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

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.

Study Overview

• Status: Completed
• Conditions: Penicillin Allergy
• Intervention / Treatment: Other: Penicillin Allergic Risk Stratification Best Practice Alert

• Study Type: Interventional
• Enrollment (Actual): 2040
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Penicillin Allergic Floor Patients- Experimental; 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.	Other: Penicillin Allergic Risk Stratification Best Practice Alert; Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
No Intervention: Penicillin Allergic Floor Patients- Control; Patients will receive current standard of care for penicillin allergy, which typically involves physician judgement on challenges versus consultation of allergy service.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Penicillin allergy label removal	The proportion of patients with low risk penicillin allergy whose labels are removed from the medical chart's allergy section.	Hospital discharge at approximately 4 days after admission
Patients with low risk penicillin allergy label who underwent amoxicillin challenge	The proportion of patients with low risk penicillin allergy who underwent amoxicillin challenge	Hospital discharge at approximately 4 days after admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (in particular, reported allergic events)	The proportion of penicillin allergic patients challenged with amoxicillin who reported adverse events	Hospital discharge at approximately 4 days after admission
Communication about penicillin allergy in discharge summary	The proportion of penicillin allergic patients whose discharge summary contains information about penicillin allergy at discharge.	Hospital discharge at approximately 4 days after admission
Antibiotic utilization by patients	The number of changes or new starts of penicillin or cephalosporin treatments as a result of penicillin allergy label removal and the proportion of patients experiencing this event, this will be looked at as "Same hospitalization" as the challenge or "Subsequent Utilization"	Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up
Durability of penicillin allergy label removal	The proportion of penicillin allergic patients whose penicillin allergy labels were removed at discharge whose labels are not reentered into the chart.	Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up
Tolerance of amoxicillin challenge	Any adverse events reported in association with amoxicillin challenge	Within 24 hours of the amoxicillin challenge
Uptake of the risk stratification tool	Determined by whether patients with a penicillin allergy label received a risk assessment	Hospital discharge at approximately 4 days after admission
Time to penicillin allergy label return	For those patients who underwent a penicillin allergy label removal and it returns, we will compare the date the allergy label returned with the date it was removed	From 3-18 months of follow up

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: Vanderbilt Institute for Clinical and Translational Research (Learning Healthcare System)
• Investigators: Principal Investigator: Cosby Stone, MD, MPH, Vanderbilt University Medical Center; Study Chair: Chris Lindsell, PhD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2020
• Primary Completion (Actual): December 11, 2021
• Study Completion (Actual): May 11, 2023

Study Registration Dates

• First Submitted: October 8, 2018
• First Submitted That Met QC Criteria: October 8, 2018
• First Posted (Actual): October 11, 2018

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Immune System Diseases; Drug-Related Side Effects and Adverse Reactions; Hypersensitivity; Drug Hypersensitivity; Anti-Infective Agents; Anti-Bacterial Agents; Penicillins
• Other Study ID Numbers: 181734

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No