Epidemiology of Suspected Epileptic Seizures

Epilepsy Clinical Trial

— EPI-lepsie  

Official title:

Epidemiology of Suspected Epileptic Seizures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04147663
• Other study ID #: EPILEPSIE2019
• Status: Not yet recruiting
• Start date: October 2020
• Est. completion date: October 2020

Study information

• Verified date: December 2019
• Source: Centre Hospitalier Saint Joseph Saint Luc de Lyon
• Contact: Sophie ARMAND
• Phone: 0033478618091
• Email: sarmand[@]ch-stjoseph-stluc-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The occurrence of isolated or recurring epileptic seizures accounts for an important use of the healthcare system. Typically, epileptic patient will consult ten times a year a physician (specialist or familial doctor) and will justify 24 diagnostic procedures or additional examinations. Moreover, epileptic seizures are associated with frequent use of emergency departments. From the first emergency call received by the Emergency medical assistance service (SAMU), the actual management of the patient having epileptic seizure includes the eventual transfer to the paramedical team then within an emergency unit. However in some cases, emergency allocation may be avoided as 70% of patients recover their baseline condition upon admission. The main objective of this study is to describe the management of the adult population suffering from suspected seizure by the emergency structures. For 3 consecutive days, all patients with suspected epileptic seizures (diagnosed by the SAMU, paramedics and emergency unit) will be enrolled in the study. Data of medical care management and information from patients or witnesses will be collected on a questionnaire by the physicians of the SAMU, paramedics and emergency unit. Then, the anonymized questionnaires will be sent to RESUVAL (Emergency Network of the Rhone Valley) to ensure data entry and statistical analysis. By identifying the factors leading the SAMU to transfer a patient with suspected epileptic seizure to an emergency unit, this study will provide a more appropriate procedure to prevent unnecessary emergency admissions. It will also gain more insights into the patient outcomes, such as complementary medication, brain examination or referral to a neurologist.

Description:

Epilepsy is a neurological disorder in which brain activity becomes abnormal, causing unpredictable seizures. It affects people of all ages and in 2018, it is estimated that 1% of the world's population is suffering from epilepsy. In France, the recommendations for care of people with a first or recurring seizures are now well codified (Société française de neurologie, 2014; Société française de Médecine d'Urgence, 2018). It is also recognized that the quality of the neurological follow-up and the subsequent control of epilepsy reduces the cost of medical care and the number of emergency entries (Manjunath, 2012). However, occurrence of epileptic seizures still accounts for an important use of the healthcare system and especially those of emergency unit. Typically, it has been reported that epileptic patient will consult ten times a year a physician (specialist or familial doctor) and will justify 24 diagnostic procedures or additional examinations (Kurth, 2010). In France, nearly 3% of calls to the Emergency medical assistance service (SAMU) and 1.6% of emergency entries are linked to an epileptic seizure. Moreover, the care and the management of epilepsy by the SAMU and emergency structures generate a significant financial cost. The French CAROLE cohort study described that in the first and second year after diagnosis of epilepsy, hospitalization cost respectively accounts for 68% and 40% of the total cost of care (de Zelicourt, 2000). In addition, it has been estimated that the extra cost of emergency admissions for patients with epilepsy represents $ 9.6 billion per year (Cramer, 2014). The decision of a physician to orient a patient toward an emergency unit is based on clinical or anamnesis criteria. An European study has highlighted factors associated with an increased risk of emergency admission (Balestrini, 2013); Patient with current psychiatric therapy, drug polytherapy, comorbidities, or that are experiencing more than one episode in the same day and changes in usual seizure pattern are more exposed to be referred to an emergency center (Balestrini, 2013). These findings were reinforced by another study showing the importance of ambulatory supervision measures in the prevention of emergency admissions not justified medically (Tatum, 2008). However, sociodemographic disparities in health care use among epileptic patients have been identified in the US, which could be explained by the executive differences of the sites of care (Begley, 2009). Such data on the practices in the emergency services nor the adequacy between practices and health recommendations are currently unavailable in France. However, we can assume that such heterogeneity of health care exists in France and leads to different health care management. Moreover, the significant emergency congestion that are collectively facing hospitals is associated with heterogeneity in patient health care (Wong, 2010). Although neuro-examination allows an adapted antiepileptic treatment when it is justified (Paliwal, 2015) and is required following episode of inaugural seizure, the possibility for a patient admitted in the emergency department to benefit from an electroencephalogram (EEG) has not been precisely studied in France. However, a study identified patterns (such as head trauma, neurovascular damage, infectious context, withdrawal context in antiepileptic drugs …) that lead to brain investigation by complementary neuroimaging (Annegers, 1995). Also, it has been reported that older patient have higher probability to benefit from neuroimaging (Martindale, 2011).

Finally, it is important to note that in some cases, emergency admissions may be avoided as 60% of patients have an already known historical diagnosis of epilepsy (Girot, 2015), 70% of patients recovered their baseline condition upon admission (Dickson, 2017) or other were discharged home without medical care (Dickson, 2017). In Australia, the prevalence of emergency presentations for recurring seizures has decreased and it is suggested to be linked with improved levels of education and health care delivery (Cordato, 2009).

Thus, we hypothesized that an optimized emergency medical pathway among epileptic patient would optimized the patient outcome (epilepsy treatments, quality of life) and would also benefit for the logistic of the emergency department.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2300
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any patient =18 years calling the SAMU and / or supported by a paramedical team and / or admitted to an emergency unit for suspected symptoms of epileptic seizure will be included.

• SAMU=Emergency medical assistance service

Exclusion Criteria:

• Patients with no epileptic seizures (assessed by the SAMU, paramedical team and the emergency unit) can't be enrolled in the study.

• SAMU=Emergency medical assistance service

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

Other:
• describe the management of the adult population suffering from suspected seizure by the emergency structures
For 3 consecutive days, all patients with suspected epileptic seizures (assessed by the Emergency medical assistance service ( SAMU), paramedical team and the emergency unit) will be included in the study. With the use of questionnaries, information will be collected from patients or witnesses by the SAMU, the paramedical team or physicians of the emergency unit. A 7-day follow-up will be carried out by the principal investigator (PI) of each center.

Locations

Country	Name	City	State
France	Centre Hospitalier St Joseph St Luc	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Saint Joseph Saint Luc de Lyon	RESCUe - RESeau Cardiologie Urgence / RESUVal - RESeau des Urgences de la vallée du Rhône

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of the management of the adult population suffering from suspected seizure by the emergency structures.	The patient journey will be followed from the call to the emergency medical assistance service (SAMU) with a possible transfer by the paramedical team until the care, within the emergency unit.	3 days
Secondary	The patient characteristics, treatment pathway and outcomes after discharge	The secondary objectives of the study will determine: the factors leading the SAMU to transfer a patient with suspected epileptic seizure to an emergency unit.; the factors leading a paramedical physician or emergency physician to prescribe an emergency antiepileptic treatment and / or a complementary brain imaging (CT or MRI) examination,; if admission to the emergency department resulted in the immediate or delayed completion of an EEG or neurology consultation, and within what period of time,; the final diagnosis and its possible adequacy with the initial diagnosis.	11 days