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CompletedNCT06437444Updated Oct 1, 2026

Asthma Crisis in Paediatrics: Impact of a Care Pathway in Primary and Hospital Care

An interventional study of The implementation strategy to encourage the adoption of the Care Pathway in Asthma in Children and Implementation Science, sponsored by Basque Health Service. Completed at 1 site in Spain. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Basque Health Service · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled May 2023, registered May 2024).
Updated Oct 1, 2026Now CompletedEnrollment updatedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
249
Allocation
Non-randomized
Sex
All
01

Study 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.

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Conditions studied

  • Asthma in Children
  • Implementation Science

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03

In context

Asthma

4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.

This study's enrollment of 249 is above the median of 78 across 3,341 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Basque Health Service is the lead sponsor of 57 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
249 participants (actual)

Study arms

  • Experimental
    Asthma Care Pathway group

    All the primary care and hospital pediatricians of the two Integrated Hospital Organizations (IHO) (Barakaldo-Sestao and Ezkerraldea-Enkarterri-Cruces) where the care pathway will be implemented. 83 participants in total.

    Behavioral: The implementation strategy to encourage the adoption of the Care Pathway

  • No intervention
    Control

    Primary care and hospital pediatricians of other IHOs where the care pathway is not implemented, but with similar characteristics to those in the experimental group, and with a proportion of 1:2. 166 participants in total.

Interventions

  • BehavioralThe implementation strategy to encourage the adoption of the Care Pathway

    1. Dissemination of the most novel aspects of the agreed Care Pathway via corporate mail. 2. Integration of information and communication tools into electronic health records to facilitate the recording and the standardized implementation of recommended practice. 3. Audit \& Feedback (A\&F) data reports, sent monthly, to each paediatrician on the rate of prescription of bronchodilators administered with a spacer chamber, together with the rates of the other indicators established in the pathway, in their health centre and in the rest of the centres in the participating health areas. 4. Interactive training sessions, in which epidemiological data and data on the health, economic and social impact of asthma attacks were presented, together with data on other indicators associated with the care pathway, and key messages on current treatment recommendations based on the latest clinical practice. 5. Distribution of reminder posters in paediatrics consultations, PEDs and health centers.

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What researchers measure

Primary outcomes

  1. Percentage of bronchodilator treatment

    The overall percentage of bronchodilator treatment with a spacer chamber in children diagnosed with mild-moderate asthma attacks.

    Time frame: from baseline to 12 months, 24 months and 36 months

Secondary outcomes

  1. Pulmonary Score registration

    Rate of Pulmonary Score registration in children diagnosed with mild-moderate asthma attacks, at all levels of care.

    Time frame: from baseline to 12 months, 24 months and 36 months

  2. Assessment and recording of persistent asthma symptoms.

    Rate of assessment and recording of persistent asthma symptoms in children diagnosed with mild-moderate asthma attacks by ussing the PACT form (Pediatric Asthma Control Tool).

    Time frame: from baseline to 12 months, 24 months and 36 months

  3. Initiation of background treatment in children with persistent asthma symptoms

    Rate of initiation of background treatment in children who have been assessed and registered with persistent asthma symptoms.

    Time frame: from baseline to 12 months, 24 months and 36 months

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Study locations

1 site
  • Primary Care Research Unit of Bizkaia
    Barakaldo, Bizkaia 48903, Spain
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References and documents

Publications

  • Montejo M, Paniagua N, Sanchez A, Rueda-Etxebarria M, Pijoan JI, Saiz Hernando C, Martin V, Vazquez Ronco MA, Santiago Burruchaga M, Garcia Urabayen D, Perez Llarena G, Castelo S, Benito J. Improving the management of acute asthma in children through an integrated care pathway: an implementation study protocol. Front Pediatr. 2025 Aug 19;13:1646499. doi: 10.3389/fped.2025.1646499. eCollection 2025. PubMed 40904739 ↗

Individual participant data

Plan to share: Yes — Individual participant data will be shared that underlie results reported in the publication, after deidentification.

Supporting information: Study protocol

Time frame: Starting 6 months after the publication of results

Access criteria: Since data supporting the present study will mostly concern routine data retrieved from the electronic health record of the Basque Health Service-Osakidetza, it will be only shared on justified request to the study guarantors (proposals should be directed to the Responsible Party). It will only be shared with researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

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Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2023 to primary completion in May 2026, 36 months.

Of 599 non-industry interventional studies with no phase under Asthma, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 50. This study's 36 months is above that.

Counting every sponsor, half of 649 studies reached it within 23 months; a quarter within 10 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
May 26, 2024
First posted
May 31, 2024
StartActual
May 7, 2023
Primary completionActual
May 7, 2026
CompletionActual
May 7, 2026
Last update
Oct 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    Recruiting→Completed
    + 4 other changes: date precision, oversight details, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT06437444
Lead sponsor
Basque Health Service
Collaborators
Basque Government Department of Public Health
Responsible party
Marta Montejo Fernandez (Principal Investigator, Basque Health Service) — Principal investigator
First posted
May 31, 2024
Start date
May 7, 2023
Primary completion
May 7, 2026
Completion
May 7, 2026
Last update
Oct 1, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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