Recruiting
Phase 4

SMART

Sponsor:

Washington University School of Medicine

Code:

NCT07241117

Conditions

Moderate to Severe Asthma

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

Implementation bundle

Study Details

Brief summary:

Purpose: This study aims to improve asthma care by helping clinicians at community health centers prescribe a guideline-recommended treatment called SMART (Single Maintenance and Reliever Therapy).

The investigators will provide training and resources to clinicians, give feedback on prescribing patterns, and offer educational tools for patients and providers. The investigators will roll out these resources in stages across clinics. The study will measure how well the program helps clinicians prescribe SMART therapy and whether it reduces asthma exacerbations in patients.

Conditions

Moderate to Severe Asthma

Study ID

NCT07241117

Start date

Jan 6, 2026

Status verified date

Sep, 2026

Completion date

Nov 15, 2028

Anticipated

Primary completion date

Nov 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

The study population can be viewed from the cluster (clinic), clinician, staff, or patient level.

At the cluster (clinic) level: To be eligible to participate in this study, a cluster (clinic) must meet all the following criteria:

(1) Clinics within participating health systems (Affinia Healthcare and Family Care Health Centers) will be considered eligible if they provided care to ≥100 patients aged ≥12 years with asthma (ICD-10-CM: J45.xx) during the calendar year preceding implementation (2024).

At the clinician level:

Clinicians will be considered eligible if they:

1. are physicians, nurse practitioners, or physician assistants;
2. are actively employed at a participating clinic during the implementation period; and
3. provided care to ≥10 patients aged ≥12 years with asthma (ICD-10-CM: J45.xx) during the 12 months preceding implementation.

At the staff level:

Staff will be considered eligible if they:

1. are actively employed at a participating clinic during the implementation period; and
2. directly support clinical care delivery for patients aged ≥12 years with asthma.

At the patient level:

Patients will be considered eligible if they:

1. are aged ≥12 years;
2. received care at a participating clinic during the implementation period; and (3) meet the study-defined definition of moderate-to-severe asthma based on diagnosis codes, medication use, and/or exacerbation history as defined in the study protocol.

Study Design

Enrollment

2000 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active Implementation

The intervention is a SMART implementation bundle delivered at community health centers. It includes (1) clinician education with practice facilitation to support guideline-concordant prescribing and (2) regular audit and feedback on inhaler prescribing patterns (3) workflow integration support, including prescribing preferences, and (4) patient-centered education tools such as instructional videos and a SMART-congruent asthma action plan designed for low health literacy. Educational outreach is co-led by the PI and a certified asthma educator, with quarterly practice facilitation and feedback visits during the active implementation period. All materials are available in paper and digital formats, with continued access to patient tools beyond the intervention. Providers retain full autonomy over prescribing decisions

no intervention: Control

During this period, prescribing patterns and asthma outcomes will be observed without active implementation.

Interventions

Implementation bundle

The intervention is a SMART implementation bundle delivered in Federally Qualified Health Centers. Unlike drug trials, no medication is supplied; providers prescribe according to guidelines. The bundle includes four components: (1) clinician education with practice facilitation, (2) audit and feedback on prescribing, (3) workflow integration support, including prescribing preferences, and (4) patient education tools such as a SMART-aligned asthma action plan and videos tailored for low health literacy

Primary outcome measure

  • Clinician-level adoption of the SMART implementation bundle [ Time Frame: Through study completion, up to 24 months ]
  • Clinic-level effectiveness of the SMART implementation bundle, measured as the proportion of SMART-eligible asthma encounters in which SMART is prescribed [ Time Frame: Through study completion, up to 24 months ]

Central Contacts and Locations

Central contacts

James Krings, MD MSCI

3143769452kringsj@wustl.edu

Krutika Chauhan, MBBS MPH

3143769452c.krutika@wustl.edu

Locations

Affinia healthcare, 1717 Biddle Street

Recruiting

St Louis, Missouri, United States, 63106

Contacts

Affinia healthcare, 4414 North Florissant Avenue

Recruiting

St Louis, Missouri, United States, 63107

Contacts

Family Care Heath Center, 4352 Manchester Ave

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Washington University in St. Louis School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Affinia healthcare, 3396 Pershall Road,

Recruiting

St Louis, Missouri, United States, 63135

Contacts

More Information

Sponsor

Washington University School of Medicine

Last update posted

Sep 10, 2026

Last verified

Sep, 2026

Keywords

  • asthma
  • SMART
  • moderate to severe asthma
  • CHEST
  • CHEST asthma study
  • asthma study
  • asthma action plan
  • implementation science
  • hybrid cluster
  • community health centers
  • MART
  • single maintenance and reliever therapy
  • maintenance and reliever therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-09-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.