CHEST：地域医療センターとの共同による喘息のためのスマート実施 (CHEST)

介入なし：コントロール

この期間中、処方パターンと喘息アウトカムは、積極的な実施なしに観察されます。

実験的：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

行動：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

Clinician-level adoption of the SMART implementation bundle

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

Clinic-level effectiveness of the SMART implementation bundle, measured as the proportion of SMART-eligible asthma encounters in which SMART is prescribed

Between-group difference in the proportion of SMART-eligible asthma encounters in which SMART is prescribed, comparing implementation vs control periods 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.

Clinic-level Reach: Reach of the SMART implementation bundle

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.

Patient-level effectiveness of SMART implementation, measured as the rate of clinic-treated asthma exacerbations and systemic corticosteroid-treated exacerbations

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.

Clinician-level Reach: Reach of the SMART implementation bundle

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).

Staff-level Reach: Reach of the SMART implementation bundle

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

Patient-level Reach: Reach of SMART among eligible patients

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.

Patient-level safety of SMART therapy (adverse events of special interest and serious adverse events)

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.

Clinician-level effectiveness of the SMART implementation bundle, measured as the proportion of clinicians classified as frequent SMART prescribers

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.

Clinician-level adherence to the SMART implementation bundle (implementation strategy adherence)

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.

Clinician-level fidelity to SMART prescribing and delivery (clinical intervention fidelity)

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.

System-level implementation cost and budget impact of the SMART implementation bundle

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.

Patient-level sustainment of SMART prescribing and asthma outcomes following completion of active implementation (maintenance outcome)

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.

Clinician-level and system-level sustainment of the SMART implementation bundle and organizational capacity to maintain SMART clinical practice (implementation sustainment outcome)

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.

Patient-level de-implementation of SABA prescribing among patients prescribed SMART (de-implementation outcome)

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.

Qualitative assessment of the determinants of patient-level reach of SMART (CFIR-informed)

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.

Qualitative assessment of the determinants of clinician- and staff-level reach of the SMART implementation bundle (CFIR-informed)

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.

Digital reach of SMART implementation materials, including the CHEST study website and SMART asthma action plan (AAP)

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.

Qualitative assessment of clinician and staff perceptions of the effectiveness of the SMART implementation bundle and SMART therapy (CFIR-informed exploratory outcome)

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.

Qualitative assessment of patient perceptions of the effectiveness and impact of the SMART implementation bundle and SMART therapy (CFIR-informed exploratory outcome)

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.

Qualitative assessment of clinician and staff adoption of the SMART implementation bundle (CFIR-informed exploratory outcome)

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.