SMART Therapy for Asthma

(CHEST Trial)

Not yet recruiting at 6 trial locations

Overseen By Krutika Chauhan, MBBS MPH

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: Washington University School of Medicine

Must be taking: Inhaled corticosteroids, LABA

Disqualifiers: Under 12 years, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve asthma care by teaching community health center clinicians to better prescribe a treatment known as SMART (Single Maintenance and Reliever Therapy). Researchers will provide training, feedback, and educational resources to help clinicians use this guideline-recommended approach. The goal is to determine if these efforts can reduce asthma flare-ups. Suitable candidates for this trial include individuals with asthma who have experienced two or more flare-ups requiring treatment in the past year. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment can benefit more patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop your current medications. It focuses on using SMART therapy, which involves specific asthma treatments, so you may need to adjust your current asthma medications. It's best to discuss this with the trial team.

What is the safety track record for the SMART implementation bundle?

Research shows that the SMART (Single Maintenance and Reliever Therapy) approach is generally easy for people to use. Studies have found that smart inhalers, a component of SMART, lead to good results. For instance, children with asthma who used these inhalers felt better after emergency room visits, suggesting the treatment is safe.

Since this study is in Phase 4, it examines treatments already approved and known to be safe, indicating a strong safety record. The study assesses how well the treatment works in everyday life, rather than testing basic safety.

Overall, past research and the current phase consider the treatment safe and effective. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores a new way to manage asthma using a SMART implementation bundle at community health centers. Unlike standard asthma treatments that rely solely on medication, this approach combines clinician education, patient-centered tools, and regular feedback to improve asthma care. The bundle is designed to support guideline-concordant prescribing and is tailored for patients with low health literacy, making it more accessible. By focusing on education and feedback, this method aims to enhance the effectiveness of existing treatments and improve patient outcomes.

What evidence suggests that this implementation bundle is effective for asthma?

Research shows that the SMART implementation bundle, which participants in this trial may receive, can improve asthma management. Studies have found that guideline-based asthma care often results in fewer asthma attacks and better symptom control. The SMART approach includes education for both doctors and patients, along with regular feedback on inhaler use. This method has been linked to fewer asthma flare-ups and reduced hospital visits. By focusing on correct inhaler use, the SMART bundle aims to maintain well-controlled asthma and enhance overall patient health. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals with asthma who are being treated at community health centers. It aims to help clinicians prescribe a specific recommended treatment more effectively.

Inclusion Criteria

I am 12 years old or older.

I have been diagnosed with asthma.

I've had 2 or more asthma attacks in the last year and use a strong asthma inhaler.

Timeline for a Trial Participant

Pre-implementation

Baseline data gathering of prescription patterns and asthma-related outcomes without specific interventions.

12 to 24 months

Active Implementation

Introduction of the SMART implementation bundle to clinicians and staff, including education, practice facilitation, and feedback.

9 to 24 months

Quarterly practice facilitation and feedback visits

Post-implementation

Assessment of sustainability and dissemination of the SMART implementation bundle findings.

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after the implementation phases.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Implementation bundle

Trial Overview The study tests an 'implementation bundle' designed to improve the prescription of SMART therapy for asthma by providing training, feedback, and educational tools in stages across clinics.

How Is the Trial Designed?

Group I: Active Implementation Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 Intervention

During this period, prescribing patterns and asthma outcomes will be observed without active implementation.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Doris Duke Charitable Foundation

Collaborator

Trials

65

Recruited

264,000+

Affinia Healthcare

Collaborator

Trials

1

Recruited

150+

Family Care Health Centers

Collaborator

Trials

1

Recruited

1,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07241117?cond=%22Asthma%22

Study Details | NCT07241117 | CHEST: A Collaboration ... The intervention is the SMART implementation bundle consisting of (1) clinician education with practice facilitation, (2) audit and feedback on ...

2. emjreviews.com emjreviews.com/respiratory/article/opportunities-and-challenges-in-the-implementation-of-smart-inhalers-to-improve-asthma-outcomes-j160123/

Opportunities and Challenges in the Implementation of ... 1. Asthma is highly prevalent, and effective treatments are outlined in established guidelines. However, poor symptom control and exacerbations ...

3. trial.medpath.com trial.medpath.com/clinical-trial/51e35db55e11299a/chest-collaboration-health-centers-smart-asthma

CHEST: A Collaboration With Community HEalth Centers to ... A clinic-level assessment of the SMART implementation bundle with the endpoint of between-group difference in the proportion of SMART- ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2213219825002600

Long-Term Effectiveness of a Digital Inhaler on Medication ... Control patients' inhaler use was passively monitored. Primary outcome was 1-year medication adherence. Secondary outcomes included asthma control, quality of ...

5. transformationpartners.nhs.uk transformationpartners.nhs.uk/wp-content/uploads/2017/10/Asthma-Care-Bundle-April-2016.pdf

Improving Outcomes in Asthma - Asthma Care Bundle Correct use of inhalers is associated with improved outcomes for patients including a reduction in risk of exacerbations and hospital admission6. Repeated ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34666208/

A Practical Guide to Implementing SMART in Asthma ... This article provides practical advice about implementing SMART in clinical practice based on evidence and clinical experience.