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

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. 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.

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

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 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

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: During the trial, randomization will occur using a stepped wedge cluster randomized controlled trial design. Medical units at VUMC will assigned to clusters. A single cluster will be selected for intervention at the outset of the trial. Subsequent additional clusters will first contribute to the control group, and be selected to randomly cross over to the intervention group at regular intervals of 1 months.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Penicillin Allergic Floor Patients- Experimental<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>|
| No Intervention: Penicillin Allergic Floor Patients- Control<br>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?
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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 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 |