An interventional study of PRAGMATIC-S in Asthma in Children, sponsored by Montefiore Medical Center. Recruiting at 1 site in United States. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Montefiore Medical Center · Not applicable, Interventional, and Health services research
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.
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.
Montefiore Medical Center is the lead sponsor of 402 studies on the registry; 70 are open to participants now.
Of its 81 completed or terminated interventional studies of FDA-regulated products, 73 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Primary Care Providers (PCPs) will use guideline-based prompts within EHR; PCPs and caregivers will complete medication administration forms electronically with forms routed directly to schools to receive asthma medications at the school, and asthma outreach workers will serve as liaison between families, PCPs, schools and provide care coordination and support.
Behavioral: PRAGMATIC-S
Standard of care EHR clinician prompts for guideline-based asthma care
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.
Asthma Control - continuous
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
Pediatric Asthma Caregiver's Quality of Life
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: Baseline, 4 months, 8 months, and 12 months
Percent of participants with 1 or more guideline-based corrective actions taken
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: Up to 24 months (following intervention)
Asthma Control - dichotomous
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: Baseline, 4 months, 8 months, and 12 months
Health care utilization - number of Emergency Department (ED) visits for asthma
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
Health care utilization - number of hospitalizations for asthma
The number of hospitalizations 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
Plan to share: Yes — In addition to the research data, study protocols, data collection instruments, codebooks that contain variable names and format codes will be provided. Quantitative datasets will be in SPSS, STATA and/or SAS formats. All datasets that are shared will be accompanied by the relevant metadata. Scientific data will require either SAS, STATA or SPSS statistical software for manipulation. No other specialized tools will be needed to access or manipulate shared scientific data to support replication or reuse. To facilitate efficient use, all data and materials will be structured and described using the following standards: The majority of the longitudinal surveys use validated, standardized instruments. The SAS, STATA or SPSS codes used to score the measures and to prepare raw data for analyses will be provided. Medical record, hospitalization and ED data, electronic adherence monitor and data for all other measures will be organized and described according to best practices.
Supporting information: Study protocol, Sap, Icf, Analytic code
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Montefiore Medical Center