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Follow-up in Pediatric Intensive Care Unit

Study of the Implementation of a Post-hospitalization Follow-up Consultation in a Pediatric Intensive Care Unit: Needs, Acceptability, Cooperation

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06363344
Acronym
APRELAREA
Enrollment
120
Registered
2024-04-12
Start date
2024-04-01
Completion date
2025-09-01
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Psychosis

Keywords

pediatrics, tertiary prevention, resuscitation, hospital organizational innovations, coordination

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

Interventions

OTHERQuestionnaires : PHQ-9 (Kroenke, 2001), the PSC (Sheldrick, 2012), the ASQ-SE (Squires, 2015), the PedsQL (Varni, 1999)

An advanced practice nurse who is a member of the PICU team monitors patients by questionnaires at 1 and 3 months. Depending on the anomalies detected, whether at the somatic, psychological, emotional or social level, the nurse refers to competent specialists and collaborators and continues monitoring of the family as needed.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Emotional and behavioral problem of the children measured by the PSC questionnaire (Sheldrick, 2012)24 months

Secondary

MeasureTime frame
Mental disorders measured by the PHQ-9 (Kroenke, 2001) questionnaire24 months
Social-emotional development measured by the ASQ-SE (Squires, 2015) questionnaire24 months
Pediatric Quality of Life measured by the the PedsQL (Varni, 1999) questionnaire24 months

Countries

France

Contacts

Primary ContactMichaël LEVY, MD, PhD
michael.levy@aphp.fr+33.1.40.03.40.98
Backup ContactEnora LE ROUX, PhD
enora.leroux@aphp.fr+33.1.40.03.23.66

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026