Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal in ICU Setting

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. The investigators objective is to demonstrate the benefit of providing risk stratification in removing penicillin allergy labels for low risk penicillin allergy patients in a single arm intervention pilot trial in the ICU setting, which will pave the way for a future stepped wedge randomized control trial (stepped wedge trial entered separately in clinical trials.gov as NCT03702270)

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 240
• 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 to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with a penicillin allergy reported in their chart under ICU care, but who are currently medically unstable.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Penicillin Allergic ICU Patients; 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.

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 7 days after ICU transfer
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 7 days after ICU transfer

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 7 days after ICU transfer
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 7 days after ICU transfer
Antibiotic Utilization by Patients	The number of changes or new starts of penicillin treatments as a result of penicillin allergy label removal and the proportion of patients experiencing this event	2 years observation

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: Vanderbilt Institute for Clinical and Translational Research (Learning Healthcare System)
• Investigators: Principal Investigator: Cosby A Stone, Jr., MD, Vanderbilt University Medical Center

Publications and helpful links

General Publications

• Koo G, Stollings JL, Lindsell C, Dear ML, Kripalani S, Nelson GE, McCoy AB, Rice TW, Phillips EJ, Stone CA Jr; Vanderbilt University Medical Center Learning Healthcare System. Low-risk penicillin allergy delabeling through a direct oral challenge in immunocompromised and/or multiple drug allergy labeled patients in a critical care setting. J Allergy Clin Immunol Pract. 2022 Jun;10(6):1660-1663.e2. doi: 10.1016/j.jaip.2022.01.041. Epub 2022 Feb 5. No abstract available.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 31, 2019
• Primary Completion (ACTUAL): March 31, 2021
• Study Completion (ACTUAL): March 31, 2021

Study Registration Dates

• First Submitted: October 8, 2018
• First Submitted That Met QC Criteria: October 10, 2018
• First Posted (ACTUAL): October 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 13, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: January 1, 2022

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 -Pilot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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