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 — BEHAVIORALNon-responding sites randomized to receive both internal and external facilitation focused on addressing determinants (barriers) of low adoption
- Internal + External Facilitation for Sustainability — BEHAVIORALResponding sites randomized to receive both internal and external facilitation focused on consolidate factors required for sustained adoption
- Internal Facilitation — BEHAVIORALBoth 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) strategyStandard scaling up of the clinical pathway augmented with Implementation Facilitation
- Experimental: Sustainability facilitation (SF) strategyStandard scaling up of the clinical pathway augmented with Sustainability Facilitation
- Active Comparator: Standard scaling (SS) strategyStandard 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
- Alvaro Sanchez Perez(+34)946006673
- Alvaro Goñi De Francisco(+34) 946006671
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