NCT07241117 · Washington University School of Medicine
CHEST: A Collaboration With Community HEalth Centers to Implement SmarT for Asthma
(CHEST)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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 measures
Patient-level Effectiveness (of the SMART implementation bundle)
Time frame: Through study completion, up to 24 months
A clinic-level assessment of the SMART implementation bundle with the endpoint of between-group difference in the proportion of SMART-recommended asthma encounters, wherein SMART was the prescribed inhaler regimen. Patient encounters wherein any diagnosis of asthma was coded in patients ≥12 years old will be queried. Asthma encounters will then be in a binary fashion, as either "SMART- non-recommended" or "SMART- recommended" based on asthma exacerbation history and currently prescribed maintenance inhaler medications. A SMART prescription will be defined as clinician prescription of budesonide- formoterol 160/4.5µg or mometasone-formoterol 100/6µg ordered for maintenance and reliever usage. The proportion of SMART prescriptions will be compared between control and intervention groups. The control period will include pre-intervention data, while the intervention period will include all time post-implementation, but exclude the first 2 months as a "transition phase."
Clinician-level adoption (of the SMART implementation bundle)
Time frame: Through study completion, up to 24 months
Proportion of eligible clinicians who adopt all three core components of the SMART implementation bundle. Clinician-level adoption will be defined as completion and initial use of all three core SMART implementation bundle components: (1) Participation in at least one SMART-focused education and practice facilitation session; (2) Participation in at least one audit-and-feedback session reviewing SMART prescribing performance; and (3) Initial use of SMART patient-centered education tools, defined as documentation and/or clinician self-report of the use of the SMART asthma action plan and/or patient education materials during clinical care. Clinicians will be considered eligible if they: (1) are state-licensed physicians, assistant physicians, nurse practitioners, or physician assistants; (2) provide outpatient clinical care to patients aged ≥12 years with asthma at participating clinics; and (3) are actively employed at the clinic during the implementation period.
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
Between-group difference in the proportion of SMART-eligible asthma encounters in which SMART is prescribed, comparing implementation vs control periods. Encounters will be SMART-eligible if patients meet study-defined criteria consistent with GINA Step 3-5 treatment, based on exacerbation history and prescribed controller medications, as defined in the study algorithm. SMART prescribing will be defined as prescription of an inhaled corticosteroid-formoterol inhaler (budesonide-formoterol 160/4.5 µg or mometasone-formoterol 100/6 µg or equivalent) with instructions consistent with use as both maintenance and reliever therapy: The primary effectiveness analysis will compare SMART prescribing rates between implementation and control periods across clinics. The control period will include pre-implementation encounters, and the implementation period will include encounters occurring after implementation initiation, excluding a predefined 2-month transition period after randomization.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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:
- Active participation in the St. Louis Integrated Health Center Network for Community Academic Partnerships.
- Employment of at least 3 clinicians who commonly manage adult asthma (defined as managing asthma for at least one adult asthma patient, on average, on a weekly basis).
- Data provided to Azara for data queries, and
- Willing and able to receive all components of the SMART implementation bundle (i.e., initial educational outreach visit, ongoing practice facilitation/supervision, audit \& feedback, and provision of education of patient-level education aides and SMART asthma action plans and monthly operations committee meetings). At the clinician/clinical staff level: To be eligible to participate in this study, a clinician/clinical staff member must meet all of the following criteria:
- Provision of a signed and dated informed consent form.
- Current state licenses of physician, assistant physician, nurse practitioner, or physician assistant.
- Regularly cares for adults with asthma (which may include those trained in family medicine, internal medicine, obstetrics/gynecology, and/or specialty medicine).
- Willing and able to integrate the SMART implementation bundle into their practice.
- Willing and able to participate for the entire duration of the study, including the pre-implementation, active implementation, and post-implementation periods.
- Willing to provide data on prescribing patterns and asthma patient outcomes for the duration of the study. At the patient level: To be eligible to participate in this study, a patient must meet all of the following criteria:
- Age ≥12 years old
- Diagnosis of asthma, of any severity, coded (i.e., International Classification of Diseases \[ICD\]-10-CM: J45\*\*).
- The patient has had ≥2 asthma exacerbations in the last year during which systemic corticosteroids were prescribed, and/or the encounter contains an active prescription for an inhaler that is congruent with medium-dose (or higher) maintenance inhaled corticosteroids (ICS) inhalers or low-dose (or higher) ICS-long-acting β-agonist (LABA) inhalers with concomitant reliever short-acting β-agonist inhalers.
Where
- St Louis, Missouri
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Doris Duke Charitable Foundation, Affinia Healthcare, Family Care Health Centers
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 19, 2026 · Source of record for eligibility and locations