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CHEST: Et samarbeid med lokale helsesentre for å implementere SmarT for astma (CHEST)

4. september 2026 oppdatert av: James Krings, Washington University School of Medicine

Formål: Denne studien har som mål å forbedre astmabehandlingen ved å hjelpe leger på helsesentre med å foreskrive en retningslinjeanbefalt behandling kalt SMART (Single Maintenance and Reliever Therapy).

Forskerne vil gi opplæring og ressurser til legene, gi tilbakemeldinger om forskrivningsmønstre, og tilby pedagogiske verktøy for pasienter og behandlere. Forskerne vil rulle ut disse ressursene i etapper på tvers av klinikker. Studien vil måle hvor godt programmet hjelper legene med å foreskrive SMART-terapi og om det reduserer astmaforverringer hos pasientene.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

CHEST er en type 1 hybrid trinnvis kile klynge randomisert studie der seks føderalt kvalifiserte helsesenterklinikker blir tilfeldig og iterativt valgt for å bevege seg i en 1-veis kryssing fra kontrollgruppen til SMART implementeringsgruppen. Den primære intervensjonen er en SMART implementeringspakke, som inneholder tre komponenter: (1) klinker-nivå utdanning om SMART med pågående praksisfasilitering/veiledning, (2) seriell klinikk- og klinker-nivå revisjon og tilbakemelding på inhalatorreseptmønstre, (3) tilbud om et papir- og nettbasert klinker- og pasientsentrert undervisningshjelpemiddel med en SMART-kongruent astma-handlingsplan designet for pasienter med lav helsekompetanse, og (4) operasjonskomitemøter under implementeringsperioden

Studien er konseptuelt delt inn i tre faser: (1) pre-implementeringsfasen (kontroll) fokusert på utvikling av implementeringsmaterialer og basisdatainnsamling av reseptmønstre, (2) den aktive implementeringsfasen, og (3) post-implementering, som vil fokusere på en vurdering av bærekraft og spredning.

  1. Pre-implementeringsfase: Pre-implementeringsfasen (som vil vare fra 12 til 24 måneder per klinikk) er designet for å være en basislinje for studien. I løpet av denne fasen vil ingen spesifikke intervensjoner bli introdusert til klinkerne på deltakende klinikker. Denne fasen vil tillate CHEST-studiegruppen å samle klinikk-nivå data om nåværende astmabehandlingsreseptpraksiser og astmarelaterte utfall.
  2. Aktiv implementeringsfase: Den andre fasen, som vil vare fra 9 til 24 måneder per klinikk, vil begynne med introduksjonen av SMART implementeringspakken til klinkere og ansatte på deltakende IHN-klinikker.
  3. Post-implementeringsfase: Den siste fasen av studien introduseres etter at den aktive implementeringen av SMART implementeringspakken er fullført på alle deltakende klinikker. I post-implementeringsfasen vil formelle vurderinger bli utført for å evaluere opprettholdelsen av SMART-pakken. I tillegg inkluderer denne fasen bestrebelser for å spre funnene fra studien. Dette omfatter analyser av rekkevidden og påvirkningen av spredningsinnsatsene, samt den praktiske anvendelsen og adopsjonen av funnene i det bredere medisinske samfunnet.

Studietype

Intervensjonell

Registrering (Antatt)

2000

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • Missouri
      • St Louis, Missouri, Forente stater, 63110
        • Rekruttering
        • Washington University in St. Louis School of Medicine
        • Ta kontakt med:
      • St Louis, Missouri, Forente stater, 63104
        • Har ikke rekruttert ennå
        • Affinia healthcare, 2220 Lemp Ave
        • Ta kontakt med:
      • St Louis, Missouri, Forente stater, 63107
        • Rekruttering
        • Affinia healthcare, 4414 North Florissant Avenue
        • Ta kontakt med:
      • St Louis, Missouri, Forente stater, 63111
        • Har ikke rekruttert ennå
        • Family Care Heath Center, 401 Holly Hills Ave
        • Ta kontakt med:
      • St Louis, Missouri, Forente stater, 63106
      • St Louis, Missouri, Forente stater, 63110
        • Rekruttering
        • Family Care Heath Center, 4352 Manchester Ave
        • Ta kontakt med:
      • St Louis, Missouri, Forente stater, 63135
        • Rekruttering
        • Affinia healthcare, 3396 Pershall Road,
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Studiepopulasjonen kan ses på fra klynge (klinikk), kliniker, personale eller pasientnivå.

På klyngenivå (klinikk): For å være kvalifisert til å delta i denne studien, må en klynge (klinikk) oppfylle alle følgende kriterier:

  1. Aktiv deltakelse i St. Louis Integrated Health Center Network for Community Academic Partnerships.
  2. Ansettelse av minst 3 klinikere som vanligvis behandler voksne med astma (definert som å behandle astma for minst én voksen astmapasient i gjennomsnitt på ukentlig basis).
  3. Data levert til Azara for datasøk, og
  4. Villig og i stand til å motta alle komponenter i SMART-implementeringspakken (dvs. første opplæringsbesøk, pågående praksisveiledning/tilsyn, revisjon og tilbakemelding, og tilgang på pasientnivå opplæringshjelpemidler og SMART astma-handlingsplaner og månedlige driftskomité-møter).

