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SMART Implementation-Effectiveness Trial 2
NCT07138027 · Children's Hospital of Philadelphia
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Single Maintenance And Reliever Therapy Strategies for IMPLementation and Effectiveness (SMART & SIMPLE) Trial
About this study
Asthma is a leading cause of childhood morbidity nationwide. Limited provider adoption of and patient adherence to the prevailing evidence-based recommendations for chronic management represent tractable areas for care improvement and implementation focus. In their 2020 Focused Updates, the NHLBI codified a new paradigm of asthma management - single maintenance and reliever therapy (SMART) - as the preferred management strategy for Steps 3 and 4 (moderate/severe) asthma management. In addition to its efficacy and safety, SMART has demonstrated real-world effectiveness in international settings, likely due in part to better adherence to daily therapy and less inhaler confusion. However, SMART has not been widely implemented in practice in the U.S. This hybrid type II implementation-effectiveness study will sequentially compare the effects of usual care to (1) electronic health record-based clinical decision support plus education (CDS+) (Study 1) and then (2) CDS+ with population health management (PHM) strategies (community health worker and nurse care manager) on SMART adoption (Study 2 - current study). Randomization for this study is at the clinic-level. Results will be reported at visit-, patient-, and clinic-levels.
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.
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.
Study design
Enrollment target: 18 participants
Allocation: randomized
Masking: single
Age groups: child, adult
Timeline
Starts: 2025-09-03
Estimated completion: 2028-02-29
Last updated: 2025-09-17
Interventions
Behavioral: Clinical decision support + education (CDS+) and population health management (PHM)Other: Control
Primary outcomes
- • Change in the Rate of Visit-Level SMART Adoption (Assessment of rates from two study intervals: Interval 1 (CDS+; 11 months), Interval 2 (CDS+ and PHM; 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).)
Sponsor
Children's Hospital of Philadelphia · other
With: National Heart, Lung, and Blood Institute (NHLBI)
Contacts & investigators
ContactChén Kenyon, MD, MSHP · contact · kenyonc@chop.edu · 267-426-6339
All locations (1)
Children's Hospital of PhiladelphiaRecruiting
Philadelphia, Pennsylvania, United States