Intervention to Reduce Early (Peanut) Allergy in Children

NCT04604431 | Completed Results DMC

• 2 other identifiers: AAABB-U01-LCH-00U01AI138907
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 30

Brief Summary

iREACH is a five-year NIH funded study aimed at assessing and improving pediatric clinician adherence to the 2017 NIAID Prevention of Peanut Allergy (PPA) Guidelines. iREACH has been developed as an electronic health record (EHR) integrated Clinical Decision Support (CDS) tool together with educational modules on the PPA guidelines to assist clinicians in implementing the 2017 NIAID PPA Guidelines. A practice-based, two-arm, cluster-randomized clinical trial will evaluate the effectiveness of iREACH in increasing pediatric clinician adherence to the PPA Guidelines and explore the end-goal of reducing peanut allergy incidence by age 2.5 years in the intervention vs control group. This study has the potential to: 1) provide evidence regarding the effectiveness of iREACH in promoting clinical processes and outcomes related to the PPA Guidelines, 2) provide important insight about practice-based implementation of PPA Guidelines by pediatric clinicians, allergists and caregivers, and 3) facilitate rapid, widespread implementation of PPA Guidelines and reduce peanut allergy incidence across the US.

Conditions

Food Allergy Peanut; Food Allergy in Infants

Keywords

Food Allergy; Peanut Allergy Incidence; Clinical Decision Support Tool; Infants; Peanut Allergy Prevention

Outcome Measures

Primary Outcomes (1)

• Pediatric Clinician Adherence to Guidelines

  The primary endpoint is the percentage of infants within each trial arm whose pediatric clinician adhered to the guidelines regarding peanut introduction assessed after completion of either a 4- or 6-month WCC. The primary endpoint concerns only the peanut introduction recommendation by the treating pediatric clinician and not additional behavior by the treating allergist or by caregivers. The primary endpoint will be measured separately by risk category as follows: * % of infants at low risk for peanut allergy whose pediatric clinician adhered to the guidelines for that infant. * % of infants at high risk for peanut allergy whose pediatric clinician adhered to the guidelines for that infant.

  18 months

Secondary Outcomes (1)

• Incidence of Peanut Allergy by Age 2.5

  2 years

Other Outcomes (3)

• Allergist Adherence to the Guidelines

  18 months

• Barriers/Facilitators to Guideline Adherence Among Pediatric Clinicians and Caregivers.

  12 to 18 months

• Caregiver Adherence to the Guidelines

  12 months

Study Arms (2)

Intervention (CDS Tool Integrated)

EXPERIMENTAL

Pediatric clinicians in this arm will receive the iREACH CDS tool and education on the PPA Guidelines to support adherence to the Guidelines.

Other: iREACH CDS Tool

Control (No CDS Tool Integrated)

NO INTERVENTION

No study procedures will be implemented in the control practices, and their pediatric clinicians will not receive extra PPA Guidelines education, nor will any EHR modifications be made in their practices to support adherence to PPA Guidelines.

Interventions

iREACH CDS Tool OTHER

Pediatric clinicians in the intervention arm will 1) receive the iREACH education module, 2) have the iREACH CDS tool integrated into the EHR templates for use at the 4-, 6-, 9-, 12-month WCC, and 3) will be reminded by EHR-embedded prompts at the 9-month WCC to ask caregivers whether peanuts were introduced and tolerated.

Intervention (CDS Tool Integrated)

Eligibility Criteria

• Age: 4 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Practice sites
• The practice utilizes a centrally-integrated EHR.
• The practice has signed a legally-binding engagement agreement with Lurie Children's Pediatric Practice Research Group.
• The practice employs at least one physician who has completed a residency in general pediatrics and is practicing as a general pediatrician.
• Pediatric Clinicians:
• Clinician is a physician, physician assistant, resident, advanced practice nurse, family practitioner, or pediatric nurse practitioner working in a pediatric practice.
• Clinician is employed by a practice that is a member of one of the participating practices in the study.
• Clinician provides well child care to infants ages 4 or 6 months.
• Infants • Infant has been seen by a pediatric clinician in the intervention or control arm for a 4- and/or 6-month WCC.
• Caregivers
• Is the caregiver of an infant seen for a 4- and/or 6-month WCC by a pediatric clinician in a practice belonging to the study's intervention or control arms.
• Is 18+ years of age or has parent or guardian permission to participate.
• Is able to understand the study and provide informed consent for the 12- and 24-month (child's age) survey.

You may not qualify if:

• Practice Sites
• Sees \<50 newborn patients/year.
• Has only temporary pediatricians on staff.
• The practice pediatric clinicians do not use an EHR system.
• Pediatric clinicians
• The clinician is a temporary employee.
• The clinician begins employment at participating practice less than three months prior to end of the 18-month study enrollment period.
• Infants
• The infant has a medical condition that chronically inhibits the ability to take food orally (i.e., dysphagia, muscular dystrophy, gastrostomy).
• The infant has past or current medical problems or findings from physical examination or laboratory testing not listed above for which the pediatric clinician indicates that implementation of PPA Guidelines may pose a medical risk other than allergic reactions or may interfere with the infant's appropriate implementation of the PPA Guidelines or study investigators conclude that implementation of the PPA Guidelines was not possible or may have impacted the quality or interpretation of the data obtained from the study.
• Caregivers
• Caregiver's primary language is not English or Spanish.

