Transmural Care for Chronically Ill Children: Scientific Guidance and Evaluation of Pilot Projects
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,000
- 试验地点
- 11
- 主要终点
- Quality of Life
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •No signed informed consent form available
结局指标
主要结局
Quality of Life
时间窗: Baseline, 6 months and through study completion, up to 18 months maximum.
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";.
Parental Quality of Life
时间窗: Baseline, 6 months and through study completion, up to 18 months maximum.
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".
Caregiver burden
时间窗: Baseline, 6 months and through study completion, up to 18 months maximum.
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"
Diagnosis
时间窗: Through study completion, up to 18 months maximum.
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.
Length of stay in the hospital
时间窗: Through study completion, up to 18 months maximum.
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.
Length of stay in transmural care
时间窗: Through study completion, up to 18 months maximum.
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.
Transmural care at school
时间窗: Through study completion, up to 18 months maximum.
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.
Adverse events
时间窗: Continuous data collection, until study completion (18 months)
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.
Patient experience
时间窗: Baseline, 6 months and through study completion, up to 18 months maximum.
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".
Parental Empowerment
时间窗: Baseline, 6 months and through study completion, up to 18 months maximum.
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".
Job Satisfaction
时间窗: Baseline, 6 months and through study completion, up to 18 months maximum.
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".
Work-related stress
时间窗: Baseline, 6 months and through study completion, up to 18 months maximum .
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".
Quality of Work
时间窗: Baseline, 6 months and through study completion, up to 18 months maximum.
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".
Competence and Training
时间窗: Baseline, 6 months and through study completion, up to 18 months maximum.
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.
Socio-demographic variables
时间窗: Baseline, 6 months and through study completion, up to 18 months maximum.
Socio-demographic variables are used as an indicator for the aim "equity and inclusion". These variables are questioned among parents and healthcare professionals.
Socio-economic variables
时间窗: Baseline, 6 months and through study completion, up to 18 months maximum.
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.
次要结局
未报告次要终点