Clinical Decision Support + Education for Childhood Asthma

(SMART & SIMPLE Trial)

Overseen By Chén Kenyon, MD, MSHP

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Must be taking: Inhaled corticosteroids

Disqualifiers: Transferred clinics, left network

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

Compensation: Varies

Number of Visits: Unknown

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well clinics can adopt a new asthma management strategy called SMART for children with moderate to severe asthma. The trial will assess whether electronic tools and education in clinics, known as Clinical Decision Support Plus (CDS+), can increase the adoption of this effective treatment plan by doctors. Clinics will be divided into two groups: one will use these tools, and the other will not. Children aged 5 to 18 with frequent asthma issues and on specific asthma medications are suitable candidates for this trial. As an unphased trial, this study offers participants the opportunity to contribute to innovative asthma care strategies that could enhance treatment for many children.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It focuses on increasing the use of a specific asthma management strategy, so it's best to discuss your current medications with the trial team.

What prior data suggests that this clinical decision support and education strategy is safe for children with asthma?

Research has shown that tools called Clinical Decision Support and Education (CDS+) are generally safe for children with asthma. These tools assist doctors in making better decisions about asthma care, leading to improved health outcomes for children. Although the primary focus has been on the effectiveness of these tools, no major safety issues have been reported. This suggests that using CDS+ is likely safe for children, even though the main goal is to enhance asthma management rather than treat it directly. As this trial examines the use of a management strategy called SMART with CDS+, the safety outlook remains positive based on these findings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Clinical Decision Support and Education (CDS+) approach for childhood asthma because it integrates technology with patient education to enhance asthma management. Unlike traditional treatments that primarily rely on medication like inhaled corticosteroids and bronchodilators, CDS+ empowers healthcare providers with real-time decision-making tools and personalized educational resources. This approach aims to improve asthma control by tailoring interventions to each patient's needs, potentially leading to better outcomes and fewer asthma-related complications. By focusing on personalized care, CDS+ could revolutionize how asthma is managed in children, offering a complementary strategy to existing treatments.

What evidence suggests that CDS+ is effective for childhood asthma?

Research has shown that tools called Clinical Decision Support and Education (CDS+) can improve asthma care for children. These tools use electronic health records to help doctors adhere to asthma care guidelines. Some studies found that CDS+ can facilitate more accurate asthma diagnoses. However, its effect on reducing asthma attacks has been mixed. In this trial, clinics in the intervention arm will receive the CDS+ intervention to assist doctors in making better decisions for managing asthma, potentially leading to better health outcomes for children. Clinics in the control arm will not receive the interventions. ^{1 2 3 4 6}

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 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

Baseline Period (Interval 0)

Assessment of baseline SMART adoption and sustainment without intervention

11 months

Intervention Period (Interval 1)

Implementation of clinical decision support and education (CDS+) to increase SMART adoption

11 months

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CDS+

Trial Overview The trial is testing if using electronic medical record support and education (CDS+) can help clinics adopt a preferred asthma treatment strategy known as SMART, compared to usual care without this support.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Clinics in Arm 1 will receive the intervention in Interval 1. Interval 1 intervention: clinical decision support and education (CDS+).

Group II: Control Active Control 1 Intervention

Clinics in Arm 2 will not be exposed to the interventions.

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

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11962314/

Development of a Clinical Decision Support Tool to ... The National Asthma Education and Prevention Program (NAEPP) guidelines are designed to prevent and reduce pediatric asthma morbidity via ...

2. nature.com nature.com/articles/s41533-022-00291-x

A systematic review on the effectiveness and impact of ... In children, CDSS use for diagnosis was found to improve the proportion diagnosed with asthma but reported mixed impact on exacerbations, ...

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0255261

Artificial intelligence-assisted clinical decision support for ... Clinical decision support (CDS) tools leveraging electronic health records (EHRs) have been an approach for addressing challenges in asthma care ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40100268/

Development of a Clinical Decision Support Tool to ... Development of a Clinical Decision Support Tool to Implement Asthma Management Guidelines in Pediatric Primary Care: Qualitative Study.

5. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT01522144

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 ...

6. withpower.com withpower.com/trial/phase-asthma-in-children-8-2025-562d7

Clinical Decision Support + Education for Childhood Asthma This study will test electronic medical record clinical decision support and education implementation strategies (CDS+) to increase adoption of SMART in ...