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

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: Recruiting
• Conditions: Moderate to Severe Asthma
• Intervention / Treatment: Behavioral: Implementation bundle

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: Interventional
• Enrollment (Estimated): 2000
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: James Krings, MD MSCI; Phone Number: 3143769452; Email: kringsj@wustl.edu
• Study Contact Backup: Name: Krutika Chauhan, MBBS MPH; Phone Number: 3143769452; Email: c.krutika@wustl.edu

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University in St. Louis School of Medicine
      • Contact: James G Krings, MD; Phone Number: 314-273-4734; Email: kringsj@wustl.edu
    • St Louis, Missouri, United States, 63104
      • Not yet recruiting
      • Affinia healthcare, 2220 Lemp Ave
      • Contact: Mellisa Tepe, MD; Phone Number: 3143769452; Email: mtepe@affiniahealthcare.org
    • St Louis, Missouri, United States, 63106
      • Not yet recruiting
      • Affinia healthcare, 1717 Biddle Street
      • Contact: Patrick Schoenwalder, PA; Phone Number: 314-814-8700; Email: pschoenwalder@affiniahealthcare.org
    • St Louis, Missouri, United States, 63107
      • Recruiting
      • Affinia healthcare, 4414 North Florissant Avenue
      • Contact: Catherine Moore, DO; Phone Number: 309-532-6707; Email: camoore@affiniahealthcare.org
    • St Louis, Missouri, United States, 63110
      • Not yet recruiting
      • Family Care Heath Center, 4352 Manchester Ave
      • Contact: Jaime Zengotita, MD; Phone Number: 3143769452; Email: jzengotita@fchcstl.org
    • St Louis, Missouri, United States, 63111
      • Not yet recruiting
      • Family Care Heath Center, 401 Holly Hills Ave
      • Contact: Jaime Zengotita, MD; Phone Number: 3143769452; Email: jzengotita@fchcstl.org
    • St Louis, Missouri, United States, 63135
      • Not yet recruiting
      • Affinia healthcare, 3396 Pershall Road,
      • Contact: Iesha Draper, MD; Phone Number: 314-793-7214; Email: idraper@affiniahealthcare.org

