Follow-up in Pediatric Intensive Care Unit (APRELAREA)

A

Assistance Publique - Hôpitaux de Paris

Status

Enrolling

Conditions

Intensive Care Psychosis

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06363344
APHP231022
IDRCB: 2023-A00660-45 (Registry Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment

120 estimated patients

Sex

All

Ages

1 day to 18 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

120 participants in 1 patient group

multi professional and comprehensive management of patients
Other group
Description:
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).
Treatment:
Other: Questionnaires : PHQ-9 (Kroenke, 2001), the PSC (Sheldrick, 2012), the ASQ-SE (Squires, 2015), the PedsQL (Varni, 1999)

Trial contacts and locations

1

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Central trial contact

Enora LE ROUX, PhD; Michaël LEVY, MD, PhD

Data sourced from clinicaltrials.gov

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