Improving Emergency Management of Status Epilepticus

Study Overview
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Brief Summary
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In the trial the effectiveness of pre-briefing physicians with the current guideline on Status epilepticus (SE) treatment or a consolidated one page guideline regarding quality enhancement of the physician's clinical performances is investigated.

Detailed Description
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Status epilepticus (SE) is a life-threatening neurological emergency defined as a state of continuous seizure or multiple seizures without full recovery of sensory, motor and/or cognitive function for at least 30 minutes. To achieve high quality management of SE, the American Epilepsy Society published an evidence-based guideline for the treatment of SE, which serves as reference for most national guidelines, but analyses regarding practicability, strict adherence, correct translation into clinical practice, and identification of recommended treatment steps at risk of being modified or missed are lacking. Simulator-based studies offer a platform for the design of standardized clinical scenarios that enable detailed investigations regarding the effect of the implementation and practicability of treatment guidelines. This randomized controlled intervention study performed at the simulation center of the medical intensive care units (ICUs) at the University Hospital Basel is to investigate the effectiveness of pre-briefing physicians with both the current guideline on Status epilepticus (SE) treatment or a consolidated one page guideline regarding quality enhancement of the physicians' clinical performances.. Physicians from different medical specialties and with different duration of clinical experience will be enrolled. Participants will be randomly assigned to one of the following three pre-briefing groups: (1) no pre-briefing prior to the simulation training; (2) pre-briefing with the current SE treatment guidelines; (3) pre-briefing with the consolidated one page SE treatment guideline.

Official Title
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Improving Emergency Management of Status Epilepticus - a High-fidelity Simulator-based Randomized Controlled Trial

Conditions
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Status Epilepticus

Intervention / Treatment
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* Other: Pre-briefing with the current SE treatment guidelines
* Other: Pre-briefing with a consolidated one page SE treatment guide
* Other: No Pre-briefing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physicians from different medical specialties working at the University Hospital Basel Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: No pre-briefing prior to the simulation training<br>No pre-briefing prior to the simulation training | Other: No Pre-briefing<br>* no instruction of the study participants prior to the simulation training<br>|
| Active Comparator: Pre-briefing with the current SE treatment guidelines<br>pre-briefing with the current SE treatment Guidelines published by the American Epilepsy Society | Other: Pre-briefing with the current SE treatment guidelines<br>* instruction of the study participants according to the evidence-based guideline for the treatment of SE published by the American Epilepsy Society prior to the simulation training<br>|
| Active Comparator: pre- briefing with consolidated SE treatment guideline<br>pre-briefing with the consolidated one page SE treatment guideline | Other: Pre-briefing with a consolidated one page SE treatment guide<br>* instruction of the study participants with a consolidated one page SE treatment guide prior to the simulation training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to SE recognition (minutes) | time to recognition of seizure and/or SE | from start of simulation training until recognition of seizure and/or SE (max. 20 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| administration of anti-seizure medication | time of administration of anti-seizure medication (minutes) | within the first 20 minutes after beginning of the simulation training | 
| dose of anti-seizure medication | dose of anti-seizure medication (mg) | within the first 20 minutes after beginning of the simulation training | 
| time to correct airways protection | time to correct airways protection (minutes) | from start of simulation training until correct airways protection (max. 20 minutes) | 
| quantification of Glasgow Coma Score (GCS) | GCS is a neurological scale recording the state of a person's consciousness ; The scale is composed of three tests: eye, verbal and motor responses. The three values separately as well as their sum are considered. The lowest possible GCS (graded 1 in each element) is 3 (deep coma or death), while the highest is 15 (fully awake person). | within the first 20 minutes after beginning of the simulation training | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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guideline for the treatment of Status Epilepticus, antiseizure drugs (ASDs)