Participation Criteria

Eligibility Criteria

• 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. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 2 months as a "transition phase."	Through study completion, up to 24 months
Clinician-level adoption (of the SMART implementation bundle)	Proportion of eligible clinicians who adopt all three core components of the SMART implementation bundle. Clinician-level adoption will be defined as completion and initial use of all three core SMART implementation bundle components: (1) Participation in at least one SMART-focused education and practice facilitation session; (2) Participation in at least one audit-and-feedback session reviewing SMART prescribing performance; and (3) Initial use of SMART patient-centered education tools, defined as documentation and/or clinician self-report of the use of the SMART asthma action plan and/or patient education materials during clinical care. Clinicians will be considered eligible if they: (1) are state-licensed physicians, assistant physicians, nurse practitioners, or physician assistants; (2) provide outpatient clinical care to patients aged ≥12 years with asthma at participating clinics; and (3) are actively employed at the clinic during the implementation period.	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. Encounters will be SMART-eligible if patients meet study-defined criteria consistent with GINA Step 3-5 treatment, based on exacerbation history and prescribed controller medications, as defined in the study algorithm. SMART prescribing will be defined as prescription of an inhaled corticosteroid-formoterol inhaler (budesonide-formoterol 160/4.5 µg or mometasone-formoterol 100/6 µg or equivalent) with instructions consistent with use as both maintenance and reliever therapy: The primary effectiveness analysis will compare SMART prescribing rates between implementation and control periods across clinics. The control period will include pre-implementation encounters, and the implementation period will include encounters occurring after implementation initiation, excluding a predefined 2-month transition period after randomization.	Through study completion, up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinic-level reach (of the SMART implementation bundle)	Number and proportion of eligible clinics that participated in any component of SMART implementation. Clinics will be counted as reached if they participated in any component the SMART implementation bundle. Clinics at partnering clinic systems will be considered potentially eligible for implementation if they cared for ≥100 individuals ≥12 years old with asthma (ICD 10-CM: J45.xx) in the calendar year prior to implementation (2024). Clinic network leadership in coordination with the study steering committee will choose two individual clinic sites within their network they believe to have the highest readiness for SMART implementation.	Through study completion, up to 24 months
Clinician-level reach (of the SMART implementation bundle)	Number and proportion of eligible clinicians that participated in any component of SMART implementation bundle. Clinicians will be counted as reached if they participated in any component of the SMART implementation bundle (education, practice facilitation, audit and feedback, and/or self-reported use of the asthma action plan or training materials and monthly operations committee meeting at each site) during the active implementation period, which is inclusive of the initial visit and all follow-up visits. A clinician will be considered potentially eligible for SMART implementation (and as such counted as potentially able to be reached) if they are both (1) a physician, nurse practitioner, or physician assistant and (2) have cared for ≥10 adolescents or adults with asthma in the year prior to implementation. This is expected to be inclusive of, but not necessarily limited to, those working in primary care, pediatric, pulmonology, allergy, and/or obstetrics and gynecology clinics.	Through study completion, up to 24 months
Qualitative assessment (of the SMART implementation bundle and evidence based practice, i.e., SMART) adoption	Interviews/focus groups (clinicians, staff) for reasons clinicians/staff participated in implementation components (e.g., time constraints). A subset of clinic leadership, clinicians, and staff will be invited to participate in semi-structured one-on-one interviews (and/or focus groups) regarding reasons for participation and adoption of the implementation bundle.	Through study completion, up to 24 months
Staff-level reach (of the SMART implementation bundle)	Number and proportion of eligible staff that participated in any component of the SMART implementation bundle. Clinic staff will be counted 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 (e.g., asthma action plans, clinical decision support, or training materials). A clinic staff member will be considered eligible for the SMART implementation (and as such counted as potentially able to be reached) 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. This is expected to be inclusive of, but not necessarily limited to, nursing staff, medical assistants, pharmacists, respiratory therapists, and/or pharmacy techs.	Through study completion, up to 24 months
Patient-level reach of (of the evidence-based practice, i.e., SMART)	Number of patients with moderate-to-severe asthma prescribed SMART. Patients will be considered to be reached if they were ever prescribed SMART during the active implementation period. A prescription for SMART will count as any script for an ICS-formoterol at the 2024 GINA-recommended dosing on a maintenance and reliever basis. 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.	Through study completion, up to 24 months
Patient-level effectiveness (of the evidence-based practice, i.e., SMART)	Between group difference in the rate of asthma exacerbations. Asthma exacerbations will be defined by 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); (2) ICD-10-CM coding for an acute asthma exacerbation (J45.901); or (3) dispensing of a systemic corticosteroid identified through linkage with Missouri Medicaid (MO HealthNet) pharmacy claims data. Corticosteroid prescriptions or dispensing occurring within 14 days of each other will be considered part of a single exacerbation episode.	Through study completion, up to 24 months
Patient-level safety (of the evidence-based practice, i.e., SMART)	Between group difference in rate of dysphonia, oral candidiasis, tremor, and/or palpitations and other reported serious adverse events. Patients will be monitored for serious adverse events and adverse events of special interest (i.e. known side effects of ICS-formoterol by identifying cases of oral candidiasis (thrush; ICD-10-CM: B37.0), dysphonia (ICD-10-CM: R49.0), tremor (ICD-10-CM: R25.1, G25.0, G25.2), or palpitations (R00.2). Serious adverse events (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. Clinicians will be asked if they have identified any serious adverse events or adverse events of special interest at site visits during the implementation period. Clinicians will also be provided with the study team's contact information, including email and phone number for reporting.	Through study completion, up to 24 months
