RecruitingNot ApplicableNCT07138027

SMART Implementation-Effectiveness Trial 2

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

Sponsor

Children's Hospital of Philadelphia

Enrollment

18 participants

Start Date

Sep 3, 2025

Study Type

INTERVENTIONAL

Conditions

Asthma in Children

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.

Eligibility

Min Age: 5 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (SMART & SIMPLE Trial 2) is a companion trial testing alternative strategies to improve asthma management in children with poorly controlled asthma through pediatric primary care clinics. Like Trial 1, it focuses on implementation approaches within the same clinic network. **You may be eligible if...** - You are a child aged 5 to 18 years - You receive care at a participating Children's Hospital of Philadelphia (CHOP) primary care clinic - You have been prescribed a maintenance asthma inhaler (inhaled corticosteroid) in the past year - Your asthma has been poorly controlled based on symptom scores or recent need for oral steroids **You may NOT be eligible if...** - Your asthma is currently well-controlled - You do not receive care at a participating CHOP clinic - You are not currently prescribed a maintenance asthma medication Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALClinical 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.

OTHERControl

Clinics in Arm 2 will not be exposed to the interventions.