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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL181061 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRAGMATIC-S | Experimental | 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. |
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| Enhanced Usual Care | No Intervention | Standard of care EHR clinician prompts for guideline-based asthma care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRAGMATIC-S | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 4 months, 8 months, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | every 4 months up to 12 months |
| Health care utilization - number of hospitalizations for asthma |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marina Reznik, MD, MS | Contact | 718-741-2494 | mreznik@montefiore.org |
| Name | Affiliation | Role |
|---|---|---|
| Marina Reznik, MD, MS | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital at Montefiore, Albert Einstein College of Medicine | Recruiting | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Walters S, Wilson L, Konty K, Day S, Agerton T, Olson C. Disparities among children with asthma in New York City. Epi Data Brief (126); September 2021. | ||
| Background | Black LI, Benson V. Tables of Summary Health Statistics for U.S. Children: 2018 National Health Interview Survey. | ||
| 24336438 | Background | Reznik M, Jaramillo Y, Wylie-Rosett J. Demonstrating and assessing metered-dose inhaler-spacer technique: pediatric care providers' self-reported practices and perceived barriers. Clin Pediatr (Phila). 2014 Mar;53(3):270-6. doi: 10.1177/0009922813512521. Epub 2013 Dec 12. | |
| 26288255 |
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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.
In accordance with the NIH policy, de-identified and/or grouped dataset will be made available upon publication of related work or end of the project period, whichever comes first, and will remain available indefinitely.
De-identified and/or grouped data from this project will accompany articles submitted to PubMed Central® (PMC) as supplementary materials. PubMed Central accepts data files (up to 2 GB) with manuscript submissions (via NIH Manuscript Submission System (NIHMS)) and ensures data is publicly accessible, persistent, and citable.
The dataset will be linked to the published manuscript(s) in PubMed Central and assigned a persistent, citable digital object identifier (DOI).
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Cluster randomized design. Prior to participant enrollment, each practice will be matched into 9 pairs based on size of the practice and provider type. Practices will then be randomly selected within each pair to receive PRAGMATIC-S or remain as an Enhanced Usual Care (eUC) site. Practices will join study in 5 waves (2-4 practices per wave).
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Follow up assessments will be collected by blinded interviewers.
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| 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. | 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. | Baseline, 4 months, 8 months, and 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. |
| every 4 months up to 12 months |
| Background |
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