ArticleContemporary clinical trials communications2026
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.
Article in Contemporary clinical trials communications, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Single Maintenance And Reliever Therapy Strategies for IMPLementation and Effectiveness (SMART & SIMPLE) Trial
Single Maintenance And Reliever Therapy Strategies for IMPLementation and Effectiveness (SMART & SIMPLE) Trial
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11 authors.
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Abstract
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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