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RECRUITING Not applicable ClinicalTrials.gov

SMART Implementation-Effectiveness Trial 2

Sponsor: Children's Hospital of Philadelphia • ClinicalTrials.gov ID: NCT07138027

Registry updated: 2026-09-18
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Description

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.

Interventions

  • Clinical decision support + education (CDS+) and population health management (PHM) (Behavioral)
    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.
  • Control (Other)
    Clinics in Arm 2 will not be exposed to the interventions.

Eligibility 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.

Conditions

Asthma in Children

Locations

  • Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record