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Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal in ICU Setting

Primary Purpose

Penicillin Allergy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Penicillin Allergic Risk Stratification Best Practice Alert
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Penicillin Allergy

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Penicillin Allergic ICU Patients

Arm Description

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.

Outcomes

Primary Outcome Measures

Penicillin Allergy Label Removal
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
The proportion of patients with low risk penicillin allergy who underwent amoxicillin challenge

Secondary Outcome Measures

Adverse Events (in Particular, Reported Allergic Events)
The proportion of penicillin allergic patients challenged with amoxicillin who reported adverse events
Communication About Penicillin Allergy in Discharge Summary
The proportion of penicillin allergic patients whose discharge summary contains information about penicillin allergy at discharge.
Antibiotic Utilization by Patients
The number of changes or new starts of penicillin treatments as a result of penicillin allergy label removal and the proportion of patients experiencing this event

Full Information

First Posted
October 8, 2018
Last Updated
March 8, 2022
Sponsor
Vanderbilt University Medical Center
Collaborators
Vanderbilt Institute for Clinical and Translational Research (Learning Healthcare System)
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1. Study Identification

Unique Protocol Identification Number
NCT03702283
Brief Title
Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal in ICU Setting
Official Title
Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal in ICU Setting
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 31, 2019 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
Vanderbilt Institute for Clinical and Translational Research (Learning Healthcare System)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Penicillin Allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Penicillin Allergic ICU Patients
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Penicillin Allergic Risk Stratification Best Practice Alert
Intervention Description
Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
Primary Outcome Measure Information:
Title
Penicillin Allergy Label Removal
Description
The proportion of patients with low risk penicillin allergy whose labels are removed from the medical chart's allergy section.
Time Frame
Hospital discharge at approximately 7 days after ICU transfer
Title
Patients With Low Risk Penicillin Allergy Label Who Underwent Amoxicillin Challenge
Description
The proportion of patients with low risk penicillin allergy who underwent amoxicillin challenge
Time Frame
Hospital discharge at approximately 7 days after ICU transfer
Secondary Outcome Measure Information:
Title
Adverse Events (in Particular, Reported Allergic Events)
Description
The proportion of penicillin allergic patients challenged with amoxicillin who reported adverse events
Time Frame
Hospital discharge at approximately 7 days after ICU transfer
Title
Communication About Penicillin Allergy in Discharge Summary
Description
The proportion of penicillin allergic patients whose discharge summary contains information about penicillin allergy at discharge.
Time Frame
Hospital discharge at approximately 7 days after ICU transfer
Title
Antibiotic Utilization by Patients
Description
The number of changes or new starts of penicillin treatments as a result of penicillin allergy label removal and the proportion of patients experiencing this event
Time Frame
2 years observation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 ICU. Exclusion Criteria: Patients with a penicillin allergy reported in their chart under ICU care, but who are currently medically unstable.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cosby A Stone, Jr., MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chris Lindsell, PhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35131513
Citation
Koo G, Stollings JL, Lindsell C, Dear ML, Kripalani S, Nelson GE, McCoy AB, Rice TW, Phillips EJ, Stone CA Jr; Vanderbilt University Medical Center Learning Healthcare System. Low-risk penicillin allergy delabeling through a direct oral challenge in immunocompromised and/or multiple drug allergy labeled patients in a critical care setting. J Allergy Clin Immunol Pract. 2022 Jun;10(6):1660-1663.e2. doi: 10.1016/j.jaip.2022.01.041. Epub 2022 Feb 5. No abstract available.
Results Reference
derived

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Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal in ICU Setting

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