Promoting Asthma Management Guidelines With Technology-Based Intervention and Care Coordination in Clinics and Schools

Official title

Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination in Clinics and Schools (PRAGMATIC-S)

Overview

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.

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.

Interventions

• Behavioral PRAGMATIC-S
  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.

Primary outcome measures

• Asthma Control - continuous [Time frame: Baseline, 4 months, 8 months, and 12 months]

Secondary outcome measures (3)

• Pediatric Asthma Caregiver's Quality of Life [Time frame: Baseline, 4 months, 8 months, and 12 months]
• Percent of participants with 1 or more guideline-based corrective actions taken [Time frame: Up to 24 months (following intervention)]
• Asthma Control - dichotomous [Time frame: Baseline, 4 months, 8 months, and 12 months]

Eligibility criteria

Inclusion criteria

• Physician-diagnosed asthma documented in EHR
• Persistent asthma, not on controller medications or uncontrolled asthma despite therapy (with any one of the following per age-specific guidelines: in past month, >2 days/week with symptoms, >2 days/week using rescue medication, >2 days/month with nighttime symptoms, or >2 episodes/year that required systemic corticosteroids
• Age 4 to 12 years, inclusive, attending pre-kindergarten through 7th grade in public / charter / private schools in New York City (the Bronx primarily) and also schools in lower Hudson Valley (Eastchester, Westchester, Rockland, Yonkers)
• 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 primary caregiver and assent from child (age ≥7 years). If there are eligible siblings with exact same asthma severity/control screening results, one child will be randomly selected to participate, otherwise the sibling with worse asthma symptoms will be selected.
• Presence of a phone to conduct surveys and smartphone, iPad or computer to electronically complete and e-sign MAF

Exclusion criteria

• Family plans to leave school or city within 6 months
• Significant medical conditions (e.g., congenital heart disease, cystic fibrosis, or other chronic lung disease)
• Children in foster care or other situations in which consent cannot be obtained from a legal guardian
• Participation in concurrent asthma intervention study
• Severe developmental delay (e.g., severe autism) precluding completion of asthma control questionnaire

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

United States · 1 center

• Children's Hospital at Montefiore, Albert Einstein College of Medicine — The Bronx

Publications

• 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.
• Black LI, Benson V. Tables of Summary Health Statistics for U.S. Children: 2018 National Health Interview Survey.
• 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. PMID 24336438
• Frey SM, Fagnano M, Halterman JS. Caregiver education to promote appropriate use of preventive asthma medications: what is happening in primary care? J Asthma. 2016;53(2):213-9. doi: 10.3109/02770903.2015.1075549. Epub 2015 Aug 18. PMID 26288255
• Halterman JS, Auinger P, Conn KM, Lynch K, Yoos HL, Szilagyi PG. Inadequate therapy and poor symptom control among children with asthma: findings from a multistate sample. Ambul Pediatr. 2007 Mar-Apr;7(2):153-9. doi: 10.1016/j.ambp.2006.11.007. PMID 17368410
• Okelo SO, Siberry GK, Solomon BS, Bilderback AL, Yamazaki M, Hetzler T, Ferrell CL, Dhepyasuwan N, Serwint JR; CORNET Investigators. Asthma treatment decisions by pediatric residents do not consistently conform to guidelines or improve with level of training. Acad Pediatr. 2014 May-Jun;14(3):287-93. doi: 10.1016/j.acap.2013.12.008. Epub 2014 Mar 12. PMID 24629404
• National Heart Lung and Blood Institute. National Asthma Education and Prevention Program. Expert panel report 3: guidelines for the diagnosis and management of asthma. NIH Publication Number 08-5846. Bethesda, MD: 2007.
• Liu AH, Zeiger R, Sorkness C, Mahr T, Ostrom N, Burgess S, Rosenzweig JC, Manjunath R. Development and cross-sectional validation of the Childhood Asthma Control Test. J Allergy Clin Immunol. 2007 Apr;119(4):817-25. doi: 10.1016/j.jaci.2006.12.662. Epub 2007 Mar 13. PMID 17353040

Identifiers

NCT: NCT07224061 · 2025-17054 · R01HL181061

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