SMART Implementation-Effectiveness Trial 1
Part of paid clinical trials in Philadelphia, Pennsylvania.
- Sponsor
- Children's Hospital of Philadelphia
- Study ID
- NCT07137923
- Status
- Recruiting
Conditions
- Asthma in Children
Eligibility Criteria
- Sex
- ALL
- Age
- 5 Years - 18 Years
- Healthy Volunteers
- Not accepted
Interventions
- Clinical decision support + education (CDS+) — BEHAVIORALIntervention 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+).
- Control — OTHERClinics in Arm 2 will not be exposed to the interventions.
Study Details
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.
Key Dates
- Start date
- Sep 3, 2025
- Status verified
- Sep 2025
- Primary completion
- Aug 31, 2027
- Completion
- Feb 29, 2028
Study Design
- Enrollment
- 18 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: InterventionClinics in Arm 1 will receive the intervention in Interval 1. Interval 1 intervention: clinical decision support and education (CDS+).
- Active Comparator: ControlClinics in Arm 2 will not be exposed to the interventions.
Primary Outcome Measure
Change in the Rate of Visit-Level SMART Adoption [ Time Frame: Assessment of rates from two study intervals: Interval 0 (baseline; 11 months), Interval 1 (CDS+; 11 months). There will be a one month ramp up period at the start of each study interval (ramp up period data will not be included in analyses). ]
Central Contacts
- Chén Kenyon, MD, MSHP267-426-6339
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 |
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