PRAGMATIC-S for Childhood Asthma

(PRAGMATIC-S Trial)

Overseen By Marina Reznik, MD, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Disqualifiers: Congenital heart disease, cystic fibrosis, others

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

Compensation: Varies

Number of Visits: 4

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called PRAGMATIC-S, designed to improve asthma care for children by connecting doctors, schools, and families. It ensures that children in urban areas receive appropriate asthma treatments at both school and home. The trial compares this new program to usual care to determine which is more effective. Children aged 4 to 12 with persistent asthma symptoms who attend public schools in NYC may qualify. As an unphased trial, this study provides a unique opportunity to contribute to innovative asthma care solutions for children.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the PRAGMATIC-S program is safe for children with asthma?

Research has shown that PRAGMATIC-S, a program designed to improve asthma care by connecting doctors, schools, and families, has potential in managing asthma. However, detailed information about its specific safety is limited. The trial is in the "Not Applicable" phase, focusing on the program's functionality rather than testing a new drug or treatment, which typically indicates low risk.

PRAGMATIC-S is not a medication but a method to enhance the management of existing, safe asthma treatments. It involves using electronic health records and coordinating care among those involved in a child's asthma care. This approach is not expected to pose direct health risks like a new drug might.

Overall, while specific safety studies on PRAGMATIC-S are lacking, the program employs existing, safe asthma treatments in a coordinated manner. This suggests it is well-tolerated and unlikely to cause harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PRAGMATIC-S for childhood asthma because it offers a comprehensive approach that integrates technology and community support. Unlike standard care that focuses primarily on medication prescribed in clinics, PRAGMATIC-S involves primary care providers using electronic health record (EHR) prompts to ensure guideline-based care. Additionally, it facilitates direct communication between healthcare providers and schools, so children receive asthma medications during school hours. This method also includes asthma outreach workers who coordinate care and support among families, doctors, and schools, aiming for a more seamless and supportive asthma management system. This holistic approach is seen as a promising way to improve asthma outcomes in children, especially in managing their condition effectively during school hours.

What evidence suggests that the PRAGMATIC-S program is effective for improving asthma care in children?

Research has shown that the PRAGMATIC-S program, which participants in this trial may receive, might improve asthma care for children by involving both schools and doctors. In a previous study, children in a similar program had better asthma control, experienced fewer flare-ups, and needed less oral medication. The program uses electronic health records to ensure adherence to asthma care guidelines and connects families, doctors, and schools to collaborate on treatment. These promising results suggest that PRAGMATIC-S could help children manage their asthma better, potentially reducing missed school days and enhancing their quality of life. ^{6 7 8 9 10}

Who Is on the Research Team?

Marina Reznik, MD, MS

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for children aged 4-12 with physician-diagnosed asthma, who have persistent or uncontrolled symptoms and attend NYC public schools. Caregivers must consent, speak English or Spanish, and have a phone/device for electronic forms. Kids with severe comorbidities, plans to move soon, in foster care without guardian consent, involved in another asthma study or with severe developmental delays can't join.

Inclusion Criteria

Consent from primary caregiver and assent from child (if ≥7 years)

Presence of phone and device (smartphone, iPad, or computer) to complete electronic forms

My caregiver speaks English or Spanish.

Exclusion Criteria

I have a serious health condition like heart disease or cystic fibrosis.

Family plans to leave school/city within 6 months

Children in foster care or situations where legal guardian consent cannot be obtained

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive guideline-based asthma care through PRAGMATIC-S intervention or enhanced usual care

12 months

Regular visits as per clinical practice

Follow-up

Participants are monitored for asthma control and caregiver's quality of life

12 months

Assessments at baseline, 4, 8, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• PRAGMATIC-S

Trial Overview The PRAGMATIC-S program is being tested to see if it improves guideline-based asthma care by connecting clinical practices with schools. It aims to help urban kids manage their asthma better by ensuring they get the right treatment both at home and school.

How Is the Trial Designed?

Group I: PRAGMATIC-S Experimental Treatment 1 Intervention

Primary Care Providers (PCPs) will use guideline-based prompts within EHR; PCPs and caregivers will complete medication administration forms electronically with forms routed directly to schools to receive asthma medications at the school, and asthma outreach workers will serve as liaison between families, PCPs, schools and provide care coordination and support.

Group II: Enhanced Usual Care Active Control 1 Intervention

Standard of care EHR clinician prompts for guideline-based asthma care

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

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/PMC12380124/

A Pilot Pragmatic Cluster Randomized Trial of School ... Childhood asthma affects 8% of children, causes over 14 million missed school days annually and costs billions of dollars in healthcare ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213219825007123

A Pilot Pragmatic Cluster Randomized Trial of School ... Children in the Asthma Link group had greater improvement in Asthma Control Test scores, longer time to first asthma exacerbation, less oral ...

3. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2108035

Pragmatic Trial of Health Care Technologies to Improve ... This pragmatic randomized clinical trial tests a speech recognition intervention to improve adherence to pediatric asthma treatment.

4. tandfonline.com tandfonline.com/doi/full/10.2147/POR.S43161

Protocol for the asthma tools study: a pragmatic practice ... The primary outcomes are changes in patient self-reported asthma control, asthma-related quality of life, and rates of exacerbations documented ...

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

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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7278574/

Pragmatic Markers in the Management of Asthma: A Real- ... The current paper will, therefore, present pragmatic biomarkers useful for asthma management that are available in daily clinical practice.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9282800/

Feedback of actionable individual patient prescription data ... In the analysis of the primary outcome, the mean number of patients with PIP of bronchodilator inhalers fell in the 118 practices that were sent ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1551714420303244

A randomized, open-label, pragmatic study to assess ... Outcomes of this study have the potential to offer powerful evidence supporting PARTICS as an effective asthma management strategy in patient populations that ...

9. tandfonline.com tandfonline.com/doi/full/10.2147/POR.S16671

Pragmatic research and outcomes in asthma and COPD Despite the widespread dissemination of clinical practice guidelines for asthma and COPD, there has been little evidence of improved outcomes.

10. researchgate.net researchgate.net/publication/394854603_A_Pilot_Pragmatic_Cluster_Randomized_Trial_of_School-Supervised_Therapy_to_Improve_Pediatric_Asthma_Control

A Pilot Pragmatic Cluster Randomized Trial of School- ... Main outcome measures were change in the proportion of patients achieving all their therapeutic targets and each individual therapeutic target at two years, and ...