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

NCT07241117 | Recruiting Phase 4 DMC

• 2 other identifiers: 2025071675K23HL171940-02
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Moderate to Severe Asthma

Keywords

asthma; SMART; moderate to severe asthma; CHEST; CHEST asthma study; asthma study; asthma action plan; implementation science; hybrid cluster; community health centers; MART; single maintenance and reliever therapy; maintenance and reliever therapy

Outcome Measures

Primary Outcomes (2)

• Patient-level Effectiveness (of the SMART implementation bundle)

  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 month as a "transition phase."

  Through study completion, up to 24 months

• Clinician-level adoption (of the SMART implementation bundle)

  Proportion of clinicians who initially utilize the 3 SMART implementation bundle components. Adoption will be defined by initial: 1) participation in an education and practice facilitation session, 2) participation in an audit and feedback session, 3) use of the patient-centered education aide and action plan, and 4) participation in monthly operations committee meetings. Eligible clinicians will be defined as any clinician that is (1) a currently state-licensed physician, assistant physician, nurse practitioner, or physician assistant, and (2) regularly cares for adults with asthma (defined as managing asthma for at least one adult asthma patient, on average, on a weekly basis).

  Through study completion, up to 24 months

Secondary Outcomes (13)

• Clinic-level reach (of the SMART implementation bundle)

  Through study completion, up to 24 months

• Clinician-level reach (of the SMART implementation bundle)

  Through study completion, up to 24 months

• Staff-level reach (of the SMART implementation bundle)

  Through study completion, up to 24 months

• Patient-level reach of (of the evidence-based practice, i.e., SMART)

  Through study completion, up to 24 months

• Patient-level effectiveness (of the evidence-based practice, i.e., SMART)

  Through study completion, up to 24 months

Other Outcomes (5)

• Qualitative assessment of the determinants of clinician and staff-reach (of the SMART implementation bundle)

  Through study completion, up to 24 months

• Qualitative assessment of the determinants of clinician and staff-reach (of the evidence-based practice, i.e., SMART

  Through study completion, up to 24 months

• Reach (of SMART implementation materials including the CHEST website and SMART focused AAP)

  Through study completion, up to 24 months

Study Arms (2)

Active Implementation

EXPERIMENTAL

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

Behavioral: Implementation bundle

Control

NO INTERVENTION

During this period, prescribing patterns and asthma outcomes will be observed without active implementation.

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

Active Implementation

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Doris Duke Charitable Foundation: collaborator
• Affinia Healthcare: collaborator
• Family Care Health Centers: collaborator
• Washington University School of Medicine: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (7)

Affinia healthcare, 2220 Lemp Ave

St Louis, Missouri, 63104, United States

NOT YET RECRUITING

Affinia healthcare, 1717 Biddle Street

St Louis, Missouri, 63106, United States

NOT YET RECRUITING

Affinia healthcare, 4414 North Florissant Avenue

St Louis, Missouri, 63107, United States

RECRUITING

Family Care Heath Center, 4352 Manchester Ave

St Louis, Missouri, 63110, United States

NOT YET RECRUITING

Washington University in St. Louis School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Family Care Heath Center, 401 Holly Hills Ave

St Louis, Missouri, 63111, United States

NOT YET RECRUITING

Affinia healthcare, 3396 Pershall Road,

St Louis, Missouri, 63135, United States

NOT YET RECRUITING

Related Publications (7)

• Ivers N, Jamtvedt G, Flottorp S, Young JM, Odgaard-Jensen J, French SD, O'Brien MA, Johansen M, Grimshaw J, Oxman AD. Audit and feedback: effects on professional practice and healthcare outcomes. Cochrane Database Syst Rev. 2012 Jun 13;2012(6):CD000259. doi: 10.1002/14651858.CD000259.pub3.

  PMID: 22696318 BACKGROUND

• Infante AF, Wells C, Loza J, Hobbs K, Jarrett JB, Elmes AT. Be SMART About Asthma Management: Single Maintenance and Reliever Therapy. J Am Board Fam Med. 2024 Jul-Aug;37(4):745-752. doi: 10.3122/jabfm.2023.230456R1.

