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

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma in Children; Implementation Science
• Intervention / Treatment: Behavioral: The implementation strategy to encourage the adoption of the Care Pathway

• Study Type: Interventional
• Enrollment (Estimated): 249
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alvaro Sanchez Perez; Phone Number: (+34)946006673; Email: ALVARO.SANCHEZPEREZ@osakidetza.eus

Study Locations

• Spain
  • Bizkaia
    • Barakaldo, Bizkaia, Spain, 48903
      • Recruiting
      • Primary Care Research Unit of Bizkaia
      • Contact: Alvaro Sanchez Perez; Phone Number: (+34)946006673; Email: ALVARO.SANCHEZPEREZ@osakidetza.eus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Dissemination of the most novel aspects of the agreed Care Pathway via corporate mail.; Integration of information and communication tools into electronic health records to facilitate the recording and the standardized implementation of recommended practice.; 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.; 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.; Distribution of reminder posters in paediatrics consultations, PEDs and health centers.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of bronchodilator treatment	The overall percentage of bronchodilator treatment with a spacer chamber in children diagnosed with mild-moderate asthma attacks.	from baseline to 12 months, 24 months and 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary Score registration	Rate of Pulmonary Score registration in children diagnosed with mild-moderate asthma attacks, at all levels of care.	from baseline to 12 months, 24 months and 36 months
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).	from baseline to 12 months, 24 months and 36 months
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.	from baseline to 12 months, 24 months and 36 months

Collaborators and Investigators

• Sponsor: Basque Health Service
• Collaborators: Health Department of the Basque Government

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2023
• Primary Completion (Estimated): May 7, 2026
• Study Completion (Estimated): May 7, 2026

Study Registration Dates

• First Submitted: May 26, 2024
• First Submitted That Met QC Criteria: May 26, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: 2021111010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data will be shared that underlie results reported in the publication, after deidentification.
• IPD Sharing Time Frame: Starting 6 months after the publication of results
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No