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

Primary Purpose

Food Allergy Peanut, Food Allergy in Infants

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iREACH CDS Tool
Sponsored by
Ann & Robert H Lurie Children's Hospital of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Food Allergy Peanut focused on measuring Food Allergy, Peanut Allergy Incidence, Clinical Decision Support Tool, Infants, Peanut Allergy Prevention

Eligibility Criteria

4 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Pediatric Associates of Arlington Heights, SC-PEDIATRUST
  • Child and Adolescent Health Associates
  • NNHSC-Winfield Moody Health Center
  • Northwestern Children's Practice
  • Streeterville Pediatrics
  • Erie Family Health Centers - Erie Teen and Young Adult Health Center
  • Erie Family Health Centers - West Town
  • Erie Family Health Centers - Helping Hands - Foster
  • NNHSC-Sunnyside Health Center
  • Lurie Children's Primary Care (Town and Country)
  • NM SoNo Pediatrics
  • NNHSC-Louise Landau Health Center
  • NNHSC-North Kostner HC
  • NNHSC -Komed-Holman Health Center
  • Children's Healthcare Associates
  • Lakeview Pediatrics
  • Chicago Area Pediatrics (Drs. Traisman, Benuck, Merens & Kimball)
  • Erie Family Health Centers - Evanston
  • Pediatric Partners, SC-PEDIATRUST
  • Drs. Bedingfield, Rosewell, Silver & Nourbash
  • Lake Shore Pediatrics, SC-PEDIATRUST
  • OSF Medical Group (MG)-Morton Pediatrics
  • UnityPoint Clinic Morton Pediatrics
  • Naperville Pediatric Associates
  • AdPark Pediatrics, SC-PEDIATRUST
  • Oak Park Pediatrics
  • UnityPoint Clinic Pediatrics Methodist Pekin
  • UICOMP-University Pediatrics
  • OSF-Center for Health (CFH)-Route 91
  • UnityPoint Clinic Pediatrics Methodist North
  • Woodfield Pediatrics, SC-PEDIATRUST
  • OSF Medical Group (MG) Washington
  • Erie Family Health Centers - Waukegan
  • Wheaton Pediatrics, SC-PEDIATRUST
  • Pediatric Associates of the North Shore
  • Elm Street Pediatrics, SC-PEDIATRUST

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention (CDS Tool Integrated)

Control (No CDS Tool Integrated)

Arm Description

Pediatric clinicians in this arm will receive the iREACH CDS tool and education on the PPA Guidelines to support adherence to the Guidelines.

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 Outcome Measures

Pediatric Clinician Adherence to Guidelines
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 Outcome Measures

Incidence of peanut allergy by age 2.5
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.

Full Information

First Posted
October 14, 2020
Last Updated
May 30, 2023
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT04604431
Brief Title
Intervention to Reduce Early (Peanut) Allergy in Children
Acronym
iREACH
Official Title
Intervention to Reduce Early (Peanut) Allergy in Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 4, 2020 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy Peanut, Food Allergy in Infants
Keywords
Food Allergy, Peanut Allergy Incidence, Clinical Decision Support Tool, Infants, Peanut Allergy Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention (CDS Tool Integrated)
Arm Type
Experimental
Arm Description
Pediatric clinicians in this arm will receive the iREACH CDS tool and education on the PPA Guidelines to support adherence to the Guidelines.
Arm Title
Control (No CDS Tool Integrated)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
iREACH CDS Tool
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pediatric Clinician Adherence to Guidelines
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Incidence of peanut allergy by age 2.5
Description
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.
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Allergist adherence to the guidelines
Description
Recommendations provided to caregiver for infant peanut product introduction.
Time Frame
18 months
Title
Barriers/facilitators to guideline adherence among pediatric clinicians and caregivers.
Description
What factors serve as barriers and facilitators for clinicians and caregivers to adhere to guidelines.
Time Frame
12 to 18 months
Title
Caregiver adherence to the guidelines
Description
Whether or not caregivers follow recommendations provided by clinicians - infant peanut product introduction and feeding frequency
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruchi S Gupta
Organizational Affiliation
Ann & Robert H Lurie Children's Hospital of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Associates of Arlington Heights, SC-PEDIATRUST
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Child and Adolescent Health Associates
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
NNHSC-Winfield Moody Health Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Northwestern Children's Practice
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Streeterville Pediatrics
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Erie Family Health Centers - Erie Teen and Young Adult Health Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60622
Country
United States
Facility Name
Erie Family Health Centers - West Town
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60622
Country
United States
Facility Name
Erie Family Health Centers - Helping Hands - Foster
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60625
Country
United States
Facility Name
NNHSC-Sunnyside Health Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Lurie Children's Primary Care (Town and Country)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60642
Country
United States
Facility Name
NM SoNo Pediatrics
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60642
Country
United States
Facility Name
NNHSC-Louise Landau Health Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60651
Country
United States
Facility Name
NNHSC-North Kostner HC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60651
Country
United States
Facility Name
NNHSC -Komed-Holman Health Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60653
Country
United States
Facility Name
Children's Healthcare Associates
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Lakeview Pediatrics
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Chicago Area Pediatrics (Drs. Traisman, Benuck, Merens & Kimball)
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60202
Country
United States
Facility Name
Erie Family Health Centers - Evanston
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60202
Country
United States
Facility Name
Pediatric Partners, SC-PEDIATRUST
City
Highland Park
State/Province
Illinois
ZIP/Postal Code
60035
Country
United States
Facility Name
Drs. Bedingfield, Rosewell, Silver & Nourbash
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Lake Shore Pediatrics, SC-PEDIATRUST
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
OSF Medical Group (MG)-Morton Pediatrics
City
Morton
State/Province
Illinois
ZIP/Postal Code
61550
Country
United States
Facility Name
UnityPoint Clinic Morton Pediatrics
City
Morton
State/Province
Illinois
ZIP/Postal Code
61550
Country
United States
Facility Name
Naperville Pediatric Associates
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Facility Name
AdPark Pediatrics, SC-PEDIATRUST
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Oak Park Pediatrics
City
Oak Park
State/Province
Illinois
ZIP/Postal Code
60302
Country
United States
Facility Name
UnityPoint Clinic Pediatrics Methodist Pekin
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
UICOMP-University Pediatrics
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
OSF-Center for Health (CFH)-Route 91
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
UnityPoint Clinic Pediatrics Methodist North
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Woodfield Pediatrics, SC-PEDIATRUST
City
Schaumburg
State/Province
Illinois
ZIP/Postal Code
60173
Country
United States
Facility Name
OSF Medical Group (MG) Washington
City
Washington
State/Province
Illinois
ZIP/Postal Code
61571
Country
United States
Facility Name
Erie Family Health Centers - Waukegan
City
Waukegan
State/Province
Illinois
ZIP/Postal Code
60085
Country
United States
Facility Name
Wheaton Pediatrics, SC-PEDIATRUST
City
Wheaton
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
Pediatric Associates of the North Shore
City
Wilmette
State/Province
Illinois
ZIP/Postal Code
60091
Country
United States
Facility Name
Elm Street Pediatrics, SC-PEDIATRUST
City
Winnetka
State/Province
Illinois
ZIP/Postal Code
60093
Country
United States

12. IPD Sharing Statement

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Intervention to Reduce Early (Peanut) Allergy in Children

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