RecruitingNot ApplicableNCT07138027

SMART Implementation-Effectiveness Trial 2

Single Maintenance And Reliever Therapy Strategies for IMPLementation and Effectiveness (SMART & SIMPLE) Trial


Sponsor

Children's Hospital of Philadelphia

Enrollment

18 participants

Start Date

Sep 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 5 YearsMax Age: 18 Years

Inclusion Criteria6

  • 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.
  • 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)

Exclusion Criteria2

  • \- The clinic is not willing to participate in SMART \& SIMPLE study interventions.
  • \- Transferred clinics or left the CHOP Pediatric Care Network.

Interventions

BEHAVIORALClinical decision support + education (CDS+) and population health management (PHM)

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.

OTHERControl

Clinics in Arm 2 will not be exposed to the interventions.


Locations(1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

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NCT07138027


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