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

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ClinicalTrials.gov Identifier: NCT03702270
Recruitment Status : Not yet recruiting
First Posted : October 11, 2018
Last Update Posted : August 21, 2019
Sponsor:
Collaborator:
Vanderbilt Institute for Clinical and Translational Research (Learning Healthcare System)
Information provided by (Responsible Party):
Elizabeth J Phillips, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Penicillin Allergy Other: Penicillin Allergic Risk Stratification Best Practice Alert Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2040 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: During the trial, randomization will occur using a stepped wedge cluster randomized controlled trial design. Medical units at VUMC will 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 2 months.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Penicillins

Arm Intervention/treatment
Experimental: 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.
Other: 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.

No Intervention: 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.



Primary Outcome Measures :
  1. Penicillin allergy label removal [ Time Frame: Hospital discharge at approximately 4 days after admission ]
    The proportion of patients with low risk penicillin allergy whose labels are removed from the medical chart's allergy section.

  2. Patients with low risk penicillin allergy label who underwent amoxicillin challenge [ Time Frame: Hospital discharge at approximately 4 days after admission ]
    The proportion of patients with low risk penicillin allergy who underwent amoxicillin challenge


Secondary Outcome Measures :
  1. Adverse events (in particular, reported allergic events) [ Time Frame: Hospital discharge at approximately 4 days after admission ]
    The proportion of penicillin allergic patients challenged with amoxicillin who reported adverse events

  2. Communication about penicillin allergy in discharge summary [ Time Frame: Hospital discharge at approximately 4 days after admission ]
    The proportion of penicillin allergic patients whose discharge summary contains information about penicillin allergy at discharge.

  3. Antibiotic utilization by patients [ Time Frame: Hospital discharge at approximately 4 days after admission and at 9 Months, 12 Months and 18 Months after discharge ]
    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

  4. Durability of penicillin allergy label removal [ Time Frame: Hospital discharge at approximately 4 days after admission and at 9 Months, 12 Months and 18 Months after discharge ]
    The proportion of penicillin allergic patients whose penicillin allergy labels were removed at discharge whose labels are not reentered into the chart.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  • Patients whose primary care is not at Vanderbilt.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03702270


Contacts
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Contact: Cosby Stone, MD, MPH 615-322-3412 cosby.a.stone@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Vanderbilt Institute for Clinical and Translational Research (Learning Healthcare System)
Investigators
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Principal Investigator: Elizabeth J Phillips, MD Vanderbilt University Medical Center
Study Chair: Chris Lindsell, PhD Vanderbilt University Medical Center

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Responsible Party: Elizabeth J Phillips, Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03702270     History of Changes
Other Study ID Numbers: 181734
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypersensitivity
Drug Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Penicillins
Anti-Bacterial Agents
Anti-Infective Agents