Effectiveness of Specialised Paediatric Palliative Care

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Paediatric Palliative Care

Intervention / Treatment
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* Other: Specialised Paediatric Palliative Care (SPPC)


Participation Criteria
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Eligibility Criteria
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Children suffering from a life-limiting condition and potentially in need of SPPC, their parents and siblings as applicable will be eligible to enter the study, along with all HCP involved in their care at all study sites. The potential need for SPPC is defined per indication criteria based on the Zurich SPPC programme's guidelines: Increase in (unplanned) hospital admissions during the last months Medical adverse events from which the child is not recovering completelyIncreasing symptom burden Unsatisfactory response to treatments Conflicting treatment goals Estimated life expectancy less than 6-12 months Patient's/parents' wish for PC support Inclusion criteria: Children, aged 0-18 years, suffering from a life-limiting condition of various origins and potentially in need of SPPC (for Zurich, additionally enrolment in the SPPC programme) Parents (mothers and fathers) of included children Siblings, aged >8 years, of included families All health care professionals involved in the care of included families Proficiency in French or German language Signed Informed Consent after being informed Exclusion criteria: Neonates with medical complications due to prematurity and/or birth complications and treated in a neonatal intensive care unit Children with an estimated life expectancy of <48 hours

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Interventional multi-centre study with 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Group<br>Patients enrolled in the Specialised Paediatric Palliative Care (SPPC) programme at the University Children's Hospital Zurich. | Other: Specialised Paediatric Palliative Care (SPPC)<br>* 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.<br>|
| No Intervention: Comparison Group<br>Patients treated at the Children's Hospital Aarau, University Children's Hospital Basel, and the University Hospital Inselspital Bern. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Caregiver QOL - QOLLTI-F Questionnaire | Longitudinal assessment of self-reported caregiver (parental) Quality of Life (QOL) using the QOLLTI-F (Quality of Life in Life Threatening Illness - Family Carer Version) questionnaire. | Up to day 330 after study entry | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Child's QOL - DISABKIDS Chronic Generic Measure (DCGM-37) Questionnaire | Longitudinal assessment of child's Quality of Life using the DCGM-37 DISABKIDS questionnaire. | Up to day 330 after study entry | 
| Change in child's symptoms - Memorial Symptom Assessment Scale (MSAS) Questionnaire | Longitudinal assessment of child's symptoms by using the Memorial Symptom Assessment Scale (MSAS) questionnaire. MSAS assesses severity, frequency and distress for symptom evaluation using separate 4 or 5 point Likert scales. Higher values are associated with higher symptom burden. | Up to day 330 after study entry | 
| Change in Siblings QOL - KIDSSCREEN-27 Questionnaire | Longitudinal assessment of sibling's health related Quality of Life using the KIDSSCREEN-27 questionnaire. | Up to day 630 after study entry | 
| Professional's QOL (ProQOL) Questionnaire | Assessing self-reported healthcare professional's Quality of Life using the ProQOL questionnaire. | Cross-sectional at the end of study year 1 | 
| Professional's QOL (ProQOL) Questionnaire | Assessing self-reported healthcare professional's Quality of Life using the ProQOL questionnaire. | Cross-sectional at the end of study year 2 | 
| Chang in grief - Würzburger Trauerinventar (WüTi) Questionnaire | Longitudinal assessment of parental grief processes using the Würzburger Trauerinventar (WüTi) questionnaire. | Up to 1 year after the child's death | 
| Change in parental QOL during bereavement - WHOQOL-BREF Questionnaire | Longitudinal assessment of parental Quality of Life during bereavement using the WHO Quality of Life-BREF questionnaire. | Up to 1 year after the child's death | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paediatrics, Palliative Care