Moderate to Severe Asthma
Conditions
Keywords
asthma, SMART, moderate to severe asthma, CHEST, CHEST asthma study, asthma study, asthma action plan, implementation science, hybrid cluster, community health centers, MART, single maintenance and reliever therapy, maintenance and reliever therapy
Brief summary
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.
Detailed description
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 the SMART implementation bundle includes four components: (1) clinician education on SMART with ongoing practice facilitation, (2) serial clinic- and clinician-level audit and feedback on inhaler prescribing patterns, (3) workflow integration support including prescribing preferences, and (4) provision of an online patient-centered education aid with a SMART congruent asthma action plan designed for patients with lower health literacy. The study is conceptually split into three phases: (1) the pre-implementation (control) phase focused on the development of implementation materials and baseline data gathering of prescription patterns; (2) the active implementation phase; and (3) the sustainment phase, which will focus on an assessment of sustainment and dissemination. 1. Pre-implementation phase: The pre-implementation phase is designed to be a baseline for the study. During this phase, no specific interventions will be introduced to the clinicians at participating IHN 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: At the start of the second phase, the implementation phase, the SMART implementation bundle will be introduced to the clinicians and staff at participating IHN clinics. 3. Sustainment phase: The final phase of the study is introduced after the active implementation of the SMART implementation bundle is complete at all participating IHN clinics. In the sustainment 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.
Interventions
BEHAVIORALImplementation bundle
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 four components: (1) clinician education with practice facilitation, (2) audit and feedback on prescribing, (3) workflow integration support, including prescribing preferences, and (4) patient education tools such as a SMART-aligned asthma action plan and videos tailored for low health literacy
Sponsors
Washington University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Doris Duke Charitable Foundation
Affinia Healthcare
Family Care Health Centers
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is a type 1 hybrid effectiveness-implementation stepped-wedge cluster randomized trial wherein six St. Louis Integrated Health Network (IHN) 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 a SMART implementation bundle that contains four 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) workflow integration support, including prescription preferences, and (4) provision of a paper and online clinician- and patient-centered education aid with a SMART-congruent asthma action plan designed for low health literacy patients. Clinics will transition from control to implementation in randomly assigned sequences at prespecified intervals according to the stepped-wedge design.
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The study population can be viewed from the cluster (clinic), clinician, staff, or patient level. At the cluster (clinic) level: To be eligible to participate in this study, a cluster (clinic) must meet all the following criteria: (1) 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). At the clinician level: 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. At the staff level: 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. At the patient level: 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 as defined in the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician-level adoption of the SMART implementation bundle | Through study completion, up to 24 months | 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 | Through study completion, up to 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinic-level Reach: Reach of the SMART implementation bundle | Through study completion, up to 24 months | 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 | Through study completion, up to 24 months | 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 | Through study completion, up to 24 months | 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 | Through study completion, up to 24 months | 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 |
| Patient-level Reach: Reach of SMART among eligible patients | Through study completion, up to 24 months | Number and proportion of eligible patients prescribed SMART during the implementation period Definition of eligible patients: 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 as defined in the study protocol. Definition of reach: Patients will be classified as "reached" if they receive ≥1 prescription for an inhaled corticosteroid-formoterol inhaler prescribed for use as both maintenance and reliever therapy (SMART) during the implementation period. Eligible SMART prescriptions include budesonide-formoterol or mometasone-formoterol prescribed at guideline-consistent dosing for maintenance and reliever use, consistent with GINA recommendations. |
| Patient-level safety of SMART therapy (adverse events of special interest and serious adverse events) | Through study completion, up to 24 months | Between-group difference in the rate of adverse events of special interest (AESI) and serious adverse events (SAEs), comparing implementation vs control periods Adverse events of special interest (AESI): AESI will include known or anticipated adverse effects potentially associated with inhaled corticosteroid-formoterol therapy, identified using diagnosis codes and/or documented clinical events, including: * Oral candidiasis (ICD-10-CM: B37.0) * Dysphonia (ICD-10-CM: R49.0) * Tremor (ICD-10-CM: R25.1, G25.0, G25.2) * Palpitations (ICD-10-CM: R00.2) Serious adverse events (SAEs): 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, or other medically important events potentially related to asthma therapy. |
