Clinical trial NCT04827602: Drug Allergy Labels After Drug Allergy Investigation
Official title: Drug Allergy Labels in Different Electronic Health Records After Drug Allergy Investigation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Hypersensitivity
Keywords: drug allergy
drug allergy labels
penicillin allergy labels
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: Research Unit Of General Practice, Copenhagen
First posted: 2021-04-01
Enrollment: 849
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Degree of matching drug allergy testing and drug allergy labels
timeFrame: Baseline
Secondary outcomes:
measure: Degree of match between registered drug allergy labels
timeFrame: Baseline
Other outcomes:
measure: Analysis of predictors for failure to update drug allergy labels
timeFrame: Baseline
Locations:
city: Copenhagen
country: Denmark
facility: Allergy Clinic, Department of Dermato-Allergology, Copenhagen University Hospital
Study officials:
affiliation: Allergy Clinic, Copenhagen University Hospital, Copenhagen
name: Lene H. Garvey
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.