Bringing SMART inhaler therapy to community health clinics

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

This project will test a program that helps community clinic clinicians start using SMART inhaler treatment for adults with moderate to severe asthma.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2000 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: Washington University School of Medicine (Academic / other)
• Locations: 7 sites (St Louis, Missouri and 6 other locations)
• Trial ID: NCT07241117 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with moderate to severe asthma who receive care at the participating community health center clinics are the intended participants and data contributors for outcomes.

Not a fit: Patients who do not receive care at the participating clinics, those with only mild asthma, or those with clinical contraindications to SMART inhaler regimens are unlikely to benefit from this implementation program.

Why it matters

Potential benefit: If successful, more patients at community clinics could receive guideline-recommended SMART therapy, which may lower asthma attacks and emergency visits.

How similar studies have performed: Randomized trials have shown SMART regimens reduce exacerbations, but implementation-focused efforts in community or lower-resource clinics are less common and have reported mixed but encouraging results.

Eligibility 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:

1. Active participation in the St. Louis Integrated Health Center Network for Community Academic Partnerships.
2. 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).
3. Data provided to Azara for data queries, and
4. 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:

1. Provision of a signed and dated informed consent form.
2. Current state licenses of physician, assistant physician, nurse practitioner, or physician assistant.
3. Regularly cares for adults with asthma (which may include those trained in family medicine, internal medicine, obstetrics/gynecology, and/or specialty medicine).
4. Willing and able to integrate the SMART implementation bundle into their practice.
5. Willing and able to participate for the entire duration of the study, including the pre-implementation, active implementation, and post-implementation periods.
6. 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:

1. Age ≥12 years old
2. Diagnosis of asthma, of any severity, coded (i.e., International Classification of Diseases \[ICD\]-10-CM: J45\*\*).
3. 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 this trial is running

St Louis, Missouri and 6 other locations

• Affinia healthcare, 2220 Lemp Ave — St Louis, Missouri, United States (Not_yet_recruiting)
• Affinia healthcare, 1717 Biddle Street — St Louis, Missouri, United States (Not_yet_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 (Not_yet_recruiting)
• Washington University in St. Louis School of Medicine — St Louis, Missouri, United States (Recruiting)
• Family Care Heath Center, 401 Holly Hills Ave — St Louis, Missouri, United States (Not_yet_recruiting)
• Affinia healthcare, 3396 Pershall Road, — St Louis, Missouri, United States (Not_yet_recruiting)

Study contacts

• Study coordinator: James Krings, MD MSCI

Conditions Moderate to Severe Asthma; asthma; SMART; moderate to severe asthma; CHEST; CHEST asthma study; asthma study; asthma action plan