Back to resultsMedical Checklists in the Emergency Department
Primary Purpose
Emergencies, Tricyclic Antidepressant Poisoning, Tricyclic Antidepressant Toxicity
Status
Not yet recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Checklist
Sponsored by
About this trial
This is an interventional treatment trial for Emergencies focused on measuring Medical checklists
Eligibility Criteria
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
Sites / Locations
- Amsterdam University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group: with checklist
Control group: without checklist
Arm Description
When starting the scenario, a checklist will be given to the emergency physician. 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.
Emergency physicians will be asked to perform the scenario as they would in their daily practice. They will be allowed to use their usual cognitive aids (eg, phone, internet) but not allowed to request help from others.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
Full Information
NCT ID
NCT05496114
First Posted
August 8, 2022
Last Updated
August 9, 2022
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1. Study Identification
Unique Protocol Identification Number
NCT05496114
Brief Title
Medical Checklists in the Emergency Department
Official Title
The Impact of Medical Checklists on the Management of Acute Situations in the Emergency Department. A Simulation-based Randomised Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to investigate whether the use of medical checklists in the emergency department can decrease resuscitation time in critically ill patients.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergencies, Tricyclic Antidepressant Poisoning, Tricyclic Antidepressant Toxicity
Keywords
Medical checklists
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants (emergency physicians) will be allocated to performing the scenario with or without checklist in a randomized fashion on a 1:1 ratio. Computerized randomization will take place using an online randomization module.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group: with checklist
Arm Type
Experimental
Arm Description
When starting the scenario, a checklist will be given to the emergency physician. 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.
Arm Title
Control group: without checklist
Arm Type
No Intervention
Arm Description
Emergency physicians will be asked to perform the scenario as they would in their daily practice. They will be allowed to use their usual cognitive aids (eg, phone, internet) but not allowed to request help from others.
Intervention Type
Device
Intervention Name(s)
Checklist
Intervention Description
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.
Primary Outcome Measure Information:
Title
Duration of the scenario
Description
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.
Time Frame
Through study completion, indicated 10 months
Secondary Outcome Measure Information:
Title
Number of indicated interventions performed by the emergency physician
Description
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.
Time Frame
Through study completion, indicated 10 months
Title
Satisfaction of emergency physicians with the checklists
Description
Participants, who run the scenarios with checklist access, will be asked to fill out a questionnaire evaluating the checklist (5-point Likert scales).
Time Frame
Through study completion, indicated 10 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Malu van der Capellen, MD
Phone
0031645144756
Email
malucapellen@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Maik Berendsen, MD
Phone
0031645556601
Email
maik.berendsen@amsterdamumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malu van der Capellen, MD
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amsterdam University Medical Center
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malu van der Capellen, MD
Phone
0031645144756
Email
malucapellen@gmail.com
First Name & Middle Initial & Last Name & Degree
Maik Berendsen, MD
Phone
0031645556601
Email
maik.berendsen@amsterdamumc.nl
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33597283
Citation
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.
Results Reference
background
Learn more about this trial
Medical Checklists in the Emergency Department
We'll reach out to this number within 24 hrs