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Intervention to Reduce Early (Peanut) Allergy in Children (iREACH)

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ClinicalTrials.gov Identifier: NCT04604431
Recruitment Status : Enrolling by invitation
First Posted : October 27, 2020
Last Update Posted : July 11, 2022
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Ruchi S Gupta, Ann & Robert H Lurie Children's Hospital of Chicago

Tracking Information
First Submitted Date  ICMJE October 14, 2020
First Posted Date  ICMJE October 27, 2020
Last Update Posted Date July 11, 2022
Actual Study Start Date  ICMJE November 4, 2020
Estimated Primary Completion Date January 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2020)
Incidence of peanut allergy by age 2.5 [ Time Frame: 2 years ]
The secondary endpoint is the incidence of peanut allergy by age 2.5 years and is assessed through a combination of parent survey data and extracted EHR data. Secondary endpoints will be measured separately by risk category as follows:
  • % of infants at low risk for peanut allergy who developed peanut allergy by age 2.5.
  • % of infants at high risk for peanut allergy who developed peanut allergy by age 2.5.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 21, 2020)
  • Allergist adherence to the guidelines [ Time Frame: 18 months ]
    Recommendations provided to caregiver for infant peanut product introduction.
  • Barriers/facilitators to guideline adherence among pediatric clinicians and caregivers. [ Time Frame: 12 to 18 months ]
    What factors serve as barriers and facilitators for clinicians and caregivers to adhere to guidelines.
  • Caregiver adherence to the guidelines [ Time Frame: 12 months ]
    Whether or not caregivers follow recommendations provided by clinicians - infant peanut product introduction and feeding frequency
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Intervention to Reduce Early (Peanut) Allergy in Children
Official Title  ICMJE Intervention to Reduce Early (Peanut) Allergy in Children
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Food Allergy Peanut
  • Food Allergy in Infants
Intervention  ICMJE Other: iREACH CDS Tool
Pediatric clinicians in the intervention arm will 1) receive the iREACH education module, 2) have the iREACH CDS tool integrated into the EHR templates for use at the 4-, 6-, 9-, 12-month WCC, and 3) will be reminded by EHR-embedded prompts at the 9-month WCC to ask caregivers whether peanuts were introduced and tolerated.
Study Arms  ICMJE
  • Experimental: 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: Other: iREACH CDS Tool
  • No Intervention: 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: October 21, 2020)
10500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2025
Estimated Primary Completion Date January 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04604431
Other Study ID Numbers  ICMJE AAABB-U01-LCH-00
U01AI138907 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Ruchi S Gupta, Ann & Robert H Lurie Children's Hospital of Chicago
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ann & Robert H Lurie Children's Hospital of Chicago
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Investigators  ICMJE
Principal Investigator: Ruchi S Gupta Ann & Robert H Lurie Children's Hospital of Chicago
PRS Account Ann & Robert H Lurie Children's Hospital of Chicago
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP