NCT06679595

Brief Summary

The goal of this Realist Evaluation is to evaluate the implementation of pilot projects for transmural care in chronically ill children. The main question it aims to answer is: To what extent and how do the pilot projects for transmural care for chronically ill children provide an answer to the quintuple aim? Participants will

  • Complete questionnaires at three timepoints
  • Participate in focus group interviews

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

11 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2024

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

November 7, 2024

Status Verified

October 1, 2024

Enrollment Period

1.5 years

First QC Date

October 9, 2024

Last Update Submit

November 6, 2024

Conditions

Chronic Diseases in ChildrenChronic Diseases in AdolescenceHealth PersonnelParents

Keywords

Realist EvaluationChronic DiseaseChildAdolescentInfantHome Care Services, Hospital-Based

Outcome Measures

Primary Outcomes (16)

  • Quality of Life

    Quality of Life is used as an indicator for the aim "health status". The PedsQL (Paediatric Quality of Life Inventory) 4.0 Generic Core Scales is used to measure health-related quality of life in children and adolescents ages 2 to 18. The scale consists of 23 items and has a child self-report and parallel proxy-report format for ages 5-7, 8-12 and 13-18 years. The items are scored on a five-point Likert-scale, ranging from "never a problem" to "almost always a problem";.

    Baseline, 6 months and through study completion, up to 18 months maximum.

  • Parental Quality of Life

    Quality of Life is used as an indicator for the aim "health status". To estimate parent's quality of life, the take care tool (4 domains, 16 items) is used. The items are scored on a three-point Likert-scale, ranging from "Satisfied" to "Not satisfied".

    Baseline, 6 months and through study completion, up to 18 months maximum.

  • Caregiver burden

    Caregiver burden is used as an indicator for the aim "health status". The 4-item version of the Zarit Burden Interview is used to estimate the caregiver burden for the parents. The items are scored on a five-point Likert-scale, ranging from "Never" tot "Nearly Always"

    Baseline, 6 months and through study completion, up to 18 months maximum.

  • Diagnosis

    The diagnosis and date of diagnosis of the participant are collected as an indicator for the aim "health status". These data will be extracted from the (electronic) patient records.

    Through study completion, up to 18 months maximum.

  • Length of stay in the hospital

    The length of stay in the hospital, prior to the start of the transmural care of the participant are collected as an indicator for the aim "health status". These data will be extracted from the (electronic) patient records.

    Through study completion, up to 18 months maximum.

  • Length of stay in transmural care

    The length of stay in transmural care, measured by counting the total number of days each child receives this care, is an indicator for the aim "health status". These data will be extracted from the (electronic) patient records.

    Through study completion, up to 18 months maximum.

  • Transmural care at school

    If transmural care has been given at school, was evaluated as an indicator for the aim "health status". These data will be extracted from the (electronic) patient records.

    Through study completion, up to 18 months maximum.

  • Adverse events

    Adverse events are logged as an indicator for the aims "health status" and "quality of care". Adverse events are continuously logged by the project coordinators in a self-developed questionnaire.

    Continuous data collection, until study completion (18 months)

  • Patient experience

    Patient experience is used as an indicator for the aim "quality of care". Patient experience is measured among children (or by proxy under the age of 8) and among their parents. To avoid lengthy statements, a questionnaire was developed by the researchers for this purpose. The items are scored on a five-point Likert-scale, ranging from "Strongly disagree" to "Strongly agree".

    Baseline, 6 months and through study completion, up to 18 months maximum.

  • Parental Empowerment

    Parental empowerment is used as an indicator for the aim "quality of care". Patient empowerment is the patient's ability to have control over their health and their ability to be involved in care. In paediatrics, parents advocate strongly for what they feel is best for their child and family and want to feel they are able to make disicions. Therefore, the empowerment of parents is questioned. A questionnaire was developed by the researchers for this purpose. The items are scored on a five-point Likert-scale, ranging from "Strongly disagree" to "Strongly agree".

    Baseline, 6 months and through study completion, up to 18 months maximum.

  • Job Satisfaction

    Job Satisfaction is used as an indicator for the aim "value healthcare professionals". The Michigan Organizational Assessment Questionnaire Job Satisfaction Subscale (MOAQ-JSS) is used to measure job satisfaction among the healthcare professionals involved. The three items are scored on a five-point Likert-scale, ranging from "Strongly disagree" to "Strongly agree".

    Baseline, 6 months and through study completion, up to 18 months maximum.

