NCT06437444 Asthma Crisis in Paediatrics: Impact of a Care Pathway in Primary and Hospital Care
| NCT ID | NCT06437444 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Basque Health Service |
| Condition | Asthma in Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 249 participants |
| Start Date | 2023-05-07 |
| Primary Completion | 2026-05-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 249 participants in total. It began in 2023-05-07 with a primary completion date of 2026-05-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to evaluate the effect of the implementation of the new Asthma Integrated Care Pathway in the Basque Healthcare Service for the improvement of care for children with asthma attacks and the reduction of variability between professionals and care settings in this care practice. Asthma is the most common chronic disease in children and has a major impact on people's quality of life. The Asthma Integrated Care Pathway is a structured multidisciplinary care plan that details the essential steps in the care of patients with mild-moderate asthma attacks and the coordinated practice of the agents involved as dictated by the evidence. This pathway will include quality indicators of compliance with diagnostic criteria, assessment of severity and prescription of drugs, as well as the experience of families and professionals, which have been collected in meetings designed for this purpose. The study consists in a mixed methods implementation trial with two phases: 1. Phase I: a quantitative evaluation will be carried out to assess implementation outcomes at the professional level through a pretest-posttest quasi-experimental study with paired control group, with a ratio of 1:2. The primary outcome variable will be the overall percentage of bronchodilator treatment with a spacer chamber in children diagnosed with mild-moderate asthma attacks. We will also include as outcomes to be measured the registration rate of the Pulmonary Score, the recording rate of the assessment of persistent asthma symptoms, and the rate of initiation of background treatment in children with persistent asthma symptoms. These variables will be analysed using differences in pre- and post-intervention outcome measures between the intervention and control groups. 2. Phase II: a qualitative evaluation will be carried out through a structured process with discussion groups focused on the identification of the main barriers and facilitators for the provision of recommended clinical practice related to asthmatic crisis in mild-moderate cases established by the Asthma Integrated Care Pathway. A purposive sample of paediatricians stratified by level of care and service organisations will be recruited to ensure that all views are represented in the discussion groups. The structured script will be designed with questions to explore each of the domains of the Theoretical Domains Framework (TDF). The study will be carried out mainly in two integrated healthcare organizations (IHO), which are made up of two primary care areas and the paediatric reference hospital emergency department of both areas, as well as the hospitalisation, intensive care and paediatric pneumology departments of said hospital, to extend in the future the Asthma Integrated Care Pathway to the rest of the Basque Health Service IHOs.
Eligibility Criteria
Eligibility for professionals: * Primary Care paediatricians and nurses * Paediatricians and nurses in the Paediatric Emergency Department * Paediatricians and nurses on the inpatient ward * Paediatric Intensive Care paediatricians and nurses * Paediatric Pneumology paediatricians and nurses Eligibility for patients: Patients between 2 and 14 years,that have being attended between the 7 May 2023 and the 7 May 2025, and with an acute episode of asthma, defined as: * an episode of wheezing and a previous diagnosis of asthma or with a previous episode of wheezing * a first episode in a child older than 2 years with a personal/family history of atopy and/or with an objective response to bronchodilators as assessed by the Pulmonary Score
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06437444 clinical trial?
This trial is open to participants of all sexes, studying Asthma in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06437444 currently recruiting?
Yes, NCT06437444 is actively recruiting participants. Contact the research team at ALVARO.SANCHEZPEREZ@osakidetza.eus for enrollment information.
Where is the NCT06437444 trial being conducted?
This trial is being conducted at Barakaldo, Spain.
Who is sponsoring the NCT06437444 clinical trial?
NCT06437444 is sponsored by Basque Health Service. The trial plans to enroll 249 participants.
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