Clinical trial NCT03702270: The Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal
Official title: The Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Penicillin Allergy
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2018-10-11
Enrollment: 2052
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: During the trial, randomization will occur using a stepped wedge cluster randomized controlled trial design. Medical units at VUMC will be 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Penicillin Allergy Label Removal
timeFrame: Hospital discharge at approximately 4 days after admission
Secondary outcomes:
measure: Adverse Events (in Particular, Reported Allergic Events)
timeFrame: Hospital discharge at approximately 4 days after admission
measure: Communication About Penicillin Allergy in Discharge Summary
timeFrame: Hospital discharge at approximately 4 days after admission
measure: Antibiotic Utilization by Patients
timeFrame: Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up
measure: Durability of Penicillin Allergy Label Removal
timeFrame: Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up
measure: Receipt of Risk Stratification Tool Assessment
timeFrame: Hospital discharge at approximately 4 days after admission
measure: Time to Penicillin Allergy Label Return
timeFrame: From 3-18 months of follow up
measure: Penicillin Utilization by Patients
timeFrame: Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up
measure: Cephalosporin Utilization by Patients
timeFrame: Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Cosby Stone, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Chris Lindsell, PhD
role: STUDY_CHAIR
References: