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

A clinic-level assessment of the SMART implementation bundle with the endpoint of between-group difference in the proportion of SMART-recommended asthma encounters, wherein SMART was the prescribed inhaler regimen. Patient encounters wherein any diagnosis of asthma was coded in patients ≥12 years old will be queried. Asthma encounters will then be in a binary fashion, as either "SMART- non-recommended" or "SMART- recommended" based on asthma exacerbation history and currently prescribed maintenance inhaler medications. A SMART prescription will be defined as clinician prescription of budesonide- formoterol 160/4.5µg or mometasone-formoterol 100/6µg ordered for maintenance and reliever usage. The proportion of SMART prescriptions will be compared between control and intervention groups. The control period will include pre-intervention data, while the intervention period will include all time post-implementation, but exclude the first 2 months as a "transition phase."

Proportion of eligible clinicians who adopt all three core components of the SMART implementation bundle. 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.

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

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: The primary effectiveness analysis will compare SMART prescribing rates between implementation and control periods across clinics.

The control period will include pre-implementation encounters, and the implementation period will include encounters occurring after implementation initiation, excluding a predefined 2-month transition period after randomization.

Number and proportion of eligible clinics that participated in any component of SMART implementation. Clinics will be counted as reached if they participated in any component the SMART implementation bundle. Clinics at partnering clinic systems will be considered potentially eligible for implementation if they cared for ≥100 individuals ≥12 years old with asthma (ICD 10-CM: J45.xx) in the calendar year prior to implementation (2024). Clinic network leadership in coordination with the study steering committee will choose two individual clinic sites within their network they believe to have the highest readiness for SMART implementation.

Number and proportion of eligible clinicians that participated in any component of SMART implementation bundle. Clinicians will be counted as reached if they participated in any component of the SMART implementation bundle (education, practice facilitation, audit and feedback, and/or self-reported use of the asthma action plan or training materials and monthly operations committee meeting at each site) during the active implementation period, which is inclusive of the initial visit and all follow-up visits. A clinician will be considered potentially eligible for SMART implementation (and as such counted as potentially able to be reached) if they are both (1) a physician, nurse practitioner, or physician assistant and (2) have cared for ≥10 adolescents or adults with asthma in the year prior to implementation. This is expected to be inclusive of, but not necessarily limited to, those working in primary care, pediatric, pulmonology, allergy, and/or obstetrics and gynecology clinics.

Number and proportion of eligible staff that participated in any component of the SMART implementation bundle. Clinic staff will be counted 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 (e.g., asthma action plans, clinical decision support, or training materials). A clinic staff member will be considered eligible for the SMART implementation (and as such counted as potentially able to be reached) 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. This is expected to be inclusive of, but not necessarily limited to, nursing staff, medical assistants, pharmacists, respiratory therapists, and/or pharmacy techs.

Number of patients with moderate-to-severe asthma prescribed SMART. Patients will be considered to be reached if they were ever prescribed SMART during the active implementation period. A prescription for SMART will count as any script for an ICS-formoterol at the 2024 GINA-recommended dosing on a maintenance and reliever basis. 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.

Between group difference in the rate of asthma exacerbations. Asthma exacerbations will be defined by 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); (2) ICD-10-CM coding for an acute asthma exacerbation (J45.901); or (3) dispensing of a systemic corticosteroid identified through linkage with Missouri Medicaid (MO HealthNet) pharmacy claims data. Corticosteroid prescriptions or dispensing occurring within 14 days of each other will be considered part of a single exacerbation episode.

Between group difference in rate of dysphonia, oral candidiasis, tremor, and/or palpitations and other reported serious adverse events. Patients will be monitored for serious adverse events and adverse events of special interest (i.e. known side effects of ICS-formoterol by identifying cases of oral candidiasis (thrush; ICD-10-CM: B37.0), dysphonia (ICD-10-CM: R49.0), tremor (ICD-10-CM: R25.1, G25.0, G25.2), or palpitations (R00.2). Serious adverse events (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. Clinicians will be asked if they have identified any serious adverse events or adverse events of special interest at site visits during the implementation period. Clinicians will also be provided with the study team's contact information, including email and phone number for reporting.

