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CHEST : Une collaboration avec les centres de santé communautaires pour mettre en œuvre SmarT pour l'asthme (CHEST)

4 septembre 2026 mis à jour par: James Krings, Washington University School of Medicine

Objectif : Cette étude vise à améliorer les soins de l'asthme en aidant les cliniciens des centres de santé communautaires à prescrire un traitement recommandé par les directives appelé SMART (thérapie unique d'entretien et de secours).

Les investigateurs fourniront une formation et des ressources aux cliniciens, donneront des retours sur les habitudes de prescription et proposeront des outils éducatifs pour les patients et les prestataires. Les investigateurs déploieront ces ressources par étapes dans les cliniques. L'étude mesurera dans quelle mesure le programme aide les cliniciens à prescrire la thérapie SMART et s'il réduit les exacerbations de l'asthme chez les patients.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

CHEST est un essai randomisé en grappes en escalier hybride de type 1 dans lequel six cliniques de centres de santé communautaires qualifiés au niveau fédéral sont sélectionnées de manière aléatoire et itérative pour passer de manière unidirectionnelle du groupe témoin au groupe de mise en œuvre SMART. L'intervention principale est un ensemble de mise en œuvre SMART, qui contient trois composantes : (1) une formation au niveau des cliniciens sur SMART avec une facilitation/supervision continue de la pratique, (2) un audit et une rétroaction en série au niveau de la clinique et des cliniciens sur les modèles de prescription d'inhalateurs, (3) la fourniture d'une aide à l'éducation sur papier et en ligne centrée sur le clinicien et le patient avec un plan d'action contre l'asthme conforme à SMART conçu pour les patients ayant un faible niveau de littératie en santé, et (4) des réunions du comité des opérations pendant la période de mise en œuvre

L'étude est conceptuellement divisée en trois phases : (1) la phase de pré-mise en œuvre (témoin) axée sur le développement des matériaux de mise en œuvre et la collecte de données de base sur les modèles de prescription, (2) la phase de mise en œuvre active, et (3) la phase post-mise en œuvre, qui se concentrera sur une évaluation de la durabilité et de la diffusion.

  1. Phase de pré-mise en œuvre : La phase de pré-mise en œuvre (qui durera de 12 à 24 mois par clinique) est conçue pour servir de référence à l'étude. Pendant cette phase, aucune intervention spécifique ne sera introduite auprès des cliniciens des cliniques participantes. Cette phase permettra à l'équipe d'étude CHEST de collecter des données au niveau de la clinique sur les pratiques actuelles de prescription des soins de l'asthme et les résultats liés à l'asthme.
  2. Phase de mise en œuvre active : La deuxième phase, qui durera de 9 à 24 mois par clinique, débutera avec l'introduction de l'ensemble de mise en œuvre SMART aux cliniciens et au personnel des cliniques IHN participantes.
  3. Phase post-mise en œuvre : La phase finale de l'étude est introduite après que la mise en œuvre active de l'ensemble de mise en œuvre SMART est terminée dans toutes les cliniques participantes. Dans la phase post-mise en œuvre, des évaluations formelles seront menées pour évaluer le maintien de l'ensemble SMART. De plus, cette phase comprend des efforts pour diffuser les résultats de l'étude. Cela comprend des analyses de la portée et de l'impact des efforts de diffusion, ainsi que l'application pratique et l'adoption des résultats dans la communauté médicale au sens large.

Type d'étude

Interventionnel

Inscription (Estimé)

2000

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: James Krings, MD MSCI
  • Numéro de téléphone: 3143769452
  • E-mail: kringsj@wustl.edu

Sauvegarde des contacts de l'étude

  • Nom: Krutika Chauhan, MBBS MPH
  • Numéro de téléphone: 3143769452
  • E-mail: c.krutika@wustl.edu

Lieux d'étude

  • États-Unis
    • Missouri
      • St Louis, Missouri, États-Unis, 63110
        • Recrutement
        • Washington University in St. Louis School of Medicine
        • Contact:
      • St Louis, Missouri, États-Unis, 63104
        • Pas encore de recrutement
        • Affinia healthcare, 2220 Lemp Ave
        • Contact:
      • St Louis, Missouri, États-Unis, 63107
        • Recrutement
        • Affinia healthcare, 4414 North Florissant Avenue
        • Contact:
      • St Louis, Missouri, États-Unis, 63111
        • Pas encore de recrutement
        • Family Care Heath Center, 401 Holly Hills Ave
        • Contact:
      • St Louis, Missouri, États-Unis, 63106
      • St Louis, Missouri, États-Unis, 63110
        • Recrutement
        • Family Care Heath Center, 4352 Manchester Ave
        • Contact:
      • St Louis, Missouri, États-Unis, 63135
        • Recrutement
        • Affinia healthcare, 3396 Pershall Road,
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

La population de l'étude peut être examinée au niveau du cluster (clinique), du clinicien, du personnel ou du patient.

Au niveau du cluster (clinique) : Pour être éligible à participer à cette étude, un cluster (clinique) doit répondre à tous les critères suivants :

  1. Participation active au Réseau de Santé Intégré de Saint-Louis pour les Partenariats Académiques Communautaires.
  2. Emploi d'au moins 3 cliniciens qui prennent couramment en charge l'asthme adulte (défini comme la prise en charge de l'asthme pour au moins un patient asthmatique adulte, en moyenne, sur une base hebdomadaire).
  3. Données fournies à Azara pour les requêtes de données, et
  4. Volonté et capacité de recevoir tous les composants du lot d'implémentation SMART (c'est-à-dire, visite éducative initiale, facilitation/supervision continue de la pratique, audit et retour d'information, et fourniture d'outils d'éducation au niveau du patient et de plans d'action SMART pour l'asthme et réunions mensuelles du comité des opérations).

