Clinical trial NCT06100978: Patient-reported Outcome and Patient-reported Experience After Status Epilepticus
Official title: Patient-reported Outcomes in Status Epilepticus Requiring Intensive Care Unit Management. A Multicenter Longitudinal Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patient Reported Outcomes
Patient Satisfaction
Long Term Outcomes
Status Epilepticus
Intensive Care Unit
Burden
Relatives
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who meet the eligibility criteria will be offered participation in the study.

Brief summary: Status epilepticus (SE) is a common life-threatening neurological emergency in which prolonged or multiple closely spaced seizures can result in long-term impairments. SE remains associated with considerable mortality and morbidity, with little progress over the last three decades. The proportion of patients who die in the hospital is about 20% overall and 40% in patients with refractory SE. Morbidity is more difficult to evaluate, as adverse effects of SE are often difficult to differentiate from those attributed to the cause of SE. Our experience suggests that nearly 50% of patients may experience long-term functional impairments. The precise description of the consequences of these functional impairments and their impact on quality of life after SE requiring intensive care management has been little studied. Indeed, if cognitive, physical and mental impairments are now identified in the populations of patients who required intensive care under the term postresuscitation syndrome (PICS), neuronal lesions consecutive to the SE itselfor to its cause could be responsible for these different functional alterations.

Thus, the following have been described: (i) cognitive disorders in the areas of attention, executive functions and verbal fluency, visual and working memory disorders, but also spatio-temporal disorders; (ii) physical disorders such as the so-called post-resuscitation polyneuromyopathy; and (iii) mental disorders such as anxiety disorders, depressive states or those related to post-traumatic stress.

Assessment and characterization of patient-reported outcomes is essential to complement the holistic assessment of clinically relevant outcomes from the patient's perspective. The POSEIDON study was a cross-sectional collection of PROs and HR-QOL components, and associated with patient functional outcomes, in those who required ICU management for status epilepticus. We propose here to continue the description of potential alterations after a subsequent ME, namely a longitudinal study (POSEIDON 2) which will also include the evaluation of patient-reported experience (PREMS) and the measurement of family burden.


Eligibility criteria: Inclusion Criteria:

* Adults 18 years old or older
* Patients previously included in the ICTAL registry (Status Epilepticus cohort NCT03457831)
* Survivors after ICU management for Status Epilepticus More than 3 months and less than 5 years after ICU discharge

Exclusion Criteria:

* Legal guardianship
* Opposition to participate
* Unread and unwritten French language
* Patient not affiliated to a Social Security system

Primary outcomes:
measure: percentage of global impairment of HRQoL
timeFrame: at 3 month and 12 month
Secondary outcomes:
measure: percentage of cognitive impairment in patients managed in the ICU for or with SE
timeFrame: at 3 month and 12 month
measure: percentage of disability in patients managed in the ICU for or with SE
timeFrame: at 3 month and 12 month
measure: percentage of physical dependency in patients managed in the ICU for or with SE
timeFrame: at 3 month and 12 month
measure: percentage of anxiety and depression in patients managed in the ICU for or with SE
timeFrame: at 3 month and 12 month
measure: percentage of post traumatic syndrome disorder in patients managed in the ICU for or with SE
timeFrame: at 3 month and 12 month
measure: score of perceived social support by the SSQ6 scale in its 2 dimensions, satisfaction and availability.
timeFrame: at 3 month and 12 month
measure: Presence or absence Post-ICU factors associated of return to work ability in patients managed in the ICU for or with SE.
timeFrame: at 3 month and 12 month
measure: patient's experience of the care system.
timeFrame: at 3 month and 12 month
measure: experience of the patient's relative at M3 and M12 of discharge from intensive care following management with or for a patient's ME.
timeFrame: at 3 month and 12 month
Other outcomes:
Locations:
city: Angoulême
country: France
facility: CH d'Angoulême
city: Béthune
country: France
facility: CH de Béthune
city: Clichy
country: France
facility: Hôpital Beaujon
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Dijon
country: France
facility: CHU de Dijon
city: Grenoble
country: France
facility: CHU de Grenoble
city: La Rochelle
country: France
facility: CH de La Rochelle
city: Le Chesnay
country: France
facility: CH Versailles
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: Hôpital Paris Saint Joseph
city: Roanne
country: France
facility: CH de Roanne
city: Suresnes
country: France
facility: Hôpital Foch
city: Tours
country: France
facility: CHU Tours
Study officials:
affiliation: CH Versailles
name: Gwenaelle Jacq, RN,MSc,PhDc
role: STUDY_DIRECTOR
affiliation: CH Versailles
name: Stephane Legriel, MD,PhD
role: STUDY_DIRECTOR
References: