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CHEST: Una Collaborazione Con i Centri di Salute Comunitaria per Implementare SmarT per l'Asma (CHEST)

4 settembre 2026 aggiornato da: James Krings, Washington University School of Medicine

Scopo: Questo studio mira a migliorare la cura dell'asma aiutando i medici dei centri sanitari comunitari a prescrivere un trattamento raccomandato dalle linee guida chiamato SMART (Terapia di Mantenimento e di Soccorso Unica).

I ricercatori forniranno formazione e risorse ai medici, daranno feedback sui modelli di prescrizione e offriranno strumenti educativi per pazienti e fornitori. I ricercatori implementeranno queste risorse in fasi successive nelle cliniche. Lo studio misurerà quanto bene il programma aiuta i medici a prescrivere la terapia SMART e se riduce le riacutizzazioni dell'asma nei pazienti.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

CHEST è uno studio di tipo 1 ibrido a cluster randomizzato a cuneo graduale in cui sei cliniche di centri sanitari comunitari qualificati a livello federale vengono selezionate in modo casuale e iterativo per passare in modo unidirezionale dal gruppo di controllo al gruppo di implementazione SMART. L'intervento principale è un pacchetto di implementazione SMART, che contiene tre componenti: (1) formazione a livello di clinico su SMART con supervisione/facilitazione pratica continua, (2) audit e feedback seriali a livello di clinica e clinico sui modelli di prescrizione degli inalatori, (3) fornitura di un supporto educativo cartaceo e online centrato sul clinico e sul paziente con un piano d'azione per l'asma conforme a SMART progettato per pazienti con bassa alfabetizzazione sanitaria e (4) riunioni del comitato operativo durante il periodo di implementazione

Lo studio è concettualmente suddiviso in tre fasi: (1) la fase pre-implementazione (controllo) focalizzata sullo sviluppo dei materiali di implementazione e sulla raccolta dei dati di base sui modelli di prescrizione, (2) la fase di implementazione attiva e (3) la post-implementazione, che si concentrerà su una valutazione della sostenibilità e della diffusione.

  1. Fase pre-implementazione: La fase pre-implementazione (che durerà da 12 a 24 mesi per clinica) è progettata per essere una linea di base per lo studio. Durante questa fase, non verranno introdotti interventi specifici per i clinici delle cliniche partecipanti. Questa fase consentirà al team di studio CHEST di raccogliere dati a livello di clinica sulle attuali pratiche di prescrizione delle cure per l'asma e sugli esiti correlati all'asma.
  2. Fase di implementazione attiva: La seconda fase, che durerà da 9 a 24 mesi per clinica, inizierà con l'introduzione del pacchetto di implementazione SMART ai clinici e al personale delle cliniche IHN partecipanti.
  3. Fase post-implementazione: La fase finale dello studio viene introdotta dopo che l'implementazione attiva del pacchetto di implementazione SMART è completata in tutte le cliniche partecipanti. Nella fase post-implementazione, verranno condotte valutazioni formali per valutare il mantenimento del pacchetto SMART. Inoltre, questa fase include gli sforzi per diffondere i risultati dello studio. Ciò comprende analisi della portata e dell'impatto degli sforzi di diffusione, nonché l'applicazione pratica e l'adozione dei risultati nella più ampia comunità medica.

Tipo di studio

Interventistico

Iscrizione (Stimato)

2000

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: James Krings, MD MSCI
  • Numero di telefono: 3143769452
  • Email: kringsj@wustl.edu

Backup dei contatti dello studio

Luoghi di studio

  • Stati Uniti
    • Missouri
      • St Louis, Missouri, Stati Uniti, 63110
        • Reclutamento
        • Washington University in St. Louis School of Medicine
        • Contatto:
      • St Louis, Missouri, Stati Uniti, 63104
        • Non ancora reclutamento
        • Affinia healthcare, 2220 Lemp Ave
        • Contatto:
      • St Louis, Missouri, Stati Uniti, 63107
        • Reclutamento
        • Affinia healthcare, 4414 North Florissant Avenue
        • Contatto:
      • St Louis, Missouri, Stati Uniti, 63111
        • Non ancora reclutamento
        • Family Care Heath Center, 401 Holly Hills Ave
        • Contatto:
      • St Louis, Missouri, Stati Uniti, 63106
      • St Louis, Missouri, Stati Uniti, 63110
        • Reclutamento
        • Family Care Heath Center, 4352 Manchester Ave
        • Contatto:
      • St Louis, Missouri, Stati Uniti, 63135
        • Reclutamento
        • Affinia healthcare, 3396 Pershall Road,
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

La popolazione dello studio può essere visualizzata a livello di cluster (clinica), clinico, personale o paziente.

A livello di cluster (clinica): Per essere idoneo a partecipare a questo studio, un cluster (clinica) deve soddisfare tutti i seguenti criteri:

  1. Partecipazione attiva alla St. Louis Integrated Health Center Network for Community Academic Partnerships.
  2. Impiego di almeno 3 clinici che gestiscono comunemente l'asma negli adulti (definito come gestione dell'asma per almeno un paziente adulto con asma, in media, su base settimanale).
  3. Dati forniti ad Azara per le query sui dati, e
  4. Disponibilità e capacità di ricevere tutti i componenti del pacchetto di implementazione SMART (ovvero, visita educativa iniziale di divulgazione, facilitazione/supervisione continua della pratica, audit e feedback, e fornitura di ausili educativi a livello paziente e piani d'azione SMART per l'asma e riunioni mensili del comitato operativo).

