N/A
Completed N=18,770
Intervention to Reduce Early (Peanut) Allergy in Children
Food Allergy Peanut · Food Allergy in Infants
Source: ClinicalTrials.gov NCT04604431 ↗
Enrolled (actual)
18,770
Serious AEs
—
Results posted
Sep 2024
Primary outcomePrimary: Pediatric Clinician Adherence to Guidelines — 7607; 3231; 62; 7 infants — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pediatric Clinician Adherence to Guidelines |
7607; 3231; 62; 7 | <0.001 sig |
| SECONDARY Incidence of Peanut Allergy by Age 2.5 |
— | — |
Eligibility Criteria
Inclusion Criteria
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT04604431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.