Intervention to Reduce Early (Peanut) Allergy in Children

Last updated: September 9, 2024
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Allergy

Allergy (Pediatric)

Allergies & Asthma

Treatment

iREACH CDS Tool

Clinical Study ID

NCT04604431
AAABB-U01-LCH-00
U01AI138907
  • Ages > 4
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Practice sites

  • The practice utilizes a centrally-integrated EHR.

  • The practice has signed a legally-binding engagement agreement with Lurie Children'sPediatric Practice Research Group.

  • The practice employs at least one physician who has completed a residency in generalpediatrics 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 pediatricpractice.

  • Clinician is employed by a practice that is a member of one of the participatingpractices 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 pediatricclinician 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.

Exclusion

Exclusion Criteria:

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 monthsprior to end of the 18-month study enrollment period.

Infants

  • The infant has a medical condition that chronically inhibits the ability to takefood orally (i.e., dysphagia, muscular dystrophy, gastrostomy).

  • The infant has past or current medical problems or findings from physicalexamination or laboratory testing not listed above for which the pediatric clinicianindicates that implementation of PPA Guidelines may pose a medical risk other thanallergic reactions or may interfere with the infant's appropriate implementation ofthe PPA Guidelines or study investigators conclude that implementation of the PPAGuidelines was not possible or may have impacted the quality or interpretation ofthe data obtained from the study.

Caregivers

• Caregiver's primary language is not English or Spanish.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: iREACH CDS Tool
Phase:
Study Start date:
November 04, 2020
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Pediatric Associates of Arlington Heights, SC-PEDIATRUST

    Arlington Heights, Illinois 60005
    United States

    Site Not Available

  • OSF Medical Group Pediatrics Bloomington

    Bloomington, Illinois 61701
    United States

    Site Not Available

  • Child and Adolescent Health Associates

    Chicago, Illinois 60610
    United States

    Site Not Available

  • Children's Health Associates

    Chicago, Illinois 60657
    United States

    Site Not Available

  • Children's Healthcare Associates

    Chicago, Illinois 60657
    United States

    Site Not Available

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

    Chicago, Illinois 60622
    United States

    Site Not Available

  • Erie Family Health Centers - Helping Hands - Foster

    Chicago, Illinois 60625
    United States

    Site Not Available

  • Erie Family Health Centers - West Town

    Chicago, Illinois 60622
    United States

    Site Not Available

  • Lakeview Pediatrics

    Chicago, Illinois 60657
    United States

    Site Not Available

  • Lurie Children's Primary Care (Town and Country)

    Chicago, Illinois 60642
    United States

    Site Not Available

  • Lurie Children's Primary Care Town & Country Pediatrics

    Chicago, Illinois 60642
    United States

    Site Not Available

  • NM SoNo Pediatrics

    Chicago, Illinois 60642
    United States

    Site Not Available

  • NNHSC -Komed-Holman Health Center

    Chicago, Illinois 60653
    United States

    Site Not Available

  • NNHSC-Louise Landau Health Center

    Chicago, Illinois 60651
    United States

    Site Not Available

  • NNHSC-North Kostner HC

    Chicago, Illinois 60651
    United States

    Site Not Available

  • NNHSC-Sunnyside Health Center

    Chicago, Illinois 60640
    United States

    Site Not Available

  • NNHSC-Winfield Moody Health Center

    Chicago, Illinois 60610
    United States

    Site Not Available

  • Near North Health Services Corporation

    Chicago, Illinois 60653
    United States

    Site Not Available

  • Northwestern Children's Practice

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Streeterville Pediatrics

    Chicago, Illinois 60611
    United States

    Site Not Available

  • OSF Medical Group Pediatrics Danville

    Danville, Illinois 61832
    United States

    Site Not Available

  • Chicago Area Pediatrics (Drs. Traisman, Benuck, Merens & Kimball)

    Evanston, Illinois 60202
    United States

    Site Not Available

  • Erie Family Health Centers - Evanston

    Evanston, Illinois 60202
    United States

    Site Not Available

  • Lurie Children's Primary Care Chicago Area Pediatrics

    Evanston, Illinois 60202
    United States

    Site Not Available

  • OSF Medical Group Pediatrics Godfrey

    Godfrey, Illinois 62035
    United States

    Site Not Available

  • Pediatric Partners, SC-PEDIATRUST

    Highland Park, Illinois 60035
    United States

    Site Not Available

  • Bedrose Pediatrics

    Hoffman Estates, Illinois 60169
    United States

    Site Not Available

  • Drs. Bedingfield, Rosewell, Silver & Nourbash

    Hoffman Estates, Illinois 60169
    United States

    Site Not Available

  • Lake Shore Pediatrics, SC-PEDIATRUST

    Libertyville, Illinois 60048
    United States

    Site Not Available

  • OSF Medical Group (MG)-Morton Pediatrics

    Morton, Illinois 61550
    United States

    Site Not Available

  • UnityPoint Clinic Morton Pediatrics

    Morton, Illinois 61550
    United States

    Site Not Available

  • Naperville Pediatric Associates

    Naperville, Illinois 60540
    United States

    Site Not Available

  • Ad-Park Pediatrics, SC-PEDIATRUST

    Northbrook, Illinois 60602
    United States

    Site Not Available

  • AdPark Pediatrics, SC-PEDIATRUST

    Northbrook, Illinois 60602
    United States

    Site Not Available

  • Oak Park Pediatrics

    Oak Park, Illinois 60302
    United States

    Site Not Available

  • UnityPoint Clinic Pediatrics Methodist Pekin

    Pekin, Illinois 61554
    United States

    Site Not Available

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

    Peoria, Illinois 61615
    United States

    Site Not Available

  • UICOMP-University Pediatrics

    Peoria, Illinois 61603
    United States

    Site Not Available

  • UnityPoint Clinic Pediatrics Methodist North

    Peoria, Illinois 61615
    United States

    Site Not Available

  • University of Illinois College of Medicine Peoria

    Peoria, Illinois 61605
    United States

    Site Not Available

  • Woodfield Pediatrics, SC-PEDIATRUST

    Schaumburg, Illinois 60173
    United States

    Site Not Available

  • OSF Medical Group (MG) Washington

    Washington, Illinois 61571
    United States

    Site Not Available

  • Erie Family Health Centers - Waukegan

    Waukegan, Illinois 60085
    United States

    Site Not Available

  • Wheaton Pediatrics, SC-PEDIATRUST

    Wheaton, Illinois 60062
    United States

    Site Not Available

  • Pediatric Associates of the North Shore

    Wilmette, Illinois 60091
    United States

    Site Not Available

  • Elm Street Pediatrics, SC-PEDIATRUST

    Winnetka, Illinois 60093
    United States

    Site Not Available

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