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.
CHEST is a type 1 hybrid stepped-wedge cluster randomized trial wherein six federally qualified community health center clinics are randomly and iteratively selected to move in a 1-way crossover from the control group to the SMART implementation group. The primary intervention is an SMART implementation bundle, which contains three components: (1) clinician-level education on SMART with ongoing practice facilitation/supervision, (2) serial clinic- and clinician-level audit and feedback on inhaler prescribing patterns, (3) provision of a paper and online clinician- and patient-centered education aide with a SMART congruent asthma action plan designed for low health literacy patients, and (4) operations committee meetings during the implementation period The study is conceptually split into three phases: (1) the pre-implementation (control) phase focused on development of implementation materials and baseline data gathering of prescription patterns, (2) the active implementation phase, and (3) post-implementation, which will focus on an assessment of sustainability and dissemination. 1. Pre-implementation phase: The pre-implementation phase (which will last from 12 to 24 months per clinic) is designed to be a baseline for the study. During this phase, no specific interventions will be introduced to the clinicians at participating clinics. This phase will allow the CHEST study team to collect clinic-level data on current asthma care prescription practices and asthma-related outcomes. 2. Active implementation phase: The second phase, which will last from 9 to 24 months per clinic, will begin with the introduction of the SMART implementation bundle to clinicians and staff at participating IHN clinics. 3. Post-implementation phase: The final phase of the study is introduced after the active implementation of the SMART implementation bundle is complete at all participating clinics. In the post-implementation phase, formal assessments will be conducted to evaluate the sustainment of the SMART bundle. Additionally, this phase includes efforts to disseminate the findings of the study. This encompasses analyses of the reach and impact of the dissemination efforts, as well as the practical application and adoption of the findings in the broader medical community.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,000
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 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
Affinia healthcare, 2220 Lemp Ave
St Louis, Missouri, United States
NOT_YET_RECRUITINGAffinia healthcare, 1717 Biddle Street
St Louis, Missouri, United States
NOT_YET_RECRUITINGAffinia healthcare, 4414 North Florissant Avenue
St Louis, Missouri, United States
RECRUITINGFamily Care Heath Center, 4352 Manchester Ave
St Louis, Missouri, United States
NOT_YET_RECRUITINGWashington University in St. Louis School of Medicine
St Louis, Missouri, United States
RECRUITINGFamily Care Heath Center, 401 Holly Hills Ave
St Louis, Missouri, United States
NOT_YET_RECRUITINGAffinia healthcare, 3396 Pershall Road,
St Louis, Missouri, United States
NOT_YET_RECRUITINGPatient-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."
Time frame: Through study completion, up to 24 months
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).
Time frame: Through study completion, up to 24 months
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.
Time frame: Through study completion, up to 24 months
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.
Time frame: Through study completion, up to 24 months
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.
Time frame: Through study completion, up to 24 months
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.
Time frame: Through study completion, up to 24 months
Patient-level effectiveness (of the evidence-based practice, i.e., SMART)
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.
Time frame: Through study completion, up to 24 months
Patient-level safety (of the evidence-based practice, i.e., SMART)
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.
Time frame: Through study completion, up to 24 months
Clinician-level effectiveness (of the SMART implementation bundle)
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.
Time frame: Through study completion, up to 24 months
Qualitative assessment (of the SMART implementation bundle and evidence based practice, i.e., SMART) adoption
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.
Time frame: Through study completion, up to 24 months
Clinician-level fidelity to the SMART implementation bundle
Proportion of clinicians that participate in both baseline visit and \>50% of practice facilitation and audit and feedback sessions.
Time frame: Through study completion, up to 24 months
Clinician-level fidelity (of the evidence-based practice, SMART)
Proportion of encounters prescribed SMART intervention as recommended at the correct dose and with SABA inhalers discontinued.
Time frame: Through study completion, up to 24 months
Other system-level implementation outcomes (of the SMART implementation bundle and evidence-based practice, i.e., SMART)
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.
Time frame: Through study completion, up to 24 months
Patient-level sustainment (of the evidence-based practice, i.e., SMART)
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.
Time frame: Through study completion, up to 24 months
Clinician-level and system-level sustainment (of the SMART implementation bundle)
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
Time frame: Through study completion, up to 24 months
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