Patient-reported Outcome and Patient-reported Experience After Status Epilepticus

Patient Satisfaction Clinical Trial

— POSEIDON2  

Official title:

Patient-reported Outcomes in Status Epilepticus Requiring Intensive Care Unit Management. A Multicenter Longitudinal Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06100978
• Other study ID #: P22/08 - POSEIDON 2
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: July 2026

Study information

• Verified date: February 2024
• Source: Versailles Hospital
• Contact: Gwenaelle Jacq, RN,MSc,PhDc
• Phone: 33139638356
• Email: gjacq[@]ght78sud.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 145
• Est. completion date: July 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burden
• Intensive Care Unit
• Patient Reported Outcomes
• Patient Satisfaction
• Relatives
• Status Epilepticus

Locations

Country	Name	City	State
France	CHVersailles	Le Chesnay

Sponsors (1)

Lead Sponsor	Collaborator
Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of global impairment of HRQoL	percentage of global impairment of HRQoL defined by one and/or other of the physical and mental impairments (after dichotomization of the SF 36 summary scores compared to the general population) in patients managed in the ICU for or with SE. 36-Item Short Form Survey (SF-36) (HRQoL)-Ranging score[0-100], a high score indicate better health status.	at 3 month and 12 month
Secondary	percentage of cognitive impairment in patients managed in the ICU for or with SE	i)The cognitive complaints questionnaire (Questionnaire de Plainte Cognitive (QPC)(Cognition)- a score=3 or more indicate cognitive complaints	at 3 month and 12 month
Secondary	percentage of disability in patients managed in the ICU for or with SE	The Glasgow Outcome Scale extended (Handicap)-Ranging score[1-8] a hight score indicate no handicap A score of 5 to 8 on the GOSE indicate a favorable outcome	at 3 month and 12 month
Secondary	percentage of physical dependency in patients managed in the ICU for or with SE	The Lawton IADL (scale contains eight items, with a summary score from 0 (low function) to 8 (high function).and Barthel index (Dependency)-Ranging score[0-100], a high score indicate no dependency.	at 3 month and 12 month
Secondary	percentage of anxiety and depression in patients managed in the ICU for or with SE	The Hospital anxiety and depression (Anxiety,Depression)-Ranging score[0-21] a score > 8 indicate in each subscale a depresion or/and anxiety	at 3 month and 12 month
Secondary	percentage of post traumatic syndrome disorder in patients managed in the ICU for or with SE	The Impact of Event Scale -Revised(post traumatic syndrome disorder)-Ranging score[0-88],scores higher than 24 are of concern; the higher scores indicate the severity of PTSD	at 3 month and 12 month
Secondary	score of perceived social support by the SSQ6 scale in its 2 dimensions, satisfaction and availability.	The Social Support Questionnaire- Short Form-SSQ6 / 6 item measure of social support, with scores ranging from 0 (no social support) to 6 (very high social) and 1 (very dissatisfied) to 6 (very satisfied) for the area of satisfaction in each item or area. From these scores in the 6 domains, an average score with the support given in each of the areas.	at 3 month and 12 month
Secondary	Presence or absence Post-ICU factors associated of return to work ability in patients managed in the ICU for or with SE.	A return to work will be interpreted by measured by the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH scale); The WPAI-GH consists of six questions: 1 = currently employed; 2 = hours missed due to health problems; 3 = hours missed other reasons; 4 = hours actually worked; 5 = degree health affected productivity while working (using a 0 to 10 Visual Analogue Scale (VAS)); 6 = degree health affected productivity in regular unpaid activities (VAS).. Four main outcomes can be generated from the WPAI-GH and expressed in percentages by multiplying the following scores by 100:	at 3 month and 12 month
Secondary	patient's experience of the care system.	Score measured by the PPE 15 (Picker Patient Experience Questionnaire) of the patient's experience of the healthcare system.; It consists of 15 questions distributed to seven dimensions of care: respect, coordination, information/communication/education, physical comfort, emotional support, involvement of relatives, and transitions and continuity The questions have two ("yes" or "no") to four response options ("yes"," no", "I did not need to", or "yes, to some extent"). Neutral answers, such as "I did not need to", and the most positive answer are coded as a "non-problem" (score = 0). The remaining responses are coded as "problems" (score = 1).	at 3 month and 12 month
Secondary	experience of the patient's relative at M3 and M12 of discharge from intensive care following management with or for a patient's ME.	Score measured by ZARIT scale Zarit Burden Interview: Revised (22-items) Total score range: 0 to 88 0-21: no to mild burden 21-40: mild to moderate burden 41-60: moderate to severe burden = 61: severe burden	at 3 month and 12 month