NCT04236180

Effectiveness of Specialised Paediatric Palliative Care

Specialised Paediatric Palliative Care: Assessing Family, Healthcare Professionals and Health System Outcomes in a Multi-site Context of Various Care Settings

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: University Children's Hospital, Zurich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the effectiveness of an existing Specialised Paediatric Palliative Care programme and reports on its potential to improve patient-, family-, health professionals-, and healthcare-related outcomes. Data will be compared between an intervention and a comparison group.

Detailed description

The number of children and adolescents living with life-limiting conditions and potentially in need for specialised paediatric palliative care (SPPC) is rising. As a highly complex subfield of palliative care, paediatric palliative care focuses on the support and involvement of the entire family, and on the impact not only at the patient level, but also at the family and health systems level. Ideally, a specialised multiprofessional team fills the complex healthcare needs of children and their families. A consultative care model might be well-suited to address each family's most important needs. The question, however, of how SPPC is beneficial for whom and under what circumstances remain largely unanswered as validation of innovative care programmes in controlled studies is lacking. This study's overall target is to evaluate the effectiveness of SPPC and to report on its potential to improve patient-, family-, health professional-, and healthcare-related outcomes. The primary objective is to explore how SPPC influences the quality of life (QOL) of caregivers, i.e. parents. Secondary objectives are to explore how SPPC influences the QOL of patients including their symptom severity and distress as well as the QOL of their siblings and of healthcare professionals not specialised in PPC. Further objectives are to determine whether the provision of SPPC reduces the utilisation of healthcare resources and direct and indirect health-related costs for families, and to evaluate implementation outcomes such as adoption, i.e., the uptake of SPPC. This interventional multi-centre study will apply a hybrid design to determine the clinical effectiveness (comparative effectiveness research) of an existing SPPC programme, while gathering information on its delivery and potential implementation in a real-life situation. This study will be conducted in compliance with the protocol, the current version of the Declaration of Helsinki, the ICH-GCP as well as all national legal and regulatory requirements.

Conditions

• Paediatric Palliative Care

Interventions

Type	Name	Description
OTHER	Specialised Paediatric Palliative Care (SPPC)	All services provided to children/families by a member of the multiprofessional SPPC team in Zurich according to local guidelines will be considered as study intervention. This includes direct consultation of the patient/family, as well as patient-/family-related consultation of the frontline care team. Bereavement support is considered an integrated part of SPPC and after the death of a child, follow-up bereavement support is routinely offered at the individual or group level as appropriate for parents and siblings.

Timeline

• Start date: 2019-11-05
• Primary completion: 2023-05-31
• Completion: 2023-05-31
• First posted: 2020-01-22
• Last updated: 2023-12-15

Locations

4 sites across 1 country: Switzerland