Initiating Pediatric Palliative Care in ACT Group 4 (StartSPP)

February 15, 2024 updated by: Assistance Publique - Hôpitaux de Paris

Initial Pediatric Palliative Care Provision in Patients Under 25 Years of Age Classified in ACT Group 4 Within Ile de France (Metropolitan Area of Paris)

Due to the wide range of diagnoses encountered in pediatric palliative care, the Association for Children's Palliative Care (ACT) and the Royal College of Paediatrics and Child Health (RCPCH) have developed a classification of life-limiting illnesses, based on support models.

This classification includes four groups. ACT 4 category is made up of children with a serious incurable non-progressive neurological disease (for example: anoxic ischemia, cerebral palsy, traumatic or infectious brain injuries).

Although data relating to specific ACT groups are scarce, experience from clinical practice suggests that the needs and use of Pediatric palliative care resources are different across the four categories.

The specific history of ACT-4 patients suggests that pediatric palliative care may be required early on in the history of the disease but effective intervention varies greatly from one patient to another. Tthis study aims to better understand the optimal timing for introducing a PPC team into the care pathway for these children. The study also aims to describe the care trajectory over the first year of PPC intervention.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The ACT 4 group is made up of children with a serious incurable non-progressive neurological disease (for example: anoxic ischemia, cerebral palsy, traumatic or infectious brain injuries).

Although data relating to specific ACT groups are scarce, experience from clinical practice suggests that the needs and use of Pediatric palliative care resources are different across the four categories.

The question of when to initiate palliative care with curative pediatric care frequently arises for specialists in pediatrics and palliative medicine. In the ACT-4 group, where the pathologies are by definition non-progressive, the initial timing and mode of intervention of palliative care are less clear. The main reasons encountered in clinical practice are: symptomatic and therapeutic assessment, goals of care discussion, and implementing a care plan. Two main modes of intervention have been identified for hospital based teams (consultations and multidisciplinary meetings) and will be confirmed by extending the study to community care. The reasons and methods of intervention will be explored in our study.

The specific history of ACT-4 patients suggests that these patients may present pediatric palliative care needs early on, but effective intervention varies greatly from one patient to another. This study aims to better understand the optimal timing for introducing a PPC team into the care pathway for these children. The study also aims to describe the care trajectory over the first year of PPC intervention.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75015
        • Hopital Necker-Enfants Malades
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

AP-HP (Assistance Publique - Hôpitaux de Paris) patients followed by the pediatric palliative care teams of the greater metropolitan area of Paris "Ile de France" (Robert-Debré hospital, Necker hospital or Paliped-Île-de-France Regional Pediatric Palliative Care Resource Team) between January 2020 and December 2022 and suffering from a serious non-progressive neurological disease.

Robert Debré et Necker Hospitals are tertiary care hospitals. Paliped is a community based service for PPC.

Description

Inclusion Criteria:

  • Patients aged 0 to 25
  • Follow-ups at APHP
  • Supported by a palliative care team from Ile de France (Robert-Debré hospital, Necker hospital or Paliped-Île-de-France Regional Pediatric Palliative Care Resource Team) between January 2020 and December 2022
  • Suffering from a serious non-progressive neurological disease (ACT-4)
  • Information and absence of opposition from the holders of parental authority of the minor patient and the guardian or curator of the adult patient if he is under guardianship/curatorship;

Exclusion Criteria:

  • Other ACT category (1, 2, 3 or 5) of the classification of diseases by the Association for Children's Palliative Care (ACT) and the Royal College of Paediatrics and Child Health (RCPCH) during treatment
  • Patients for whom there was no pediatric palliative care intervention
  • Patients in palliative care without follow-up at the APHP

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
AP-HP patients followed by the pediatric palliative care teams of Ile de France (metropolitan area of Paris) between January 2020 and December 2022 and suffering from a serious non-progressive neurological disease.
Other: Collection of data from the patient's medical file
Collection of data from the patient's medical file. The data collected concerns the first year of follow-up (from the initial PPC intervention to one year to date post-intervention).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of first pediatric palliative care intervention
Time Frame: 12 months
The first pediatric palliative care team intervention will be listed for each patient (symptom management, multidisciplinary ethical meeting, care coordination, or team and family support). Collection of data from the patient's medical file. The data collected concerns the initial intervention.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of the patient situation
Time Frame: 12 months

Clinical description of the patient: ICD (international classification of diseases) diagnosis, acute symptoms, treatment, demographic characteristics and the place of care (hospital, hospice, palliative care unit, home).

Collection of data from the patient's medical file. The data collected concerns the first year of follow-up, from the initial pediatric palliative care intervention to one year to date post-intervention.
12 months
Timing of pediatric palliative care intervention
Time Frame: 12 months
Determine whether there is a significant difference in the reasons and modes of initiating pediatric palliative care depending on the precocity of the first intervention in relation to diagnosis and death if it has occurred. Analysis of time elapsed between diagnosis and palliative care intervention as well as time elapsed between palliative care and death if it has occured.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Ashley RIDLEY, M.D., Assistance Publique - Hôpitaux de Paris
  • Study Director: Hélène GEFFROY, Resident, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

January 31, 2024

First Submitted That Met QC Criteria

February 15, 2024

First Posted (Estimated)

February 22, 2024

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP231232

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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