Initiating Pediatric Palliative Care in ACT Group 4

Cerebral Palsy Clinical Trial

— StartSPP  

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06273267
• Other study ID #: APHP231232
• Status: Not yet recruiting
• Start date: February 2024
• Est. completion date: August 2024

Study information

• Verified date: January 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Ashley RIDLEY, M.D.
• Phone: 1 42 19 27 28
• Email: ashley.ridley[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Cerebral Palsy
• Craniocerebral Trauma
• Encephalopathy
• Traumatic Head Injury

Intervention

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).

Locations

Country	Name	City	State
France	Hôpital Necker-Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (8)

Bender HU, Riester MB, Borasio GD, Fuhrer M. "Let's Bring Her Home First." Patient Characteristics and Place of Death in Specialized Pediatric Palliative Home Care. J Pain Symptom Manage. 2017 Aug;54(2):159-166. doi: 10.1016/j.jpainsymman.2017.04.006. Epub 2017 Jun 8. — View Citation

DeCourcey DD, Silverman M, Oladunjoye A, Balkin EM, Wolfe J. Patterns of Care at the End of Life for Children and Young Adults with Life-Threatening Complex Chronic Conditions. J Pediatr. 2018 Feb;193:196-203.e2. doi: 10.1016/j.jpeds.2017.09.078. Epub 2017 Nov 22. — View Citation

Feudtner C, Kang TI, Hexem KR, Friedrichsdorf SJ, Osenga K, Siden H, Friebert SE, Hays RM, Dussel V, Wolfe J. Pediatric palliative care patients: a prospective multicenter cohort study. Pediatrics. 2011 Jun;127(6):1094-101. doi: 10.1542/peds.2010-3225. Epub 2011 May 9. — View Citation

Good PD, Cavenagh J, Ravenscroft PJ. Survival after enrollment in an Australian palliative care program. J Pain Symptom Manage. 2004 Apr;27(4):310-5. doi: 10.1016/j.jpainsymman.2003.12.011. — View Citation

Himmelmann K, Sundh V. Survival with cerebral palsy over five decades in western Sweden. Dev Med Child Neurol. 2015 Aug;57(8):762-7. doi: 10.1111/dmcn.12718. Epub 2015 Feb 19. — View Citation

Mack JW, Wolfe J. Early integration of pediatric palliative care: for some children, palliative care starts at diagnosis. Curr Opin Pediatr. 2006 Feb;18(1):10-4. doi: 10.1097/01.mop.0000193266.86129.47. — View Citation

Namisango E, Bristowe K, Allsop MJ, Murtagh FEM, Abas M, Higginson IJ, Downing J, Harding R. Symptoms and Concerns Among Children and Young People with Life-Limiting and Life-Threatening Conditions: A Systematic Review Highlighting Meaningful Health Outcomes. Patient. 2019 Feb;12(1):15-55. doi: 10.1007/s40271-018-0333-5. — View Citation

Siden H, Chavoshi N, Harvey B, Parker A, Miller T. Characteristics of a pediatric hospice palliative care program over 15 years. Pediatrics. 2014 Sep;134(3):e765-72. doi: 10.1542/peds.2014-0381. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of first pediatric palliative care intervention	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	Description of the patient situation	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
Secondary	Timing of pediatric palliative care intervention	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