Clinical trial NCT06697236: SOcioeconomics Status and Post-Intensive Care Syndrome
Official title: SOcioeconomics Status and Post-Intensive Care Syndrome
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Post Intensive Care Syndrome (PICS)
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients will be identified on leaving intensive care.

Brief summary: Intensive care units provide care for patients with multiple organ failure, with the aim (over and above survival) of guaranteeing an acceptable quality of life after resuscitation and proportionate care in accordance with the therapeutic plan and the wishes of the patient and his family. In addition to the independent prognostic factors for mortality that are well known in intensive care (reason for admission, initial severity, etc.) and after intensive care (age, co-morbidities, life trajectory, etc.), patients who survive are more likely to have a good quality of life. ), patients who survive are likely to present complications with variable repercussions, depending in part on their demographic characteristics (age, comorbidities, presence or absence of a chronic pathology, etc.), their frailty, social determinants of health and, logically enough, the reason for admission and the occurrence of complications during hospitalisation.

Thus, the potential consequences of a stay in intensive care may take several forms: 1) quality of life on leaving intensive care, 2) the occurrence or persistence of physical, psychological/psychiatric and/or cognitive symptoms grouped together under the term Post Intensive Care Syndrome (PICS) and PICS-F when these manifestations concern the patient's relatives (F for Family) and 3) socio-economic status (SE) prior to admission with risks of a drop in income, social isolation and withdrawal, and the development of feelings of uselessness or of being a burden on family and friends. This last point is particularly important because social inequalities in health (SIH), which are a true reflection of the link between health and social determinants (income and social status, employment and working conditions, education/literacy, healthy environment and support, behaviours, access to health services), represent a higher risk of being admitted to intensive care with greater severity and a more serious short-term prognosis in intensive care and post-resuscitation. The concept of PICS and PICS-F makes it possible to highlight the importance of each of these physical, psychological and cognitive dimensions in the main spheres of the daily life of patients and their relatives after resuscitation: family and social life, professional and private activity, economic resources. In addition to the manifestations of PICS, we must therefore add the impact that SE status can have on the pre- and post-resuscitation phases of a stay in intensive care. In this way, SE status and SIH reveal the weaknesses of a healthcare system and the social gradient associated with precariousness. As was shown during the Covid-19 pandemic, SIHs are probably factors that can add up and/or potentiate each other and have a significant influence on the outcome of patients leaving the intensive care unit and beyond.

" Post Intensive Care Syndrome " (PICS) The frequency and intensity of disabling symptoms in the ICU and in the aftermath of an ICU stay vary widely. These may be physical (e.g. extreme muscle weakness in around 40% of patients), psychological (anxiety, depression, post-traumatic stress disorder in 20 to 35% of patients) or cognitive (memory loss, loss of verbal fluency, problems with attention, executive functions and visio-spatial perception in 20 to 40% of patients). Cognitive impairment occurs most often in the aftermath of an acute confusional state ("delirium"), which develops in intensive care and whose causes are multifactorial, but linked in particular to the underlying disease and the treatments administered in intensive care. The aim, after the stay in intensive care and on return home, is to be able to detect one or other of the components of the PICS using easy-to-use tools as part of personalised monitoring by telephone, during a consultation in a GP's surgery or hospital, or during a medical visit to the patient's home, in order to adapt physical, cognitive, psychological and speech rehabilitation and the return to an acceptable quality of life for patients and their families. Patient follow-up, particularly in the context of the PICS, could be monitored by a resuscitation doctor as part of a post-resuscitation consultation, as proposed by the Haute Autorité de Santé in France in June 2023.


Eligibility criteria: Inclusion Criteria:

Patients :

* Patients hospitalised in intensive care for septic shock or acute respiratory distress syndrome or with a duration of mechanical ventilation and/or treatment with catecholamines ≥ 3 days (population targeted by the HAS 2023 recommendations for the risk of developing a PICS).
* Patients who have given their oral consent after having been informed about the conduct of this study.

Patient's relatives :

* Person identified by the patient as the reference person or the person to be informed
* Person who has given oral consent after having been informed about the conduct of this study
* Person able to complete a questionnaire
* Limited to 1 relative per patient

Exclusion Criteria:

Patients :

* Patient not affiliated to or not benefiting from a social security scheme
* Patients who are minors
* Person subject to a legal protection measure (curatorship, guardianship)
* Person subject to a legal protection measure
* Patient unable to understand the French language and to consent to the research protocol
* Major incapable or unable to express consent
* A bedridden or demented patient

Patient's relatives :

* Minor
* Relative unable to be interviewed due to state of health
* Relative under guardianship, curatorship or safeguard of justice
* Relative unable to understand the French language and to consent to the research protocol

Primary outcomes:
measure: Number of PICS
timeFrame: Up to 12 months after leaving intensive care
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References: