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

NCT03702270 | Completed Results DMC

• 1 other identifier: 181734
• Study Type: interventional
• Target: 2,052
• Locations: 1 country
• Sites: 1

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.

Conditions

Penicillin Allergy

Outcome Measures

Primary Outcomes (1)

• Penicillin Allergy Label Removal

  The percentage 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

Secondary Outcomes (8)

• Adverse Events (in Particular, Reported Allergic Events)

  Hospital discharge at approximately 4 days after admission

• Communication About Penicillin Allergy in Discharge Summary

  Hospital discharge at approximately 4 days after admission

• Antibiotic Utilization by Patients

  Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up

• Durability of Penicillin Allergy Label Removal

  Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up

• Receipt of Risk Stratification Tool Assessment

  Hospital discharge at approximately 4 days after admission

Study Arms (2)

Penicillin Allergic Floor Patients- Experimental

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.

Other: Penicillin Allergic Risk Stratification Best Practice Alert

Penicillin Allergic Floor Patients- Control

NO INTERVENTION

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

Interventions

Penicillin Allergic Risk Stratification Best Practice Alert OTHER

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

Penicillin Allergic Floor Patients- Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with a penicillin allergy reported in their chart, but who are currently medically unstable.
• Pregnant patients

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Results Point of Contact

• Title: Dr. Cosby A Stone, Jr.
• Organization: VANDERBILT UNIVERSITY MEDICAL CENTER

Cosby.a.stone@vumc.org

6153223412

Study Officials

• Cosby Stone, MD, MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Chris Lindsell, PhD

  Vanderbilt University Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Model Details: 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.

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 11, 2018
• Study Start: November 11, 2020
• Primary Completion: December 11, 2021
• Study Completion: May 11, 2023
• Last Updated: December 18, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)