Contemporary clinical trials communications · 2026
Single maintenance and reliever therapy strategies for Implementation and effectiveness trial (SMART & SIMPLE Trial): study protocol for a type II hybrid effectiveness-implementation cluster-randomized controlled trial.
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Wood Jordan I, Stephens-Shields Alisa J, Xie Dawei, Karavite Dean J, Thayer Jeritt G, Grundmeier Robert W, Bonafide Christopher P, Fiks Alexander G, Bryant-Stephens Tyra C, Huertas Laura M, Kenyon Chén C
Аннотация
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.
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.