Single Maintenance And Reliever Therapy Strategies for Implementation and Effectiveness Trial

Project Summary / Abstract Asthma is a leading cause of childhood morbidity and disparities nationwide and limited provider adoption of and patient adherence to the prevailing evidence-based recommendations for chronic management represent tractable areas for implementation focus. In their 2020 Focused Updates, the NHLBI codified a new paradigm

of asthma management - single maintenance and reliever therapy (SMART) - as the preferred management strategy for moderate/severe asthma management. In addition to its efficacy and safety, SMART has demonstrated real-world effectiveness in international settings, likely due in part to better adherence to daily

therapy and less inhaler confusion. However, SMART has not been widely implemented in practice in the US and there are no prior studies of its real-world effectiveness in US pediatric populations. In preliminary work, investigators identified several critical barriers to SMART implementation, including insufficient: (1) decision

support/training for providers to identify and educate eligible patients at the point of care, (2) ongoing patient education on key components of SMART once prescribed, and (3) systems-level issues, such as negative reinforcement by providers unfamiliar with SMART and insurance denials. The proposed study is a type II

hybrid effectiveness-implementation study that uses a cluster-randomized design within 18 pediatric primary care clinics in a large US pediatric health system whose demographics mirror US asthma morbidity statistics. Enrolled clinics will be randomized to one of two study conditions, to iteratively compare a real-world control

condition and two successive implementation strategies: (Phase 1) electronic health record-based Clinical Decision Support integrated with clinician workflows plus provider and patient education outreach (referred to as CDS+), and (Phase 2) CDS+ combined with Population Health Management (PHM), which adds

longitudinal caregiver/patient SMART education, social support, and health system/insurance navigation provided by an evidence-based asthma community health worker program and nurse care manager. Using this approach, the project’s specific aims are to (1) conduct a cluster RCT that sequentially compares the effects of

first CDS+ alone and then CDS+ with PHM to usual care on visit-level SMART adoption (primary outcome), patient-level sustained adoption, and clinic-level penetration of SMART (secondary outcomes); (2) determine the real-world effectiveness of SMART in reducing severe asthma exacerbations in a predominantly Black

cohort of children with poorly controlled asthma; and (3) assess mechanisms of successful SMART implementation and effectiveness using mixed methods. The findings of this study will inform broader national implementation and dissemination strategies for SMART by establishing an evidence base for SMART

effectiveness in a racially diverse US pediatric population and through sharing of potentially effective clinical decision support enhancements or implementation manuals through existing national networks.