Recruiting

SMART

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT07137923

Conditions

Asthma in Children

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

Interventions

Clinical decision support + education (CDS+)

Control

Study Details

Brief 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 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.

Conditions

Asthma in Children

Study ID

NCT07137923

Start date

Sep 3, 2025

Status verified date

Sep, 2025

Completion date

Feb 29, 2028

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

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

18 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention

Clinics in Arm 1 will receive the intervention in Interval 1. Interval 1 intervention: clinical decision support and education (CDS+).

active comparator: Control

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

Interventions

Clinical decision support + education (CDS+)

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+).

Control

Clinics 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 and Locations

Central contacts

Chén Kenyon, MD, MSHP

267-426-6339kenyonc@chop.edu

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Chén Kenyon, MD, MSHP

267-426-6339kenyonc@chop.edu

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Sep 17, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2025-09-17.