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.
Brief Title
Promoting Asthma Management Guidelines With Technology-Based Intervention and Care Coordination in Clinics and Schools
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.
Participants will be followed for 12 months. Outcomes will be assessed as outlined in this registration.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
718-741-2494
Central Contact Email
mreznik@montefiore.org
Completion Date
Completion Date Type
Estimated
Conditions
Asthma in Children
Eligibility Criteria
Inclusion Criteria:
* Physician-diagnosed asthma documented in EHR
* Persistent or uncontrolled asthma, defined by age-specific guidelines (symptoms ≥2 days/week, rescue medication use ≥2 days/week, nighttime symptoms ≥2 days/month, or ≥2 steroid-requiring episodes/year)
* Age 4 to 12 years, attending pre-kindergarten through 6th grade in NYC public schools
* Caregiver able to speak English or Spanish
* Consent from primary caregiver and assent from child (if ≥7 years)
* Presence of phone and device (smartphone, iPad, or computer) to complete electronic forms
Exclusion Criteria:
* Family plans to leave school/city within 6 months
* Significant comorbidities (e.g., congenital heart disease, cystic fibrosis, chronic lung disease)
* Children in foster care or situations where legal guardian consent cannot be obtained
* Participation in concurrent asthma intervention study
* Severe developmental delay precluding completion of ACT questionnaire
* Physician-diagnosed asthma documented in EHR
* Persistent or uncontrolled asthma, defined by age-specific guidelines (symptoms ≥2 days/week, rescue medication use ≥2 days/week, nighttime symptoms ≥2 days/month, or ≥2 steroid-requiring episodes/year)
* Age 4 to 12 years, attending pre-kindergarten through 6th grade in NYC public schools
* Caregiver able to speak English or Spanish
* Consent from primary caregiver and assent from child (if ≥7 years)
* Presence of phone and device (smartphone, iPad, or computer) to complete electronic forms
Exclusion Criteria:
* Family plans to leave school/city within 6 months
* Significant comorbidities (e.g., congenital heart disease, cystic fibrosis, chronic lung disease)
* Children in foster care or situations where legal guardian consent cannot be obtained
* Participation in concurrent asthma intervention study
* Severe developmental delay precluding completion of ACT questionnaire
Inclusion Criteria
Inclusion Criteria:
* Physician-diagnosed asthma documented in EHR
* Persistent or uncontrolled asthma, defined by age-specific guidelines (symptoms ≥2 days/week, rescue medication use ≥2 days/week, nighttime symptoms ≥2 days/month, or ≥2 steroid-requiring episodes/year)
* Age 4 to 12 years, attending pre-kindergarten through 6th grade in NYC public schools
* Caregiver able to speak English or Spanish
* Consent from primary caregiver and assent from child (if ≥7 years)
* Presence of phone and device (smartphone, iPad, or computer) to complete electronic forms
* Physician-diagnosed asthma documented in EHR
* Persistent or uncontrolled asthma, defined by age-specific guidelines (symptoms ≥2 days/week, rescue medication use ≥2 days/week, nighttime symptoms ≥2 days/month, or ≥2 steroid-requiring episodes/year)
* Age 4 to 12 years, attending pre-kindergarten through 6th grade in NYC public schools
* Caregiver able to speak English or Spanish
* Consent from primary caregiver and assent from child (if ≥7 years)
* Presence of phone and device (smartphone, iPad, or computer) to complete electronic forms
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
12 Years
Minimum Age
4 Years
NCT Id
NCT07224061
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2025-17054
Overall Status
Not yet recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination in Clinics and Schools (PRAGMATIC-S)
Primary Outcomes
Outcome Description
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 0-5, 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.
Asthma control will be analyzed as a continuous variable.
Outcome Measure
Asthma Control - continuous
Outcome Time Frame
Baseline, 4 months, 8 months, and 12 months
Secondary Ids
Secondary Id
R01HL181061
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Baseline, 4 months, 8 months, and 12 months
Outcome Measure
Pediatric Asthma Caregiver's Quality of Life
Outcome Description
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.
Outcome Time Frame
Up to 24 months (following intervention)
Outcome Measure
Percent of participants with 1 or more guideline-based corrective actions taken
Outcome Description
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.
Asthma control will be analyzed as dichotomous variable with a score of 19 or less indicating uncontrolled asthma.
Outcome Time Frame
Baseline, 4 months, 8 months, and 12 months
Outcome Measure
Asthma Control - dichotomous
Start Date
Start Date Type
Estimated
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
12
Minimum Age Number (converted to Years and rounded down)
4
Investigators
Investigator Type
Principal Investigator
Investigator Name
Marina Reznik
Investigator Email
MREZNIK@montefiore.org
Investigator Phone
718-405-5260
Investigator Department
Pediatrics
Investigator Division
Academic General Pediatrics
Investigator Sponsor Organization
Einstein
Study Department
Pediatrics
Study Division
Academic General Pediatrics