Single maintenance and reliever therapy strategies for Implementation and effectiveness trial (SMART & SIMPLE Trial):...

Area of Science:

• Pediatric Pulmonology
• Implementation Science
• Health Services Research

Background:

• Asthma is a significant cause of illness in children.
• Single Maintenance and Reliever Therapy (SMART) is a guideline-recommended asthma management approach for children aged 5 and above requiring Step 3-4 therapy.
• Real-world effectiveness and implementation strategies for SMART in U.S. pediatric populations remain understudied.

Purpose of the Study:

• To test strategies for improving the adoption of SMART in pediatric primary care.
• To evaluate the real-world clinical effectiveness of SMART in reducing severe asthma exacerbations.
• To inform national dissemination and implementation efforts for SMART.

Main Methods:

• A hybrid type-II effectiveness-implementation trial using a clinic-level, cluster-randomized design.
• Comparison of two successive, cumulative implementation strategies against usual care.
• Assessment of SMART adoption using visit-level data and clinical effectiveness via target trial emulation.

Main Results:

• The primary implementation outcome is visit-level SMART adoption.
• The study will assess the impact of SMART on reducing severe asthma exacerbations.
• Mediation analyses will explore mechanisms of SMART implementation and effectiveness.

Conclusions:

• Findings will guide the scaling of SMART implementation nationally.
• This research will build a robust evidence base for SMART effectiveness in U.S. children.
• The study addresses critical gaps in understanding SMART implementation and outcomes.