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CHEST: Een Samenwerking Met GemeenschapsGezondheidsCentra om SmarT voor Astma te Implementeren (CHEST)

4 september 2026 bijgewerkt door: James Krings, Washington University School of Medicine

CHEST: Een Samenwerking Met Gemeenschapsgezondheidscentra om SmarT voor Astma te Implementeren

Doel: Deze studie beoogt de zorg voor astma te verbeteren door clinici in gezondheidscentra in de gemeenschap te helpen een richtlijn-aanbevolen behandeling genaamd SMART (Single Maintenance and Reliever Therapy) voor te schrijven.

De onderzoekers zullen training en middelen aan clinici verstrekken, feedback geven over voorschrijfpatronen en educatieve hulpmiddelen bieden voor patiënten en zorgverleners. De onderzoekers zullen deze middelen in fasen over klinieken uitrollen. De studie zal meten hoe goed het programma clinici helpt SMART-therapie voor te schrijven en of het astma-exacerbaties bij patiënten vermindert.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

CHEST is een type 1 hybride stepped-wedge cluster gerandomiseerde trial waarbij zes federaal gekwalificeerde gemeenschapsgezondheidscentra klinieken willekeurig en iteratief worden geselecteerd om in een 1-richting crossover van de controlegroep naar de SMART implementatiegroep over te gaan. De primaire interventie is een SMART implementatiebundel, die drie componenten bevat: (1) opleiding op clinici-niveau over SMART met doorlopende praktijkbegeleiding/supervisie, (2) seriële kliniek- en clinici-niveau audit en feedback over inhalator voorschrijfpatronen, (3) verstrekking van een papieren en online clinici- en patiëntgerichte educatieve hulp met een SMART-conforme astma-actieplan ontworpen voor patiënten met lage gezondheidsvaardigheden, en (4) operationele commissievergaderingen tijdens de implementatieperiode

Het onderzoek is conceptueel opgesplitst in drie fasen: (1) de pre-implementatie (controle) fase gericht op ontwikkeling van implementatiematerialen en basislijngegevensverzameling van voorschrijfpatronen, (2) de actieve implementatiefase, en (3) post-implementatie, die zich zal richten op een beoordeling van duurzaamheid en verspreiding.

  1. Pre-implementatiefase: De pre-implementatiefase (die 12 tot 24 maanden per kliniek zal duren) is ontworpen als basislijn voor het onderzoek. Tijdens deze fase zullen geen specifieke interventies worden geïntroduceerd bij de clinici van deelnemende klinieken. Deze fase stelt het CHEST-onderzoeksteam in staat om kliniekniveau gegevens te verzamelen over huidige astmazorg voorschrijfpraktijken en astma-gerelateerde uitkomsten.
  2. Actieve implementatiefase: De tweede fase, die 9 tot 24 maanden per kliniek zal duren, begint met de introductie van de SMART implementatiebundel aan clinici en personeel bij deelnemende IHN klinieken.
  3. Post-implementatiefase: De laatste fase van het onderzoek wordt geïntroduceerd nadat de actieve implementatie van de SMART implementatiebundel is voltooid bij alle deelnemende klinieken. In de post-implementatiefase zullen formele beoordelingen worden uitgevoerd om de voortzetting van de SMART-bundel te evalueren. Bovendien omvat deze fase inspanningen om de bevindingen van het onderzoek te verspreiden. Dit omvat analyses van het bereik en de impact van de verspreidingsinspanningen, evenals de praktische toepassing en adoptie van de bevindingen in de bredere medische gemeenschap.

Studietype

Ingrijpend

Inschrijving (Geschat)

2000

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • Missouri
      • St Louis, Missouri, Verenigde Staten, 63110
        • Werving
        • Washington University in St. Louis School of Medicine
        • Contact:
      • St Louis, Missouri, Verenigde Staten, 63104
        • Nog niet aan het werven
        • Affinia healthcare, 2220 Lemp Ave
        • Contact:
      • St Louis, Missouri, Verenigde Staten, 63107
        • Werving
        • Affinia healthcare, 4414 North Florissant Avenue
        • Contact:
      • St Louis, Missouri, Verenigde Staten, 63111
        • Nog niet aan het werven
        • Family Care Heath Center, 401 Holly Hills Ave
        • Contact:
      • St Louis, Missouri, Verenigde Staten, 63106
      • St Louis, Missouri, Verenigde Staten, 63110
        • Werving
        • Family Care Heath Center, 4352 Manchester Ave
        • Contact:
      • St Louis, Missouri, Verenigde Staten, 63135

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

De studiepopulatie kan worden bekeken op het niveau van de cluster (kliniek), clinicus, personeel of patiënt.

Op het niveau van de cluster (kliniek): Om in aanmerking te komen voor deelname aan deze studie, moet een cluster (kliniek) aan alle volgende criteria voldoen:

  1. Actieve deelname aan het St. Louis Integrated Health Center Network for Community Academic Partnerships.
  2. In dienst hebben van ten minste 3 clinici die regelmatig volwassen astma behandelen (gedefinieerd als het behandelen van astma voor ten minste één volwassen astmapatiënt, gemiddeld op wekelijkse basis).
  3. Gegevens verstrekken aan Azara voor gegevensquery's, en
  4. Bereid en in staat om alle componenten van de SMART-implementatiebundel te ontvangen (d.w.z. initieel educatief outreachbezoek, doorlopende praktijkondersteuning/supervisie, audit & feedback, en verstrekking van educatie van patiëntniveau educatiemiddelen en SMART astma-actieplannen en maandelijkse operationele comitévergaderingen).

