Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363344
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-01-31
Brief Title:
Follow-up in Pediatric Intensive Care Unit
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Study of the Implementation of a Post-hospitalization Follow-up Consultation in a Pediatric Intensive Care Unit Needs Acceptability Cooperation
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APRELAREA
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 andor 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 childrens 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
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 childrens 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 andor 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 childrens 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
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 childrens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IDRCB 2023-A00660-45 | REGISTRY | IDRCB ANSM | None |