CHEST: A Collaboration With Community HEalth Centers to Implement SmarT for Asthma

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07241117
Phase
PHASE4
Status
Recruiting

Conditions

  • Moderate to Severe Asthma

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Implementation bundle — BEHAVIORAL
    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 three components: (1) clinician education with practice facilitation, (2) audit and feedback on prescribing, (3) patient education tools such as a SMART-aligned asthma action plan and videos tailored for low health literacy, and (4) operations committee meetings during the implementation period

Study Details

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.

Key Dates

Start date
Jan 6, 2026
Status verified
Jan 2026
Primary completion
Nov 15, 2027
Completion
Nov 15, 2028

Study Design

Enrollment
2,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

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) patient-centered education tools such as instructional videos and a SMART-congruent asthma action plan designed for low health literacy, and (4) operations committee meetings during the implementation period. 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.

Primary Outcome Measure

Patient-level Effectiveness (of the SMART implementation bundle) [ Time Frame: Through study completion, up to 24 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Affinia healthcare, 1717 Biddle StreetSt LouisMissouri63106
Patrick Schoenwalder, PA
314-814-8700
Affinia healthcare, 2220 Lemp AveSt LouisMissouri63104
Mellisa Tepe, MD
3143769452
Affinia healthcare, 3396 Pershall Road,St LouisMissouri63135
Iesha Draper, MD
314-793-7214
Affinia healthcare, 4414 North Florissant AvenueSt LouisMissouri63107
Catherine Moore, DO
309-532-6707
Family Care Heath Center, 401 Holly Hills AveSt LouisMissouri63111
Jaime Zengotita, MD
3143769452
Family Care Heath Center, 4352 Manchester AveSt LouisMissouri63110
Jaime Zengotita, MD
3143769452
Washington University in St. Louis School of MedicineSt LouisMissouri63110
James G Krings, MD
314-273-4734

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