Implementing SMART asthma care in pediatric primary clinics
Single Maintenance And Reliever Therapy Strategies for IMPLementation and Effectiveness (SMART & SIMPLE) Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT07137923 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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. Clinic Exclusion Criteria: \- The clinic is not willing to participate in SMART \& SIMPLE study interventions. 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) Patient Exclusion Criteria: \- Transferred clinics or left the CHOP Pediatric Care Network.
Where this trial is running
Philadelphia, Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Chén Kenyon, MD, MSHP
- Email: kenyonc@chop.edu
- Phone: 267-426-6339
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.