Bringing SMART inhaler therapy to community health clinics

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

CHEST uses a stepped-wedge cluster randomized design across six federally qualified community health center clinics to roll out an implementation bundle for SMART (single maintenance and reliever therapy). The bundle includes clinician education and practice facilitation, serial audit-and-feedback on inhaler prescribing, patient- and clinician-facing education aids with SMART-congruent action plans, and regular operations committee meetings. Clinics serve as clusters that move from a pre-implementation baseline period through active implementation to a post-implementation sustainability assessment. Primary outcomes include change in SMART prescribing patterns at clinician and clinic levels and whether implementation is associated with reduced asthma exacerbations.

Why it matters

Who can join: the full rules

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.

Where it's running

• Affinia healthcare, 1717 Biddle Street
  St Louis, Missouri, United States Recruiting
• Affinia healthcare, 4414 North Florissant Avenue
  St Louis, Missouri, United States Recruiting
• Family Care Heath Center, 4352 Manchester Ave
  St Louis, Missouri, United States Recruiting
• Washington University in St. Louis School of Medicine
  St Louis, Missouri, United States Recruiting
• Affinia healthcare, 3396 Pershall Road,
  St Louis, Missouri, United States Recruiting
• Affinia healthcare, 2220 Lemp Ave
  St Louis, Missouri, United States Not yet recruiting

Study contacts

• Study coordinator: James Krings, MD MSCI
• Email: kringsj@wustl.edu
• Phone: 3143769452

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.