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Penicillin Allergy Risk-Stratification and Delabeling of Low-Risk Patients

NCT05561777 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-03-08

No results posted yet for this study

Summary

Children are often reported to have antibiotics allergies, with approximately 10% of the US population labeled as allergic to an antibiotic, however, recent studies have demonstrated that the majority of symptoms reported as an allergy by parents are often non-IgE-mediated adverse reactions or symptoms of a viral illness (e.g. rash, vomiting, diarrhea). Additionally, over 90% of patients with reported penicillin allergy have negative skin testing results. Several studies in children have found that an allergy questionnaire can accurately identify those who are at low risk for severe antibiotic allergy and the allergy label can be safely removed. Appropriately delabeling antibiotic allergies has been shown to improve patient care through changing prescribing behavior and lowering health care costs.

In this study, the investigators will perform a randomized trial comparing a provider-targeted clinical decision support tool to a pharmacist-led approach. The physician-targeted CDS tool will inform providers of their patient's allergy risk stratification result, protocol, electronic health record order and documentation support. The pharmacist-led approach consists of electronic health record dashboard that includes identical information to the provider arm. The primary outcome will be the frequency of penicillin allergy encounters with an allergy label removed at the time of discharge. Secondary outcomes will include the percentage of encounter with a penicillin allergy label in the electronic medical record 3 months after discharge, hospital length of stay and antibiotic utilization.

Conditions

  • Antibiotic Allergy

Interventions

OTHER

Physician-targeted CDS tool for PCN allergy delabeling

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.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • James Antoon, MD, PhD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2023-12-01
Completion
2023-12-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05561777 on ClinicalTrials.gov