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (30)

Pediatric Associates of Arlington Heights, SC-PEDIATRUST

Arlington Heights, Illinois, 60005, United States

Location

OSF Medical Group Pediatrics Bloomington

Bloomington, Illinois, 61701, United States

Location

Child and Adolescent Health Associates

Chicago, Illinois, 60610, United States

Location

Northwestern Children's Practice

Chicago, Illinois, 60611, United States

Location

Streeterville Pediatrics

Chicago, Illinois, 60611, United States

Location

Erie Family Health Centers - Erie Teen and Young Adult Health Center

Chicago, Illinois, 60622, United States

Location

Erie Family Health Centers - West Town

Chicago, Illinois, 60622, United States

Location

Erie Family Health Centers - Helping Hands - Foster

Chicago, Illinois, 60625, United States

Location

Lurie Children's Primary Care Town & Country Pediatrics

Chicago, Illinois, 60642, United States

Location

Near North Health Services Corporation

Chicago, Illinois, 60653, United States

Location

Children's Health Associates

Chicago, Illinois, 60657, United States

Location

Lakeview Pediatrics

Chicago, Illinois, 60657, United States

Location

OSF Medical Group Pediatrics Danville

Danville, Illinois, 61832, United States

Location

Erie Family Health Centers - Evanston

Evanston, Illinois, 60202, United States

Location

Lurie Children's Primary Care Chicago Area Pediatrics

Evanston, Illinois, 60202, United States

Location

OSF Medical Group Pediatrics Godfrey

Godfrey, Illinois, 62035, United States

Location

Pediatric Partners, SC-PEDIATRUST

Highland Park, Illinois, 60035, United States

Location

Bedrose Pediatrics

Hoffman Estates, Illinois, 60169, United States

Location

Lake Shore Pediatrics, SC-PEDIATRUST

Libertyville, Illinois, 60048, United States

Location

OSF Medical Group (MG)-Morton Pediatrics

Morton, Illinois, 61550, United States

Location

Ad-Park Pediatrics, SC-PEDIATRUST

Northbrook, Illinois, 60602, United States

Location

Oak Park Pediatrics

Oak Park, Illinois, 60302, United States

Location

University of Illinois College of Medicine Peoria

Peoria, Illinois, 61605, United States

Location

OSF-Center for Health (CFH)-Route 91

Peoria, Illinois, 61615, United States

Location

Woodfield Pediatrics, SC-PEDIATRUST

Schaumburg, Illinois, 60173, United States

Location

OSF Medical Group (MG) Washington

Washington, Illinois, 61571, United States

Location

Erie Family Health Centers - Waukegan

Waukegan, Illinois, 60085, United States

Location

Wheaton Pediatrics, SC-PEDIATRUST

Wheaton, Illinois, 60062, United States

Location

Pediatric Associates of the North Shore

Wilmette, Illinois, 60091, United States

Location

Elm Street Pediatrics, SC-PEDIATRUST

Winnetka, Illinois, 60093, United States

Location

Related Publications (3)

• Bilaver LA, Ariza AJ, Binns HJ, Jiang J, Cohn R, Sansweet S, Hultquist H, Panza JL, Togias A, Gupta RS. Design of the Intervention to Reduce Early Peanut Allergy in Children (iREACH): A practice-based clinical trial. Pediatr Allergy Immunol. 2024 Apr;35(4):e14115. doi: 10.1111/pai.14115.

  PMID: 38566365 BACKGROUND

• Samady W, Negris O, Jiang J, Bilaver LA, Gupta RS. Developing an infant atopic dermatitis scorecard for pediatric clinicians. Ann Allergy Asthma Immunol. 2024 Oct;133(4):469-470. doi: 10.1016/j.anai.2024.06.009. Epub 2024 Jun 15. No abstract available.

  PMID: 38880210 BACKGROUND

• Samady W, Bilaver LA, Jiang J, Iyer A, Laurienzo Panza J, Togias A, Gupta RS. Evaluation of Training to Increase Knowledge of the Addendum Guidelines for the Prevention of Peanut Allergy in the US. JAMA Netw Open. 2023 Mar 1;6(3):e234706. doi: 10.1001/jamanetworkopen.2023.4706.

  PMID: 36961467 RESULT

MeSH Terms

Conditions

Peanut Hypersensitivity; Food Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Lucy Bilaver, Associate Professor of Pediatrics, iREACH Co-Investigator
• Organization: Northwestern University Feinberg School of Medicine

l-bilavere@northwestern.edu

312-503-5618

Study Officials

• Ruchi S Gupta

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 27, 2020
• Study Start: November 4, 2020
• Primary Completion: January 31, 2023
• Study Completion: July 26, 2024
• Last Updated: April 8, 2026
• Results First Posted: September 19, 2024

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (30)