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NCT07241117PHASE4Recruiting

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

Washington University School of Medicine

Start Date

1/6/2026

Completion Date

11/15/2028

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.

Detailed Description

CHEST is a type 1 hybrid stepped-wedge cluster randomized trial wherein six federally qualified community health center clinics are randomly and iteratively selected to move in a 1-way crossover from the control group to the SMART implementation group. The primary intervention is the SMART implementation bundle includes four components: (1) clinician education on SMART with ongoing practice facilitation, (2) serial clinic- and clinician-level audit and feedback on inhaler prescribing patterns, (3) workflow integration support including prescribing preferences, and (4) provision of an online patient-centered education aid with a SMART congruent asthma action plan designed for patients with lower health literacy. The study is conceptually split into three phases: (1) the pre-implementation (control) phase focused on the development of implementation materials and baseline data gathering of prescription patterns; (2) the active implementation phase; and (3) the sustainment phase, which will focus on an assessment of sustainment and dissemination. 1. Pre-implementation phase: The pre-implementation phase is designed to be a baseline for the study. During this phase, no specific interventions will be introduced to the clinicians at participating IHN clinics. This phase will allow the CHEST study team to collect clinic-level data on current asthma care prescription practices and asthma-related outcomes. 2. Active implementation phase: At the start of the second phase, the implementation phase, the SMART implementation bundle will be introduced to the clinicians and staff at participating IHN clinics. 3. Sustainment phase: The final phase of the study is introduced after the active implementation of the SMART implementation bundle is complete at all participating IHN clinics. In the sustainment phase, formal assessments will be conducted to evaluate the sustainment of the SMART bundle. Additionally, this phase includes efforts to disseminate the findings of the study. This encompasses analyses of the reach and impact of the dissemination efforts, as well as the practical application and adoption of the findings in the broader medical community.

Eligibility Criteria

Age Range: 12 years to No maximum

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.

Interventions

BEHAVIORAL

Implementation bundle

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Conditions

Moderate to Severe Asthma

Locations

Affinia healthcare, 2220 Lemp Ave

St Louis, Missouri 63104

United States

Affinia healthcare, 1717 Biddle Street

St Louis, Missouri 63106

United States

Affinia healthcare, 4414 North Florissant Avenue

St Louis, Missouri 63107

United States

Family Care Heath Center, 4352 Manchester Ave

St Louis, Missouri 63110

United States

Washington University in St. Louis School of Medicine

St Louis, Missouri 63110

United States

Family Care Heath Center, 401 Holly Hills Ave

St Louis, Missouri 63111

United States

Affinia healthcare, 3396 Pershall Road,

St Louis, Missouri 63135

United States