  PMID: 39455262 BACKGROUND

• Chapman KR, Barnes NC, Greening AP, Jones PW, Pedersen S. Single maintenance and reliever therapy (SMART) of asthma: a critical appraisal. Thorax. 2010 Aug;65(8):747-52. doi: 10.1136/thx.2009.128504. Epub 2010 Jun 27.

  PMID: 20581409 BACKGROUND

• Reddel HK, Bateman ED, Schatz M, Krishnan JA, Cloutier MM. A Practical Guide to Implementing SMART in Asthma Management. J Allergy Clin Immunol Pract. 2022 Jan;10(1S):S31-S38. doi: 10.1016/j.jaip.2021.10.011. Epub 2021 Oct 16.

  PMID: 34666208 BACKGROUND

• Norris MR, Modi S, Al-Shaikhly T. SMART - is it practical in the United States? Curr Opin Pulm Med. 2022 May 1;28(3):245-250. doi: 10.1097/MCP.0000000000000862. Epub 2022 Feb 7.

  PMID: 35131990 BACKGROUND

• Krings JG, Sekhar TC, Chen V, Blake KV, Sumino K, James AS, Clover AK, Lenze EJ, Brownson RC, Castro M. Beginning to Address an Implementation Gap in Asthma: Clinicians' Views of Prescribing Reliever Budesonide-Formoterol Inhalers and SMART in the United States. J Allergy Clin Immunol Pract. 2023 Sep;11(9):2767-2777. doi: 10.1016/j.jaip.2023.05.023. Epub 2023 May 26.

  PMID: 37245736 BACKGROUND

• Zaeh SE, Zimmerman ZE, Eakin MN, Chupp G. Adoption and implementation of maintenance and reliever therapy for adults with moderate-to-severe asthma. Ann Allergy Asthma Immunol. 2024 Sep;133(3):318-324. doi: 10.1016/j.anai.2024.06.011. Epub 2024 Jun 17.

  PMID: 38897404 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

James Krings, MD MSCI

CONTACT

3143769452; kringsj@wustl.edu

Krutika Chauhan, MBBS MPH

CONTACT

3143769452; c.krutika@wustl.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: This is a Phase 4, type 1 hybrid stepped-wedge cluster randomized trial conducted in six Federally Qualified Health Centers in St. Louis, Missouri. The unit of randomization is the clinic, with each site sequentially crossing over in a one-way fashion from control to intervention, allowing each to serve as its own control. The intervention is the SMART implementation bundle consisting of (1) clinician education with practice facilitation, (2) audit and feedback on prescribing, (3) patient-centered education aides, including a SMART-congruent asthma action plan, and (4) monthly operations committee meetings during implementation period. The trial proceeds in three phases: pre-implementation (baseline), active implementation (rollout), and post-implementation (sustainability/dissemination). The study population includes clinicians, staff, and patients ≥12 years with moderate-to-severe asthma.

Study Record Dates

• First Submitted: November 7, 2025
• First Posted: November 21, 2025
• Study Start: January 6, 2026
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): November 15, 2028
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: De-identified IPD and supporting materials will be submitted to NHLBI's BioLINCC within 12 months after completion of data collection or prior to primary publication, whichever comes first. Data will undergo quality and compliance review before public release. Shared data will remain archived and accessible for long-term preservation within BioLINCC, consistent with NIH and NHLBI repository practices, to enable future secondary analyses and replication studies.
• Access Criteria: De-identified IPD and supporting materials will be shared through NHLBI's BioLINCC repository. Access will be open to qualified investigators without restriction for research, replication, or secondary analyses consistent with the study's aims and public health interests. Privacy and confidentiality protections will be maintained per approvals from the WUSM IRB, Office of Information Security, community health center regulatory bodies, and the study's DSMB. Data requests will be reviewed and managed through BioLINCC's standard procedures, which require submission of a data request and execution of a Research Materials Distribution Agreement. Oversight of compliance and continued protection of participant confidentiality will be ensured through WUSM and NHLBI regulatory oversight mechanisms.

Locations

US (7)