Au niveau du clinicien/personnel clinique :

Pour être éligible à participer à cette étude, un clinicien/membre du personnel clinique doit répondre à tous les critères suivants :

  1. Fourniture d'un formulaire de consentement éclairé signé et daté.
  2. Licence d'État actuelle de médecin, médecin assistant, infirmier praticien ou assistant médical.
  3. Prend régulièrement en charge des adultes asthmatiques (ce qui peut inclure ceux formés en médecine familiale, médecine interne, obstétrique/gynécologie et/ou médecine spécialisée).
  4. Volonté et capacité d'intégrer le lot d'implémentation SMART dans leur pratique.
  5. Volonté et capacité de participer pendant toute la durée de l'étude, y compris les périodes de pré-implémentation, d'implémentation active et de post-implémentation.
  6. Volonté de fournir des données sur les habitudes de prescription et les résultats des patients asthmatiques pendant la durée de l'étude.

Au niveau du patient :

Pour être éligible à participer à cette étude, un patient doit répondre à tous les critères suivants :

  1. Âge ≥ 12 ans
  2. Diagnostic d'asthme, de toute sévérité, codé (c'est-à-dire, Classification Internationale des Maladies [CIM]-10-CM : J45**).
  3. Le patient a eu ≥ 2 exacerbations d'asthme au cours de la dernière année pendant lesquelles des corticostéroïdes systémiques ont été prescrits, et/ou la consultation contient une ordonnance active pour un inhalateur qui est conforme aux inhalateurs de corticostéroïdes inhalés (CSI) d'entretien à dose moyenne (ou supérieure) ou aux inhalateurs CSI-agoniste β à longue durée d'action (LABA) à faible dose (ou supérieure) avec des inhalateurs de secours agoniste β à courte durée d'action concomitants.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Contrôle
Pendant cette période, les schémas de prescription et les résultats de l'asthme seront observés sans mise en œuvre active.
Expérimental: 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
Comportemental: 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Clinician-level adoption of the SMART implementation bundle
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Clinic-level Reach: Reach of the SMART implementation bundle
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Qualitative assessment of the determinants of patient-level reach of SMART (CFIR-informed)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Washington University School of Medicine

Collaborateurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

6 janvier 2026

Achèvement primaire (Estimé)

15 novembre 2027

Achèvement de l'étude (Estimé)

15 novembre 2028

Dates d'inscription aux études

Première soumission

7 novembre 2025

Première soumission répondant aux critères de contrôle qualité

19 novembre 2025

Première publication (Réel)

21 novembre 2025

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 202507167
  • 5K23HL171940-02 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Oui. Les données individuelles pseudonymisées seront partagées, y compris les données quantitatives (démographie, questionnaires validés, registres de présence et données pseudonymisées du DSE sur les consultations, diagnostics et prescriptions d'asthme) ainsi que les transcriptions d'entretiens qualitatifs et de groupes de discussion vérifiées pour exactitude et pseudonymisées. Le protocole, le plan d'analyse statistique, le dictionnaire de données et le code analytique seront également partagés via BioLINCC du NHLBI. Les données seront stockées de manière sécurisée dans WUSM REDCap, RIS ou Box avant le partage. La transcription conforme à la HIPAA et la validation REDCap garantissent l'exactitude. La supervision et la conformité seront maintenues par le CERE de WUSM, le Bureau de la sécurité de l'information, les organismes de réglementation des centres de santé communautaires et le DSMB de l'étude. Les données suivront les normes COREQ, CONSORT et TIDieR et seront partagées après la publication principale.

Délai de partage IPD

Les IPD anonymisées et les documents de soutien seront soumis à BioLINCC du NHLBI dans les 12 mois suivant la fin de la collecte des données ou avant la publication principale, selon la première éventualité. Les données feront l'objet d'un examen de la qualité et de la conformité avant leur mise à disposition publique. Les données partagées resteront archivées et accessibles pour une préservation à long terme au sein de BioLINCC, conformément aux pratiques des dépôts du NIH et du NHLBI, afin de permettre de futures analyses secondaires et études de réplication.

Critères d'accès au partage IPD

Les DPI dépersonnalisés et les documents de soutien seront partagés via le référentiel BioLINCC du NHLBI. L'accès sera ouvert aux chercheurs qualifiés sans restriction pour la recherche, la réplication ou les analyses secondaires compatibles avec les objectifs de l'étude et les intérêts de santé publique. Les protections de la vie privée et de la confidentialité seront maintenues conformément aux approbations du CERE de WUSM, du Bureau de la sécurité de l'information, des organismes de réglementation des centres de santé communautaires et du DSMB de l'étude. Les demandes de données seront examinées et gérées selon les procédures standard de BioLINCC, qui nécessitent la soumission d'une demande de données et la signature d'un accord de distribution des matériels de recherche. La surveillance de la conformité et la protection continue de la confidentialité des participants seront assurées par les mécanismes de surveillance réglementaire de WUSM et du NHLBI.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • ANALYTIC_CODE
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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