Clinical trial NCT04604431: Intervention to Reduce Early (Peanut) Allergy in Children
Official title: Intervention to Reduce Early (Peanut) Allergy in Children
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Food Allergy Peanut
Food Allergy in Infants
Keywords: Food Allergy
Peanut Allergy Incidence
Clinical Decision Support Tool
Infants
Peanut Allergy Prevention
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2020-10-27
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

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.

Primary outcomes:
measure: Pediatric Clinician Adherence to Guidelines
timeFrame: 18 months
Secondary outcomes:
measure: Incidence of Peanut Allergy by Age 2.5
timeFrame: 2 years
Other outcomes:
measure: Allergist Adherence to the Guidelines
timeFrame: 18 months
measure: Barriers/Facilitators to Guideline Adherence Among Pediatric Clinicians and Caregivers.
timeFrame: 12 to 18 months
measure: Caregiver Adherence to the Guidelines
timeFrame: 12 months
Locations:
city: Arlington Heights
country: United States
facility: Pediatric Associates of Arlington Heights, SC-PEDIATRUST
state: Illinois
city: Bloomington
country: United States
facility: OSF Medical Group Pediatrics Bloomington
state: Illinois
city: Chicago
country: United States
facility: Child and Adolescent Health Associates
state: Illinois
city: Chicago
country: United States
facility: Northwestern Children's Practice
state: Illinois
city: Chicago
country: United States
facility: Streeterville Pediatrics
state: Illinois
city: Chicago
country: United States
facility: Erie Family Health Centers - Erie Teen and Young Adult Health Center
state: Illinois
city: Chicago
country: United States
facility: Erie Family Health Centers - West Town
state: Illinois
city: Chicago
country: United States
facility: Erie Family Health Centers - Helping Hands - Foster
state: Illinois
city: Chicago
country: United States
facility: Lurie Children's Primary Care Town & Country Pediatrics
state: Illinois
city: Chicago
country: United States
facility: Near North Health Services Corporation
state: Illinois
city: Chicago
country: United States
facility: Children's Health Associates
state: Illinois
city: Chicago
country: United States
facility: Lakeview Pediatrics
state: Illinois
city: Danville
country: United States
facility: OSF Medical Group Pediatrics Danville
state: Illinois
city: Evanston
country: United States
facility: Erie Family Health Centers - Evanston
state: Illinois
city: Evanston
country: United States
facility: Lurie Children's Primary Care Chicago Area Pediatrics
state: Illinois
city: Godfrey
country: United States
facility: OSF Medical Group Pediatrics Godfrey
state: Illinois
city: Highland Park
country: United States
facility: Pediatric Partners, SC-PEDIATRUST
state: Illinois
city: Hoffman Estates
country: United States
facility: Bedrose Pediatrics
state: Illinois
city: Libertyville
country: United States
facility: Lake Shore Pediatrics, SC-PEDIATRUST
state: Illinois
city: Morton
country: United States
facility: OSF Medical Group (MG)-Morton Pediatrics
state: Illinois
city: Northbrook
country: United States
facility: Ad-Park Pediatrics, SC-PEDIATRUST
state: Illinois
city: Oak Park
country: United States
facility: Oak Park Pediatrics
state: Illinois
city: Peoria
country: United States
facility: University of Illinois College of Medicine Peoria
state: Illinois
city: Peoria
country: United States
facility: OSF-Center for Health (CFH)-Route 91
state: Illinois
city: Schaumburg
country: United States
facility: Woodfield Pediatrics, SC-PEDIATRUST
state: Illinois
city: Washington
country: United States
facility: OSF Medical Group (MG) Washington
state: Illinois
city: Waukegan
country: United States
facility: Erie Family Health Centers - Waukegan
state: Illinois
city: Wheaton
country: United States
facility: Wheaton Pediatrics, SC-PEDIATRUST
state: Illinois
city: Wilmette
country: United States
facility: Pediatric Associates of the North Shore
state: Illinois
city: Winnetka
country: United States
facility: Elm Street Pediatrics, SC-PEDIATRUST
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Ruchi S Gupta
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.