På kliniker/klinisk personale-nivå:

For å være kvalifisert til å delta i denne studien, må en kliniker/klinisk personalemedlem oppfylle alle følgende kriterier:

  1. Innsending av et signert og datert informert samtykkeskjema.
  2. Nåværende statlig lisens som lege, assistentlege, sykepleier eller legeassistent.
  3. Regelmessig behandling av voksne med astma (som kan inkludere de med utdanning i allmennmedisin, indremedisin, fødselshjelp/gynekologi og/eller spesialistmedisin).
  4. Villig og i stand til å integrere SMART-implementeringspakken i sin praksis.
  5. Villig og i stand til å delta i hele studiens varighet, inkludert før-implementering, aktiv implementering og etter-implementeringsperioder.
  6. Villig til å gi data om reseptutskrivningsmønstre og astmapasientresultater i løpet av studien.

På pasientnivå:

For å være kvalifisert til å delta i denne studien, må en pasient oppfylle alle følgende kriterier:

  1. Alder ≥12 år
  2. Diagnose astma, av enhver alvorlighetsgrad, kodet (dvs. International Classification of Diseases [ICD]-10-CM: J45**).
  3. Pasienten har hatt ≥2 astmaforverringer det siste året der systemiske kortikosteroider ble foreskrevet, og/eller konsultasjonen inneholder en aktiv resept for en inhalator som samsvarer med middels dose (eller høyere) vedlikeholdsinhalerte kortikosteroider (ICS) inhalatorer eller lav dose (eller høyere) ICS-langtidsvirkende β-agonist (LABA) inhalatorer med samtidige lindrende korttidsvirkende β-agonist inhalatorer.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Kontroll
I løpet av denne perioden vil reseptmønstre og astmaresultater bli observert uten aktiv implementering.
Eksperimentell: 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
Atferdsmessig: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Clinician-level adoption of the SMART implementation bundle
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Clinic-level Reach: Reach of the SMART implementation bundle
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Qualitative assessment of the determinants of patient-level reach of SMART (CFIR-informed)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Washington University School of Medicine

Samarbeidspartnere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

6. januar 2026

Primær fullføring (Antatt)

15. november 2027

Studiet fullført (Antatt)

15. november 2028

Datoer for studieregistrering

Først innsendt

7. november 2025

Først innsendt som oppfylte QC-kriteriene

19. november 2025

Først lagt ut (Faktiske)

21. november 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 202507167
  • 5K23HL171940-02 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Ja. Avidentifisert IPD vil deles, inkludert kvantitative data (demografi, validerte spørreundersøkelser, oppmøtelogger og avidentifiserte EHR-data om astmamøter, diagnoser og resepter) og kvalitative intervju- og fokusgruppe transkripsjoner verifisert for nøyaktighet og avidentifisert.
Protokollen, statistisk analyseplan, datatolkning og analytisk kode vil også deles via NHLBIs BioLINCC.
Data vil bli sikkert lagret i WUSM REDCap, RIS eller Box før deling.
HIPAA-kompatibel transkripsjon og REDCap-validering sikrer nøyaktighet.
Tilsyn og overholdelse vil bli opprettholdt gjennom WUSM IRB, Office of Information Security, samfunnshelsesenterets regulatoriske organer og studiens DSMB.
Data vil følge COREQ, CONSORT og TIDieR-standarder og bli delt etter primærpublikasjon.

IPD-delingstidsramme

Anonymiserte individuelle pasientdata og støttematerialer vil bli sendt til NHLBIs BioLINCC innen 12 måneder etter fullføring av datainnsamling eller før primærpublikasjon, avhengig av hva som kommer først. Data vil gjennomgå kvalitets- og overholdelsesvurdering før offentliggjøring. Delte data vil forbli arkivert og tilgjengelig for langtidsbevaring i BioLINCC, i samsvar med NIH og NHLBI sine arkivpraksiser, for å muliggjøre fremtidige sekundæranalyser og replikasjonsstudier.

Tilgangskriterier for IPD-deling

De-identifiserte IPD og støttematerialer vil bli delt gjennom NHLBIs BioLINCC-repositorium. Tilgang vil være åpen for kvalifiserte forskere uten restriksjoner for forskning, replikering eller sekundæranalyser som er i samsvar med studiens mål og folkehelseinteresser. Personvern og konfidensialitetsbeskyttelse vil bli opprettholdt i henhold til godkjenninger fra WUSM IRB, kontoret for informasjonssikkerhet, helsesenterregulerende organer i lokalsamfunnet og studiens DSMB. Databønner vil bli gjennomgått og administrert gjennom BioLINCCs standardprosedyrer, som krever innsending av en databønn og signering av en forskningsmaterialfordelingsavtale. Overvåkning av overholdelse og fortsatt beskyttelse av deltakernes konfidensialitet vil bli sikret gjennom WUSMs og NHLBIs regulatoriske overvåkningsmekanismer.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • ANALYTIC_CODE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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