Actively Recruiting

Phase Not Applicable
All Genders
NCT06437444

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

Led by Basque Health Service · Updated on 2025-09-19

249

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

B

Basque Health Service

Lead Sponsor

H

Health Department of the Basque Government

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged between 2 and 14 years
  • Patients attended between May 7, 2023, and May 7, 2025
  • Patients with an acute asthma episode defined as wheezing with previous asthma diagnosis or previous wheezing episode
  • Patients with a first wheezing episode after age 2 with personal or family history of atopy or positive response to bronchodilators as assessed by Pulmonary Score
  • Primary care pediatricians and nurses
  • Pediatricians and nurses in the Pediatric Emergency Department
  • Pediatricians and nurses on inpatient wards
  • Pediatric Intensive Care pediatricians and nurses
  • Pediatric Pneumology pediatricians and nurses
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

Primary Care Research Unit of Bizkaia

Barakaldo, Bizkaia, Spain, 48903

Actively Recruiting

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Research Team

A

Alvaro Sanchez Perez

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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