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Effectiveness of Specialised Paediatric Palliative Care

NCT ID: NCT04236180

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-05

Study Completion Date

2023-05-31

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.

Conditions

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Paediatric Palliative Care

Keywords

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Paediatrics Palliative Care

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention Group

Patients enrolled in the Specialised Paediatric Palliative Care (SPPC) programme at the University Children's Hospital Zurich.

Group Type ACTIVE_COMPARATOR

Specialised Paediatric Palliative Care (SPPC)

Intervention Type OTHER

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.

Comparison Group

Patients treated at the Children's Hospital Aarau, University Children's Hospital Basel, and the University Hospital Inselspital Bern.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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


* 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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Basel

OTHER

Sponsor Role collaborator

Cantonal Hospital of Aarau, Switzerland

OTHER

Sponsor Role collaborator

University Children's Hospital Basel

OTHER

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role collaborator

University Children's Hospital, Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karin Zimmermann, PhD RN

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital, Zurich

Locations

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Cantonal Children's Hospital

Aarau, , Switzerland

Site Status

University Children's Hospital

Basel, , Switzerland

Site Status

Department of Pediatrics, University Hospital Inselspital

Bern, , Switzerland

Site Status

University Children's Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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Mitterer S, Zimmermann K, Fink G, Simon M, Gerber AK, Bergstrasser E. Hospitalization- and death-related financial and employment effects in parents of children with life-limiting conditions: a fixed-effects analysis. Eur J Pediatr. 2024 Oct;183(10):4215-4227. doi: 10.1007/s00431-024-05680-7. Epub 2024 Jul 10.

Reference Type DERIVED
PMID: 38985175 (View on PubMed)

Gerber AK, Feuz U, Zimmermann K, Mitterer S, Simon M, von der Weid N, Bergstrasser E. Work-related quality of life in professionals involved in pediatric palliative care: a repeated cross-sectional comparative effectiveness study. Palliat Care Soc Pract. 2024 May 9;18:26323524241247857. doi: 10.1177/26323524241247857. eCollection 2024.

Reference Type DERIVED
PMID: 38737405 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36324132 (View on PubMed)

Other Identifiers

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2019-INV-001

Identifier Type: -

Identifier Source: org_study_id