Clinical trial NCT06363344: Follow-up in Pediatric Intensive Care Unit
Official title: Study of the Implementation of a Post-hospitalization Follow-up Consultation in a Pediatric Intensive Care Unit: Needs, Acceptability, Cooperation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intensive Care Psychosis
Keywords: pediatrics
tertiary prevention
resuscitation
hospital organizational innovations
coordination
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background In developed countries, mortality rates in pediatric intensive care units (PICUs) are around 4% and thus, most children admitted to these units survive. However, some pediatric survivors experience long-term morbidity (cognitive, psychological, social and/or physical disorders) associated with their intensive care stay. Currently in France, there are no recommendations for the management of these patients and most of them do not have standardized follow-up.

Objectives Main objective: To assess the feasibility of implementing systematic and comprehensive management of pediatric patients who have been admitted to the PICU.

Intermediate objectives are to study:

* The needs of the children and their families which should be met by this management
* The acceptability of this organizational innovation for all the actors involved
* The cooperation between actors of the hospital and city health system + social professionals involved
* The costs of implementation and the budgetary impact of such a system

Methods Needs assessment: questionnaires and interviews with patients and their families (parents and possibly siblings if involved) to collect the medico-psycho-social impact of the PICU stay at the time of discharge and 3 months later.

Study of acceptability: quantitative survey of health professionals involved in the care of these children and expected care modalities. This includes pediatric intensivists, professionals from the children's usual care services (if applicable), attending physician.

Study of cooperation: analysis of needs and of the network usually solicited for the children benefiting from this care: who is identified, who remains to be identified, obstacles. Quantitative analysis of consultation reports and survey of professionals.

Budgetary impact analysis: study of the cost of setting up consultations for the health care system, and study of its financial and health consequences for the main needs identified, on the basis of data from the literature and expert opinions

Perspectives Compare the benefit of this systematic, multi professional and comprehensive management of pediatric patients after PICU discharge versus standard of care

Detailed description: Background In developed countries, mortality rates in pediatric intensive care units (PICUs) are around 4% and thus, most children admitted to these units survive. However, some pediatric survivors experience long-term morbidity (cognitive, psychological, social and/or physical disorders) associated with their intensive care stay. Currently in France, there are no recommendations for the management of these patients and most of them do not have standardized follow-up.

Objectives Main objective: To assess the feasibility of implementing systematic and comprehensive management of pediatric patients who have been admitted to the PICU.

Intermediate objectives are to study:

* The needs of the children and their families which should be met by this management
* The acceptability of this organizational innovation for all the actors involved
* The cooperation between actors of the hospital and city health system + social professionals involved
* The costs of implementation and the budgetary impact of such a system

Methods Needs assessment: questionnaires and interviews with patients and their families (parents and possibly siblings if involved) to collect the medico-psycho-social impact of the PICU stay at the time of discharge and 3 months later.

Study of acceptability: quantitative survey of health professionals involved in the care of these children and expected care modalities. This includes pediatric intensivists, professionals from the children's usual care services (if applicable), attending physician.

Study of cooperation: analysis of needs and of the network usually solicited for the children benefiting from this care: who is identified, who remains to be identified, obstacles. Quantitative analysis of consultation reports and survey of professionals.

Budgetary impact analysis: study of the cost of setting up consultations for the health care system, and study of its financial and health consequences for the main needs identified, on the basis of data from the literature and expert opinions

Perspectives Compare the benefit of this systematic, multi professional and comprehensive management of pediatric patients after PICU discharge versus standard of care

Eligibility criteria: Inclusion Criteria:

* All children discharged alive from the paediatric intensive care unit
* Hospitalized in paediatric intensive care unit for 3 days or more
* Parents and children agreeing to follow-up by the advanced practice nurse

Exclusion Criteria:

* Impromptu transfers (making it impossible to collect information the day before discharge) or death
* Intellectual retardation of child/parent preventing data collection by questionnaire
* Participant unable or unwilling to comply with study procedures (including those unable to speak French; those unable to honor a follow-up consultation within 3 months)

Primary outcomes:
measure: Emotional and behavioral problem of the children measured by the PSC questionnaire (Sheldrick, 2012)
timeFrame: 24 months
Secondary outcomes:
measure: Mental disorders measured by the PHQ-9 (Kroenke, 2001) questionnaire
timeFrame: 24 months
measure: Social-emotional development measured by the ASQ-SE (Squires, 2015) questionnaire
timeFrame: 24 months
measure: Pediatric Quality of Life measured by the the PedsQL (Varni, 1999) questionnaire
timeFrame: 24 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Robert Debre Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Michaël LEVY
role: PRINCIPAL_INVESTIGATOR
References: