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OpenTrials
Completed

NCT Number: NCT03066596

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

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.

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Key information

Conditions

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

The Bronx, New York, 10467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eMPI

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)

    Time frame: every 3 months up to 12 months

    caregiver asthma related quality of life

  2. Health Care Utilization: Number of ED Visits for Asthma

    Time frame: every 3 months up to 12 months

    number of ED visits for asthma

  3. Health Care Utilization: Number Hospitalizations for Asthma

    Time frame: every 3 months up to 12 months

    number hospitalizations for asthma

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: PRAGMATIC

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Feb 28, 2017
Registry last updated
Oct 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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