Effectiveness of Specialised Paediatric Palliative Care (SPhAERA)

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

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.

Study Overview

• Status: Completed
• Conditions: Paediatric Palliative Care
• Intervention / Treatment: Other: Specialised Paediatric Palliative Care (SPPC)

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Aarau, Switzerland
    • Cantonal Children's Hospital
  • Basel, Switzerland
    • University Children's Hospital
  • Bern, Switzerland
    • Department of Pediatrics, University Hospital Inselspital
  • Zürich, Switzerland, 8032
    • University Children's Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of hospital admissions as assessed longitudinally via chart review	Number of admissions including number of emergency and/or outpatient consultations and number of admissions to a pediatric palliative care unit. Routine data, chart review, longitudinally during the child's palliative care phase.	Up to day 330 after study entry
Number of resuscitations	Routine data, chart review, continuously during the child's palliative care phase.	Up to day 330 after study entry
Number of invasive procedures	E.g. surgery and imaging requiring sedation. Routine data, chart review, continuously during the child's palliative care phase.	Up to day 330 after study entry
Length of Stay (LOS)	Total length of hospital stay per admission. Routine data, chart review, continuously during the child's palliative care phase.	Up to day 330 after study entry
Number of days receiving professional community home care services	Routine data, chart review, continuously during the child's palliative care phase.	Up to day 330 after study entry
Place of Death	(Hospital, Home, Hospice, Other) Data extraction from routine data/cart reviews at time of death.	Place of death will be recorded, if the patient dies within 1 year after study enrollment.
Effective costs charged and paid for by formal payers	Cost estimations based on resource utilization combined with publicly available sources or retrieved from payers for each family who consented.	Up to day 630 after study entry
Family household expenditures	Direct and indirect household expenditures. Household data obtained using questionnaires.	after 1 year or at child's death; 1 year after the child's death
SPPC - Paediatric Palliative Screening Scale (PaPas-Scale) Questionnaire	Identification of patients in need of specialised paediatric palliative care using the Paediatric Palliative Screening Scale (PaPas-Scale) questionnaire. Higher scores indicate a higher need for paediatric palliative care.	For each patient at baseline (study enrollment), through study completion, ca. 2 years.
Sense of coherence (SOC) Questionnaire	Assessment of self-reported Family Sense of Coherence with the FSOC questionnaire.	For each family at baseline (study enrollment), through study completion, ca. 2 years.
Family hardiness (FH) Questionnaire	Assessing the internal strengths and cooperativeness, the resourcefulness and willingness to learn and the sense of having control over life circumstances by using the Family Hardiness Index (FHI) questionnaire.	For each family at baseline (study enrollment), through study completion, ca. 2 years.

Collaborators and Investigators

• Sponsor: University Children's Hospital, Zurich
• Collaborators: University of Basel; Cantonal Hospital of Aarau, Switzerland; University Children's Hospital Basel; Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Karin Zimmermann, PhD RN, University Children's Hospital, Zurich

Publications and helpful links

General Publications

• 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. Erratum In: BMC Palliat Care. 2023 Feb 22;22(1):13.

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2019
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: March 15, 2019
• First Submitted That Met QC Criteria: January 16, 2020
• First Posted (Actual): January 22, 2020

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Palliative Care; Paediatrics
• Other Study ID Numbers: 2019-INV-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No