SMART Implementation-Effectiveness Trial 1

NCT07137923 | Recruiting

• 2 other identifiers: 23-021702 AR01HL173600
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in the Rate of Visit-Level SMART Adoption

  The difference in the rate of SMART prescribing (initiation) among eligible primary care visits (i.e., when a child is eligible to start SMART) where SMART is first prescribed (initiated) comparing the first intervention period (Interval 1) and the baseline period (Interval 0). Adoption is visit-level. The denominator represents eligible primary care visits, and the numerator represents visits where SMART is first prescribed (initiated).

  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).

Secondary Outcomes (1)

• Change in the Proportion of Patient-Level SMART Sustainment

  Assessment of proportions 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).

Other Outcomes (1)

• Change in the Proportion of Clinic-Level SMART Penetration

  Assessment of proportions 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).

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Clinical decision support + education (CDS+)

Control

ACTIVE COMPARATOR

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

Other: Control

Interventions

Clinical decision support + education (CDS+) BEHAVIORAL

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+).

Also known as: CDS+

Intervention

Control OTHER

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

Control

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Central Study Contacts

Chén Kenyon, MD, MSHP

CONTACT

267-426-6339; kenyonc@chop.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will use a cluster randomized control trial (RCT) study design to test the impact of the clinical decision support and education (CDS+) to increase adoption of SMART therapy.

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 22, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): February 29, 2028
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

US (1)