Intervention to Reduce Early (Peanut) Allergy in Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 30
- Locations
- 30
- Primary Endpoint
- Pediatric Clinician Adherence to Guidelines
Study Overview
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.
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
- To determine allergists' adherence to the PPA Guidelines
- To identify common barriers/facilitators for PPA Guideline adherence among pediatric clinicians and caregivers
- To determine caregiver adherence to the PPA Guidelines
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 4 Months to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
- •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.
- •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.
- •Caregiver's primary language is not English or Spanish.
Arms & Interventions
Intervention (CDS Tool Integrated)
Pediatric clinicians in this arm will receive the iREACH CDS tool and education on the PPA Guidelines to support adherence to the Guidelines.
Intervention: iREACH CDS Tool (Other)
Control (No CDS Tool Integrated)
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.
Outcomes
Primary Outcomes
Pediatric Clinician Adherence to Guidelines
Time Frame: 18 months
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.
Secondary Outcomes
- Incidence of Peanut Allergy by Age 2.5(2 years)
Investigators
Ruchi S Gupta
Professor
Ann & Robert H Lurie Children's Hospital of Chicago