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RecruitingNCT06437444Updated Sep 19, 2025

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. Recruiting at 1 site in Spain. Per ClinicalTrials.gov, last updated 2025-09-19.

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

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.

02

Conditions studied

  • Asthma in Children
  • Implementation Science
03

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
04

Study design

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

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.

05

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

06

Study locations

1 of 1 sites recruiting
07

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

08

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 (estimated)
Completion
May 7, 2026 (estimated)
Last update
Sep 19, 2025

Study contacts

Alvaro Sanchez Perez
Contact
ALVARO.SANCHEZPEREZ@osakidetza.eus
(+34)946006673

Oversight

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

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