Design of the Intervention to Reduce Early Peanut Allergy in Children (iREACH): A practice-based clinical trial

Lucy A. Bilaver; Adolfo J. Ariza; Helen J. Binns; Jialing Jiang; Rich Cohn; Samantha Sansweet; Haley Hultquist; Joy Laurienzo Panza; Alkis Togias; Ruchi S. Gupta

doi:10.1111/pai.14115

Design of the Intervention to Reduce Early Peanut Allergy in Children (iREACH): A practice-based clinical trial

Lucy A. Bilaver, Adolfo J. Ariza, Helen J. Binns, Jialing Jiang, Rich Cohn, Samantha Sansweet, Haley Hultquist, Joy Laurienzo Panza, Alkis Togias, Ruchi S. Gupta^*

^*Corresponding author for this work

Pediatrics

Research output: Contribution to journal › Article › peer-review

4 Scopus citations

Abstract

Background: Introducing peanut products early can prevent peanut allergy (PA). The “Addendum guidelines for the prevention of PA in the United States” (PPA guidelines) recommend early introduction of peanut products to low and moderate risk infants and evaluation prior to starting peanut products for infants at high risk for PA (those with severe eczema and/or egg allergy). Rapid adoption of guidelines could aid in lowering the prevalence of PA. The Intervention to Reduce Early (Peanut) Allergy in Children (iREACH) trial was designed to promote PPA guideline adherence by pediatric clinicians. Methods: A two-arm, cluster-randomized, controlled clinical trial was designed to measure the effectiveness of an intervention that included clinician education and accompanying clinical decision support tools integrated in electronic health records (EHR) versus standard care. Randomization was at the practice level (n = 30). Primary aims evaluated over an 18-month trial period assess adherence to the PPA guidelines using EHR documentation at 4- and 6-month well-child care visits aided by natural language processing. A secondary aim will evaluate the effectiveness in decreasing the incidence of PA by age 2.5 years using EHR documentation and caregiver surveys. The unit of observation for evaluations are individual children with clustering at the practice level. Conclusion: Application of this intervention has the potential to inform the development of strategies to speed implementation of PPA guidelines.

Original language	English (US)
Article number	e14115
Journal	Pediatric Allergy and Immunology
Volume	35
Issue number	4
DOIs	https://doi.org/10.1111/pai.14115
State	Published - Apr 2024

Funding

We would like to thank the iREACH team for carrying out and supporting the study. The Pediatric Practice Research Group (PPRG) is supported by Northwestern University Clinical and Translational Science Institute (NUCATS) under Grant Number 5UL1TR001422-06 from the National Center for Advancing Translational Sciences, Clinical and Translational Sciences Award. REDCap is supported at FSM by the Northwestern University Clinical and Translational Science (NUCATS) Institute, Research reported in this publication was supported, in part, by the National Institutes of Health's National Center for Advancing Translational Sciences, Grant Number UL1TR001422. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Dr. Lucy Bilaver reported receiving research support from the National Institutes of Health (NIH), National Institute on Independent Living, Disability, and Rehabilitation Research, FARE, Thermo Fisher Scientific, National Chocolate Association, Yobee Care, Before Brands, Novartis, and Genentech outside the submitted work. Dr. Ruchi Gupta received research support from the NIH, Food Allergy Research & Education (FARE), Melchiorre Family Foundation, Sunshine Charitable Foundation, The Walder Foundation, UnitedHealth Group, Thermo Fisher Scientific, and Genentech; she also serves as a medical consultant/advisor for Genentech, Novartis, Aimmune LLC, Allergenis LLC, and FARE; and Dr. Gupta has ownership interest in Yobee Care Inc. No other disclosures to report from other authors. We would like to thank the iREACH team for carrying out and supporting the study. The Pediatric Practice Research Group (PPRG) is supported by Northwestern University Clinical and Translational Science Institute (NUCATS) under Grant Number 5UL1TR001422\u201006 from the National Center for Advancing Translational Sciences, Clinical and Translational Sciences Award. REDCap is supported at FSM by the Northwestern University Clinical and Translational Science (NUCATS) Institute, Research reported in this publication was supported, in part, by the National Institutes of Health's National Center for Advancing Translational Sciences, Grant Number UL1TR001422. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. This work was supported by the National Institute of Allergy and Infectious Diseases [U01AI138907].

Keywords

clinical trial
peanut allergy prevention
pediatric primary care
practice-based research

ASJC Scopus subject areas

Pediatrics, Perinatology, and Child Health
Immunology and Allergy
Immunology

Access to Document

10.1111/pai.14115

Cite this

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title = "Design of the Intervention to Reduce Early Peanut Allergy in Children (iREACH): A practice-based clinical trial",

abstract = "Background: Introducing peanut products early can prevent peanut allergy (PA). The “Addendum guidelines for the prevention of PA in the United States” (PPA guidelines) recommend early introduction of peanut products to low and moderate risk infants and evaluation prior to starting peanut products for infants at high risk for PA (those with severe eczema and/or egg allergy). Rapid adoption of guidelines could aid in lowering the prevalence of PA. The Intervention to Reduce Early (Peanut) Allergy in Children (iREACH) trial was designed to promote PPA guideline adherence by pediatric clinicians. Methods: A two-arm, cluster-randomized, controlled clinical trial was designed to measure the effectiveness of an intervention that included clinician education and accompanying clinical decision support tools integrated in electronic health records (EHR) versus standard care. Randomization was at the practice level (n = 30). Primary aims evaluated over an 18-month trial period assess adherence to the PPA guidelines using EHR documentation at 4- and 6-month well-child care visits aided by natural language processing. A secondary aim will evaluate the effectiveness in decreasing the incidence of PA by age 2.5 years using EHR documentation and caregiver surveys. The unit of observation for evaluations are individual children with clustering at the practice level. Conclusion: Application of this intervention has the potential to inform the development of strategies to speed implementation of PPA guidelines.",

keywords = "clinical trial, peanut allergy prevention, pediatric primary care, practice-based research",

author = "Bilaver, {Lucy A.} and Ariza, {Adolfo J.} and Binns, {Helen J.} and Jialing Jiang and Rich Cohn and Samantha Sansweet and Haley Hultquist and Panza, {Joy Laurienzo} and Alkis Togias and Gupta, {Ruchi S.}",

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year = "2024",

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doi = "10.1111/pai.14115",

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AU - Ariza, Adolfo J.

AU - Binns, Helen J.

AU - Jiang, Jialing

AU - Cohn, Rich

AU - Sansweet, Samantha

AU - Hultquist, Haley

AU - Panza, Joy Laurienzo

AU - Togias, Alkis

AU - Gupta, Ruchi S.

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Design of the Intervention to Reduce Early Peanut Allergy in Children (iREACH): A practice-based clinical trial

Abstract

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