Effectiveness of Specialised Paediatric Palliative Care
- Conditions
- Paediatric Palliative Care
- Interventions
- Other: Specialised Paediatric Palliative Care (SPPC)
- Registration Number
- NCT04236180
- Lead Sponsor
- University Children's Hospital, Zurich
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Specialised Paediatric Palliative Care (SPPC) Patients enrolled in the Specialised Paediatric Palliative Care (SPPC) programme at the University Children's Hospital Zurich.
- Primary Outcome Measures
Name Time Method Change in Caregiver QOL - QOLLTI-F Questionnaire Up to day 330 after study entry 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.
- Secondary Outcome Measures
Name Time Method Change in Siblings QOL - KIDSSCREEN-27 Questionnaire Up to day 630 after study entry Longitudinal assessment of sibling's health related Quality of Life using the KIDSSCREEN-27 questionnaire.
Professional's QOL (ProQOL) Questionnaire Cross-sectional at the end of study year 2 Assessing self-reported healthcare professional's Quality of Life using the ProQOL questionnaire.
Change in parental QOL during bereavement - WHOQOL-BREF Questionnaire Up to 1 year after the child's death Longitudinal assessment of parental Quality of Life during bereavement using the WHO Quality of Life-BREF questionnaire.
Chang in grief - "Würzburger Trauerinventar (WüTi)" Questionnaire Up to 1 year after the child's death Longitudinal assessment of parental grief processes using the "Würzburger Trauerinventar (WüTi)" questionnaire.
Change in child's symptoms - Memorial Symptom Assessment Scale (MSAS) Questionnaire Up to day 330 after study entry 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.
Change in Child's QOL - DISABKIDS Chronic Generic Measure (DCGM-37) Questionnaire Up to day 330 after study entry Longitudinal assessment of child's Quality of Life using the DCGM-37 DISABKIDS questionnaire.
Trial Locations
- Locations (4)
Cantonal Children's Hospital
🇨🇭Aarau, Switzerland
Department of Pediatrics, University Hospital Inselspital
🇨🇭Bern, Switzerland
University Children's Hospital
🇨🇭Basel, Switzerland
University Children's Hospital Zurich
🇨🇭Zürich, Switzerland