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

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

This project will test whether adding community health workers and nurse care managers to electronic health record decision support and education helps children ages 5–18 with uncontrolled asthma use single maintenance and reliever therapy (SMART).

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 5 Years to 18 Years
• Sex: All
• Sponsor: Children's Hospital of Philadelphia (Academic / other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT07138027 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Children ages 5–18 who receive care at participating CHOP primary care clinics, have had an inhaled corticosteroid (with or without LABA) prescription in the past year, and show evidence of uncontrolled asthma are the intended candidates.

Not a fit: Children who have transferred care away from CHOP or who do not meet the age, medication, or uncontrolled asthma criteria are unlikely to receive benefit from this implementation program.

Why it matters

Potential benefit: If successful, more children with moderate-to-severe asthma could be prescribed and use SMART therapy, potentially reducing exacerbations and simplifying inhaler use.

How similar studies have performed: SMART therapy has demonstrated efficacy and real-world effectiveness in international settings, but implementation efforts in U.S. primary care are limited and this clinic-level PHM addition is a relatively novel implementation approach here.

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.

Where this trial is running

Philadelphia, Pennsylvania

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

Study contacts

• Study coordinator: Chén Kenyon, MD, MSHP

Conditions Asthma in Children