Scaling up the Integrated Care Pathway for Acute Asthma to All Osakidetza Pediatric Services Thro… (NCT07642388) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Scaling up the Integrated Care Pathway for Acute Asthma to All Osakidetza Pediatric Services Through a Cluster-randomized SMART Design
Spain4,680 participantsStarted 2026-07-01
Plain-language summary
The main goal of this study is to evaluate the effectiveness of adaptive sequential implementation strategies based on facilitation in promoting the sustainable and widespread adoption and scaling up of the Integrated Care Pathway for Acute Asthma - ASMAbat across all Primary Care and Hospital Pediatric Services of Osakidetza - Basque Health Service.
Who can participate
Age range
2 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Eligibility for healthcare settings:
\- All Pediatric Services (Primary Care n=108 and Hospital Care n=9) from 11 of the 13 Osakidetza Integrated Healthcare Organizations that are not currently implementing the ASMAbat Pathway.
Eligibility for professionals:
* Primary Care pediatricians and nurses
* Pediatricians and nurses in the Pediatric Emergency Department
* Pediatricians and nurses on the inpatient ward
* Pediatric Intensive Care pediatricians and nurses
* Pediatric Pneumology pediatricians and nurses
Eligibility for patients:
Patients between 2 and 14 years that have being attended between the 1st of July 2026 and the 28th of February 2029, 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 a severity Score
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial isn't recruiting yet — do you know when it might open, and would it even make sense for us to wait for it before starting treatment for my child's asthma?
2The trial is measuring whether more doctors properly record bronchodilator treatment during asthma attacks — since it's testing a care process rather than a new drug, what would actually be different about how my child is treated if we were in the trial versus receiving standard care right now?
3This study uses a cluster-randomized design, meaning whole pediatric services are assigned to the new pathway rather than individual patients choosing — can you explain what that means for my child's options and whether we would even have a choice about participating?
4Since this trial is focused on improving care documentation and pathways rather than testing a new medication, do you think my child's acute asthma management is already following best-practice guidelines, or is there a gap this kind of study is trying to address?
5Are there existing integrated care pathways for pediatric acute asthma that my child could benefit from right now, without waiting for this trial to begin recruiting?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the registration rate of bronchodilator treatment
Timeframe: Change from period 1 (baseline to 8 months) to period 2 (8 to 16 months); from period 1 or 2 to period 3 (16 to 24 months); and from period 3 to period 4 (24 to 32 months)