Follow-up in Pediatric Intensive Care Unit (APRELAREA)

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

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

Study Overview

• Status: Recruiting
• Conditions: Intensive Care Psychosis
• Intervention / Treatment: Other: Questionnaires : PHQ-9 (Kroenke, 2001), the PSC (Sheldrick, 2012), the ASQ-SE (Squires, 2015), the PedsQL (Varni, 1999)

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

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michaël LEVY, MD, PhD; Phone Number: +33.1.40.03.40.98; Email: michael.levy@aphp.fr
• Study Contact Backup: Name: Enora LE ROUX, PhD; Phone Number: +33.1.40.03.23.66; Email: enora.leroux@aphp.fr

Study Locations

• France
  • Paris, France, 75019
    • Recruiting
    • Robert Debré Hospital
    • Contact: Michaël LEVY, MD, PhD; Phone Number: +33.1.40.03.40.98; Email: michael.levy@aphp.fr
    • Contact: Enora LE ROUX, PhD; Phone Number: +33.1.40.03.23.66; Email: enora.leroux@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: multi professional and comprehensive management of patients; An advanced practice nurse who is a member of the PICU team monitors patients. Contact with children and their family is established shortly before leaving intensive care, and the child and his family are seen again few days after by the nurse where the child was discharged, then closely in the 3 months following discharge (at 1 and 3 months).

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Emotional and behavioral problem of the children measured by the PSC questionnaire (Sheldrick, 2012)	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Mental disorders measured by the PHQ-9 (Kroenke, 2001) questionnaire	24 months
Social-emotional development measured by the ASQ-SE (Squires, 2015) questionnaire	24 months
Pediatric Quality of Life measured by the the PedsQL (Varni, 1999) questionnaire	24 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Michaël LEVY, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: pediatrics; coordination; resuscitation; tertiary prevention; hospital organizational innovations
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders
• Other Study ID Numbers: APHP231022; IDRCB: 2023-A00660-45 (Registry Identifier: IDRCB ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No