Allergy Delabeling Tool for Antibiotic Allergy

N/A

Waitlist Available

Led By James Antoon, MD, PhD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 1 day of discharge for each encounter

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate how an allergy label can be safely removed in children, which can improve patient care & reduce healthcare costs.

Who is the study for?

This trial is for children in the hospital with a penicillin allergy label, who are considered low-risk for a true allergy based on standard questions asked when they're admitted. There's no exclusion criteria; however, doctors can choose not to use the decision support tool.

What is being tested?

The study tests if a clinical decision support (CDS) tool aimed at doctors or one led by pharmacists is better at removing unnecessary penicillin allergy labels from kids' medical records. It measures how often these labels are removed and looks at antibiotic use and hospital stay length.

What are the potential side effects?

Since this trial involves information management rather than direct patient treatment, there aren't typical medication side effects. However, inaccuracies in delabeling could lead to incorrect antibiotic administration.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 1 day of discharge for each encounter

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 1 day of discharge for each encounter

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 day of discharge for each encounter for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Allergy Delabeling Performed

Secondary study objectives

Allergy Label Adjustments in EHR

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: Provider-targeted Clinical Decision Support ToolExperimental Treatment1 Intervention

This intervention will provide access to a best-practices alert (BPA) containing the patient's risk-stratification status and a link to the local standard of care protocol, oral amoxicillin challenge order set and written consent form (same resources as used in pharmacist -led electronic health record dashboard). If the provider opts to perform the oral challenge and it is successfully passed, a second BPA will prompt them to update the allergy status in the medical record.

Group II: Pharmacist-led EvaluationActive Control1 Intervention

Patients randomized to the pharmacist-led arm will appear in the pharmacy-penicillin electronic health care dashboard. A pharmacist may, at their discretion and in consultation with the primary care team, perform an allergy risk-stratification and oral challenge in low-risk patients using local standard of care protocol

Do I qualify?Apply below to find out