Clinical trial NCT04236180: Effectiveness of Specialised Paediatric Palliative Care
Official title: Specialised Paediatric Palliative Care: Assessing Family, Healthcare Professionals and Health System Outcomes in a Multi-site Context of Various Care Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paediatric Palliative Care
Keywords: Paediatrics
Palliative Care
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
Collaborators: name: University of Basel
name: Cantonal Hospital of Aarau, Switzerland
name: University Children's Hospital Basel
name: Insel Gruppe AG, University Hospital Bern
First posted: 2020-01-22
Enrollment: 70
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Caregiver QOL - QOLLTI-F Questionnaire
timeFrame: Up to day 330 after study entry
Secondary outcomes:
measure: Change in Child's QOL - DISABKIDS Chronic Generic Measure (DCGM-37) Questionnaire
timeFrame: Up to day 330 after study entry
measure: Change in child's symptoms - Memorial Symptom Assessment Scale (MSAS) Questionnaire
timeFrame: Up to day 330 after study entry
measure: Change in Siblings QOL - KIDSSCREEN-27 Questionnaire
timeFrame: Up to day 630 after study entry
measure: Professional's QOL (ProQOL) Questionnaire
timeFrame: Cross-sectional at the end of study year 1
measure: Professional's QOL (ProQOL) Questionnaire
timeFrame: Cross-sectional at the end of study year 2
measure: Chang in grief - "Würzburger Trauerinventar (WüTi)" Questionnaire
timeFrame: Up to 1 year after the child's death
measure: Change in parental QOL during bereavement - WHOQOL-BREF Questionnaire
timeFrame: Up to 1 year after the child's death
Other outcomes:
measure: Number of hospital admissions as assessed longitudinally via chart review
timeFrame: Up to day 330 after study entry
measure: Number of resuscitations
timeFrame: Up to day 330 after study entry
measure: Number of invasive procedures
timeFrame: Up to day 330 after study entry
measure: Length of Stay (LOS)
timeFrame: Up to day 330 after study entry
measure: Number of days receiving professional community home care services
timeFrame: Up to day 330 after study entry
measure: Place of Death
timeFrame: Place of death will be recorded, if the patient dies within 1 year after study enrollment.
measure: Effective costs charged and paid for by formal payers
timeFrame: Up to day 630 after study entry
measure: Family household expenditures
timeFrame: after 1 year or at child's death; 1 year after the child's death
measure: SPPC - Paediatric Palliative Screening Scale (PaPas-Scale) Questionnaire
timeFrame: For each patient at baseline (study enrollment), through study completion, ca. 2 years.
measure: Sense of coherence (SOC) Questionnaire
timeFrame: For each family at baseline (study enrollment), through study completion, ca. 2 years.
measure: Family hardiness (FH) Questionnaire
timeFrame: For each family at baseline (study enrollment), through study completion, ca. 2 years.
Locations:
city: Aarau
country: Switzerland
facility: Cantonal Children's Hospital
city: Basel
country: Switzerland
facility: University Children's Hospital
city: Bern
country: Switzerland
facility: Department of Pediatrics, University Hospital Inselspital
city: Zürich
country: Switzerland
facility: University Children's Hospital Zurich
Study officials:
affiliation: University Children's Hospital, Zurich
name: Karin Zimmermann, PhD RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zimmermann K, Simon M, Scheinemann K, Tinner Oehler EM, Widler M, Keller S, Fink G, Mitterer S, Gerber AK, von Felten S, Bergstraesser E. Specialised Paediatric PAlliativE CaRe: Assessing family, healthcare professionals and health system outcomes in a multi-site context of various care settings: SPhAERA study protocol. BMC Palliat Care. 2022 Nov 2;21(1):188. doi: 10.1186/s12904-022-01089-x.