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Food Allergy PeanutiREACHNCT04604431

Intervention to Reduce Early (Peanut) Allergy in Children

A study testing iREACH CDS Tool in people with Food Allergy Peanut and Food Allergy in Infants, run by Ann & Robert H Lurie Children's Hospital of Chicago at 30 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 4 months and olderHealthy volunteers can take part
Conditions the study is for
Food Allergy Peanut, Food Allergy in Infants
What is being tested?
iREACH CDS Tool
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
30 sitesUnited States
Study dates
4 Nov 2020to 26 Jul 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 months and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.
Show all 13Show fewer
  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

United States30 sites

  • Pediatric Associates of Arlington Heights, SC-PEDIATRUST

    Arlington Heights, Illinois, 60005

  • OSF Medical Group Pediatrics Bloomington

    Bloomington, Illinois, 61701

  • Child and Adolescent Health Associates

    Chicago, Illinois, 60610

  • Northwestern Children's Practice

    Chicago, Illinois, 60611

  • Streeterville Pediatrics

    Chicago, Illinois, 60611

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

    Chicago, Illinois, 60622

  • Erie Family Health Centers - West Town

    Chicago, Illinois, 60622

  • Erie Family Health Centers - Helping Hands - Foster

    Chicago, Illinois, 60625

  • Lurie Children's Primary Care Town & Country Pediatrics

    Chicago, Illinois, 60642

  • Near North Health Services Corporation

    Chicago, Illinois, 60653

  • Children's Health Associates

    Chicago, Illinois, 60657

  • Lakeview Pediatrics

    Chicago, Illinois, 60657

  • OSF Medical Group Pediatrics Danville

    Danville, Illinois, 61832

  • Erie Family Health Centers - Evanston

    Evanston, Illinois, 60202

  • Lurie Children's Primary Care Chicago Area Pediatrics

    Evanston, Illinois, 60202

  • OSF Medical Group Pediatrics Godfrey

    Godfrey, Illinois, 62035

  • Pediatric Partners, SC-PEDIATRUST

    Highland Park, Illinois, 60035

  • Bedrose Pediatrics

    Hoffman Estates, Illinois, 60169

  • Lake Shore Pediatrics, SC-PEDIATRUST

    Libertyville, Illinois, 60048

  • OSF Medical Group (MG)-Morton Pediatrics

    Morton, Illinois, 61550

  • Ad-Park Pediatrics, SC-PEDIATRUST

    Northbrook, Illinois, 60602

  • Oak Park Pediatrics

    Oak Park, Illinois, 60302

  • University of Illinois College of Medicine Peoria

    Peoria, Illinois, 61605

  • OSF-Center for Health (CFH)-Route 91

    Peoria, Illinois, 61615

  • Woodfield Pediatrics, SC-PEDIATRUST

    Schaumburg, Illinois, 60173

  • OSF Medical Group (MG) Washington

    Washington, Illinois, 61571

  • Erie Family Health Centers - Waukegan

    Waukegan, Illinois, 60085

  • Wheaton Pediatrics, SC-PEDIATRUST

    Wheaton, Illinois, 60062

  • Pediatric Associates of the North Shore

    Wilmette, Illinois, 60091

  • Elm Street Pediatrics, SC-PEDIATRUST

    Winnetka, Illinois, 60093

Other trials in United States

About this study

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.

Read more

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.

Read the detailed description

A minimum of 30 pediatric practice sites will be randomized to the iREACH intervention arm or to the control arm.

Primary Objective To determine the effectiveness of iREACH in increasing adherence to the PPA Guidelines among pediatric clinicians.

Secondary Objective To determine the effectiveness of iREACH in decreasing the incidence of peanut allergy by age 2.5.

Exploratory Objectives

  1. To determine allergists' adherence to the PPA Guidelines
  2. To identify common barriers/facilitators for PPA Guideline adherence among pediatric clinicians and caregivers
  3. To determine caregiver adherence to the PPA Guidelines

All pediatric clinicians within each participating practice (n≈200 total) will be assigned to the arm to which their practice is randomized. The trial will be conducted over an 18-month period. During this time, approximately 500 high-risk infants and 10,000 low-risk infants are expected to be seen for 4- and 6-month well child care visit (WCC). The primary outcome, pediatric clinician adherence to the PPA Guidelines, will be assessed using EHR data for each infant following the 6-month WCC.

Data for the secondary outcome will be obtained by a combination of EHR data extracted after the infant's 6-month WCC and data collected from caregivers. EHR data extraction will be performed to obtain data from the infant's 9-, 12-, 15-, 18-, 24-month WCC and any sick visits and allergist progress notes entered from 4-30 months of age. Caregivers' data will be collected via surveys of caregivers of children seen for 4- or 6-month WCC visits during the study period. Caregivers will be recruited and asked to provide informed consent at the time of the child's first birthday and questions will be asked to determine the incidence of peanut allergy. A follow-up survey will be sent to caregivers after the child's second birthday.

Data for exploratory outcomes will be obtained through EHR data extraction and surveys of pediatric clinicians and the caregivers of infants seen for 4- or 6-month WCC. Pediatric clinicians in the intervention arm will be asked to provide informed consent and will complete three surveys over approximately 21 months. Pediatric clinicians in the control arm will be asked to provide informed consent following completion of data collection for the primary outcome and will complete one survey. Finally, caregivers, through the two surveys conducted at the time of their child's first and second birthdays, will provide information for exploratory outcomes.

Being tested
iREACH CDS Tool
Keywords
Food Allergy, Peanut Allergy Incidence, Clinical Decision Support Tool, Infants, Peanut Allergy Prevention
Medical subject headings
Peanut Hypersensitivity, Food Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iREACH CDS ToolOther

    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.

Study groups in NCT04604431
Study groupRoleWhat they receive
Intervention (CDS Tool Integrated)ExperimentalPediatric clinicians in this arm will receive the iREACH CDS tool and education on the PPA Guidelines to support adherence to the Guidelines.
Receives: Other: iREACH CDS Tool
Control (No CDS Tool Integrated)No interventionNo 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 18 months

Secondary outcomes (1)

  1. Incidence of Peanut Allergy by Age 2.5

    The secondary endpoint is the incidence of peanut allergy by age 2.5 years and is assessed through a combination of parent survey data and extracted EHR data. Secondary endpoints will be measured separately by risk category as follows:

    • % of infants at low risk for peanut allergy who developed peanut allergy by age 2.5.
    • % of infants at high risk for peanut allergy who developed peanut allergy by age 2.5.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2020
  2. Study start4 Nov 2020
  3. Primary completion31 Jan 2023
  4. Study completion26 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04604431
Sponsor's protocol ID
AAABB-U01-LCH-00
Other IDs
U01AI138907
Acronym
iREACH
Status last verified
Mar 2026
First submitted
14 Oct 2020
Last updated
8 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38566365

  • 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.

    PubMed 38880210

  • 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.

    PubMed 36961467

  • Wong AF, Bilaver LA, Jiang J, Luo Y, Gupta RS, Rosenman M, Carroll MS. Assessing pediatric clinician adherence to the guidelines for prevention of peanut allergy: a natural language processing study. BMC Med Inform Decis Mak. 2025 Dec 6;26(1):9. doi: 10.1186/s12911-025-03287-y.

    PubMed 41353134

Questions about this trial

What is this clinical trial studying?

A study testing iREACH CDS Tool in people with Food Allergy Peanut and Food Allergy in Infants, run by Ann & Robert H Lurie Children's Hospital of Chicago at 30 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pediatric Clinician Adherence to Guidelines (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04604431, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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