Effectiveness of Specialised Paediatric Palliative Care

NCT04236180 | Completed DMC

• 1 other identifier: 2019-INV-001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 4

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.

Conditions

Paediatric Palliative Care

Keywords

Paediatrics; Palliative Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in Child's QOL - DISABKIDS Chronic Generic Measure (DCGM-37) Questionnaire

  Up to day 330 after study entry

• Change in child's symptoms - Memorial Symptom Assessment Scale (MSAS) Questionnaire

  Up to day 330 after study entry

• Change in Siblings QOL - KIDSSCREEN-27 Questionnaire

  Up to day 630 after study entry

• Professional's QOL (ProQOL) Questionnaire

  Cross-sectional at the end of study year 1

• Professional's QOL (ProQOL) Questionnaire

  Cross-sectional at the end of study year 2

Other Outcomes (11)

• Number of hospital admissions as assessed longitudinally via chart review

  Up to day 330 after study entry

• Number of resuscitations

  Up to day 330 after study entry

• Number of invasive procedures

  Up to day 330 after study entry

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

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

Other: Specialised Paediatric Palliative Care (SPPC)

Comparison Group

NO INTERVENTION

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

Interventions

Specialised Paediatric Palliative Care (SPPC) 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.

Intervention Group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead
• University of Basel: collaborator
• Cantonal Hospital of Aarau, Switzerland: collaborator
• University Children's Hospital Basel: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator

Study Sites (4)

Cantonal Children's Hospital

Aarau, Switzerland

Location

University Children's Hospital

Basel, Switzerland

Location

Department of Pediatrics, University Hospital Inselspital

Bern, Switzerland

Location

University Children's Hospital Zurich

Zurich, 8032, Switzerland

Location

Related Publications (3)

• 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.

  PMID: 38985175 DERIVED

• 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.

  PMID: 38737405 DERIVED

• 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.

  PMID: 36324132 DERIVED

Study Officials

• Karin Zimmermann, PhD RN

  University Children's Hospital, Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: January 22, 2020
• Study Start: November 5, 2019
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (4)