An observational study in Chronic Diseases in Children, Chronic Diseases in Adolescence and Health Personnel, sponsored by University Hospital, Ghent. Enrolling by invitation at 11 sites in Belgium. Per ClinicalTrials.gov, last updated 2024-11-07.
Sponsored by University Hospital, Ghent · Observational
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
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
990 studies on the registry are indexed under Chronic Disease; 178 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 419 across 249 observational studies indexed under Chronic Disease.
Browse Chronic Disease studies →University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.
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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.
Exclusion Criteria:
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/ legal guardians of children included in a pilot project for paediatric transmural care
Other: Pilot project paediatric transmural care
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
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";.
Time frame: 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".
Time frame: 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"
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: 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".
Time frame: 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".
Time frame: 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".
Time frame: 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".
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 months and through study completion, up to 18 months maximum.
Plan to share: Undecided
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University Hospital, Ghent