Using technology and school–clinic coordination to improve asthma care for children.
Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination in Clinics and Schools (PRAGMATIC-S)
This project will try a tech-enabled program plus school care coordination to help children ages 4–12 with persistent or uncontrolled asthma follow guideline-based treatment and have fewer symptoms and school problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 420 (estimated) |
| Ages | 4 Years to 12 Years |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT07224061 on ClinicalTrials.gov |
What this trial studies
This is a cluster randomized trial enrolling 420 children ages 4–12 from 18 Montefiore clinics to compare a multi-level intervention (PRAGMATIC-S) to enhanced usual care. The PRAGMATIC-S arm adds EHR-based guideline prompts, a medication administration form that providers sign and route electronically to schools, and Asthma Outreach Worker coordination to support daily adherence at home and school. The control arm receives enhanced usual care with EHR prompts but without the electronic school routing or outreach worker support. Participants are followed for 12 months with clinical and adherence outcomes collected through the medical record and study visits.
Who should consider this trial
Good fit: Children ages 4–12 with physician-diagnosed persistent or uncontrolled asthma who attend public, charter, or private schools in the Bronx or nearby Hudson Valley communities and whose caregiver speaks English or Spanish are ideal candidates.
Not a fit: Children with well-controlled asthma on stable therapy, those who do not attend participating schools or live outside the study area, or families unable to engage with school-based coordination are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could increase controller medication adherence and reduce asthma symptoms, emergency visits, and missed school days for participating children.
How similar studies have performed: Previous work using EHR prompts or school-based supports has shown modest improvements in care, but this combined electronic routing plus outreach coordination approach is relatively novel and not fully tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Physician-diagnosed asthma documented in EHR * Persistent asthma, not on controller medications or uncontrolled asthma despite therapy (with any one of the following per age-specific guidelines: in past month, \>2 days/week with symptoms, \>2 days/week using rescue medication, \>2 days/month with nighttime symptoms, or \>2 episodes/year that required systemic corticosteroids * Age 4 to 12 years, inclusive, attending pre-kindergarten through 7th grade in public / charter / private schools in New York City (the Bronx primarily) and also schools in lower Hudson Valley (Eastchester, Westchester, Rockland, Yonkers) * Caregiver is able to speak and understand either English or Spanish. Participants unable to read will be eligible as all surveys will be administered verbally by research personnel * Consent from primary caregiver and assent from child (age ≥7 years). If there are eligible siblings with exact same asthma severity/control screening results, one child will be randomly selected to participate, otherwise the sibling with worse asthma symptoms will be selected. * Presence of a phone to conduct surveys and smartphone, iPad or computer to electronically complete and e-sign MAF Exclusion Criteria: * Family plans to leave school or city within 6 months * Significant medical conditions (e.g., congenital heart disease, cystic fibrosis, or other chronic lung disease) * Children in foster care or other situations in which consent cannot be obtained from a legal guardian * Participation in concurrent asthma intervention study * Severe developmental delay (e.g., severe autism) precluding completion of asthma control questionnaire
Where this trial is running
The Bronx, New York
- Children's Hospital at Montefiore, Albert Einstein College of Medicine — The Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Marina Reznik, MD, MS — Montefiore Medical Center
- Study coordinator: Marina Reznik, MD, MS
- Email: mreznik@montefiore.org
- Phone: 718-741-2494
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.