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Penicillin Allergy Risk-Stratification and Delabeling of Low-Risk Patients

Primary Purpose

Antibiotic Allergy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physician-targeted CDS tool for PCN allergy delabeling
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Antibiotic Allergy

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Pediatric Hospital Medicine service Existing penicillin allergy label in the EHR Screened as low-risk for true PCN allergy (based on usual-care nursing intake questions at time of admission)

Exclusion Criteria:

None, provider may opt out of CDS tool at any time

Sites / Locations

  • Monroe Carell Jr Children's Hospital at VanderbiltRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Pharmacist-led Evaluation

Provider-targeted Clinical Decision Support Tool

Arm Description

Patients randomized to the pharmacist-led arm will appear in the pharmacy-penicillin electronic health care dashboard. A pharmacist may, at their discretion and in consultation with the primary care team, perform an allergy risk-stratification and oral challenge in low-risk patients using local standard of care protocol

This intervention will provide access to a best-practices alert (BPA) containing the patient's risk-stratification status and a link to the local standard of care protocol, oral amoxicillin challenge order set and written consent form (same resources as used in pharmacist -led electronic health record dashboard). If the provider opts to perform the oral challenge and it is successfully passed, a second BPA will prompt them to update the allergy status in the medical record.

Outcomes

Primary Outcome Measures

Allergy Delabeling Performed
Percentage of enrolled encounters (intervention arm) in which providers perform allergy delabeling

Secondary Outcome Measures

Allergy Label Adjustments in EHR
Percentage of enrolled encounters with an oral challenge in which allergy label has been removed from patients' medical records.

Full Information

First Posted
September 26, 2022
Last Updated
February 21, 2023
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05561777
Brief Title
Penicillin Allergy Risk-Stratification and Delabeling of Low-Risk Patients
Official Title
Implementation of Penicillin Allergy Risk Stratification and Delabeling of Low-Risk Patients: Provider-Targeted Clinical Decision Support Versus Pharmacist-Led Approach
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

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

5. Study Description

Brief Summary
Children are often reported to have antibiotics allergies, with approximately 10% of the US population labeled as allergic to an antibiotic, however, recent studies have demonstrated that the majority of symptoms reported as an allergy by parents are often non-IgE-mediated adverse reactions or symptoms of a viral illness (e.g. rash, vomiting, diarrhea). Additionally, over 90% of patients with reported penicillin allergy have negative skin testing results. Several studies in children have found that an allergy questionnaire can accurately identify those who are at low risk for severe antibiotic allergy and the allergy label can be safely removed. Appropriately delabeling antibiotic allergies has been shown to improve patient care through changing prescribing behavior and lowering health care costs. In this study, the investigators will perform a randomized trial comparing a provider-targeted clinical decision support tool to a pharmacist-led approach. The physician-targeted CDS tool will inform providers of their patient's allergy risk stratification result, protocol, electronic health record order and documentation support. The pharmacist-led approach consists of electronic health record dashboard that includes identical information to the provider arm. The primary outcome will be the frequency of penicillin allergy encounters with an allergy label removed at the time of discharge. Secondary outcomes will include the percentage of encounter with a penicillin allergy label in the electronic medical record 3 months after discharge, hospital length of stay and antibiotic utilization.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pharmacist-led Evaluation
Arm Type
No Intervention
Arm Description
Patients randomized to the pharmacist-led arm will appear in the pharmacy-penicillin electronic health care dashboard. A pharmacist may, at their discretion and in consultation with the primary care team, perform an allergy risk-stratification and oral challenge in low-risk patients using local standard of care protocol
Arm Title
Provider-targeted Clinical Decision Support Tool
Arm Type
Experimental
Arm Description
This intervention will provide access to a best-practices alert (BPA) containing the patient's risk-stratification status and a link to the local standard of care protocol, oral amoxicillin challenge order set and written consent form (same resources as used in pharmacist -led electronic health record dashboard). If the provider opts to perform the oral challenge and it is successfully passed, a second BPA will prompt them to update the allergy status in the medical record.
Intervention Type
Other
Intervention Name(s)
Physician-targeted CDS tool for PCN allergy delabeling
Intervention Description
This intervention will provide access to a best-practices alert (BPA) containing the patient's risk-stratification status and a link to the local standard of care protocol, oral amoxicillin challenge order set and written consent form (same resources as used in pharmacist -led electronic health record dashboard). If the provider opts to perform the oral challenge and it is successfully passed, a second BPA will prompt them to update the allergy status in the medical record.
Primary Outcome Measure Information:
Title
Allergy Delabeling Performed
Description
Percentage of enrolled encounters (intervention arm) in which providers perform allergy delabeling
Time Frame
Within 1 day of discharge for each encounter
Secondary Outcome Measure Information:
Title
Allergy Label Adjustments in EHR
Description
Percentage of enrolled encounters with an oral challenge in which allergy label has been removed from patients' medical records.
Time Frame
3 months after discharge for each encounter

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pediatric Hospital Medicine service Existing penicillin allergy label in the EHR Screened as low-risk for true PCN allergy (based on usual-care nursing intake questions at time of admission) Exclusion Criteria: None, provider may opt out of CDS tool at any time
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Justine Stassun
Phone
6159367276
Email
justine.c.stassun@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Antoon, MD, PhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Monroe Carell Jr Children's Hospital at Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Antoon, MD, PhD
Phone
615-936-9348
Email
james.antoon@vumc.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Penicillin Allergy Risk-Stratification and Delabeling of Low-Risk Patients

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