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Behavioural Intervention
iREACH CDS Tool for Preventing Peanut Allergy (iREACH Trial)
N/A
Waitlist Available
Led By Ruchi S Gupta
Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must not have
Practice Sites: Sees <50 newborn patients/year.
Infants: The infant has a medical condition that chronically inhibits the ability to take food orally (i.e., dysphagia, muscular dystrophy, gastrostomy).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will assess whether an electronic health record-based tool can help doctors better adhere to guidelines around preventing peanut allergies, with the goal of reducing the incidence of peanut allergies.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since iREACH is a decision support tool rather than a medication, it does not have direct side effects like drugs do. However, its impact on clinical practice and patient outcomes related to peanut allergy prevention will be closely monitored.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My practice sees fewer than 50 newborn patients a year.
Select...
My infant cannot eat by mouth due to a long-term health issue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pediatric Clinician Adherence to Guidelines
Secondary study objectives
Incidence of Peanut Allergy by Age 2.5
Other study objectives
Allergist Adherence to the Guidelines
Barriers/Facilitators to Guideline Adherence Among Pediatric Clinicians and Caregivers.
Caregiver Adherence to the Guidelines
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention (CDS Tool Integrated)Experimental Treatment1 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 Control1 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.
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Who is running the clinical trial?
Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
265 Previous Clinical Trials
5,181,789 Total Patients Enrolled
3 Trials studying Food Allergy
112 Patients Enrolled for Food Allergy
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,320 Previous Clinical Trials
5,364,615 Total Patients Enrolled
12 Trials studying Food Allergy
12,456 Patients Enrolled for Food Allergy
Ruchi S GuptaPrincipal InvestigatorAnn & Robert H Lurie Children's Hospital of Chicago
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My infant has seen a pediatrician for a 4 or 6-month wellness check.I can understand the study details and agree to participate in surveys when my child is 12 and 24 months old.My practice sees fewer than 50 newborn patients a year.I provide routine care for infants who are 4 or 6 months old.The infant has other medical conditions or test results that could make it unsafe or difficult to follow the study guidelines.I am over 18 years old or have permission to participate.My infant cannot eat by mouth due to a long-term health issue.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention (CDS Tool Integrated)
- Group 2: Control (No CDS Tool Integrated)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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