NCT05561777

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

Withdrawn NA Last updated 8 March 2024

What this trial tests

NA trial testing Physician-targeted CDS tool for PCN allergy delabeling in Antibiotic Allergy. Withdrawn.

Timeline

1 December 2022

Primary endpoint
1 December 2023

1 December 2023

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Start date	1 December 2022
Primary completion	1 December 2023
Estimated completion	1 December 2023
Sites	1 location across United States

Drugs / interventions tested

• Physician-targeted CDS tool for PCN allergy delabeling

Conditions studied

• Antibiotic Allergy — all drugs for Antibiotic Allergy →

Sponsor

Vanderbilt University Medical Center

Who can join

1 and older, any sex, with Antibiotic Allergy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.