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Single maintenance and reliever therapy strategies for Implementation and effectiveness trial (SMART & SIMPLE Trial):
Jordan I Wood1,2, Alisa J Stephens-Shields3, Dawei Xie3
1Clinical Futures, Children's Hospital of Philadelphia, 2716 South Street, Philadelphia, PA, 19146, United States of America.
Insights
This study evaluates strategies to implement Single Maintenance and Reliever Therapy (SMART) for childhood asthma. It aims to improve treatment adherence and reduce severe asthma exacerbations in U.S. children.
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.
Background:
Asthma is a leading cause of childhood morbidity. In 2020, the National Heart, Lung, and Blood Institute codified a different paradigm of asthma management, single maintenance and reliever therapy (SMART), as guideline-recommended care for children ages 5 and above requiring Step 3-4 asthma therapy. Strategies for implementing SMART and its real-world effectiveness-have not been studied in U.S. children.
Methods:
This hybrid type-II effectiveness-implementation trial will compare effects of two successive, cumulative implementation strategies to usual care using a clinic-level, cluster-randomized design in a large pediatric primary care network. Participating clinics will be randomized to usual care or active implementation strategies. Active implementation strategy clinics will first receive electronic health record-based clinical decision support plus education. After one year, nurse care coordinator and community health worker support will be added in active strategy clinics to help families overcome system-level barriers (e.g., insurance prior authorization, social needs support) for one year, followed by a 6-month sustainment phase. The primary implementation outcome will be visit-level SMART adoption among SMART-eligible children in a repeated cross-sectional sample assessed using difference-in-differences. The study will also assess real-world clinical effectiveness of SMART in reducing severe asthma exacerbations using target trial emulation and mechanisms of SMART implementation and effectiveness using mediation analyses.
Discussion:
This pragmatic hybrid effectiveness-implementation trial will test strategies for improving SMART adoption and evaluate SMART's impact on asthma outcomes. Findings will inform efforts to scale implementation and dissemination strategies nationally and build real-world evidence base for SMART effectiveness in U.S. pediatric populations.
Trial Registration:
ClinicalTrials.gov identifiers: NCT07137923; NCT07138027. There are two ClinicalTrials.gov records, one to evaluate each implementation strategy. Registration dates: August 22, 2025.
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