Promoting Asthma Management Guidelines With Technology-Based Intervention and Care Coordination in Clinics and Schools

NCT07224061 | Recruiting

• 2 other identifiers: 2025-17054R01HL181061
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Asthma Control - continuous

  Asthma control will be measured using the Childhood Asthma Control Test (cACT), 7-item scale which determines a score based on the sum of the response codes. The child answers the first 4 questions on a 4-point scale ranging from 0-3 and the caregiver provides responses for the final 3 items using a reverse-coded scale ranging from 0 ("Everyday") to 5 ("Not at all"), yielding an overall possible scoring range of 0-27, with higher scores indicating better asthma control. Asthma control will be analyzed as a continuous variable.

  Baseline, 4 months, 8 months, and 12 months

Secondary Outcomes (3)

• Pediatric Asthma Caregiver's Quality of Life

  Baseline, 4 months, 8 months, and 12 months

• Percent of participants with 1 or more guideline-based corrective actions taken

  Up to 24 months (following intervention)

• Asthma Control - dichotomous

  Baseline, 4 months, 8 months, and 12 months

Other Outcomes (2)

• Health care utilization - number of Emergency Department (ED) visits for asthma

  every 4 months up to 12 months

• Health care utilization - number of hospitalizations for asthma

  every 4 months up to 12 months

Study Arms (2)

PRAGMATIC-S

EXPERIMENTAL

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.

Behavioral: PRAGMATIC-S

Enhanced Usual Care

NO INTERVENTION

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

Interventions

PRAGMATIC-S 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.

PRAGMATIC-S

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

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

The Bronx, New York, 10467, United States

RECRUITING

Related Publications (58)

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Study Officials

• Marina Reznik, MD, MS

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina Reznik, MD, MS

CONTACT

718-741-2494; mreznik@montefiore.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Follow up assessments will be collected by blinded interviewers.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 30, 2025
• First Posted: November 3, 2025
• Study Start: February 12, 2026
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): June 30, 2033
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: In accordance with the NIH policy, de-identified and/or grouped dataset will be made available upon publication of related work or end of the project period, whichever comes first, and will remain available indefinitely.
• Access Criteria: De-identified and/or grouped data from this project will accompany articles submitted to PubMed Central® (PMC) as supplementary materials. PubMed Central accepts data files (up to 2 GB) with manuscript submissions (via NIH Manuscript Submission System (NIHMS)) and ensures data is publicly accessible, persistent, and citable. The dataset will be linked to the published manuscript(s) in PubMed Central and assigned a persistent, citable digital object identifier (DOI).

Locations

US (1)