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

Study Overview
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Brief Summary
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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)

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

Conditions
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Penicillin Allergy

Intervention / Treatment
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* Other: Penicillin Allergic Risk Stratification Best Practice Alert


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Penicillin Allergic ICU Patients<br>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<br>* Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.<br>|

What is the study measuring?
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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 |