Clinician-level effectiveness (of the SMART implementation bundle)	The proportion of clinicians who are "frequent SMART prescribers" (defined as prescribing SMART in ≥30% of indicated encounters). A prescription for SMART will count as a script for an ICS- formoterol on a maintenance and reliever basis. 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. This is expected to be inclusive of, but not necessarily limited to, those working in primary care, pediatric, pulmonology, allergy, and/or obstetrics and gynecology clinics.	Through study completion, up to 24 months
Clinician-level fidelity to the SMART implementation bundle	Clinician adherence to the implementation bundle will be defined as meeting all of the following: (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 in ≥50% of SMART-eligible encounters.	Through study completion, up to 24 months
Clinician-level fidelity (of the evidence-based practice, SMART)	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 SABA rescue inhalers when appropriate; and (3) provision of SMART-specific patient education. Fidelity will be assessed via structured clinician fidelity assessments on a random sample of approximately 50 SMART-prescribing encounters.	Through study completion, up to 24 months
Other system-level implementation outcomes (of the SMART implementation bundle and evidence-based practice, i.e., SMART)	Exploratory assessment of costs by the investigators' team to implement the SMART implementation bundle and cost of asthma management to the payors. Implementation costs will be estimated using micro-costing methods and will include personnel time associated with implementation activities, training and educational material development and dissemination costs, implementation infrastructure and operational costs, and administrative and implementation support costs. Costs will be reported in inflation-adjusted U.S. dollars. A preliminary assessment of the estimated cost of training, implementation, asthma morbidity, inhalers, and other associated costs will be guided by the Good Practice for Budget Impact Analysis Taskforce recommendations and use cost data from MO HealthNet and the Medical Expenditure Panel Survey.	Through study completion, up to 24 months
Patient-level sustainment (of the evidence-based practice, i.e., SMART)	Proportion of indicated encounters wherein SMART was prescribed and rate of asthma exacerbations during sustainment vs. intervention period. Maintenance will be assessed by comparing 1) the prescription of SMART and 2) exacerbation rates in the implementation period vs. sustainment period. The sustainment period will be defined as the period following completion of active implementation activities (cessation of structured practice facilitation and audit-and-feedback sessions). Sustainment of SMART prescribing (%) = (Number of SMART-eligible encounters with SMART prescribed during sustainment ÷ Total SMART-eligible encounters during sustainment) × 100; exacerbation rates will be calculated as exacerbations per patient-year.	Through study completion, up to 24 months
Clinician-level and system-level sustainment (of the SMART implementation bundle)	A validated sustainability assessment instrument, 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. Semi-structured interviews will also be conducted with clinic leadership at the conclusion of the sustainment period to assess organizational readiness, leadership engagement, and barriers and facilitators to long-term sustainment, analyzed using thematic analysis guided by CFIR.	Through study completion, up to 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative assessment of the determinants of clinician and staff-reach (of the SMART implementation bundle)	Reasons clinicians and staff decided to, or decided not to, participate in any component of the SMART implementation bundle. All clinic leadership, clinicians, and staff who were potentially eligible for reach will be invited to complete a survey on why they did (or did not) participate in any component of the SMART implementation bundle. A subset of clinic leadership, clinicians, and staff will be invited to participate in semi- structured one-on-one interviews (and/or focus groups) regarding the reasons they did, or did not, participate in any component 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	Reasons patients decided to or decided not to use SMART. A subset of patients prescribed SMART will be invited to participate in semi- structured one-on-one interviews (and/or focus groups) regarding the reasons they did or did not use SMART.	Through study completion, up to 24 months
Qualitative assessment (of the SMART implementation bundle and evidence-based practice, i.e., SMART) effectiveness	Interviews with clinicians, and staff on effects of the SMART implementation (e.g., workflow, knowledge, self- efficacy) an SMART prescription. All clinic leadership, clinicians, and staff who were potentially eligible for reach will be invited to complete a survey on other effects of the SMART implementation bundle. A subset of clinic leadership, clinicians, and staff will be invited to participate in semi- structured one-on-one interviews (and/or focus groups) regarding other effects of the SMART implementation bundle.	Through study completion, up to 24 months
Qualitative assessment (of the SMART implementation bundle and evidence based practice, i.e., SMART) effectiveness	Interviews with patients on effects of SMART implementation (i.e., workflow, knowledge, self- efficacy) and SMART prescription. A subset of patients will be invited to participate in semi- structured one-on-one interviews (and/or focus groups) regarding other effects of the SMART implementation bundle.	Through study completion, up to 24 months
Reach (of SMART implementation materials including the CHEST website and SMART focused AAP)	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). 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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2026
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): November 15, 2028

Study Registration Dates

• First Submitted: November 7, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): August 19, 2026
• Last Update Submitted That Met QC Criteria: August 17, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: asthma; implementation science; SMART; community health centers; moderate to severe asthma; CHEST; CHEST asthma study; asthma study; asthma action plan; hybrid cluster; MART; single maintenance and reliever therapy; maintenance and reliever therapy
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID 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