Clinical trial NCT06679595: Transmural Care for Chronically Ill Children: Scientific Guidance and Evaluation of Pilot Projects
Official title: Transmural Care for Chronically Ill Children: Scientific Guidance and Evaluation of Pilot Projects
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Chronic Diseases in Children
Chronic Diseases in Adolescence
Health Personnel
Parents
Keywords: Realist Evaluation
Chronic Disease
Child
Adolescent
Infant
Home Care Services, Hospital-Based
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Regional de la Citadelle
name: Centre Hospitalier Jolimont-Lobbes
name: University Hospital, Antwerp
name: Universitaire Ziekenhuizen KU Leuven
name: Centre Hospitalier Universitaire de Liege
name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Universitair Ziekenhuis Brussel
name: Institut de Pathologie et de Génétique Charleroi
name: CHC Montlegia
name: Hôpital universitaire des enfant Reine Fabiola
First posted: 2024-11-07
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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

Detailed description: Introduction Chronic diseases have been increasing over the past few years, including in children. The chronic condition affects their daily functioning and quality of life and leads to frequent hospital admissions. To avoid unneccessary hospital admissions and to offer alternative and innovative forms of care, the Belgian Federal Public Service of Public Health, Food Chain Safety and Environment selected five pilot projects for transmural care for chronically ill children. This study was designed to evaluate these projects.

Methods and design The overall approach is a two-year longitudinal prospective Realist Evaluation using a mixed-methods design.

The quantitative strand, using routine data and questionnaires, will examine whether data from children, parents/legal guardians and healthcare professionals involved in a pilot project for paediatric transmural care comply with the quintuple aim outcomes.

The qualitative strand will be used (1) to evaluate the structure of the interventions, (2) for process evaluation and context analysis, and (3) to gather more in-depth information. This includes document analysis (including logbooks), focus groups with children, parents/legal guardians and healthcare professionals, and non-participatory observations.

Ethical Informed consent is required prior to inclusion in the evaluation study. Informed assent is requested from children older than 12 years. For this study, advice is asked from the Research Ethics Committee of Ghent University Hospital

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* No signed informed consent form available

Primary outcomes:
measure: Quality of Life
timeFrame: Baseline, 6 months and through study completion, up to 18 months maximum.
measure: Parental Quality of Life
timeFrame: Baseline, 6 months and through study completion, up to 18 months maximum.
measure: Caregiver burden
timeFrame: Baseline, 6 months and through study completion, up to 18 months maximum.
measure: Diagnosis
timeFrame: Through study completion, up to 18 months maximum.
measure: Length of stay in the hospital
timeFrame: Through study completion, up to 18 months maximum.
measure: Length of stay in transmural care
timeFrame: Through study completion, up to 18 months maximum.
measure: Transmural care at school
timeFrame: Through study completion, up to 18 months maximum.
measure: Adverse events
timeFrame: Continuous data collection, until study completion (18 months)
measure: Patient experience
timeFrame: Baseline, 6 months and through study completion, up to 18 months maximum.
measure: Parental Empowerment
timeFrame: Baseline, 6 months and through study completion, up to 18 months maximum.
measure: Job Satisfaction
timeFrame: Baseline, 6 months and through study completion, up to 18 months maximum.
measure: Work-related stress
timeFrame: Baseline, 6 months and through study completion, up to 18 months maximum .
measure: Quality of Work
timeFrame: Baseline, 6 months and through study completion, up to 18 months maximum.
measure: Competence and Training
timeFrame: Baseline, 6 months and through study completion, up to 18 months maximum.
measure: Socio-demographic variables
timeFrame: Baseline, 6 months and through study completion, up to 18 months maximum.
measure: Socio-economic variables
timeFrame: Baseline, 6 months and through study completion, up to 18 months maximum.
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Hôpital universitaire des enfants Reine Fabiola
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Charleroi
country: Belgium
facility: Institut de Pathologie et de Génétique Charleroi
city: Edegem
country: Belgium
facility: University Hospital Antwerp
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: La Louvière
country: Belgium
facility: Centre Hospitalier Jolimont-Lobbes
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
city: Liège
country: Belgium
facility: Centre Hospitalier Régional de la Citadelle
city: Liège
country: Belgium
facility: Centre Hospitaliere Universitaire de Liège
city: Liège
country: Belgium
facility: Clinique CHC MontLégia
Study officials:
affiliation: University Hospital, Ghent
name: Sabine Van daele, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Ghent
name: Veerle Duprez, dr.
role: PRINCIPAL_INVESTIGATOR
References: