- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04604431
Intervention to Reduce Early (Peanut) Allergy in Children (iREACH)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Arlington Heights, Illinois, United States, 60005
- Pediatric Associates of Arlington Heights, SC-PEDIATRUST
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Chicago, Illinois, United States, 60610
- Child and Adolescent Health Associates
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Chicago, Illinois, United States, 60610
- NNHSC-Winfield Moody Health Center
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Chicago, Illinois, United States, 60611
- Northwestern Children's Practice
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Chicago, Illinois, United States, 60611
- Streeterville Pediatrics
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Chicago, Illinois, United States, 60622
- Erie Family Health Centers - Erie Teen and Young Adult Health Center
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Chicago, Illinois, United States, 60622
- Erie Family Health Centers - West Town
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Chicago, Illinois, United States, 60625
- Erie Family Health Centers - Helping Hands - Foster
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Chicago, Illinois, United States, 60640
- NNHSC-Sunnyside Health Center
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Chicago, Illinois, United States, 60642
- Lurie Children's Primary Care (Town and Country)
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Chicago, Illinois, United States, 60642
- NM SoNo Pediatrics
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Chicago, Illinois, United States, 60651
- NNHSC-Louise Landau Health Center
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Chicago, Illinois, United States, 60651
- NNHSC-North Kostner HC
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Chicago, Illinois, United States, 60653
- NNHSC -Komed-Holman Health Center
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Chicago, Illinois, United States, 60657
- Children's Healthcare Associates
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Chicago, Illinois, United States, 60657
- Lakeview Pediatrics
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Evanston, Illinois, United States, 60202
- Chicago Area Pediatrics (Drs. Traisman, Benuck, Merens & Kimball)
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Evanston, Illinois, United States, 60202
- Erie Family Health Centers - Evanston
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Highland Park, Illinois, United States, 60035
- Pediatric Partners, SC-PEDIATRUST
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Hoffman Estates, Illinois, United States, 60169
- Drs. Bedingfield, Rosewell, Silver & Nourbash
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Libertyville, Illinois, United States, 60048
- Lake Shore Pediatrics, SC-PEDIATRUST
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Morton, Illinois, United States, 61550
- OSF Medical Group (MG)-Morton Pediatrics
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Morton, Illinois, United States, 61550
- UnityPoint Clinic Morton Pediatrics
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Naperville, Illinois, United States, 60540
- Naperville Pediatric Associates
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Northbrook, Illinois, United States, 60602
- AdPark Pediatrics, SC-PEDIATRUST
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Oak Park, Illinois, United States, 60302
- Oak Park Pediatrics
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Pekin, Illinois, United States, 61554
- UnityPoint Clinic Pediatrics Methodist Pekin
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Peoria, Illinois, United States, 61603
- UICOMP-University Pediatrics
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Peoria, Illinois, United States, 61615
- OSF-Center for Health (CFH)-Route 91
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Peoria, Illinois, United States, 61615
- UnityPoint Clinic Pediatrics Methodist North
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Schaumburg, Illinois, United States, 60173
- Woodfield Pediatrics, SC-PEDIATRUST
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Washington, Illinois, United States, 61571
- OSF Medical Group (MG) Washington
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Waukegan, Illinois, United States, 60085
- Erie Family Health Centers - Waukegan
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Wheaton, Illinois, United States, 60062
- Wheaton Pediatrics, SC-PEDIATRUST
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Wilmette, Illinois, United States, 60091
- Pediatric Associates of the North Shore
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Winnetka, Illinois, United States, 60093
- Elm Street Pediatrics, SC-PEDIATRUST
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pediatric Clinician Adherence to Guidelines
Time Frame: 18 months
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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:
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18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of peanut allergy by age 2.5
Time Frame: 2 years
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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:
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2 years
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Allergist adherence to the guidelines
Time Frame: 18 months
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Recommendations provided to caregiver for infant peanut product introduction.
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18 months
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Barriers/facilitators to guideline adherence among pediatric clinicians and caregivers.
Time Frame: 12 to 18 months
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What factors serve as barriers and facilitators for clinicians and caregivers to adhere to guidelines.
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12 to 18 months
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Caregiver adherence to the guidelines
Time Frame: 12 months
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Whether or not caregivers follow recommendations provided by clinicians - infant peanut product introduction and feeding frequency
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12 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Ruchi S Gupta, Ann & Robert H Lurie Children's Hospital of Chicago
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAABB-U01-LCH-00
- U01AI138907 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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