iREACH CDS Tool for Preventing Peanut Allergy

(iREACH Trial)

Recruiting at 45 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Disqualifiers: Dysphagia, Muscular dystrophy, Gastrectomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the iREACH CDS Tool treatment for preventing peanut allergy?

Research shows that early introduction of peanuts to infants can help prevent peanut allergies. The iREACH CDS Tool aims to improve how doctors follow these guidelines, which could lead to better prevention of peanut allergies in children. ^{1 2 3 4 5}

How does the iREACH CDS Tool treatment for preventing peanut allergy differ from other treatments?

The iREACH CDS Tool is unique because it focuses on preventing peanut allergies rather than treating them after they occur. This approach is different from traditional methods that often involve managing symptoms or desensitizing individuals to peanuts after an allergy has developed. ^{4 6 7 8 9}

Research Team

Ruchi S Gupta

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria

This trial is for pediatric practices using an integrated EHR, clinicians providing infant care, and caregivers of infants seen for well-child visits at 4 or 6 months. Infants with conditions that risk PPA guideline implementation are excluded, as are temporary clinicians or non-English/Spanish speaking caregivers.

Inclusion Criteria

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.

The practice has signed a legally-binding engagement agreement with Lurie Children's Pediatric Practice Research Group.

Exclusion Criteria

The practice pediatric clinicians do not use an EHR system.

My practice sees fewer than 50 newborn patients a year.

Has only temporary pediatricians on staff.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Pediatric clinicians receive the iREACH CDS tool and education on the PPA Guidelines to support adherence

18 months

Regular well child care visits at 4, 6, 9, 12, 15, 18, and 24 months

Follow-up

Participants are monitored for adherence to guidelines and incidence of peanut allergy

2 years

Follow-up surveys at child's first and second birthdays

Treatment Details

Interventions

• iREACH CDS Tool

Trial Overview The iREACH study tests a tool designed to help pediatricians follow guidelines to prevent peanut allergies in children. It's a randomized trial comparing the effectiveness of this tool in reducing peanut allergy incidence by age 2.5 years between intervention and control groups.

Participant Groups

Group I: Intervention (CDS Tool Integrated) Experimental Treatment 1 Intervention

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

Group II: Control (No CDS Tool Integrated) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials

275

Recruited

5,182,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

International Peanut Allergy Prevention, 6 Years After the Learning Early About Peanut Study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Early Peanut Introduction in Infants: Improving Guideline Adherence With EMR Standardization. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Tree nut allergy: a systematic review. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Early Peanut Introduction in Primary Care: Evaluation of a Multicomponent Intervention. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The Case for Prompt Salvage Infant Peanut Oral Immunotherapy Following Failed Primary Prevention. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Mass cytometry analysis of blood from peanut-sensitized tolerant and clinically allergic infants. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Diagnosis of Peanut Allergy in Preschool Children: The Impact of Skin Testing With a Novel Composition of Peanuts. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Qualitative polymerase chain reaction methods for detecting major food allergens (peanut, soybean, and wheat) by using internal transcribed spacer region. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Epidemiology of childhood peanut allergy. [2016]