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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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)

Locations
United States
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Contact Information
Primary
Chén Kenyon, MD, MSHP
kenyonc@chop.edu
267-426-6339
Time Frame
Start Date: 2025-09-03
Estimated Completion Date: 2028-02-29
Participants
Target number of participants: 18
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital of Philadelphia
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov