EmergenciesNCT05496114
Medical Checklists in the Emergency Department
A study testing Checklist in people with Emergencies and Tricyclic Antidepressant Poisoning, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Emergencies, Tricyclic Antidepressant Poisoning, Tricyclic Antidepressant Toxicity
- What is being tested?
- Checklist
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2023to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Emergency Physicians recognised by KNMG (Koninklijke Nederlandsche Maatschappij tot bevordering van de Geneeskunst) working in the Netherlands
Who cannot join
- Residents (in Dutch: AIOS) Emergency Medicine
- Interns (in Dutch: ANIOS) Emergency Medicine
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam University Medical Center
Amsterdam, 1105 AZ
Malu van der Capellen, MD, 0031645144756, malucapellen@gmail.com
Maik Berendsen, MD, 0031645556601, maik.berendsen@amsterdamumc.nl
About this study
Official title: 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.
Read the 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.
- Being tested
- Checklist
- Keywords
- Medical checklists
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, indicated 10 months
Secondary outcomes (2)
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.
Measured: Through study completion, indicated 10 months
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).
Measured: Through study completion, indicated 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start1 Sep 2023
- Primary completionSep 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malu van der Capellen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Malu van der Capellen, MD, Principal investigator, Amsterdam University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496114
- Sponsor's protocol ID
- W22_163
- Status last verified
- May 2024
- First submitted
- 8 Aug 2022
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33597283
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Medical Checklists on the Management of Acute Situations in the Emergency Department. A Simulation-based Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT05496114
- Acronym / sponsor ID
- W22_163
- Keywords
- Medical checklists
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group: with checklist | Experimental | Device: ChecklistWhen 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Emergency Physicians recognised by KNMG (Koninklijke Nederlandsche Maatschappij tot bevordering van de Geneeskunst) working in the Netherlands
Key exclusion criteria (2 listed)
- Residents (in Dutch: AIOS) Emergency Medicine
- Interns (in Dutch: ANIOS) Emergency Medicine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChecklistA 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. | Device | Intervention group: with checklist |
Primary outcome
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.
2 secondary outcomes
Number of indicated interventions performed by the emergency physician
Time frame: Through study completion, indicated 10 months
Satisfaction of emergency physicians with the checklists
Time frame: Through study completion, indicated 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Background: PubMed 33597283Dryver 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malu van der Capellen, MD principal investigator
Amsterdam University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Checklist in people with Emergencies and Tricyclic Antidepressant Poisoning, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Malu van der Capellen, MD (0031645144756, malucapellen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of the scenario (time frame: Through study completion, indicated 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05496114, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.