SMART Implementation-Effectiveness Trial 2
Recruiting · NCT07138027 · 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+) and population health management (PHM)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 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.
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