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

April 23, 2026 updated by: Montefiore Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Children's Hospital at Montefiore, Albert Einstein College of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.
No Intervention: Enhanced Usual Care
Standard of care EHR clinician prompts for guideline-based asthma care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma Control - continuous
Time Frame: Baseline, 4 months, 8 months, and 12 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Asthma Caregiver's Quality of Life
Time Frame: Baseline, 4 months, 8 months, and 12 months
The caregiver's quality of life will be assessed using the validated Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ; also referred to as Juniper's Asthma Quality of Life Questionnaire). This questionnaire consists of 13 items which evaluate the impact of the child's asthma on the caregiver's quality of life. Responses to each item are rated on a 7-point scale ranging from 1-7, wherein 1 means "all of the time" or "very, very worried/concerned," and 7 means "none of the time" or "not worried/concerned," yielding an overall possible scoring range of 7-91, such that higher scores are indicative of less asthma related quality of life impairment.
Baseline, 4 months, 8 months, and 12 months
Percent of participants with 1 or more guideline-based corrective actions taken
Time Frame: Up to 24 months (following intervention)
Percent of participants with 1 or more guideline-based corrective actions taken (i.e., controller medication prescription or adjustment, trigger evaluation), as recorded in the electronic health record (EHR), will be summarized by study arm.
Up to 24 months (following intervention)
Asthma Control - dichotomous
Time Frame: Baseline, 4 months, 8 months, and 12 months

Asthma control will also be measured as a dichotomous variable 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 0-5, yielding an overall possible scoring range of 0-27, with higher scores indicating better asthma control.

Asthma control will be analyzed as dichotomous variable with a score of 19 or less indicating uncontrolled asthma.
Baseline, 4 months, 8 months, and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health care utilization - number of Emergency Department (ED) visits for asthma
Time Frame: every 4 months up to 12 months
The number of ED visits directly related to asthma will be summarized by study arm every four months up to 12 months in total.
every 4 months up to 12 months
Health care utilization - number of hospitalizations for asthma
Time Frame: every 4 months up to 12 months
The number of hospitalizations directly related to asthma will be summarized by study arm every four months up to 12 months in total.
every 4 months up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Marina Reznik, MD, MS, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2026

Primary Completion (Estimated)

June 30, 2031

Study Completion (Estimated)

June 30, 2033

Study Registration Dates

First Submitted

October 30, 2025

First Submitted That Met QC Criteria

October 30, 2025

First Posted (Actual)

November 3, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2025-17054
  • R01HL181061 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In addition to the research data, study protocols, data collection instruments, codebooks that contain variable names and format codes will be provided. Quantitative datasets will be in SPSS, STATA and/or SAS formats. All datasets that are shared will be accompanied by the relevant metadata. Scientific data will require either SAS, STATA or SPSS statistical software for manipulation. No other specialized tools will be needed to access or manipulate shared scientific data to support replication or reuse.

To facilitate efficient use, all data and materials will be structured and described using the following standards: The majority of the longitudinal surveys use validated, standardized instruments.

The SAS, STATA or SPSS codes used to score the measures and to prepare raw data for analyses will be provided. Medical record, hospitalization and ED data, electronic adherence monitor and data for all other measures will be organized and described according to best practices.

IPD Sharing 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.

IPD Sharing 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).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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