Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination (PRAGMATIC)

October 3, 2025 updated by: Montefiore Medical Center
The overall goal of this research study is to test the effectiveness of a multifaceted and multi-level prompting intervention in a real world urban primary care office setting on improving provider-delivered guideline-based asthma care and reducing asthma morbidity among urban children with persistent or uncontrolled asthma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Investigators will conduct a cluster randomized trial comparing the intervention to enhanced usual care (eUC) in 20 Bronx practices serving over 5,000 children ages 2-12 years with persistent or uncontrolled asthma. Eleven eUC practices will receive guideline information and assess children's asthma severity and control, but active intervention components will not be provided. Practices will join the study in 4 waves over 4 years (4-6 practices per year). Provider adoption of guidelines and utilization of care in all patients (~5,000) ages 2-12 years with persistent or uncontrolled asthma from intervention and eUC practices will be evaluated using Electronic Health Records (EHR) data and practice-based screening for asthma severity and control. Investigators will also enroll a random subset of 512 caregivers of children with persistent/uncontrolled asthma from both study arms to systematically evaluate caregiver-reported child morbidity outcomes and obtain measures not available in EHR.

Intervention consists of academic detailing in the EHR that follow national asthma guidelines and outreach worker care coordination for patients with persistent or uncontrolled asthma.

Comment: While caregivers reported on child outcomes, caregivers were not subjects of the study. See "Pre-Assignment Details" section within the Participant Flow module for more details.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
530

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

The criteria listed below will apply to ~5,000 children from eMPI and eUC practices:

  • Physician-diagnosed asthma (based on EHR)
  • Persistent or uncontrolled asthma as per clinic assessment. Based on NHLBI guidelines, any one of the following: in past month, > 2 days/week with asthma symptoms, >2 days/week with rescue medication use, >2 days/month with nighttime symptoms, or > 2 episodes in the past year that required systemic corticosteroids
  • Age 2 and 12 years, inclusive

Additional inclusion criteria will apply to a subset of 512 of children whose caregivers will be interviewed to obtain caregiver-reported morbidity outcomes:

  • 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 the primary caregiver, caregiver permission for the child to participate as well as assent from the child (>7 years). If there are eligible siblings, only one child will be randomly selected

Exclusion Criteria:

  • The child has other significant medical conditions, such as congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures

Additional exclusion criteria will apply to a subset of 512 children/caregivers as described above:

  • No access to a telephone to conduct follow-up surveys
  • Children in foster care or other situations in which consent cannot be obtained from a guardian

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Enhanced Multifaceted Prompting Intervention (eMPI)
The enhanced MPI program (eMPI) consists of innovative multi-level and team-based strategies to enable providers to effectively and efficiently adopt asthma care guidelines. eMPI uses guideline-based prompts at the time of an office visit to support providers' decision-making, increasing the likelihood that they will recommend corrective actions (i.e., preventive medication prescription) to improve asthma management.
Behavioral: eMPI

The core elements of the multilevel strategy for implementation include:

Direct Support for Providers' Delivery of Guideline-Based Care in Practice; Enhancements to Increase the Feasibility and Sustainability of eMPI; Involving Clinic Staff in Promoting and Supporting Use of Guidelines; Building Accountability and Commitment to Guideline-Based Care; Promoting Providers' Understanding, Acceptance, and Use of Guidelines
No Intervention: Enhanced Usual Care (eUC) Practices
Participants will receive a review packet of the National Asthma Education and Prevention Program (NAEPP) guidelines and educational resources for families. Children will be assessed for asthma severity and level of control at each visit as part of best-practice care, but active intervention components will not be provided.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With 1 or More Guideline-based Corrective Actions Taken
Time Frame: Immediately post-intervention, up to 1 year
The percentage 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) is reported. Results are summarized in number/percentage of participants with 1 or more guideline-based corrective actions taken by study arm.
Immediately post-intervention, up to 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Symptom Free Days (SFDs)
Time Frame: Baseline, and 3 month, 6 month, 9 month, and 12 month follow-up evaluations
The number of days without symptoms during the past 14 days is summarized by study arm at baseline and every 3 months up through the 12 month follow up evaluation.
Baseline, and 3 month, 6 month, 9 month, and 12 month follow-up evaluations

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)
Time Frame: every 3 months up to 12 months
caregiver asthma related quality of life
every 3 months up to 12 months
Health Care Utilization: Number of ED Visits for Asthma
Time Frame: every 3 months up to 12 months
number of ED visits for asthma
every 3 months up to 12 months
Health Care Utilization: Number Hospitalizations for Asthma
Time Frame: every 3 months up to 12 months
number hospitalizations for asthma
every 3 months up to 12 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Montefiore Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 24, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 24, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016-6258
  • 1R01HL133789 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared for this study. This study predated the 2023 Data Management and Sharing Policy and was subject to the 2003 NIH Data Sharing Policy. Based on this policy it did not meet the requirements for the sharing of research, and therefore IPD, data.

IPD Sharing Time Frame

In accordance with the NIH Data Management and Sharing (DMS) Policy "the timely release and sharing" of IPD data will be considered no later than the acceptance for publication of the main findings from the final data set allowing for "a reasonable grace period" (30-60 days) as described in the Policy. Data will be available for a period of up to XX years.

IPD Sharing Access Criteria

Access to BDC is controlled by the NHLBI Data Access Committee (DAC), which uses the database of Genotypes and Phenotypes (dbGaP) permissions infrastructure. To access controlled-access data in BDC, an investigator must have an approved Data Access Request (DAR) in dbGaP. The DAC will review and approve (or deny) investigator-submitted DARs to ensure investigator compliance with the Data Sharing Policy.

Data and associated documentation will be made available to users only under a data-sharing agreement that will require:

  1. the recipient not to transfer the data to other users;
  2. the data to be used only for research purposes;
  3. commitment not to manipulate data for the purposes of identifying any individual subject;
  4. proposed research using the data to be reviewed by an IRB;
  5. commitment to securing the data using appropriate computer technology;
  6. commitment to destroy or return the data after analyses are completed.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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