Medical Checklists in the Emergency Department

August 9, 2022 updated by: Malu van der Capellen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

The Impact of Medical Checklists on the Management of Acute Situations in the Emergency Department. A Simulation-based Randomised Controlled Trial.

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention group: with checklist
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
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.
NO_INTERVENTION: Control group: without checklist
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of the scenario
Time Frame: Through study completion, indicated 10 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of indicated interventions performed by the emergency physician
Time Frame: Through study completion, indicated 10 months
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
Satisfaction of emergency physicians with the checklists
Time Frame: Through study completion, indicated 10 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Investigators

  • Principal Investigator: Malu van der Capellen, MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2022

Primary Completion (ANTICIPATED)

June 1, 2023

Study Completion (ANTICIPATED)

August 1, 2023

Study Registration Dates

First Submitted

August 8, 2022

First Submitted That Met QC Criteria

August 9, 2022

First Posted (ACTUAL)

August 11, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 11, 2022

Last Update Submitted That Met QC Criteria

August 9, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W22_163

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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