utilizing the checklists versus treatment on discretion of the treating physician. The simulation will be terminated when all indicated interventions are performed, when the team expresses that they cannot think of any other intervention to perform or when 15 minutes have elapsed. Through study completion, indicated 10 months
Secondary Number of indicated interventions performed by the emergency physician Based on the checklist, a number of predefined indicated interventions is established. When reviewing the video recordings, it will be noted whether indicated interventions were performed and when these interventions were performed. The order according to which interventions are performed will not impact on this secondary outcome. Through study completion, indicated 10 months
Secondary Satisfaction of emergency physicians with the checklists Participants, who run the scenarios with checklist access, will be asked to fill out a questionnaire evaluating the checklist (5-point Likert scales). Through study completion, indicated 10 months
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