NCT07138027

SMART Implementation-Effectiveness Trial 2

Single Maintenance And Reliever Therapy Strategies for IMPLementation and Effectiveness (SMART & SIMPLE) Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

While single maintenance and reliever therapy (SMART) has been the preferred management strategy for Step 3 and 4 (moderate/severe) asthma management since the 2020 NIH asthma guideline updates, adoption of SMART has not been rigorously assessed. This study will test population health management (PHM; asthma community health worker, asthma nurse care manager) implementation strategies building on electronic medical record clinical decision support and education implementation strategies (CDS+), to increase adoption of SMART. This is the second of two related records.

Detailed description

Asthma is a leading cause of childhood morbidity nationwide. Limited provider adoption of and patient adherence to the prevailing evidence-based recommendations for chronic management represent tractable areas for care improvement and 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 Steps 3 and 4 (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 U.S. This hybrid type II implementation-effectiveness study will sequentially compare the effects of usual care to (1) electronic health record-based clinical decision support plus education (CDS+) (Study 1) and then (2) CDS+ with population health management (PHM) strategies (community health worker and nurse care manager) on SMART adoption (Study 2 - current study). Randomization for this study is at the clinic-level. Results will be reported at visit-, patient-, and clinic-levels.

Conditions

• Asthma in Children

Interventions

Type	Name	Description
BEHAVIORAL	Clinical decision support + education (CDS+) and population health management (PHM)	In Interval 1, intervention clinic providers will experience nudges in the electronic medical record to encourage prescribing SMART where clinically-appropriate and intervention clinic providers, families/patients, and nurses will receive education (collectively CDS+). In Interval 2, intervention clinics will have CDS+ and population health management (PHM) strategies, including an asthma community health worker and an asthma nurse care manager.
OTHER	Control	Clinics in Arm 2 will not be exposed to the interventions.

Timeline

• Start date: 2025-09-03
• Primary completion: 2027-08-31
• Completion: 2028-02-29
• First posted: 2025-08-22
• Last updated: 2025-09-17

Locations

1 site across 1 country: United States