Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06437444
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-05-26
Brief Title:
Asthma Crisis in Paediatrics Impact of a Care Pathway in Primary and Hospital Care
Sponsor:
Basque Health Service
Organization:
Basque Health Service
Study Overview
Official Title:
Asthma Crisis in Paediatrics Impact of a Care Pathway in Primary and Hospital Care
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 peoples 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 12 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
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 12 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None