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

Sponsor
Basque Health Service
Study ID
NCT07642388
Status
Not Yet Recruiting

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Conditions

  • Asthma in Children

Eligibility Criteria

Sex
ALL
Age
2 Years - 14 Years
Healthy Volunteers
Not accepted

Interventions

  • Internal + External Facilitation for Implementation — BEHAVIORAL
    Non-responding sites randomized to receive both internal and external facilitation focused on addressing determinants (barriers) of low adoption
  • Internal + External Facilitation for Sustainability — BEHAVIORAL
    Responding sites randomized to receive both internal and external facilitation focused on consolidate factors required for sustained adoption
  • Internal Facilitation — BEHAVIORAL
    Both responding and non-responding randomized to receive the standard scaling

Study Details

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.

Key Dates

First listed
Jun 11, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Feb 28, 2029
Completion
Feb 28, 2029

Study Design

Enrollment
4,680 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Implementation facilitation (IF) strategy
    Standard scaling up of the clinical pathway augmented with Implementation Facilitation
  • Experimental: Sustainability facilitation (SF) strategy
    Standard scaling up of the clinical pathway augmented with Sustainability Facilitation
  • Active Comparator: Standard scaling (SS) strategy
    Standard scaling up of the clinical pathway

Primary Outcome Measure

Change in the registration rate of bronchodilator treatment [ Time Frame: 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) ]

Central Contacts

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