CHEST: A Collaboration With Community HEalth Centers to Implement SmarT for Asthma

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

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.