Boosting use of SMART inhaler therapy for children with moderate-to-severe asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This hybrid Type II implementation-effectiveness trial tests whether adding population health management (PHM) — community health workers and nurse care managers — to an existing electronic health record-based clinical decision support plus education (CDS+) increases clinician prescribing and patient use of SMART therapy in children aged 5–18 with uncontrolled moderate-to-severe asthma. Clinics in the CHOP Pediatric Research Consortium are randomized at the clinic level to receive CDS+ with PHM versus CDS+ alone. Outcomes include SMART adoption and related clinical measures reported at visit, patient, and clinic levels using electronic health record data and implementation metrics. The study focuses on real-world implementation and tracks medication prescribing, fills, and exacerbation-related care.

Why it matters

Who can join: the full rules

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.

Where it's running

• Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Chén Kenyon, MD, MSHP
• Email: kenyonc@chop.edu
• Phone: 267-426-6339

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.