Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination (PRAGMATIC)
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ClinicalTrials.gov Identifier: NCT03066596 |
Recruitment Status :
Active, not recruiting
First Posted : February 28, 2017
Last Update Posted : August 24, 2022
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Condition or disease | Intervention/treatment | Phase |
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Asthma Childhood | Behavioral: PRAGMATIC | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 530 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | enhanced Usual Care and Intervention sites |
Masking: | None (Open Label) |
Masking Description: | Follow up assessments will be collected by blinded interviewers |
Primary Purpose: | Supportive Care |
Official Title: | Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination |
Actual Study Start Date : | March 7, 2017 |
Estimated Primary Completion Date : | August 30, 2024 |
Estimated Study Completion Date : | August 30, 2025 |
Arm | Intervention/treatment |
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Experimental: PRAGMATIC
Intervention practices will receive guideline information and assess children's asthma severity and control. For children with persistent/uncontrolled asthma, academic detailing and prompt in EHR following asthma guidelines will guide asthma management; outreach worker will follow up with patients referred to the by providers to receive care coordination to assure that provider management plan is followed by patient at home.
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Behavioral: PRAGMATIC
Provider educational seminar, EHR prompt, outreach-worker care coordination |
- Proportion of visits with >1 guideline-based corrective actions [ Time Frame: through study completion, an average of 5 years ]provider adoption of guidelines
- Symptom free days [ Time Frame: 14 days ]number of days without symptoms in the past 14 days
- Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) [ Time Frame: 3-12 months ]caregiver asthma related quality of life
- Health care utilization: number of ED visits for asthma [ Time Frame: 3-12 months ]number of ED visits for asthma
- Health care utilization: number hospitalizations for asthma [ Time Frame: 3-12 months ]number hospitalizations for asthma

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Ages Eligible for Study: | 2 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066596
United States, New York | |
Children's Hospital at Montefiore, Albert Einstein College of Medicine | |
Bronx, New York, United States, 10467 |
Principal Investigator: | Marina Reznik, MD, MS | Montefiore Medical Center |
Responsible Party: | Marina Reznik, Associate Professor, Montefiore Medical Center |
ClinicalTrials.gov Identifier: | NCT03066596 |
Other Study ID Numbers: |
2016-6258 1R01HL133789-01 ( U.S. NIH Grant/Contract ) |
First Posted: | February 28, 2017 Key Record Dates |
Last Update Posted: | August 24, 2022 |
Last Verified: | August 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Investigators will share de-identified data using Data Sharing Agreement process after the study is completed and main study aims manuscripts have been published. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |