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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,052
Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Penicillin Allergy Label Removal
The percentage of patients with low risk penicillin allergy whose labels are removed from the medical chart's allergy section.
Time frame: Hospital discharge at approximately 4 days after admission
Adverse Events (in Particular, Reported Allergic Events)
The percentage of penicillin allergic patients challenged with amoxicillin who reported adverse events
Time frame: Hospital discharge at approximately 4 days after admission
Communication About Penicillin Allergy in Discharge Summary
The percentage of penicillin allergic patients whose discharge summary contains information about penicillin allergy at discharge.
Time frame: 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"
Time frame: Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up
Durability of Penicillin Allergy Label Removal
The percentage of penicillin allergic patients whose penicillin allergy labels were removed at discharge whose labels are not reentered into the chart.
Time frame: Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up
Receipt of Risk Stratification Tool Assessment
Number of patients with a penicillin allergy label who received a risk assessment.
Time frame: 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
Time frame: From 3-18 months of follow up
Penicillin 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, this will be looked at as "Same hospitalization" as the challenge or "Subsequent Utilization"
Time frame: Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up
Cephalosporin Utilization by Patients
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"
Time frame: Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up
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