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

September 4, 2026 updated by: James Krings, Washington University School of Medicine

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University in St. Louis School of Medicine
        • Contact:
      • St Louis, Missouri, United States, 63104
        • Not yet recruiting
        • Affinia healthcare, 2220 Lemp Ave
        • Contact:
      • St Louis, Missouri, United States, 63107
        • Recruiting
        • Affinia healthcare, 4414 North Florissant Avenue
        • Contact:
      • St Louis, Missouri, United States, 63111
        • Not yet recruiting
        • Family Care Heath Center, 401 Holly Hills Ave
        • Contact:
      • St Louis, Missouri, United States, 63106
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Family Care Heath Center, 4352 Manchester Ave
        • Contact:
      • St Louis, Missouri, United States, 63135

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
During this period, prescribing patterns and asthma outcomes will be observed without active implementation.
Experimental: Active Implementation
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 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
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
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 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.
Through study completion, up to 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinic-level Reach: Reach of the SMART implementation bundle
Time Frame: Through study completion, up to 24 months

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.
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
Time Frame: Through study completion, up to 24 months

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.
Through study completion, up to 24 months
Clinician-level Reach: Reach of the SMART implementation bundle
Time Frame: Through study completion, up to 24 months

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).
Through study completion, up to 24 months
Staff-level Reach: Reach of the SMART implementation bundle
Time Frame: Through study completion, up to 24 months

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
Through study completion, up to 24 months
Patient-level Reach: Reach of SMART among eligible patients
Time Frame: Through study completion, up to 24 months

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.
Through study completion, up to 24 months
Patient-level safety of SMART therapy (adverse events of special interest and serious adverse events)
Time Frame: Through study completion, up to 24 months

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.
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
Time Frame: Through study completion, up to 24 months
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.
Through study completion, up to 24 months
Clinician-level adherence to the SMART implementation bundle (implementation strategy adherence)
Time Frame: Through study completion, up to 24 months

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.
Through study completion, up to 24 months
Clinician-level fidelity to SMART prescribing and delivery (clinical intervention fidelity)
Time Frame: Through study completion, up to 24 months

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.
Through study completion, up to 24 months
System-level implementation cost and budget impact of the SMART implementation bundle
Time Frame: Through study completion, up to 24 months

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.
Through study completion, up to 24 months
Patient-level sustainment of SMART prescribing and asthma outcomes following completion of active implementation (maintenance outcome)
Time Frame: Through study completion, up to 24 months

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.
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)
Time Frame: Through study completion, up to 24 months

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.
Through study completion, up to 24 months
Patient-level de-implementation of SABA prescribing among patients prescribed SMART (de-implementation outcome)
Time Frame: Through study completion, up to 24 months

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.
Through study completion, up to 24 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Qualitative assessment of the determinants of patient-level reach of SMART (CFIR-informed)
Time Frame: Through study completion, up to 24 months

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.
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)
Time Frame: Through study completion, up to 24 months

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.
Through study completion, up to 24 months
Digital reach of SMART implementation materials, including the CHEST study website and SMART asthma action plan (AAP)
Time Frame: Through study completion, up to 24 months

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.
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)
Time Frame: Through study completion, up to 24 months

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.
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)
Time Frame: Through study completion, up to 24 months

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.
Through study completion, up to 24 months
Qualitative assessment of clinician and staff adoption of the SMART implementation bundle (CFIR-informed exploratory outcome)
Time Frame: Through study completion, up to 24 months

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.
Through study completion, up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)
Doris Duke Charitable Foundation
Family Care Health Centers
Affinia Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 6, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202507167
  • 5K23HL171940-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings