SMART Implementation-Effectiveness Trial 1
Recruiting · NCT07137923 · Interventional (participants receive a specific treatment) · Lead sponsor: Children's Hospital of Philadelphia
View the official record on ClinicalTrials.gov →Interventions studied
Clinical decision support + education (CDS+)Control
What this trial is about
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 electronic medical record clinical decision support and education implementation strategies (CDS+) to increase adoption of SMART in pediatric primary care. This is the first of two related records.
Who can take part
Age range
5 Years to 18 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- Children's Hospital of Philadelphia - Philadelphia, Pennsylvania, United States