Children's Hospital at Montefiore, Albert Einstein College of Medicine
The Bronx, New York, 10467, United States
Location status: Recruiting
NCT Number: NCT07224061
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.
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Request Info4 year–12 year
All sexes
Interventional
Not applicable
The Bronx, New York, 10467, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Montefiore Medical Center
Other
Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination in Clinics and Schools (PRAGMATIC-S)
Acronym: PRAGMATIC-S
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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