Food Allergy in Infants, Food Allergy Peanut
Conditions
Keywords
Food Allergy, Peanut Allergy Incidence, Clinical Decision Support Tool, Infants, Peanut Allergy 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.
Interventions
OTHERiREACH 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.
Sponsors
Ann & Robert H Lurie Children's Hospital of Chicago
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Months to No maximum
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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Clinician Adherence to Guidelines | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Peanut Allergy by Age 2.5 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRuchi S Gupta
Ann & Robert H Lurie Children's Hospital of Chicago
Participant flow
Recruitment details
Participating practices (n=30) were recruited and enrolled prior to the start of the study. During an 18-month observation period (start date varied by network), 290 clinicians and 18480 infants seen for 4- and/or 6- month well child care visits were observed via electronic health records (EHR). EHR notes were pulled between November 1, 2020 through October 31, 2022. EHR data was available for use per the agreements outlined during practice recruitment.
Pre-assignment details
For the primary outcome, practices were enrolled and randomized. No individual participants were enrolled. 37 practices were invited. 7 practices decided not to participate. Finally, 30 practices were enrolled and randomized into the intervention vs control arm based off of annual patient volume of 4- and 6-month well child care (WCC) visits. Four patient volume strata were considered (\<500 visits, 500-999, 1000-1499, ≥1500). Practices were randomized in a 1:1 ratio within each stratum.
Participants by arm
| Arm | Count |
|---|---|
| Intervention (CDS Tool Integrated) Pediatric clinicians in all intervention practices received the iREACH CDS tool and education on the PPA Guidelines to support adherence to the Guidelines. All infants in the intervention arm were observed.
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. | 9,290 |
| 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. | 9,190 |
| Total | 18,480 |
Baseline characteristics
| Characteristic | Total | Control (No CDS Tool Integrated) | Intervention (CDS Tool Integrated) |
|---|---|---|---|
| Age, Customized Age in Days | 126 Days | 126 Days | 127 Days |
| Eczema Mild-Moderate Eczema | 1166 Participants | 435 Participants | 731 Participants |
| Eczema No Eczema | 17088 Participants | 8702 Participants | 8386 Participants |
| Eczema Severe Eczema | 226 Participants | 53 Participants | 173 Participants |
| Egg Allergy Egg Allergy | 73 Participants | 14 Participants | 59 Participants |
| Egg Allergy No Egg Allergy | 18407 Participants | 9176 Participants | 9231 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2989 Participants | 1082 Participants | 1907 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12281 Participants | 6252 Participants | 6029 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3210 Participants | 1856 Participants | 1354 Participants |
| Health Insurance Type Missing | 143 Participants | 80 Participants | 63 Participants |
| Health Insurance Type Other | 1157 Participants | 962 Participants | 195 Participants |
| Health Insurance Type Private | 13501 Participants | 6828 Participants | 6673 Participants |
| Health Insurance Type Public | 3679 Participants | 1320 Participants | 2359 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 75 Participants | 26 Participants | 49 Participants |
| Race (NIH/OMB) Asian | 1205 Participants | 590 Participants | 615 Participants |
| Race (NIH/OMB) Black or African American | 1506 Participants | 926 Participants | 580 Participants |
| Race (NIH/OMB) More than one race | 788 Participants | 465 Participants | 323 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 16 Participants | 3 Participants | 13 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3480 Participants | 1909 Participants | 1571 Participants |
| Race (NIH/OMB) White | 11410 Participants | 5271 Participants | 6139 Participants |
| Region of Enrollment United States | 18480 participants | 9190 participants | 9290 participants |
| Sex: Female, Male Female | 9466 Participants | 4692 Participants | 4774 Participants |
| Sex: Female, Male Male | 9014 Participants | 4498 Participants | 4516 Participants |
| Well Child Visits Both | 11883 Participants | 6108 Participants | 5775 Participants |
| Well Child Visits Only 4 Month Well Child Visits | 3155 Participants | 1449 Participants | 1706 Participants |
| Well Child Visits Only 6 Month Well Child Visits | 3442 Participants | 1633 Participants | 1809 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: 18 months
Population: Infants seen for a 4- and/or 6- month WCC visits. Low-risk infants (n=18182) were categorized as those with no/mild/moderate eczema and no egg allergy. High-risk infants (n=298) were categorized as those with severe eczema and/or egg allergy. Clinician adherence was analyzed with infants as the unit of analysis. Odds ratios reported
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention (CDS Tool Integrated) | Pediatric Clinician Adherence to Guidelines | Adherent Low-Risk | 7607 infants |
| Intervention (CDS Tool Integrated) | Pediatric Clinician Adherence to Guidelines | Adherent High-Risk | 62 infants |
| Control (No CDS Tool Integrated) | Pediatric Clinician Adherence to Guidelines | Adherent Low-Risk | 3231 infants |
| Control (No CDS Tool Integrated) | Pediatric Clinician Adherence to Guidelines | Adherent High-Risk | 7 infants |
Comparison: Odds ratios will be computed to describe the odds of adherence for the iREACH intervention compared to the control intervention for low-risk infants.p-value: <0.00195% CI: [6.9, 29.1]Mixed Models Analysis
Comparison: Odds ratios will be computed to describe the odds of adherence for the iREACH intervention compared to the control intervention for high-risk infants.p-value: 0.03495% CI: [1.1, 8.8]Mixed Models Analysis
Secondary
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.
Time frame: 2 years
Other Pre-specified
Allergist Adherence to the Guidelines
Recommendations provided to caregiver for infant peanut product introduction.
Time frame: 18 months
Other Pre-specified
Barriers/Facilitators to Guideline Adherence Among Pediatric Clinicians and Caregivers.
What factors serve as barriers and facilitators for clinicians and caregivers to adhere to guidelines.
Time frame: 12 to 18 months
Other Pre-specified
Caregiver Adherence to the Guidelines
Whether or not caregivers follow recommendations provided by clinicians - infant peanut product introduction and feeding frequency
Time frame: 12 months