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

NCT ID: NCT03702270

Last Updated: 2024-12-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2052 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-11

Study Completion Date

2023-05-11

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.

Detailed Description

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Conditions

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Penicillin Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Penicillin Allergic Floor Patients- Experimental

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.

Group Type EXPERIMENTAL

Penicillin Allergic Risk Stratification Best Practice Alert

Intervention Type OTHER

Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.

Penicillin Allergic Floor Patients- Control

Patients will receive current standard of care for penicillin allergy, which typically involves physician judgement on challenges versus consultation of allergy service.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Penicillin Allergic Risk Stratification Best Practice Alert

Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Cosby Stone

Instructor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cosby Stone, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Chris Lindsell, PhD

Role: STUDY_CHAIR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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181734

Identifier Type: -

Identifier Source: org_study_id