A Phase 4 interventional study of Implementation bundle in Moderate to Severe Asthma, sponsored by Washington University School of Medicine. Recruiting at 7 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Washington University School of Medicine · Phase 4, Interventional, and Treatment
Among 13 studies in Asthma by Washington University School of Medicine — 2 open to participants now, 3 under way, none of them phase 3. Asthma · Washington University School of Medicine.
Among the 13 studies in Asthma by Washington University School of Medicine, this one has the largest planned enrollment of the 11 interventional ones, is one of 2 that started in 2026, is one of 2 in phase 4, and was the 12th registered.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →2 of the 13 studies in Asthma by Washington University School of Medicine are open now, in 1 country. Each count lists the studies.
Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 146 take children under 18; 104 take healthy volunteers.
This study: 12 Years and older · all sexes · no healthy volunteers.
The full table on the hub →13 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 2 started in 2026.
Median enrollment 191 across the 11 interventional studies, 127 across the 2 observational. Of the 10 that completed or were terminated, 1 (10%) have results posted.
Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
2 of the studies in Asthma by Washington University School of Medicine that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05111262Washington University School of MedicineSymptom-driven ICS/LABA Therapy for Patients With Asthma Non-adherent to Daily Maintenance Inhalers | 2027-09-30 |
| NCT07241117Washington University School of MedicineCHEST: A Collaboration With Community HEalth Centers to Implement SmarT for Asthma | 2027-11-15 |
Among the 13 studies in Asthma by Washington University School of Medicine, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
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:
At the staff level:
Staff will be considered eligible if they:
At the patient level:
Patients will be considered eligible if they:
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) workflow integration support, including prescribing preferences, and (4) patient-centered education tools such as instructional videos and a SMART-congruent asthma action plan designed for low health literacy. 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
During this period, prescribing patterns and asthma outcomes will be observed without active implementation.
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
Clinician-level adoption of the SMART implementation bundle
Proportion of eligible clinicians who adopt all three core components of the SMART implementation bundle Definition of adoption: 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
Time frame: Through study completion, up to 24 months
Clinic-level effectiveness of the SMART implementation bundle, measured as the proportion of SMART-eligible asthma encounters in which SMART is prescribed
Between-group difference in the proportion of SMART-eligible asthma encounters in which SMART is prescribed, comparing implementation vs control periods Unit of analysis: Individual asthma-related clinical encounters among patients aged ≥12 years. Definition of eligible encounters: Encounters will be classified as 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. Definition of SMART prescribing: 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.
Time frame: Through study completion, up to 24 months
Clinic-level Reach: Reach of the SMART implementation bundle
Number and proportion of eligible clinics that participated in ≥1 component of the SMART implementation bundle. Definition of eligible clinics: 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). Definition of reach: Clinics will be classified as "reached" if they participate in ≥1 predefined implementation activity, including kickoff meeting, staff training, workflow integration, clinical decision support deployment, or audit-and-feedback reporting. Site selection: Final clinic participation will be determined collaboratively by clinic system leadership and the study steering committee based on operational readiness and feasibility.
Time frame: Through study completion, up to 24 months
Patient-level effectiveness of SMART implementation, measured as the rate of clinic-treated asthma exacerbations and systemic corticosteroid-treated exacerbations
Between-group difference in the rate of asthma exacerbations treated with systemic corticosteroids, comparing implementation vs control periods Definition of asthma exacerbation: An exacerbation will be defined as any of the following: 1. Prescription of a new systemic corticosteroid associated with an asthma-related clinical encounter (clinic visit, telephone encounter, or telehealth encounter), identified in the electronic health record; 2. Encounter with a diagnosis code for acute asthma exacerbation (ICD-10-CM: J45.901); or 3. Dispensing of a systemic corticosteroid (e.g., prednisone, prednisolone, methylprednisolone, dexamethasone) identified through linkage with Missouri Medicaid (MO HealthNet) pharmacy claims data among enrolled patients.
Time frame: Through study completion, up to 24 months
Clinician-level Reach: Reach of the SMART implementation bundle
Number and proportion of eligible clinicians who participate in ≥1 SMART implementation activity. Definition of eligible clinicians: 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. Eligible clinicians may include those practicing in primary care, pediatrics, pulmonology, allergy/immunology, and obstetrics/gynecology settings. Definition of reach: Clinicians will be classified as "reached" if they participate in ≥1 predefined implementation activity, including attendance at implementation kickoff meetings, educational sessions, practice facilitation encounters, audit-and-feedback sessions, or engagement with implementation tools (e.g., asthma action plans, clinical decision support, or training materials).
