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

Not Applicable

Completed

• Conditions: Penicillin Allergy
• Interventions: Other: Penicillin Allergic Risk Stratification Best Practice Alert

• Registration Number: NCT03702270
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-08
• Study First Posted: 2018-10-11
• Study Start: 2020-11-11
• Primary Completion: 2021-12-11
• Study Completion: 2023-05-11
• Results First Submitted: 2024-04-29
• Results First Submitted QC: 2024-07-05
• Results First Posted: 2024-10-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2052

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Penicillin Allergic Floor Patients- Experimental	Penicillin Allergic Risk Stratification Best Practice Alert	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.

Primary Outcome Measures

Name	Time	Method
Penicillin Allergy Label Removal	Hospital discharge at approximately 4 days after admission	The percentage of patients with low risk penicillin allergy whose labels are removed from the medical chart's allergy section.

Secondary Outcome Measures

Name	Time	Method
Adverse Events (in Particular, Reported Allergic Events)	Hospital discharge at approximately 4 days after admission	The percentage of penicillin allergic patients challenged with amoxicillin who reported adverse events
Communication About Penicillin Allergy in Discharge Summary	Hospital discharge at approximately 4 days after admission	The percentage of penicillin allergic patients whose discharge summary contains information about penicillin allergy at discharge.
Antibiotic Utilization by Patients	Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up	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"
Durability of Penicillin Allergy Label Removal	Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up	The percentage of penicillin allergic patients whose penicillin allergy labels were removed at discharge whose labels are not reentered into the chart.
Receipt of Risk Stratification Tool Assessment	Hospital discharge at approximately 4 days after admission	Number of patients with a penicillin allergy label who received a risk assessment.
Time to Penicillin Allergy Label Return	From 3-18 months of follow up	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
Penicillin Utilization by Patients	Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up	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, this will be looked at as "Same hospitalization" as the challenge or "Subsequent Utilization"
Cephalosporin Utilization by Patients	Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up	The number of changes or new starts of 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"

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States