Promoting Asthma Management Guidelines With Technology-Based Intervention and Care Coordination in Clinics and Schools
NCT ID: NCT07224061
Last Updated: 2025-11-03
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
NA
Total Enrollment
420 participants
Study Classification
INTERVENTIONAL
Study Start Date
2026-01-02
Study Completion Date
2032-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Asthma in Children
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Cluster randomized design. Prior to participant enrollment, each practice will be matched into 9 pairs based on size of the practice and provider type. Practices will then be randomly selected within each pair to receive PRAGMATIC-S or remain as an Enhanced Usual Care (eUC) site. Practices will join study in 5 waves (2-4 practices per wave).
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Follow up assessments will be collected by blinded interviewers
Study Groups
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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.
Group Type
EXPERIMENTAL
PRAGMATIC-S
Intervention Type
BEHAVIORAL
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.
Enhanced Usual Care
Standard of care EHR clinician prompts for guideline-based asthma care
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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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.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
4 Years
Maximum Eligible Age
12 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Sponsor Role
collaborator
Montefiore Medical Center
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Marina Reznik, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Locations
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Children's Hospital at Montefiore, Albert Einstein College of Medicine
The Bronx, New York, United States
Site Status
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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2025-17054
Identifier Type: -
Identifier Source: org_study_id
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