Op het niveau van de clinicus/klinisch personeel:

Om in aanmerking te komen voor deelname aan deze studie, moet een clinicus/klinisch personeelslid aan alle volgende criteria voldoen:

  1. Verstrekking van een ondertekend en gedateerd informed consent-formulier.
  2. Huidige staatlicentie van arts, assistent-arts, verpleegkundig specialist, of physician assistant.
  3. Regelmatig zorgt voor volwassenen met astma (wat kan inclusief zijn degenen die zijn opgeleid in huisartsgeneeskunde, interne geneeskunde, verloskunde/gynaecologie, en/of specialistische geneeskunde).
  4. Bereid en in staat om de SMART-implementatiebundel in hun praktijk te integreren.
  5. Bereid en in staat om deel te nemen voor de volledige duur van de studie, inclusief de pre-implementatie, actieve implementatie en post-implementatieperiodes.
  6. Bereid om gegevens te verstrekken over voorschrijfpatronen en astmapatiëntresultaten voor de duur van de studie.

Op het patiëntniveau:

Om in aanmerking te komen voor deelname aan deze studie, moet een patiënt aan alle volgende criteria voldoen:

  1. Leeftijd ≥12 jaar oud
  2. Diagnose van astma, van elke ernst, gecodeerd (d.w.z. Internationale Classificatie van Ziekten [ICD]-10-CM: J45**).
  3. De patiënt heeft ≥2 astma-exacerbaties in het afgelopen jaar gehad waarbij systemische corticosteroïden werden voorgeschreven, en/of de ontmoeting bevat een actief voorschrift voor een inhaler die overeenkomt met onderhoudsinhalatoren met middelhoge (of hogere) dosis geïnhaleerde corticosteroïden (ICS) of inhalatoren met lage (of hogere) dosis ICS-langwerkende β-agonist (LABA) met gelijktijdige verlichtende kortwerkende β-agonist inhalatoren.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Controle
Tijdens deze periode worden voorschrijfpatronen en astma-uitkomsten geobserveerd zonder actieve implementatie.
Experimenteel: 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
Gedragsmatig: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Clinician-level adoption of the SMART implementation bundle
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Clinic-level Reach: Reach of the SMART implementation bundle
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Qualitative assessment of the determinants of patient-level reach of SMART (CFIR-informed)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Washington University School of Medicine

Medewerkers

National Heart, Lung, and Blood Institute (NHLBI)
Doris Duke Charitable Foundation
Family Care Health Centers
Affinia Healthcare

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

6 januari 2026

Primaire voltooiing (Geschat)

15 november 2027

Studie voltooiing (Geschat)

15 november 2028

Studieregistratiedata

Eerst ingediend

7 november 2025

Eerst ingediend dat voldeed aan de QC-criteria

19 november 2025

Eerst geplaatst (Werkelijk)

21 november 2025

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 september 2026

Laatste update ingediend die voldeed aan QC-criteria

4 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 202507167
  • 5K23HL171940-02 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Ja. Gedeïdentificeerde IPD zal worden gedeeld, waaronder kwantitatieve gegevens (demografie, gevalideerde enquêtes, aanwezigheidslogboeken en gedeïdentificeerde EHR-gegevens over astma-ontmoetingen, diagnoses en voorschriften) en kwalitatieve interview- en focusgroeptranscripties gecontroleerd op nauwkeurigheid en gedeïdentificeerd. Het protocol, statistisch analyseplan, datadictionary en analytische code zullen ook worden gedeeld via NHLBI's BioLINCC. Gegevens worden veilig opgeslagen in WUSM REDCap, RIS of Box voordat ze worden gedeeld. HIPAA-conforme transcriptie en REDCap-validatie zorgen voor nauwkeurigheid. Toezicht en naleving worden gehandhaafd door WUSM IRB, het Office of Information Security, regelgevende instanties van gemeenschapsgezondheidscentra en de DSMB van de studie. Gegevens zullen voldoen aan COREQ-, CONSORT- en TIDieR-standaarden en worden gedeeld na de primaire publicatie.

IPD-tijdsbestek voor delen

Gedeïdentificeerde IPD en ondersteunende materialen worden binnen 12 maanden na voltooiing van de gegevensverzameling of vóór de primaire publicatie, wat het eerst komt, ingediend bij NHLBI's BioLINCC. Gegevens ondergaan een kwaliteits- en nalevingsbeoordeling voordat ze openbaar worden gemaakt. Gedeelde gegevens blijven gearchiveerd en toegankelijk voor langdurige bewaring binnen BioLINCC, in overeenstemming met NIH- en NHLBI-repositorypraktijken, om toekomstige secundaire analyses en replicatiestudies mogelijk te maken.

IPD-toegangscriteria voor delen

Gedeïdentificeerde IPD en ondersteunende materialen worden gedeeld via NHLBI's BioLINCC-repository. Toegang is open voor gekwalificeerde onderzoekers zonder beperkingen voor onderzoek, replicatie of secundaire analyses in overeenstemming met de doelstellingen van de studie en de belangen van de volksgezondheid. Privacy- en vertrouwelijkheidsbescherming worden gehandhaafd volgens goedkeuringen van de WUSM IRB, het Office of Information Security, regelgevende instanties van gemeenschapsgezondheidscentra en de DSMB van de studie. Gegevensverzoeken worden beoordeeld en beheerd via BioLINCC's standaardprocedures, die indiening van een gegevensverzoek en ondertekening van een Research Materials Distribution Agreement vereisen. Toezicht op naleving en voortdurende bescherming van de vertrouwelijkheid van deelnemers wordt gewaarborgd via WUSM- en NHLBI-regelgevingstoezichtsmechanismen.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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