The Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal

Vanderbilt University Medical Center

Status: Completed

Conditions: Penicillin Allergy

Treatments: Other: Penicillin Allergic Risk Stratification Best Practice Alert

Study type: Interventional

Funder types: Other

Identifiers

NCT03702270

181734

Details and patient eligibility

About

Currently it is estimated that at least 25 million people in the United States are labeled as penicillin allergic although less than 1.5 million of these are truly allergic. Although combined skin testing and oral challenge is an evidence-based de-labeling strategy the high burden of penicillin allergy labels means these services are available only through specialty allergy practices. There is therefore a need to provide evidence for alternative penicillin de-labeling strategies such as direct oral challenge. Previous studies have utilized quasi-experimental designs. Test dose challenges are currently recommended as a strategy for removal of low risk drug allergies, but the current experience is limited to single arm observational studies and evidence-based strategies for identifying low risk patients are lacking. Our objective is to demonstrate the benefit of providing risk stratification in removing penicillin allergy labels for low risk penicillin allergy patients in a randomized controlled trial.

Enrollment: 2,052 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• VUMC patients age 18 or older with a penicillin allergy reported in their chart, and are medically stable, currently admitted to stepdown unit or regular floor bed.

Exclusion criteria

• Patients with a penicillin allergy reported in their chart, but who are currently medically unstable.
• Pregnant patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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2,052 participants in 2 patient groups

Penicillin Allergic Floor Patients- Experimental

Experimental group

Description:

The intervention will provide access to a best-practices alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk.

Treatment:

Other: Penicillin Allergic Risk Stratification Best Practice Alert

Penicillin Allergic Floor Patients- Control

No Intervention group

Description:

Patients will receive current standard of care for penicillin allergy, which typically involves physician judgement on challenges versus consultation of allergy service.