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SMART Implementation-Effectiveness Trial 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
5 Years to 18 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ways to help clinics use SMART for children and teens with uncontrolled asthma. SMART uses the same asthma medicine for daily control and symptom relief. The study adds help from an asthma community health worker and nurse care manager to electronic health record tools and education.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Clinics must be pediatric primary care clinics in the Children's Hospital of Philadelphia (CHOP) Pediatric Research Consortium.
  • Clinics must agree to join the SMART & SIMPLE study.
  • Patients must be ages 5–18.
  • Patients must have a sick, well, or follow-up visit at a participating clinic during the study.
  • Patients must have been prescribed a daily asthma control inhaler containing a steroid, alone or with a long-acting airway-opening medicine, in the past year.
  • Patients must have uncontrolled asthma: either a score showing poor control on an asthma questionnaire in the past 6 months, or at least 2 prescriptions for steroid medicine to treat asthma flare-ups in the past year, including 1 in the past 6 months.

Who can't join

  • Clinics that are not willing to take part in the SMART & SIMPLE study activities.
  • Patients who have switched clinics or left the CHOP Pediatric Care Network.

Simplified for readability. The official criteria below are what the study team uses.

Official 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. 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) Clinic Exclusion Criteria: \- The clinic is not willing to participate in SMART \& SIMPLE study interventions. Patient Exclusion Criteria: \- Transferred clinics or left the CHOP Pediatric Care Network.

Study sites (1)

PA