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EpilepsyEPI-lepsieNCT04147663

Epidemiology of Suspected Epileptic Seizures

An observational study of Epilepsy, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Epilepsy
What is being tested?
describe the management of the adult population suffering from suspected seizure by the emergency structures
How many people
2,300 participants
Where
1 siteFrance
Study dates
Oct 2020to Oct 2020
Phase
Observational
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Any patient ≥18 years calling the Emergency medical assistance service (SAMU)

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site
  • Centre Hospitalier St Joseph St Luc

    Lyon, 69007

Other trials in France

About this study

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.

Read the detailed 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.

Conditions
Epilepsy
Being tested
describe the management of the adult population suffering from suspected seizure by the emergency structures
Keywords
emergency, epileptic seizure, epilepsy, neurology
Medical subject headings
Epilepsy, Emergencies, Seizures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • describe the management of the adult population suffering from suspected seizure by the emergency structuresOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 days

Secondary outcomes (1)
  1. 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.

    Measured: 11 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2019
  2. Study startOct 2020 (estimated)
  3. Primary completionOct 2020 (estimated)
  4. Study completionOct 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
2,300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04147663
Sponsor's protocol ID
EPILEPSIE2019
Acronym
EPI-lepsie
Status last verified
Dec 2019
First submitted
30 Oct 2019
Last updated
26 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The questionnaires contain personal data: age and sex of the patient, place of care, treatment and home address.

Questions about this trial

What is this clinical trial studying?

An observational study of Epilepsy, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon at 1 site in France.

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 2 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 26 Dec 2019. 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 France. 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 Sophie ARMAND (0033478618091, sarmand@ch-stjoseph-stluc-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Description of the management of the adult population suffering from suspected seizure by the emergency structures. (time frame: 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 26 Dec 2019.

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