Clinical trial NCT06437444: Asthma Crisis in Paediatrics: Impact of a Care Pathway in Primary and Hospital Care
Official title: Asthma Crisis in Paediatrics: Impact of a Care Pathway in Primary and Hospital Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma in Children
Implementation Science
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
Collaborators: name: Health Department of the Basque Government
First posted: 2024-05-31
Enrollment: 249
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quasi-experimental pre-post cluster trial with control group
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Percentage of bronchodilator treatment
timeFrame: from baseline to 12 months, 24 months and 36 months
Secondary outcomes:
measure: Pulmonary Score registration
timeFrame: from baseline to 12 months, 24 months and 36 months
measure: Assessment and recording of persistent asthma symptoms.
timeFrame: from baseline to 12 months, 24 months and 36 months
measure: Initiation of background treatment in children with persistent asthma symptoms
timeFrame: from baseline to 12 months, 24 months and 36 months
Other outcomes:
Locations:
city: Barakaldo
country: Spain
facility: Primary Care Research Unit of Bizkaia
state: Bizkaia
Study officials:
References: