Drug Allergy Labels After Drug Allergy Investigation

Drug Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04827602
• Other study ID #: GEH-R-20068776
• Status: Completed
• Start date: April 15, 2021
• Est. completion date: July 15, 2021

Study information

• Verified date: May 2022
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 849
• Est. completion date: July 15, 2021
• Est. primary completion date: July 15, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Drug Hypersensitivity
• Hypersensitivity

Intervention

Other:
• Drug allergy label status in electronic health records
Registered drug allergy labels in primary care and hospital electronic medical charts

Locations

Country	Name	City	State
Denmark	Allergy Clinic, Department of Dermato-Allergology, Copenhagen University Hospital	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen	Research Unit Of General Practice, Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

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 — View 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. Review. — View 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). pii: e20173466. doi: 10.1542/peds.2017-3466. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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