Purpose: This study aims to improve asthma care by helping clinicians at community health centers prescribe a guideline-recommended treatment called SMART (Single Maintenance and Reliever Therapy).
The investigators will provide training and resources to clinicians, give feedback on prescribing patterns, and offer educational tools for patients and providers. The investigators will roll out these resources in stages across clinics. The study will measure how well the program helps clinicians prescribe SMART therapy and whether it reduces asthma exacerbations in patients.
Active participation in the St. Louis Integrated Health Center Network for Community Academic Partnerships.
Employment of at least 3 clinicians who commonly manage adult asthma (defined as managing asthma for at least one adult asthma patient, on average, on a weekly basis).
Data provided to Azara for data queries, and
Willing and able to receive all components of the SMART implementation bundle (i.e., initial educational outreach visit, ongoing practice facilitation/supervision, audit & feedback, and provision of education of patient-level education aides and SMART asthma action plans and monthly operations committee meetings).
None
Crossover
Implementation bundle
BehavioralThe 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 three components: (1) clinician education with practice facilitation, (2) audit and feedback on prescribing, (3) patient education tools such as a SMART-aligned asthma action plan and videos tailored for low health literacy, and (4) operations committee meetings during the implementation period
Patient-level Effectiveness (of the SMART implementation bundle)
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."
Clinician-level adoption (of the SMART implementation bundle)
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).
Clinic-level reach (of the SMART implementation bundle)
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.
Clinician-level reach (of the SMART implementation bundle)
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.
Staff-level reach (of the SMART implementation bundle)
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.
Patient-level reach of (of the evidence-based practice, i.e., SMART)
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.
Qualitative assessment of the determinants of clinician and staff-reach (of the SMART implementation bundle)
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.
Qualitative assessment of the determinants of clinician and staff-reach (of the evidence-based practice, i.e., SMART
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.
Reach (of SMART implementation materials including the CHEST website and SMART focused AAP)
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.
Qualitative assessment (of the SMART implementation bundle and evidence-based practice, i.e., SMART) effectiveness
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.
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Washington University School of Medicine
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Doris Duke Charitable Foundation
Collaborator
Affinia Healthcare
Collaborator
Family Care Health Centers
Collaborator
