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

Not Applicable

Withdrawn

• Conditions: Antibiotic Allergy
• Interventions: Other: Physician-targeted CDS tool for PCN allergy delabeling

• Registration Number: NCT05561777
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-09-29
• Study First Posted: 2022-09-30
• Study Start: 2022-12-01
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Provider-targeted Clinical Decision Support Tool	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.

Primary Outcome Measures

Name	Time	Method
Allergy Delabeling Performed	Within 1 day of discharge for each encounter	Percentage of enrolled encounters (intervention arm) in which providers perform allergy delabeling

Secondary Outcome Measures

Name	Time	Method
Allergy Label Adjustments in EHR	3 months after discharge for each encounter	Percentage of enrolled encounters with an oral challenge in which allergy label has been removed from patients' medical records.

Trial Locations

Locations (1)

Monroe Carell Jr Children's Hospital at Vanderbilt; 🇺🇸 Nashville, Tennessee, United States