NCT05496114

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

August 8, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

August 8, 2022

Last Update Submit

May 2, 2024

Conditions

Keywords

Medical checklists

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Number of indicated interventions performed by the emergency physician

    Through study completion, indicated 10 months

  • Satisfaction of emergency physicians with the checklists

    Through study completion, indicated 10 months

Study Arms (2)

Intervention group: with checklist

EXPERIMENTAL

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.

Device: Checklist

Control group: without checklist

NO INTERVENTION

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.

Interventions

ChecklistDEVICE

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.

Intervention group: with checklist

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Emergency Physicians recognised by KNMG (Koninklijke Nederlandsche Maatschappij tot bevordering van de Geneeskunst) working in the Netherlands

You may not qualify if:

  • Residents (in Dutch: AIOS) Emergency Medicine
  • Interns (in Dutch: ANIOS) Emergency Medicine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam University Medical Center

Amsterdam, 1105 AZ, Netherlands

RECRUITING

Related 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.

    PMID: 33597283BACKGROUND

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Malu van der Capellen, MD

    Amsterdam University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Malu van der Capellen, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 8, 2022

First Posted

August 11, 2022

Study Start

September 1, 2023

Primary Completion

September 1, 2024

Study Completion

February 1, 2025

Last Updated

May 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations