Scaling up the Integrated Care Pathway for Acute Asthma to All Osakidetza Pediatric Services Through a Cluster-randomized SMART Design

NCT07642388 | Not Yet Recruiting

• 1 other identifier: PI2026062
• Study Type: interventional
• Target: 4,680
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal of this study is to evaluate the effectiveness of adaptive sequential implementation strategies based on facilitation in promoting the sustainable and widespread adoption and scaling up of the Integrated Care Pathway for Acute Asthma - ASMAbat across all Primary Care and Hospital Pediatric Services of Osakidetza - Basque Health Service.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (1)

• Change in bronchodilator treatment registration

  Between-period change by strategy (e.g., the change from month 8 to month 16 under one strategy compared with the corresponding change under another strategy) in the rates of mild-to-moderate acute asthma episodes with documented administration of bronchodilator therapy delivered via MDI with spacer device.

  Change from period 1 (baseline to 8 months) to period 2 (8 to 16 months); from period 1 or 2 to period 3 (16 to 24 months); and from period 3 to period 4 (24 to 32 months)

Secondary Outcomes (3)

• Change in Pulmonary Score registration

  Change from period 1 (baseline to 8 months) to period 2 (8 to 16 months); from period 1 or 2 to period 3 (16 to 24 months); and from period 3 to period 4 (24 to 32 months)

• Change in persistent asthma symptoms registration

  Change from period 1 (baseline to 8 months) to period 2 (8 to 16 months); from period 1 or 2 to period 3 (16 to 24 months); and from period 3 to period 4 (24 to 32 months)

• Change in initiation of background treatment in children with persistent asthma symptoms registration

  Change from period 1 (baseline to 8 months) to period 2 (8 to 16 months); from period 1 or 2 to period 3 (16 to 24 months); and from period 3 to period 4 (24 to 32 months)

Study Arms (3)

Implementation facilitation (IF) strategy

EXPERIMENTAL

Standard scaling up of the clinical pathway augmented with Implementation Facilitation

Behavioral: Internal + External Facilitation

Sustainability facilitation (SF) strategy

EXPERIMENTAL

Standard scaling up of the clinical pathway augmented with Sustainability Facilitation

Behavioral: Internal + External Facilitation

Standard scaling (SS) strategy

ACTIVE COMPARATOR

Standard scaling up of the clinical pathway

Behavioral: Internal Facilitation

Interventions

Internal + External Facilitation BEHAVIORAL

Non-responding sites randomized to receive both internal and external facilitation focused on addressing determinants (barriers) of low adoption

Implementation facilitation (IF) strategy

Internal Facilitation BEHAVIORAL

Both responding and non-responding randomized to receive the standard scaling

Standard scaling (SS) strategy

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Eligibility for healthcare settings: \- All Pediatric Services (Primary Care n=108 and Hospital Care n=9) from 11 of the 13 Osakidetza Integrated Healthcare Organizations that are not currently implementing the ASMAbat Pathway. Eligibility for professionals: * Primary Care pediatricians and nurses * Pediatricians and nurses in the Pediatric Emergency Department * Pediatricians and nurses on the inpatient ward * Pediatric Intensive Care pediatricians and nurses * Pediatric Pneumology pediatricians and nurses Eligibility for patients: Patients between 2 and 14 years that have being attended between the 1st of July 2026 and the 28th of February 2029, 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 a severity Score

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Basque Health Service: lead
• Health Department of the Basque Government: collaborator

Study Sites (1)

Primary Care Research Unit of Bizkaia

Barakaldo, Bizkaia, 48903, Spain

Location

Central Study Contacts

Alvaro Sanchez Perez

CONTACT

(+34)946006673; ALVARO.SANCHEZPEREZ@osakidetza.eus

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Cluster-randomized Sequential, Multiple Assignment, Randomized Trial (SMART)

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 11, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2029
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months after the publication of results.
• 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.

Locations

ES (1)