Time frame: Through study completion, up to 24 months
Staff-level Reach: Reach of the SMART implementation bundle
Number and proportion of eligible staff who participate in ≥1 SMART implementation activity. Definition of eligible staff: 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. Eligible staff may include nurses, medical assistants, pharmacists, respiratory therapists, pharmacy technicians, care coordinators, and other staff involved in asthma-related clinical workflows, as determined by clinic leadership and study personnel. Definition of reach: Staff will be classified as "reached" if they participate in ≥1 predefined implementation activity, including attendance at implementation kickoff meetings, educational sessions, practice facilitation encounters, workflow redesign activities, audit-and-feedback sessions, or engagement with implementation tools
Time frame: Through study completion, up to 24 months
Patient-level Reach: Reach of SMART among eligible patients
Number and proportion of eligible patients prescribed SMART during the implementation period Definition of eligible patients: 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. Definition of reach: Patients will be classified as "reached" if they receive ≥1 prescription for an inhaled corticosteroid-formoterol inhaler prescribed for use as both maintenance and reliever therapy (SMART) during the implementation period. Eligible SMART prescriptions include budesonide-formoterol or mometasone-formoterol prescribed at guideline-consistent dosing for maintenance and reliever use, consistent with GINA recommendations.
Time frame: Through study completion, up to 24 months
Patient-level safety of SMART therapy (adverse events of special interest and serious adverse events)
Between-group difference in the rate of adverse events of special interest (AESI) and serious adverse events (SAEs), comparing implementation vs control periods Adverse events of special interest (AESI): AESI will include known or anticipated adverse effects potentially associated with inhaled corticosteroid-formoterol therapy, identified using diagnosis codes and/or documented clinical events, including: * Oral candidiasis (ICD-10-CM: B37.0) * Dysphonia (ICD-10-CM: R49.0) * Tremor (ICD-10-CM: R25.1, G25.0, G25.2) * Palpitations (ICD-10-CM: R00.2) Serious adverse events (SAEs): SAEs will be defined according to standard regulatory criteria, including death, life-threatening event, inpatient hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity, or other medically important events potentially related to asthma therapy.
Time frame: Through study completion, up to 24 months
Clinician-level effectiveness of the SMART implementation bundle, measured as the proportion of clinicians classified as frequent SMART prescribers
Proportion of eligible clinicians classified as frequent SMART prescribers, defined as prescribing SMART in ≥30% of SMART-eligible encounters Definition of eligible clinicians: 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) managed ≥10 patients aged ≥12 years with moderate-to-severe asthma during the 12 months preceding implementation initiation. Definition of SMART-eligible encounters: Encounters will be classified as 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. Definition of SMART prescribing: SMART prescribing will be defined as the prescription of an inhaled corticosteroid-formoterol inhaler with instructions consistent with use as both maintenance and reliever therapy.
Time frame: Through study completion, up to 24 months
Clinician-level adherence to the SMART implementation bundle (implementation strategy adherence)
Proportion of eligible clinicians meeting predefined adherence thresholds to implementation bundle components. Definition of implementation adherence: Clinician adherence to the implementation bundle will be defined as meeting all of the following criteria: (1) Participation in the baseline implementation visit; (2) Participation in ≥50% of offered practice facilitation sessions; (3) Participation in ≥50% of offered audit-and-feedback sessions; and (4) Self-reported use of SMART patient education tools (SMART asthma action plan and/or patient education materials) in ≥50% of SMART-eligible encounters. Definition of eligible clinicians: Eligible clinicians will include physicians, assistant physicians, nurse practitioners, and physician assistants actively employed at participating clinics who manage patients aged ≥12 years with asthma.
Time frame: Through study completion, up to 24 months
Clinician-level fidelity to SMART prescribing and delivery (clinical intervention fidelity)
Proportion of clinicians and sampled encounters in which SMART was delivered consistent with recommended clinical practice Definition of fidelity: Fidelity will be defined as clinician-reported delivery of SMART therapy consistent with recommended clinical practice, including: 1. Prescription of an ICS-formoterol inhaler intended for both maintenance and reliever use; 2. Discontinuation or intentional non-prescribing of short-acting beta-agonist (SABA) rescue inhalers when appropriate; and 3. Provision of SMART-specific patient education, including asthma action plan use and instruction on SMART dosing. Assessment method: Fidelity will be assessed using structured clinician fidelity assessments conducted by study personnel. A random sample of approximately 50 SMART-prescribing encounters across participating clinicians will be selected, and clinicians will be asked to confirm whether SMART was delivered consistent with recommended clinical practice.
