Promoting Asthma Management Guidelines With Technology-Based Intervention and Care Coordination in Clinics and Schools (PRAGMATIC-S)

Montefiore Medicine Academic Health System

Status: Not yet enrolling

Conditions: Asthma in Children

Treatments: Behavioral: PRAGMATIC-S

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07224061

2025-17054

R01HL181061 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The overall goal of this research study is to evaluate a multi-level program called PRAGMATIC-S to improve the delivery of guideline-based asthma care through a unique partnership between clinical practices and schools. PRAGMATIC-S represents a novel approach that addresses multiple barriers to adherence by bridging primary care and schools, ensuring delivery of guideline-based asthma care to urban children across these settings thereby improving adherence to therapy and clinical outcomes.

Full description

The research team will conduct a cluster randomized controlled trial, enrolling 420 children, ages 4-12, from 18 Montefiore clinics during office visits. Children in the intervention group (PRAGMATIC-S) will receive updated guideline-based care prompts, with providers completing the medication administration form (MAF), electronically signing it, and routing it directly to the school via the EHR system. Asthma Outreach Worker (AOW) care coordination will support daily adherence to prescribed treatments at home and school. Children in the control group will receive enhanced usual care, which includes EHR prompts for guideline-based care but without the additional PRAGMATIC-S components.

Participants will be followed for 12 months. Outcomes will be assessed as outlined in this registration.

Enrollment: 420 estimated patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Physician-diagnosed asthma documented in EHR
• Persistent or uncontrolled asthma, defined by age-specific guidelines (symptoms ≥2 days/week, rescue medication use ≥2 days/week, nighttime symptoms ≥2 days/month, or ≥2 steroid-requiring episodes/year)
• Age 4 to 12 years, attending pre-kindergarten through 6th grade in NYC public schools
• Caregiver able to speak English or Spanish
• Consent from primary caregiver and assent from child (if ≥7 years)
• Presence of phone and device (smartphone, iPad, or computer) to complete electronic forms

Exclusion criteria

• Family plans to leave school/city within 6 months
• Significant comorbidities (e.g., congenital heart disease, cystic fibrosis, chronic lung disease)
• Children in foster care or situations where legal guardian consent cannot be obtained
• Participation in concurrent asthma intervention study
• Severe developmental delay precluding completion of ACT questionnaire

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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420 participants in 2 patient groups

PRAGMATIC-S

Experimental group

Description:

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.

Treatment:

Behavioral: PRAGMATIC-S

Enhanced Usual Care

No Intervention group

Description:

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