CHEST: A Collaboration With Community HEalth Centers to Implement SmarT for Asthma
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 14
- 主要终点
- Clinic-level effectiveness of the SMART implementation bundle, measured as the proportion of SMART-eligible asthma encounters in which SMART is prescribed
研究概览
简要总结
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.
详细描述
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.
- 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.
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •are physicians, nurse practitioners, or physician assistants;
- •are actively employed at a participating clinic during the implementation period; and
- •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:
- •are actively employed at a participating clinic during the implementation period; and
- •directly support clinical care delivery for patients aged ≥12 years with asthma.
- •At the patient level:
- •Patients will be considered eligible if they:
- •are aged ≥12 years;
- •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.
排除标准
- 未提供
研究组 & 干预措施
Control
During this period, prescribing patterns and asthma outcomes will be observed without active implementation.
Active Implementation
The intervention is a SMART implementation bundle delivered at community health centers. It includes (1) clinician education with practice facilitation to support guideline-concordant prescribing and (2) regular audit and feedback on inhaler prescribing patterns (3) workflow integration support, including prescribing preferences, and (4) patient-centered education tools such as instructional videos and a SMART-congruent asthma action plan designed for low health literacy. Educational outreach is co-led by the PI and a certified asthma educator, with quarterly practice facilitation and feedback visits during the active implementation period. All materials are available in paper and digital formats, with continued access to patient tools beyond the intervention. Providers retain full autonomy over prescribing decisions
干预措施: Implementation bundle (Behavioral)
结局指标
主要结局
Clinic-level effectiveness of the SMART implementation bundle, measured as the proportion of SMART-eligible asthma encounters in which SMART is prescribed
时间窗: 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.
Clinician-level adoption of the SMART implementation bundle
时间窗: 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
Patient-level Effectiveness (of the SMART implementation bundle)
时间窗: Through study completion, up to 24 months
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."
Clinician-level adoption (of the SMART implementation bundle)
时间窗: Through study completion, up to 24 months
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.
次要结局
- Clinic-level Reach: Reach of the SMART implementation bundle(Through study completion, up to 24 months)
- 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)
- Clinician-level Reach: Reach of the SMART implementation bundle(Through study completion, up to 24 months)
- Staff-level Reach: Reach of the SMART implementation bundle(Through study completion, up to 24 months)
- Patient-level Reach: Reach of SMART among eligible patients(Through study completion, up to 24 months)
- Patient-level safety of SMART therapy (adverse events of special interest and serious adverse events)(Through study completion, up to 24 months)
- 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)
- Clinician-level adherence to the SMART implementation bundle (implementation strategy adherence)(Through study completion, up to 24 months)
- Clinician-level fidelity to SMART prescribing and delivery (clinical intervention fidelity)(Through study completion, up to 24 months)
- System-level implementation cost and budget impact of the SMART implementation bundle(Through study completion, up to 24 months)
- Patient-level sustainment of SMART prescribing and asthma outcomes following completion of active implementation (maintenance outcome)(Through study completion, up to 24 months)
- 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)
- Patient-level de-implementation of SABA prescribing among patients prescribed SMART (de-implementation outcome)(Through study completion, up to 24 months)
- Clinic-level reach (of the SMART implementation bundle)(Through study completion, up to 24 months)
- Clinician-level reach (of the SMART implementation bundle)(Through study completion, up to 24 months)
- Staff-level reach (of the SMART implementation bundle)(Through study completion, up to 24 months)
- Patient-level reach of (of the evidence-based practice, i.e., SMART)(Through study completion, up to 24 months)
- Patient-level effectiveness (of the evidence-based practice, i.e., SMART)(Through study completion, up to 24 months)
- Patient-level safety (of the evidence-based practice, i.e., SMART)(Through study completion, up to 24 months)
- Clinician-level effectiveness (of the SMART implementation bundle)(Through study completion, up to 24 months)
- Qualitative assessment (of the SMART implementation bundle and evidence based practice, i.e., SMART) adoption(Through study completion, up to 24 months)
- Clinician-level fidelity to the SMART implementation bundle(Through study completion, up to 24 months)
- Clinician-level fidelity (of the evidence-based practice, SMART)(Through study completion, up to 24 months)
- Other system-level implementation outcomes (of the SMART implementation bundle and evidence-based practice, i.e., SMART)(Through study completion, up to 24 months)
- Clinician-level and system-level sustainment (of the SMART implementation bundle)(Through study completion, up to 24 months)
- Patient-level sustainment (of the evidence-based practice, i.e., SMART)(Through study completion, up to 24 months)
研究者
James Krings
Assistant Professor of Medicine
Washington University School of Medicine