Time frame: Through study completion, up to 24 months
System-level implementation cost and budget impact of the SMART implementation bundle
Estimated implementation costs and exploratory budget impact associated with implementation of the SMART implementation bundle and asthma-related healthcare utilization Objective: To estimate the cost of implementing the SMART implementation bundle and assess the exploratory budget impact of SMART adoption on asthma-related healthcare costs from healthcare system and payer perspectives. Implementation cost assessment: Implementation costs will be estimated using micro-costing methods and will include: • Personnel time associated with implementation activities (education sessions, practice facilitation, audit-and-feedback delivery, and coordination); • Training and educational material development and dissemination costs; • Implementation infrastructure and operational costs; and • Administrative and implementation support costs borne by participating clinics and the study team.
Time frame: Through study completion, up to 24 months
Patient-level sustainment of SMART prescribing and asthma outcomes following completion of active implementation (maintenance outcome)
Proportion of SMART-eligible encounters prescribed SMART and rate of asthma exacerbations during the sustainment period compared with the active implementation period Definition of sustainment period: The sustainment period will be defined as the period following completion of active implementation activities (e.g., cessation of structured practice facilitation and audit-and-feedback sessions), during which clinics continue routine clinical care without active implementation support. Primary sustainment measures: Sustainment will be assessed by comparing: 1. The proportion of SMART-eligible encounters in which SMART is prescribed during the sustainment period compared with the active implementation period; and 2. The rate of asthma exacerbations (defined as systemic corticosteroid-treated exacerbations or exacerbation-related encounters) during the sustainment period compared with the active implementation period.
Time frame: Through study completion, up to 24 months
Clinician-level and system-level sustainment of the SMART implementation bundle and organizational capacity to maintain SMART clinical practice (implementation sustainment outcome)
Continued use of SMART implementation bundle components following completion of active implementation support Definition of sustainment: Sustainment will be defined as the continued use of SMART implementation bundle components during the sustainment period, including ongoing use of SMART asthma action plans, continued incorporation of SMART into clinical workflows, and continued engagement with SMART-related clinical practices in the absence of active implementation support. Sustainment capacity assessment: A validated sustainability assessment instrument, such as the Clinical Sustainability Assessment Tool (CSAT), will be administered to clinic leadership, site champions, and clinical staff at the beginning and conclusion of the sustainment period to assess organizational capacity to maintain SMART implementation.
Time frame: Through study completion, up to 24 months
Patient-level de-implementation of SABA prescribing among patients prescribed SMART (de-implementation outcome)
Proportion of SMART-prescribing encounters in which SABA inhalers are not concurrently prescribed Definition of de-implementation: De-implementation will be defined as the absence of an active SABA prescription following initiation of SMART therapy or documented discontinuation of an existing SABA prescription at the time SMART is prescribed. Eligible encounters: All clinical encounters in which SMART is prescribed for maintenance and reliever therapy (ICS-formoterol prescribed for both maintenance and reliever use). Objective: This outcome assesses the extent to which SMART implementation replaces legacy SABA prescribing practices consistent with guideline-recommended care.
Time frame: Through study completion, up to 24 months
Qualitative assessment of the determinants of patient-level reach of SMART (CFIR-informed)
Identification of barriers and facilitators influencing patient receipt and use of SMART therapy Objective: To identify patient-level determinants influencing receipt and use of SMART therapy among eligible patients, guided by the Consolidated Framework for Implementation Research (CFIR). Participant recruitment: A purposive sample of eligible patients aged ≥12 years with moderate-to-severe asthma will be invited to participate in semi-structured interviews and/or focus groups. Sampling will include patients who: (1) were prescribed SMART and use it consistently; (2) were prescribed SMART but do not use it consistently; and (3) were eligible for SMART but were not prescribed SMART. This sampling strategy will ensure representation of diverse experiences with SMART implementation.
Time frame: Through study completion, up to 24 months
Qualitative assessment of the determinants of clinician- and staff-level reach of the SMART implementation bundle (CFIR-informed)
Identification of barriers and facilitators influencing clinician and staff participation in SMART implementation activities Objective: To identify multilevel determinants influencing clinician and staff participation ("reach") in the SMART implementation bundle, guided by the Consolidated Framework for Implementation Research (CFIR). Participant recruitment: All eligible clinicians, staff, and clinic leadership at participating sites will be invited to complete structured surveys assessing participation and determinants of participation. A purposive sample of clinicians, staff, and clinic leaders representing high, moderate, and low levels of implementation participation will be invited to participate in semi-structured interviews and/or focus groups. Snowball sampling may be used to identify additional individuals with relevant perspectives.
