Intervention to Reduce Early (Peanut) Allergy in Children (NCT04604431) | Clinical Trial Compass
CompletedNot Applicable
Intervention to Reduce Early (Peanut) Allergy in Children
United States30 participantsStarted 2020-11-04
Plain-language 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.
Who can participate
Age range
4 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 prac…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pediatric Clinician Adherence to Guidelines
Timeframe: 18 months
Trial details
NCT IDNCT04604431
SponsorAnn & Robert H Lurie Children's Hospital of Chicago