Recruiting

PRAGMATIC-S

Sponsor:

Montefiore Medical Center

Code:

NCT07224061

Conditions

Asthma in Children

Eligibility Criteria

Sex: All

Age: 4 - 12

Healthy Volunteers: Not accepted

Interventions

PRAGMATIC-S

Study Details

Brief summary:

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.

Conditions

Asthma in Children

Study ID

NCT07224061

Start date

Feb 12, 2026

Status verified date

Apr, 2026

Completion date

Jun 30, 2033

Anticipated

Primary completion date

Jun 30, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 12

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

420 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: PRAGMATIC-S

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.

no intervention: Enhanced Usual Care

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

Interventions

PRAGMATIC-S

Intervention combines EHR-based guideline prompts, electronic MAF submission, school-based directly observed therapy (DOT), and Asthma Outreach Workers (AOWs) providing care coordination, adherence support, and communication between families, schools, and providers.

Primary outcome measure

  • Asthma Control - continuous [ Time Frame: Baseline, 4 months, 8 months, and 12 months ]

Central Contacts and Locations

Central contacts

Marina Reznik, MD, MS

718-741-2494mreznik@montefiore.org

Locations

Children's Hospital at Montefiore, Albert Einstein College of Medicine

Recruiting

The Bronx, New York, United States, 10467

Contacts

Marina Reznik, MD, MS

718-741-2494mreznik@montefiore.org

More Information

Sponsor

Montefiore Medical Center

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-04-29.