Clinical trial Recruiting at 1 site Interventional Ages 5 to 18

Implementing SMART asthma care in pediatric primary clinics

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

Run by Children's Hospital of Philadelphia · NCT07137923 · Data updated 2026-11-12

This project will test whether electronic medical record decision support plus clinician education helps pediatric clinics adopt SMART single maintenance and reliever inhaler therapy for children ages 5–18 with uncontrolled asthma.

Quick facts

Study typeInterventional
Ages5 Years to 18 Years
SexAll
Enrollment18 (estimated)
SponsorChildren's Hospital of Philadelphia
Academic / other
Locations1 site (Philadelphia, Pennsylvania)
StatusRecruiting
StartedSeptember 3, 2025
Main results expectedAugust 31, 2027
Study endsFebruary 29, 2028
Registry record updatedSeptember 18, 2026
Trial IDNCT07137923 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children ages 5–18 with uncontrolled asthma who have been prescribed an ICS or ICS-LABA and who receive care at participating CHOP pediatric primary care clinics are the intended participants.

Probably not a fit

Children with well-controlled asthma, those not on maintenance inhaled corticosteroids, or those who do not receive care at participating CHOP clinics are unlikely to benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial compares usual care to an electronic health record clinical decision support intervention combined with clinician education (CDS+) to increase adoption of SMART for Step 3–4 pediatric asthma. Randomization is at the clinic level among Children's Hospital of Philadelphia (CHOP) primary care practices, and outcomes will be reported at visit-, patient-, and clinic-levels. Eligible patients are children aged 5–18 with evidence of uncontrolled asthma and recent prescriptions for inhaled corticosteroid–containing maintenance therapy. This is the first of two linked implementation-effectiveness records, with a later phase adding population health management strategies.

Why it matters

Potential benefit: If successful, more children with moderate-to-severe asthma could be prescribed a simpler SMART inhaler approach, potentially improving adherence and reducing exacerbations.

How similar studies have gone: SMART therapy has demonstrated efficacy and real-world effectiveness internationally, but clinic-level implementation strategies like EHR-based decision support have not been widely tested in U.S. pediatric primary care.

Who can join: the full rules

Show full inclusion / exclusion criteria
Clinic Inclusion Criteria:

* The clinic is a pediatric primary care clinic that is part of the Children's Hospital of Philadelphia (CHOP) Pediatric Research Consortium (PeRC).
* The clinic agrees to participate in SMART \& SIMPLE study.

Patient Inclusion Criteria:

* Ages 5-18 years;
* Has clinic visit at participating practice during study interval (sick, well, or follow-up)
* Prescribed at least one prescription for an inhaled corticosteroid (ICS) or ICS-long-acting beta agonist (ICS-LABA) for maintenance asthma therapy in the past year;
* Evidence of uncontrolled asthma as determined by: (1) uncontrolled Asthma Control Tool score in the past 6 months OR (2) two or more systemic corticosteroids prescribed for an asthma exacerbation in the past 12 months (one occurring in the past 6 months)

Clinic Exclusion Criteria:

\- The clinic is not willing to participate in SMART \& SIMPLE study interventions.

Patient Exclusion Criteria:

\- Transferred clinics or left the CHOP Pediatric Care Network.

Where it's running

  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania, United States
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.