# Single Maintenance And Reliever Therapy Strategies for Implementation and Effectiveness Trial

> **NIH NIH R01** · CHILDREN'S HOSP OF PHILADELPHIA · 2024 · $797,130

## Abstract

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
dec...

## Key facts

- **NIH application ID:** 10859260
- **Project number:** 1R01HL173600-01
- **Recipient organization:** CHILDREN'S HOSP OF PHILADELPHIA
- **Principal Investigator:** Chen Collin Kenyon
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $797,130
- **Award type:** 1
- **Project period:** 2024-09-17 → 2028-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10859260

## Citation

> US National Institutes of Health, RePORTER application 10859260, Single Maintenance And Reliever Therapy Strategies for Implementation and Effectiveness Trial (1R01HL173600-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10859260. Licensed CC0.

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