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

Implementation of Penicillin Allergy Risk Stratification and Delabeling of Low-Risk Patients: Provider-Targeted Clinical Decision Support Versus Pharmacist-Led Approach

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05561777
Enrollment
0
Registered
2022-09-30
Start date
2022-12-01
Completion date
2023-12-01
Last updated
2024-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Allergy

Brief 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.

Interventions

OTHERPhysician-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

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Pediatric Hospital Medicine service Existing penicillin allergy label in the EHR Screened as low-risk for true PCN allergy (based on usual-care nursing intake questions at time of admission)

Exclusion criteria

None, provider may opt out of CDS tool at any time

Design outcomes

Primary

MeasureTime frameDescription
Allergy Delabeling PerformedWithin 1 day of discharge for each encounterPercentage of enrolled encounters (intervention arm) in which providers perform allergy delabeling

Secondary

MeasureTime frameDescription
Allergy Label Adjustments in EHR3 months after discharge for each encounterPercentage of enrolled encounters with an oral challenge in which allergy label has been removed from patients' medical records.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026