CHEST: A Collaboration With Community HEalth Centers to Implement SmarT for Asthma
Purpose
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.
Condition
- Moderate to Severe Asthma
Eligibility
- Eligible Ages
- Over 12 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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. Active participation in the St. Louis Integrated Health Center Network for Community
Academic Partnerships.
2. 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).
3. Data provided to Azara for data queries, and
4. 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).
At the clinician/clinical staff level:
To be eligible to participate in this study, a clinician/clinical staff member must meet
all of the following criteria:
1. Provision of a signed and dated informed consent form.
2. Current state licenses of physician, assistant physician, nurse practitioner, or
physician assistant.
3. Regularly cares for adults with asthma (which may include those trained in family
medicine, internal medicine, obstetrics/gynecology, and/or specialty medicine).
4. Willing and able to integrate the SMART implementation bundle into their practice.
5. Willing and able to participate for the entire duration of the study, including the
pre-implementation, active implementation, and post-implementation periods.
6. Willing to provide data on prescribing patterns and asthma patient outcomes for the
duration of the study.
At the patient level:
To be eligible to participate in this study, a patient must meet all of the following
criteria:
1. Age ≥12 years old
2. Diagnosis of asthma, of any severity, coded (i.e., International Classification of
Diseases [ICD]-10-CM: J45**).
3. The patient has had ≥2 asthma exacerbations in the last year during which systemic
corticosteroids were prescribed, and/or the encounter contains an active
prescription for an inhaler that is congruent with medium-dose (or higher)
maintenance inhaled corticosteroids (ICS) inhalers or low-dose (or higher)
ICS-long-acting β-agonist (LABA) inhalers with concomitant reliever short-acting
β-agonist inhalers.
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Intervention Model Description
- This is a Phase 4, type 1 hybrid stepped-wedge cluster randomized trial conducted in six Federally Qualified Health Centers in St. Louis, Missouri. The unit of randomization is the clinic, with each site sequentially crossing over in a one-way fashion from control to intervention, allowing each to serve as its own control. The intervention is the SMART implementation bundle consisting of (1) clinician education with practice facilitation, (2) audit and feedback on prescribing, (3) patient-centered education aides, including a SMART-congruent asthma action plan, and (4) monthly operations committee meetings during implementation period. The trial proceeds in three phases: pre-implementation (baseline), active implementation (rollout), and post-implementation (sustainability/dissemination). The study population includes clinicians, staff, and patients ≥12 years with moderate-to-severe asthma.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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) patient-centered education tools such as instructional videos and a SMART-congruent asthma action plan designed for low health literacy, and (4) operations committee meetings during the implementation period. 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 |
|
|
No Intervention Control |
During this period, prescribing patterns and asthma outcomes will be observed without active implementation. |
|
Recruiting Locations
Washington University in St. Louis and nearby locations
St Louis 4407066, Missouri 4398678 63110
More Details
- NCT ID
- NCT07241117
- Status
- Recruiting
- Sponsor
- Washington University School of Medicine
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 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.