## Protocol Section
### Identification Module
**NCT ID:** NCT06437444

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 2021111010
#### Organization
**Class:** OTHER_GOV
**Full Name:** Basque Health Service
### Status Module
#### Completion Date
**Date:** 2026-05-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-26

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-05-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-07

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Health Department of the Basque Government

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Basque Health Service

#### Responsible Party

**Investigator Affiliation:** Basque Health Service

**Investigator Full Name:** Marta Montejo Fernandez

**Investigator Title:** Pediatrician

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 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.

### Conditions Module

**Conditions:**

- Asthma in Children

- Implementation Science

- Inappropriate Prescribing

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Quasi-experimental pre-post cluster trial with control group

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 249

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Behavioral: The implementation strategy to encourage the adoption of the Care Pathway

**Label:** Asthma Care Pathway group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Label:** Control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Asthma Care Pathway group

**Description:** 1. Dissemination of the most novel aspects of the agreed Care Pathway via corporate mail.
2. 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.
3. 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.
4. Distribution of reminder posters in paediatrics consultations, PEDs and health centers.

**Name:** The implementation strategy to encourage the adoption of the Care Pathway

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** The overall percentage of bronchodilator treatment with a spacer chamber in children diagnosed with mild-moderate asthma attacks.

**Measure:** Percentage of bronchodilator treatment

**Time Frame:** from baseline to 12 months and 24 months

#### Secondary Outcomes

**Description:** Rate of Pulmonary Score registration in children diagnosed with mild-moderate asthma attacks, at all levels of care.

**Measure:** Pulmonary Score registration

**Time Frame:** from baseline to 12 months and 24 months

**Description:** 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).

**Measure:** Assessment and recording of persistent asthma symptoms.

**Time Frame:** from baseline to 12 months and 24 months

**Description:** Rate of initiation of background treatment in children who have been assessed and registered with persistent asthma symptoms.

**Measure:** Initiation of background treatment in children with persistent asthma symptoms

**Time Frame:** from baseline to 12 months and 24 months

### Eligibility Module

**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 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, or 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, that have being attended between the 05/07/2024 and the 05/07/2025.

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ALVARO.SANCHEZPEREZ@osakidetza.eus

**Name:** Alvaro Sanchez Perez

**Phone:** (+34)946006673

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Barakaldo

**Contacts:**

***Contact 1:***

- **Email:** ALVARO.SANCHEZPEREZ@osakidetza.eus

- **Name:** Alvaro Sanchez Perez

- **Phone:** (+34)946006673

- **Role:** CONTACT

**Country:** Spain

**Facility:** Primary Care Research Unit of Bizkaia

**State:** Bizkaia

**Status:** RECRUITING

**Zip:** 48903

### IPD Sharing Statement Module

**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.

**Description:** Individual participant data will be shared that underlie results reported in the publication, after deidentification.

**Info Types:**

- STUDY_PROTOCOL

**IPD Sharing:** YES

**Time Frame:** Starting 6 months after the publication of results

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001982

- Term: Bronchial Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000008173

- Term: Lung Diseases, Obstructive

- ID: D000008171

- Term: Lung Diseases

- ID: D000012130

- Term: Respiratory Hypersensitivity

- ID: D000006969

- Term: Hypersensitivity, Immediate

- ID: D000006967

- Term: Hypersensitivity

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4556

- Name: Asthma

- Relevance: HIGH

- As Found: Asthma

- ID: M5258

- Name: Bronchial Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: LOW

- As Found: Unknown

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M14967

- Name: Respiratory Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M10020

- Name: Hypersensitivity, Immediate

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001249

- Term: Asthma

### Intervention Browse Module - Browse Branches

- Abbrev: Resp

- Name: Respiratory System Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M5269

- Name: Bronchodilator Agents

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
