Clinical Trials Logo

Clinical 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 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04604431
Study type Interventional
Source Ann & Robert H Lurie Children's Hospital of Chicago
Contact
Status Enrolling by invitation
Phase N/A
Start date November 4, 2020
Completion date December 31, 2025

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06260956 - Expecting Mother's Study of Consumption or Avoidance of Peanut and Egg N/A
Recruiting NCT05965063 - The Role of Bifidobacterium Intervention in Food Allergic Infants N/A
Completed NCT04851340 - Investigating the Detection of Bovine and Soy Proteins in Human Milk N/A
Completed NCT04651829 - Suspicion of Non IgE-mediated Cow's Milk Protein Allergy: Prevalence and Evolution
Not yet recruiting NCT06262867 - Early Allergen System Experience N/A
Active, not recruiting NCT04801823 - The TreEat Study- Can Early Introduction of Tree Nuts Prevent Tree Nut Allergy in Infants With Peanut Allergy Phase 3
Enrolling by invitation NCT05287074 - The Significance of a Timely Food Allergy Diagnosis and Optimal Surveillance of Nutritional Status in Children
Enrolling by invitation NCT04955132 - Impact of E-learning on Parental Confidence in Managing Food Allergy N/A
Recruiting NCT03309488 - Basophil Activation Test to Diagnose Food Allergy
Active, not recruiting NCT04017520 - Breast Milk: Influence of the Micro-transcriptome Profile on Atopy in Children Over Time
Recruiting NCT05309772 - The Clinical Impact of the Basophil Activation Test to Diagnose Food Allergy N/A
Completed NCT05215080 - The Tolerance of Organic Formula Milk and Its Fecal Microbiome Characteristic in Infants N/A
Recruiting NCT04653324 - A Registry for the Food Allergy Community
Recruiting NCT06273605 - The Egg Up Trial - Testing a New Treatment Pathway for Infants With Newly Diagnosed Egg Allergy N/A