Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal in ICU Setting
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Penicillin Allergy Label Removal
Study Overview
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. 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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: Penicillin Allergic Risk Stratification Best Practice Alert (Other)
Outcomes
Primary Outcomes
Penicillin Allergy Label Removal
Time Frame: Hospital discharge at approximately 7 days after ICU transfer
The proportion of patients with low risk penicillin allergy whose labels are removed from the medical chart's allergy section.
Patients With Low Risk Penicillin Allergy Label Who Underwent Amoxicillin Challenge
Time Frame: Hospital discharge at approximately 7 days after ICU transfer
The proportion of patients with low risk penicillin allergy who underwent amoxicillin challenge
Secondary Outcomes
- Communication About Penicillin Allergy in Discharge Summary(Hospital discharge at approximately 7 days after ICU transfer)
- Adverse Events (in Particular, Reported Allergic Events)(Hospital discharge at approximately 7 days after ICU transfer)
- Antibiotic Utilization by Patients(2 years observation)
Investigators
Elizabeth J Phillips
Professor
Vanderbilt University Medical Center