A livello di clinico/personale clinico:

Per essere idoneo a partecipare a questo studio, un clinico/membro del personale clinico deve soddisfare tutti i seguenti criteri:

  1. Fornitura di un modulo di consenso informato firmato e datato.
  2. Licenze statali attuali di medico, assistente medico, infermiere specializzato o assistente medico.
  3. Si prende regolarmente cura di adulti con asma (che può includere quelli formati in medicina di famiglia, medicina interna, ostetricia/ginecologia e/o medicina specialistica).
  4. Disponibilità e capacità di integrare il pacchetto di implementazione SMART nella loro pratica.
  5. Disponibilità e capacità di partecipare per l'intera durata dello studio, inclusi i periodi pre-implementazione, implementazione attiva e post-implementazione.
  6. Disponibilità a fornire dati sui modelli di prescrizione e sugli esiti dei pazienti con asma per la durata dello studio.

A livello di paziente:

Per essere idoneo a partecipare a questo studio, un paziente deve soddisfare tutti i seguenti criteri:

  1. Età ≥12 anni
  2. Diagnosi di asma, di qualsiasi gravità, codificata (ovvero, Classificazione Internazionale delle Malattie [ICD]-10-CM: J45**).
  3. Il paziente ha avuto ≥2 riacutizzazioni di asma nell'ultimo anno durante le quali sono stati prescritti corticosteroidi sistemici, e/o l'incontro contiene una prescrizione attiva per un inalatore che è congruente con inalatori di corticosteroidi inalatori (ICS) a dose media (o superiore) o inalatori ICS-agonista β a lunga durata d'azione (LABA) a basso dosaggio (o superiore) con inalatori concomitanti di agonista β a breve durata d'azione per il sollievo.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Controllo
Durante questo periodo, i modelli di prescrizione e gli esiti dell'asma saranno osservati senza implementazione attiva.
Sperimentale: 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
Comportamentale: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Clinician-level adoption of the SMART implementation bundle
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Clinic-level Reach: Reach of the SMART implementation bundle
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Qualitative assessment of the determinants of patient-level reach of SMART (CFIR-informed)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Washington University School of Medicine

Collaboratori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

6 gennaio 2026

Completamento primario (Stimato)

15 novembre 2027

Completamento dello studio (Stimato)

15 novembre 2028

Date di iscrizione allo studio

Primo inviato

7 novembre 2025

Primo inviato che soddisfa i criteri di controllo qualità

19 novembre 2025

Primo Inserito (Effettivo)

21 novembre 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 202507167
  • 5K23HL171940-02 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Sì. Verranno condivisi i DPI anonimizzati, inclusi i dati quantitativi (dati demografici, sondaggi convalidati, registri di partecipazione e dati EHR anonimizzati su incontri, diagnosi e prescrizioni per l'asma) e le trascrizioni qualitative di interviste e focus group verificate per accuratezza e anonimizzazione. Il protocollo, il piano di analisi statistica, il dizionario dei dati e il codice analitico saranno anche condivisi tramite il BioLINCC del NHLBI. I dati saranno archiviati in modo sicuro all'interno di WUSM REDCap, RIS o Box prima della condivisione. La trascrizione conforme all'HIPAA e la convalida REDCap garantiscono l'accuratezza. La supervisione e la conformità saranno mantenute tramite l'IRB del WUSM, l'Ufficio per la Sicurezza delle Informazioni, gli organi regolatori dei centri sanitari comunitari e il DSMB dello studio. I dati seguiranno gli standard COREQ, CONSORT e TIDieR e saranno condivisi dopo la pubblicazione primaria.

Periodo di condivisione IPD

I dati individuali dei partecipanti (IPD) anonimizzati e i materiali di supporto saranno inviati al BioLINCC del NHLBI entro 12 mesi dal completamento della raccolta dei dati o prima della pubblicazione primaria, a seconda di quale evento si verifichi per primo. I dati saranno sottoposti a una revisione di qualità e conformità prima del rilascio pubblico. I dati condivisi rimarranno archiviati e accessibili per la conservazione a lungo termine all'interno di BioLINCC, in linea con le pratiche dei repository NIH e NHLBI, per consentire future analisi secondarie e studi di replicazione.

Criteri di accesso alla condivisione IPD

I DPI anonimizzati e i materiali di supporto saranno condivisi tramite il repository BioLINCC del NHLBI. L'accesso sarà aperto a investigatori qualificati senza restrizioni per ricerca, replicazione o analisi secondarie coerenti con gli obiettivi dello studio e gli interessi di salute pubblica. Le protezioni della privacy e della riservatezza saranno mantenute conformemente alle approvazioni del WUSM IRB, dell'Ufficio di Sicurezza Informatica, degli organi regolatori dei centri sanitari comunitari e del DSMB dello studio. Le richieste di dati saranno esaminate e gestite attraverso le procedure standard di BioLINCC, che richiedono la presentazione di una richiesta di dati e la stipula di un Accordo di Distribuzione dei Materiali di Ricerca. La supervisione della conformità e la protezione continua della riservatezza dei partecipanti saranno garantite attraverso i meccanismi di supervisione regolatoria del WUSM e del NHLBI.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • CODICE_ANALITICO
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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