| Clinician-level effectiveness of the SMART implementation bundle, measured as the proportion of clinicians classified as frequent SMART prescribers | Through study completion, up to 24 months | Proportion of eligible clinicians classified as frequent SMART prescribers, defined as prescribing SMART in ≥30% of SMART-eligible encounters 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) managed ≥10 patients aged ≥12 years with moderate-to-severe asthma during the 12 months preceding implementation initiation. Definition of SMART-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 the prescription of an inhaled corticosteroid-formoterol inhaler with instructions consistent with use as both maintenance and reliever therapy. |
| Clinician-level adherence to the SMART implementation bundle (implementation strategy adherence) | Through study completion, up to 24 months | Proportion of eligible clinicians meeting predefined adherence thresholds to implementation bundle components. Definition of implementation adherence: Clinician adherence to the implementation bundle will be defined as meeting all of the following criteria: (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 (SMART asthma action plan and/or patient education materials) in ≥50% of SMART-eligible encounters. Definition of eligible clinicians: Eligible clinicians will include physicians, assistant physicians, nurse practitioners, and physician assistants actively employed at participating clinics who manage patients aged ≥12 years with asthma. |
| Clinician-level fidelity to SMART prescribing and delivery (clinical intervention fidelity) | Through study completion, up to 24 months | Proportion of clinicians and sampled encounters in which SMART was delivered consistent with recommended clinical practice Definition of fidelity: 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 short-acting beta-agonist (SABA) rescue inhalers when appropriate; and 3. Provision of SMART-specific patient education, including asthma action plan use and instruction on SMART dosing. Assessment method: Fidelity will be assessed using structured clinician fidelity assessments conducted by study personnel. A random sample of approximately 50 SMART-prescribing encounters across participating clinicians will be selected, and clinicians will be asked to confirm whether SMART was delivered consistent with recommended clinical practice. |
| System-level implementation cost and budget impact of the SMART implementation bundle | Through study completion, up to 24 months | Estimated implementation costs and exploratory budget impact associated with implementation of the SMART implementation bundle and asthma-related healthcare utilization Objective: To estimate the cost of implementing the SMART implementation bundle and assess the exploratory budget impact of SMART adoption on asthma-related healthcare costs from healthcare system and payer perspectives. Implementation cost assessment: Implementation costs will be estimated using micro-costing methods and will include: • Personnel time associated with implementation activities (education sessions, practice facilitation, audit-and-feedback delivery, and coordination); • Training and educational material development and dissemination costs; • Implementation infrastructure and operational costs; and • Administrative and implementation support costs borne by participating clinics and the study team. |
| Patient-level sustainment of SMART prescribing and asthma outcomes following completion of active implementation (maintenance outcome) | Through study completion, up to 24 months | Proportion of SMART-eligible encounters prescribed SMART and rate of asthma exacerbations during the sustainment period compared with the active implementation period Definition of sustainment period: The sustainment period will be defined as the period following completion of active implementation activities (e.g., cessation of structured practice facilitation and audit-and-feedback sessions), during which clinics continue routine clinical care without active implementation support. Primary sustainment measures: Sustainment will be assessed by comparing: 1. The proportion of SMART-eligible encounters in which SMART is prescribed during the sustainment period compared with the active implementation period; and 2. The rate of asthma exacerbations (defined as systemic corticosteroid-treated exacerbations or exacerbation-related encounters) during the sustainment period compared with the active implementation period. |
| Clinician-level and system-level sustainment of the SMART implementation bundle and organizational capacity to maintain SMART clinical practice (implementation sustainment outcome) | Through study completion, up to 24 months | Continued use of SMART implementation bundle components following completion of active implementation support Definition of sustainment: Sustainment will be defined as the continued use of SMART implementation bundle components during the sustainment period, including ongoing use of SMART asthma action plans, continued incorporation of SMART into clinical workflows, and continued engagement with SMART-related clinical practices in the absence of active implementation support. Sustainment capacity assessment: A validated sustainability assessment instrument, such as 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 to assess organizational capacity to maintain SMART implementation. |
| Patient-level de-implementation of SABA prescribing among patients prescribed SMART (de-implementation outcome) | Through study completion, up to 24 months | Proportion of SMART-prescribing encounters in which SABA inhalers are not concurrently prescribed Definition of de-implementation: De-implementation will be defined as the absence of an active SABA prescription following initiation of SMART therapy or documented discontinuation of an existing SABA prescription at the time SMART is prescribed. Eligible encounters: All clinical encounters in which SMART is prescribed for maintenance and reliever therapy (ICS-formoterol prescribed for both maintenance and reliever use). Objective: This outcome assesses the extent to which SMART implementation replaces legacy SABA prescribing practices consistent with guideline-recommended care. |
Countries
United States
Contacts
CONTACTJames Krings, MD MSCI
CONTACTKrutika Chauhan, MBBS MPH
Outcome results
None listed