  • Work-related stress

    Work-related stress is used as an indicator for the aim "value healthcare professionals". Work-related stress is measured using a single question developed by the researchers. The item is scored on a five-point Likert-scale, ranging from "Strongly disagree" to "Strongly agree".

    Baseline, 6 months and through study completion, up to 18 months maximum .

  • Quality of Work

    Quality of Work is used as an indicator for the aim "value healthcare professionals". The dimension Quality of Work of the COPSOQ II is used to measure the experience by the healthcare professional of the immediate output of work. The two items are scored on a five-point Likert-scale, ranging from "To a very large extent" to "To a very small extent".

    Baseline, 6 months and through study completion, up to 18 months maximum.

  • Competence and Training

    Competence and Training is used as an indicator for the aim "value healthcare professionals". It is important that the healthcare professional providing care at home with children has solid paediatric competencies and experience. Competence and training are questioned among healthcare professionals, using a self-developed questionnaire.

    Baseline, 6 months and through study completion, up to 18 months maximum.

  • Socio-demographic variables

    Socio-demographic variables are used as an indicator for the aim "equity and inclusion". These variables are questioned among parents and healthcare professionals.

    Baseline, 6 months and through study completion, up to 18 months maximum.

  • Socio-economic variables

    Socio-economic variables are used as an indicator for the aim "equity and inclusion". Financial status, education, employment status and productivity loss based on the iCPQ are questioned among parents.

    Baseline, 6 months and through study completion, up to 18 months maximum.

Study Arms (3)

Children

Children up to the age of 18 with a chronic condition included in a pilot project for paediatric transmural care

Other: Pilot project paediatric transmural care

Parents

Parents/ legal guardians of children included in a pilot project for paediatric transmural care

Other: Pilot project paediatric transmural care

Healthcare professionals

Project coordinators and healtcare professionals involved in a pilot project for paediatric transmural care

Other: Pilot project paediatric transmural care

Interventions

Pilot project paediatric transmural careOTHER

The implementation of pilot projects for transmural care for chronically ill children

ChildrenHealthcare professionalsParents

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The setting of the study is defined as the five pilot projects for paediatric transmural care, conducted by Belgian acute care hospitals in collaboration with primary care. These projects focus on transfusions of concentrated red blood cells at home, ventilation of children with a respiratory disease at home, home enzyme therapy by infusion for children suffering from lysosomal metabolic disease and early discharge of neonates with (partial) tube feeding. The study population consists of the people for whom the services offered by the pilot project are intended as defined in the implementation plan. This study population can be divided into four subgroups: the patients (children), their parents/legal guardians, healthcare professionals involved and the coordinators of the pilot projects.

You may qualify if:

  • Children: any child up to the age of 18 participating in a pilot project for paediatric transmural care.
  • Parent/Legal guardian: any parent or legal guardian of a child participating in a pilot project for paediatric transmural care
  • Healthcare professionals: any healthcare professional with patient contact involved within a pilot project for paediatric transmural care
  • Coordinators: all study and care coordinators involved within a pilot project for paediatric transmural care

You may not qualify if:

  • No signed informed consent form available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Hôpital universitaire des enfants Reine Fabiola

Brussels, 1020, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Institut de Pathologie et de Génétique Charleroi

Charleroi, 6041, Belgium

Location

University Hospital Antwerp

Edegem, 2650, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Universitair Ziekenhuis Brussel

Jette, 1090, Belgium

Location

Centre Hospitalier Jolimont-Lobbes

La Louvière, 7100, Belgium

Location

Universitaire Ziekenhuizen Leuven

Leuven, 3000, Belgium

Location

Centre Hospitalier Régional de la Citadelle

Liège, 4000, Belgium

Location

Centre Hospitaliere Universitaire de Liège

Liège, 4000, Belgium

Location

Clinique CHC MontLégia

Liège, 4000, Belgium

Location

Related Publications (1)

  • Dequeker S, Vanderwee K, Van Daele S, Duprez V; PETRACA Study Group. Realist evaluation of Belgian pilot projects for paediatric transmural care: protocol for a mixed methods study. BMJ Open. 2025 Jun 25;15(6):e102152. doi: 10.1136/bmjopen-2025-102152.

    PMID: 40562551DERIVED

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sabine Van daele, Prof. dr.

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

  • Veerle Duprez, dr.

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2024

First Posted

November 7, 2024

Study Start

September 10, 2024

Primary Completion

February 28, 2026

Study Completion

February 28, 2026

Last Updated

November 7, 2024

Record last verified: 2024-10

Locations

BE(11)