SMART Implementation-Effectiveness Trial 2

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT07138027
Status
Recruiting
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Conditions

  • Asthma in Children

Eligibility Criteria

Sex
ALL
Age
5 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Clinical decision support + education (CDS+) and population health management (PHM) — BEHAVIORAL
    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.
  • Control — OTHER
    Clinics in Arm 2 will not be exposed to the interventions.

Study Details

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.

Key Dates

Start date
Sep 3, 2025
Status verified
Sep 2025
Primary completion
Aug 31, 2027
Completion
Feb 29, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Intervention
    Clinics in Arm 1 will receive the interventions in Intervals 1 and 2. Interval 1 intervention: clinical decision support and education (CDS+). Interval 2 interventions: CDS and education (CDS+) and population health management (community health worker and nurse care manager) (PHM).
  • Active Comparator: 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 1 (CDS+; 11 months), Interval 2 (CDS+ and PHM; 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

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Chén Kenyon, MD, MSHP
[email protected]
267-426-6339

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Children's Hospital of Philadelphia· Philadelphia, PA

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