Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-29 @ 2:46 PM
Study NCT ID:
NCT07224061
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-03
First Post:
2025-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promoting Asthma Management Guidelines With Technology-Based Intervention and Care Coordination in Clinics and Schools
Sponsor:
Montefiore Medical Center
Organization:
Study Overview
Official Title:
Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination in Clinics and Schools (PRAGMATIC-S)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRAGMATIC-S
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.
Detailed 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.
Participants will be followed for 12 months. Outcomes will be assessed as outlined in this registration.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01HL181061 | NIH | None | https://reporter.nih.gov/quic… | View |