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

Asthma in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06437444
• Other study ID #: 2021111010
• Status: Recruiting
• Phase: N/A
• Start date: May 7, 2024
• Est. completion date: May 7, 2026

Study information

• Verified date: June 2024
• Source: Basque Health Service
• Contact: Alvaro Sanchez Perez
• Phone: (+34)946006673
• Email: ALVARO.SANCHEZPEREZ[@]osakidetza.eus
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the effect of the implementation of the new Asthma 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 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 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 Care Pathway to the rest of the Basque Health Service IHOs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 249
• Est. completion date: May 7, 2026
• Est. primary completion date: May 7, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 05/07/2024 and the 05/07/2025, 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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children
• Implementation Science
• Inappropriate Prescribing

Intervention

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. Audit & Feedback (A&F) data reports, sent every two weeks, 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.

Locations

Country	Name	City	State
Spain	Primary Care Research Unit of Bizkaia	Barakaldo	Bizkaia

Sponsors (2)

Lead Sponsor	Collaborator
Basque Health Service	Health Department of the Basque Government

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 and 24 months
Secondary	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 and 24 months
Secondary	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 and 24 months
Secondary	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 and 24 months