Transmural Care for Chronically Ill Children: Scientific Guidance and Evaluation of Pilot Projects (PETRACA)

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Parents; Health Personnel; Chronic Diseases in Children; Chronic Diseases in Adolescence
• Intervention / Treatment: Other: Pilot project paediatric transmural care

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

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires Saint-Luc
  • Bruxelles, Belgium, 1020
    • Hôpital Universitaire des Enfants Reine Fabiola
  • Charleroi, Belgium, 6041
    • Institut de Pathologie et de Génétique Charleroi
  • Edegem, Belgium, 2650
    • University Hospital Antwerp
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Jette, Belgium, 1090
    • Universitair Ziekenhuis Brussel
  • La Louvière, Belgium, 7100
    • Centre Hospitalier Jolimont-Lobbes
  • Leuven, Belgium, 3000
    • Universitaire Ziekenhuizen Leuven
  • Liège, Belgium, 4000
    • Centre Hospitalier Regional de la Citadelle
  • Liège, Belgium, 4000
    • Clinique CHC MontLégia
  • Liège, Belgium, 4000
    • Centre Hospitaliere Universitaire de Liège

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; The implementation of pilot projects for transmural care for chronically ill children
Parents; Parents/ legal guardians of children included in a pilot project for paediatric transmural care	Other: Pilot project paediatric transmural care; The implementation of pilot projects for transmural care for chronically ill children
Healthcare professionals; Project coordinators and healtcare professionals involved in a pilot project for paediatric transmural care	Other: Pilot project paediatric transmural care; The implementation of pilot projects for transmural care for chronically ill children

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Universitaire Ziekenhuizen KU Leuven; Universitair Ziekenhuis Brussel; University Hospital, Antwerp; Centre Hospitalier Régional de la Citadelle; Centre Hospitalier Universitaire de Liege; CHC MontLégia; Cliniques universitaires Saint-Luc; Centre Hospitalier Jolimont-Lobbes; Institut de Pathologie et de Génétique Charleroi; Hôpital universitaire des enfant Reine Fabiola
• Investigators: Principal Investigator: Sabine Van daele, Prof. dr., University Hospital, Ghent; Principal Investigator: Veerle Duprez, dr., University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2024
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Estimated): November 7, 2024

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Adolescent; Child; Infant; Chronic Disease; Home Care Services, Hospital-Based; Realist Evaluation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: B670204000193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No