18 Participants Needed

SMART Strategy for Childhood Asthma

(SMART SIMPLE Trial)

CK
Overseen ByChén Kenyon, MD, MSHP
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Children's Hospital of Philadelphia
Must be taking: Inhaled corticosteroids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how clinics adopt a specific asthma management strategy called SMART, which combines medication for both daily use and quick relief. Researchers are testing whether support from health workers and nurses, along with enhanced education (Clinical decision support + education, CDS+, and population health management, PHM), can help clinics better implement this strategy using electronic health records. The trial involves two groups: one receiving the intervention and another serving as a comparison. Children aged 5-18 with asthma that has been hard to control, especially those needing frequent medication adjustments, might be a good fit for this study. As an unphased trial, this study offers participants the opportunity to contribute to improving asthma care strategies in clinics.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, since it involves asthma management, you might continue with your prescribed inhaled corticosteroids or ICS-long-acting beta agonists.

What prior data suggests that this strategy is safe for childhood asthma management?

Research shows that decision-support tools for doctors, combined with asthma education, can improve asthma management. These tools help doctors make better treatment choices for asthma. Studies have found that this approach can reduce emergency visits for asthma patients, indicating that the treatment is generally safe and well-tolerated.

Furthermore, managing health at the community level with community health workers and nurse care managers has been linked to better health outcomes for asthma patients. This method provides additional support and education to patients.

No specific data indicates serious side effects from these interventions, suggesting they are likely safe to use. Since this trial focuses on implementing these strategies rather than testing a new drug, the risk of serious side effects is lower.12345

Why are researchers excited about this trial?

Researchers are excited about the SMART Strategy for Childhood Asthma because it offers a comprehensive approach beyond typical medication regimens. While standard asthma treatments often focus on inhalers and medications like corticosteroids, this strategy combines clinical decision support with education, and adds population health management involving community health workers and nurse care managers. This holistic method aims to improve asthma management by not only treating symptoms but also addressing broader healthcare engagement and education, potentially leading to better long-term outcomes for children.

What evidence suggests that this trial's interventions could be effective for childhood asthma?

This trial will compare the effectiveness of clinical decision support and education (CDS+) combined with population health management (PHM) against standard care. Research has shown that special tools and education can improve asthma management. These tools provide doctors with the latest information, aiding in better treatment decisions. Education helps patients understand and control their asthma. Support from community health workers and nurse care managers, known as population health management, can further enhance asthma care by offering personalized advice and follow-up. Together, these strategies aim to improve asthma control and reduce flare-ups, easing life for those with moderate to severe asthma.15678

Are You a Good Fit for This Trial?

This trial is for pediatric primary care clinics within the Children's Hospital of Philadelphia network that agree to participate in a study on asthma management. It focuses on children with moderate to severe asthma.

Inclusion Criteria

My child's clinic is part of the CHOP Pediatric Research Consortium.
My clinic is participating in the SMART & SIMPLE study.
Clinic

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Interval 1: CDS+ Intervention

Implementation of clinical decision support and education strategies

11 months

Interval 2: CDS+ and PHM Intervention

Implementation of clinical decision support, education, and population health management strategies

11 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Clinical decision support + education (CDS+) and population health management (PHM)
Trial Overview The trial tests if adding population health management strategies, like working with an asthma community health worker and nurse care manager, can improve the adoption of SMART (single maintenance and reliever therapy) for childhood asthma.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials
749
Recruited
11,400,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Citations

Development of a Clinical Decision Support Tool to ...This study aimed to follow user-centered design principles and describe the formative qualitative work with target stakeholders (ie, PCPs and IT professionals)
Pediatric Order Set Utilization and Infrastructure Within a ...SOS infrastructure was measured by a novel survey based on the Clinical Decision Support (CDS) Operations Maturity Model and the Unified Theory ...
Artificial intelligence-assisted clinical decision support for ...Here we report results of an exploratory pragmatic RCT that assessed the effectiveness and efficiency of intervention via A-GPS on pertinent ...
236.pdfUtilizing automatic clinical decision support reduced the need to rely on education to cause a change, an important element of our tool. Future steps include ...
SMART Implementation-Effectiveness Trial 2 (SMART SIMPLE)This study will test population health management (PHM; asthma community health worker, asthma nurse care manager) implementation strategies ...
An Electronic Decision Support Tool to Improve Outpatient ...Using the EHR, a clinical decision support tool will be designed to help the primary care physician's in caring for children with asthma. The goal will be to ...
Electronic clinical decision support system (eCDSS) in the ...Asthma action plans, combined with asthma education and regular follow-up, can improve the symptoms and quality of life of the patient and can reduce ...
Social Risk Interventions and Health Care Utilization for ...The results of this systematic review and meta-analysis indicate that social risk interventions are associated with decreased asthma-related ED visits and ...
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