Time frame: Through study completion, up to 24 months
Digital reach of SMART implementation materials, including the CHEST study website and SMART asthma action plan (AAP)
Number of unique website users, number of website sessions, number of SMART asthma action plan (AAP) downloads, and number of views of SMART-related implementation materials Definition of digital reach: Digital reach will be defined as engagement with the CHEST study website and associated SMART implementation resources by any website user. Metrics will include: (1) number of unique users accessing the website; (2) number of website sessions; (3) number of page views of SMART-related materials; and (4) number of downloads of the SMART asthma action plan (AAP). Outcome definition: The primary dissemination reach outcomes will include cumulative and monthly counts of website access and SMART AAP downloads. Secondary descriptive metrics will include user engagement trends over time.
Time frame: Through study completion, up to 24 months
Qualitative assessment of clinician and staff perceptions of the effectiveness of the SMART implementation bundle and SMART therapy (CFIR-informed exploratory outcome)
Identification of clinician and staff perceptions of the effects of the SMART implementation bundle on workflow, prescribing behavior, knowledge, self-efficacy, and asthma care delivery Objective: To assess clinician and staff perceptions of the effectiveness and impact of the SMART implementation bundle and SMART therapy, guided by the Consolidated Framework for Implementation Research (CFIR). Participant recruitment: All eligible clinic leadership, clinicians, and staff will be invited to complete structured surveys assessing perceived effects of the implementation bundle. A purposive sample of clinicians, staff, and clinic leaders representing varying levels of implementation engagement and SMART prescribing will be invited to participate in semi-structured interviews and/or focus groups. Snowball sampling may be used to identify additional participants with relevant perspectives.
Time frame: Through study completion, up to 24 months
Qualitative assessment of patient perceptions of the effectiveness and impact of the SMART implementation bundle and SMART therapy (CFIR-informed exploratory outcome)
Identification of patient perceptions of the effects of SMART therapy and associated implementation efforts on asthma management, treatment confidence, self-efficacy, usability, and satisfaction Objective: To assess patient perceptions of the effectiveness and impact of SMART therapy and the SMART implementation bundle on asthma self-management and care delivery. Participant recruitment: A purposive sample of eligible patients aged ≥12 years with moderate-to-severe asthma receiving care at participating clinics will be invited to participate in semi-structured interviews and/or focus groups. Sampling will include patients who were prescribed SMART and patients eligible for SMART but not prescribed SMART to capture diverse perspectives. Site CMOs, site champions, and study personnel may assist with identifying eligible participants. Snowball sampling may be used to identify additional participants with relevant perspectives.
Time frame: Through study completion, up to 24 months
Qualitative assessment of clinician and staff adoption of the SMART implementation bundle (CFIR-informed exploratory outcome)
Identification of clinician and staff perspectives on adoption of the SMART implementation bundle, including reasons for participation, non-participation, and variation in adoption across implementation components Objective: To assess clinician and staff perspectives on adoption of the SMART implementation bundle and identify barriers and facilitators influencing uptake. Participant recruitment: A purposive sample of clinic leadership, clinicians, and staff eligible for participation in the SMART implementation bundle will be invited to participate in semi-structured interviews and/or focus groups. Participants will be selected to represent a range of adoption levels, including early adopters, delayed adopters, and non-adopters. Site CMOs, site champions, and study personnel may assist with identifying eligible participants. Snowball sampling may be used to identify additional participants with relevant perspectives.
Time frame: Through study completion, up to 24 months
Plan to share: Yes — Yes. De-identified IPD will be shared, including quantitative data (demographics, validated surveys, attendance logs, and de-identified EHR data on asthma encounters, diagnoses, and prescriptions) and qualitative interview and focus group transcripts verified for accuracy and de-identified. The protocol, statistical analysis plan, data dictionary, and analytic code will also be shared via NHLBI's BioLINCC. Data will be securely stored within WUSM REDCap, RIS, or Box prior to sharing. HIPAA-compliant transcription and REDCap validation ensure accuracy. Oversight and compliance will be maintained through WUSM IRB, the Office of Information Security, community health center regulatory bodies, and the study's DSMB. Data will follow COREQ, CONSORT, and TIDieR standards and be shared following primary publication.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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.
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