Drug Allergy Labels After Drug Allergy Investigation

Drug Allergy Labels in Different Electronic Health Records After Drug Allergy Investigation

The aim of this study is to investigate the degree of match between the drug allergy label in the hospital's electronic health record and primary care's electronic health record among patients who previously have been drug allergy tested.

Study Overview

• Status: Completed
• Conditions: Drug Hypersensitivity
• Intervention / Treatment: Other: Drug allergy label status in electronic health records

Detailed Description

Patients who previously have been penicillin allergy tested in 2017 to 2019 at the Allergy Clinic at Gentofte Hospital is included in the study. Patients are identified through a drug allergy database at the department.

A letter describing the study and the data collection process will be sent to the patients' General Practice offices (GP).

Data collection: The patients GP's are contacted by telephone where the information about the drug allergy labels in their electronical medical charts are shared. On the same day as the phone contact to the GP's office, the patient's electronical health record in the hospital system is accessed in order to gain information about the current drug allergy registrations.

Predictors for the explanatory analysis is collected partly through the phone call to the GP (such as numbers of patients and physicians at each GP and the electronic health system used), from the hospital electronic health record (such as number of hospital admissions since drug allergy testing) and from the drug allergy database.

• Study Type: Observational
• Enrollment (Actual): 849

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2900
    • Allergy Clinic, Department of Dermato-Allergology, Copenhagen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population is made up of patients who completed penicillin allergy testing in 2017 to 2019 at the Allergy Clinic, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark. The study population is estimated to 900 participants from both the Capital Region and Region Zealand.

Description

Inclusion Criteria:

• Penicillin allergy tested at the Allergy Clinic, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark in 2017-2019

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Allergy tested group; Patients who have completed penicillin allergy testing	Other: Drug allergy label status in electronic health records; Registered drug allergy labels in primary care and hospital electronic medical charts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of matching drug allergy testing and drug allergy labels	Degree of match between allergy testing outcomes and registered drug allergy labels in primary care and hospital electronic health records	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of match between registered drug allergy labels	Degree of match between registered drug allergy labels in primary care and hospital electronic health records	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of predictors for failure to update drug allergy labels	Exploratory analysis of predictors for failure to update the drug allergy labels. Predictors include sex, age, immediate/delayed index allergic reaction, drug allergy test results, patients pr GP, doctors pr GP, electronic system used, drug allergy test referrals from the same GP, drug allergy labels pr patient and admissions since drug allergy testing pr patient.	Baseline

Collaborators and Investigators

• Sponsor: University Hospital, Gentofte, Copenhagen
• Collaborators: Research Unit Of General Practice, Copenhagen
• Investigators: Principal Investigator: Lene H. Garvey, Allergy Clinic, Copenhagen University Hospital, Copenhagen

Publications and helpful links

General Publications

• Lachover-Roth I, Sharon S, Rosman Y, Meir-Shafrir K, Confino-Cohen R. Long-Term Follow-Up After Penicillin Allergy Delabeling in Ambulatory Patients. J Allergy Clin Immunol Pract. 2019 Jan;7(1):231-235.e1. doi: 10.1016/j.jaip.2018.04.042. Epub 2018 May 22.
• Vyles D, Chiu A, Routes J, Castells M, Phillips EJ, Kibicho J, Brousseau DC. Antibiotic Use After Removal of Penicillin Allergy Label. Pediatrics. 2018 May;141(5):e20173466. doi: 10.1542/peds.2017-3466.
• Sacco KA, Bates A, Brigham TJ, Imam JS, Burton MC. Clinical outcomes following inpatient penicillin allergy testing: A systematic review and meta-analysis. Allergy. 2017 Sep;72(9):1288-1296. doi: 10.1111/all.13168. Epub 2017 Apr 26.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Actual): July 15, 2021
• Study Completion (Actual): July 15, 2021

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: drug allergy; drug allergy labels; penicillin allergy labels
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Immune System Diseases; Drug-Related Side Effects and Adverse Reactions; Hypersensitivity; Drug Hypersensitivity
• Other Study ID Numbers: GEH-R-20068776

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No