Follow-up in Pediatric Intensive Care Unit

Intensive Care Psychosis Clinical Trial

— APRELAREA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06363344
• Other study ID #: APHP231022
• Secondary ID: IDRCB: 2023-A006
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: January 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Michaël LEVY, MD, PhD
• Phone: +33.1.40.03.40.98
• Email: michael.levy[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Intensive Care Psychosis
• Psychotic Disorders

Intervention

Other:
• Questionnaires : 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.

Locations

Country	Name	City	State
France	Robert Debre Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emotional and behavioral problem of the children measured by the PSC questionnaire (Sheldrick, 2012)		24 months
Secondary	Mental disorders measured by the PHQ-9 (Kroenke, 2001) questionnaire		24 months
Secondary	Social-emotional development measured by the ASQ-SE (Squires, 2015) questionnaire		24 months
Secondary	Pediatric Quality of Life measured by the the PedsQL (Varni, 1999) questionnaire		24 months