Simulation of a clinical scenario of status epilepticus to investigate the adherence of the physician's response to treatment guidelines

ISRCTN	ISRCTN60369617
DOI	https://doi.org/10.1186/ISRCTN60369617
Protocol serial number	Protocol01/2017
Sponsor	University Hospital Basel
Funder	University Hospital Basel

Submission date: 03/03/2019
Registration date: 06/03/2019
Last edited: 10/10/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Status epilepticus (SE) is a life-threatening condition in which a person has a seizure (fit) lasting more than 5 minutes or repeated seizures within 5 minutes without returning to normal in between. It can result in death or long-lasting injury to the brain. SE can occur in people with epilepsy or in people who don't have epilepsy and can have a variety of causes. SE should be treated as an emergency and requires several assessments and treatments to be given quickly. The European and American Epilepsy Societies have published guidelines for the treatment of SE to encourage consistent high-quality treatment of SE. Most national guidelines are based on these guidelines. However, the quality of SE treatment and whether the guidelines are followed by doctors has not been tested in a standardized setting. The study will simulate an emergency where a person has SE from alcohol withdrawal and will test the doctor's decisions in how to investigate, treat and follow up the patient. The aim is to measure the quality of doctors' emergency first response to SE and to identify risk factors for not following treatment guidelines.

Who can participate?
Voluntary workshops will be offered to medical doctors working as resident physicians in the following four medical fields: intensive care medicine, emergency medicine, internal medicine and neurology at the University Hospital Basel.

What does the study involve?
All participants will receive an introduction to the simulator and the simulator room and how they work. Participants will perform the simulation one by one. Participants will be informed that the scenario is that they are the physician on call on an emergency unit and that a nurse will be available to support them. The nurse will be instructed to display a helpful manner but to act on the doctor's command only.

What are the benefits and risks of participating?
There are no anticipated risks, since the participants will only be taking part in a simulated emergency. Participants might benefit from the opportunity to practice an emergency scenario.

Where is the study run from?
University Hospital Basel (Switzerland)

When is the study starting and how long is it expected to run for?
June 2016 to July 2018

Who is funding the study?
University Hospital Basel (Switzerland)

Who is the main contact?
Dr Raoul Sutter (raoul.sutter@usb.ch)

Contact information

Dr Raoul Sutter
Scientific

University Hospital Basel
Petersgraben 4
4031 Basel
Basel
4031
Switzerland

ORCID ID	0000-0002-6575-356X
Phone	0041612652525
Email	raoul.sutter@usb.ch

Study information

Primary study design	Observational
Study design	Prospective single-blinded observational study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	Emergency management of convulsive status epilepticus in a high-fidelity simulation: a prospective single-blinded study
Study acronym	SESIM
Study objectives	We hypothesize that emergency response to patients with suspected status epilepticus does not strictly adhere to current international treatment guidelines.
Ethics approval(s)	Ethics approval not required: this study is part of our quality assurance program
Health condition(s) or problem(s) studied	Status epilepticus
Intervention	All participating physicians will receive a standardized introduction of the technicalities of the simulator and the simulator room. Participating physicians will be asked if they would like to voluntarily be trained for clinical emergency scenarios. Upon their agreement, they will be informed that for the scenario they will be the physician on call on an emergency unit and that a nurse will be available to support them. The nurse will be instructed to display a helpful manner but to act on command only. The scenario will represent a patient admitted to the emergency room with convulsive status epilepticus induced by alcohol withdrawal.
Intervention type	Behavioural
Primary outcome measure(s)	1. Time to airway protection 2. Time to administration of supplementary oxygen 3. Time to administration of first- and second-line antiseizure drugs All times are measured during simulation (i.e. time from start of simulated scenario to action/treatment).
Key secondary outcome measure(s)	1. Assessment of vital signs and neurologic status 2. Ascertainment of medical history and laboratory results 3. Performance of and time to assessment of treatment responsiveness 4. Correct aftermath reporting of clinical characteristics, management aspects, diagnosis and etiology 5. Subjective self-evaluation, including subjective stress level, quality of their performance, the performance of the nurse and certainty of diagnosis, assessed using a questionnaire Secondary outcomes 1-4 are assessed by analyses of the audio-video recordings by two independent investigators. In cases of disagreement or discrepancies, re-analysis of the recordings are performed to reach consensus.
Completion date	01/07/2018

Eligibility

Participant type(s)	Health professional
Age group	Adult
Sex	All
Target sample size at registration	50
Total final enrolment	58
Key inclusion criteria	Volunteering medical doctors working as resident physicians in different medical fields, including intensive care medicine, emergency medicine, internal medicine, and neurology
Key exclusion criteria	Physicians already having participated in the same simulated clinical scenario
Date of first enrolment	01/01/2017
Date of final enrolment	01/07/2018

Locations

Countries of recruitment

Switzerland

Study participating centre

University Hospital Basel

Petersgraben 4
Basel
4031
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available due to confidentiality issues.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	05/11/2019	10/10/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

10/10/2019: The following changes were made:
1. Publication reference added.
2. The final enrolment number was added from the reference.
05/03/2019: Trial's existence confirmed by Ethikkommision Nordwest- und Zentralschweiz [North-west and Central Switzerland Ethics Committee].