Asthma in ChildrenSMART SIMPLENCT07138027
SMART Implementation-Effectiveness Trial 2
A study testing Clinical decision support + education (CDS+) and population health management (PHM) in people with Asthma in Children, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Clinical decision support + education (CDS+) and population health management (PHM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2025to 29 Feb 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Chén Kenyon, MD, MSHP, 267-426-6339, kenyonc@chop.edu
About this study
Official title: Single Maintenance And Reliever Therapy Strategies for IMPLementation and Effectiveness (SMART & SIMPLE) Trial
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.
Read the detailed description
Asthma is a leading cause of childhood morbidity nationwide. Limited provider adoption of and patient adherence to the prevailing evidence-based recommendations for chronic management represent tractable areas for care improvement and implementation focus. In their 2020 Focused Updates, the NHLBI codified a new paradigm of asthma management - single maintenance and reliever therapy (SMART) - as the preferred management strategy for Steps 3 and 4 (moderate/severe) asthma management. In addition to its efficacy and safety, SMART has demonstrated real-world effectiveness in international settings, likely due in part to better adherence to daily therapy and less inhaler confusion. However, SMART has not been widely implemented in practice in the U.S. This hybrid type II implementation-effectiveness study will sequentially compare the effects of usual care to (1) electronic health record-based clinical decision support plus education (CDS+) (Study 1) and then (2) CDS+ with population health management (PHM) strategies (community health worker and nurse care manager) on SMART adoption (Study 2 - current study). Randomization for this study is at the clinic-level. Results will be reported at visit-, patient-, and clinic-levels.
- Conditions
- Asthma in Children
- Being tested
- Clinical decision support + education (CDS+) and population health management (PHM), Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical decision support + education (CDS+) and population health management (PHM)Behavioural
Also called CDS+ and PHM
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.
ControlOther
Clinics in Arm 2 will not be exposed to the interventions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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). Receives: Behavioral: Clinical decision support + education (CDS+) and population health management (PHM) |
| Control | Active comparator | Clinics in Arm 2 will not be exposed to the interventions. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 second intervention period (Interval 2) and the first intervention period (Interval 1). Adoption is visit-level. The denominator represents eligible primary care visits, and the numerator represents visits where SMART is first prescribed (initiated).
Measured: 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).
Secondary outcomes (1)
Change in the Proportion of Patient-Level SMART Sustainment
The difference in the proportion of patients who are prescribed (initiated) SMART who continue on SMART for at least 6 months comparing the second intervention period (Interval 2) and the first intervention period (Interval 1). Sustainment is patient-level. The denominator represents patients who are prescribed (initiated) SMART, and the numerator represents patients who continue on SMART for at least 6 months.
Measured: Assessment of proportions 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start3 Sep 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will use a cluster randomized control trial (RCT) study design to test the impact of the clinical decision support and education (CDS+) and the added population health management (PHM) strategies to increase adoption of SMART therapy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138027
- Sponsor's protocol ID
- 23-021702 B
- Other IDs
- R01HL173600
- Acronym
- SMART SIMPLE
- Status last verified
- Sep 2026
- First submitted
- 15 Aug 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wood JI, Stephens-Shields AJ, Xie D, Karavite DJ, Thayer JG, Grundmeier RW, Bonafide CP, Fiks AG, Bryant-Stephens TC, Huertas LM, Kenyon CC. Single maintenance and reliever therapy strategies for Implementation and effectiveness trial (SMART & SIMPLE Trial): study protocol for a type II hybrid effectiveness-implementation cluster-randomized controlled trial. Contemp Clin Trials Commun. 2026 Jul 31;53:101677. doi: 10.1016/j.conctc.2026.101677. eCollection 2026 Oct.
PubMed 42602550