The proportion of clinicians who are "frequent SMART prescribers" (defined as prescribing SMART in ≥30% of indicated encounters). A prescription for SMART will count as a script for an ICS- formoterol on a maintenance and reliever basis. 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. This is expected to be inclusive of, but not necessarily limited to, those working in primary care, pediatric, pulmonology, allergy, and/or obstetrics and gynecology clinics.

Interviews/focus groups (clinicians, staff) for reasons clinicians/staff participated in implementation components (e.g., time constraints). A subset of clinic leadership, clinicians, and staff will be invited to participate in semi-structured one-on-one interviews (and/or focus groups) regarding reasons for participation and adoption of the implementation bundle.

Clinician adherence to the implementation bundle will be defined as meeting all of the following: (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 in ≥50% of SMART-eligible encounters.

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 SABA rescue inhalers when appropriate; and (3) provision of SMART-specific patient education. Fidelity will be assessed via structured clinician fidelity assessments on a random sample of approximately 50 SMART-prescribing encounters.

Exploratory assessment of costs by the investigators' team to implement the SMART implementation bundle and cost of asthma management to the payors. Implementation costs will be estimated using micro-costing methods and will include personnel time associated with implementation activities, training and educational material development and dissemination costs, implementation infrastructure and operational costs, and administrative and implementation support costs. Costs will be reported in inflation-adjusted U.S. dollars. A preliminary assessment of the estimated cost of training, implementation, asthma morbidity, inhalers, and other associated costs will be guided by the Good Practice for Budget Impact Analysis Taskforce recommendations and use cost data from MO HealthNet and the Medical Expenditure Panel Survey.

Proportion of indicated encounters wherein SMART was prescribed and rate of asthma exacerbations during sustainment vs. intervention period. Maintenance will be assessed by comparing 1) the prescription of SMART and 2) exacerbation rates in the implementation period vs. sustainment period. The sustainment period will be defined as the period following completion of active implementation activities (cessation of structured practice facilitation and audit-and-feedback sessions). Sustainment of SMART prescribing (%) = (Number of SMART-eligible encounters with SMART prescribed during sustainment ÷ Total SMART-eligible encounters during sustainment) × 100; exacerbation rates will be calculated as exacerbations per patient-year.

A validated sustainability assessment instrument, 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. Semi-structured interviews will also be conducted with clinic leadership at the conclusion of the sustainment period to assess organizational readiness, leadership engagement, and barriers and facilitators to long-term sustainment, analyzed using thematic analysis guided by CFIR.

Reasons clinicians and staff decided to, or decided not to, participate in any component of the SMART implementation bundle. All clinic leadership, clinicians, and staff who were potentially eligible for reach will be invited to complete a survey on why they did (or did not) participate in any component of the SMART implementation bundle. A subset of clinic leadership, clinicians, and staff will be invited to participate in semi- structured one-on-one interviews (and/or focus groups) regarding the reasons they did, or did not, participate in any component of the SMART implementation bundle.

Reasons patients decided to or decided not to use SMART. A subset of patients prescribed SMART will be invited to participate in semi- structured one-on-one interviews (and/or focus groups) regarding the reasons they did or did not use SMART.

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). 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.

Interviews with clinicians, and staff on effects of the SMART implementation (e.g., workflow, knowledge, self- efficacy) an SMART prescription. All clinic leadership, clinicians, and staff who were potentially eligible for reach will be invited to complete a survey on other effects of the SMART implementation bundle. A subset of clinic leadership, clinicians, and staff will be invited to participate in semi- structured one-on-one interviews (and/or focus groups) regarding other effects of the SMART implementation bundle.

Interviews with patients on effects of SMART implementation (i.e., workflow, knowledge, self- efficacy) and SMART prescription. A subset of patients will be invited to participate in semi- structured one-on-one interviews (and/or focus groups) regarding other effects of the SMART implementation bundle.