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 month as a "transition phase."

Proportion of clinicians who initially utilize the 3 SMART implementation bundle components. Adoption will be defined by initial: 1) participation in an education and practice facilitation session, 2) participation in an audit and feedback session, 3) use of the patient-centered education aide and action plan, and 4) participation in monthly operations committee meetings. Eligible clinicians will be defined as any clinician that is (1) a currently state-licensed physician, assistant physician, nurse practitioner, or physician assistant, and (2) regularly cares for adults with asthma (defined as managing asthma for at least one adult asthma patient, on average, on a weekly basis).

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 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 clinic staff will be considered potentially eligible for the SMART implementation (and as such counted as potentially able to be reached) if they: (1) provide or may provide clinical advice, and (2) interact with adolescents or adults with asthma, in the opinion of the site CMO and/or site champion. 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 eligible for reach will include any patient age ≥12 years who meets the study- defined definition of moderate-to-severe asthma.

Between group difference in the rate of sthma exacerbations. Asthma exacerbations will be defined by: (1) prescription of a new systemic corticosteroid within 7 days of a clinic/telephone encounter for asthma, and/or (2) ICD-10 coding for an acute asthma exacerbation.

Between group difference in rate of dysphonia, oral candidiasis, tremor, and/or palpitations and othere 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- 10CM: B37.0), dysphonia (ICD-10-CM: R49.0), tremor (ICD-10-CM: R25.1, G25.0, G25.2), or palpitations (R00.2). 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 script for an ICS- formoterol on a maintenance and reliever basis. Clinicians will be considered eligible if they are both: (1) a physician, nurse practitioner, or physician assistant, and (2) managed ≥10 patients with moderate-to-severe 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.

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.

Proportion of clinicians that participate in both baseline visit and >50% of practice facilitation and audit and feedback sessions.

Proportion of encounters prescribed SMART intervention as recommended at the correct dose and with SABA inhalers discontinued.

Exploratory assessment of costs by the investigators team to implement SMART implementation bundle and cost of asthma management to the payors. A preliminary assessment of 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.

A validated sustainability survey will be administered to clinic staff, the site champion, and CMO at each site at the beginning of the sustainment period. At the conclusion of the sustainment period, site champions and CMOs will be given a survey querying how often SMART implementation components were continued during the sustainment period. A

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.

Number of times CHEST website is visited, and number of times SMART AAP is downloaded from the website. The investigators will describe how often the CHEST website (chestasthmastudy.wustl.edu) is reached by the public and the number of times the SMART AAP is downloaded.

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.