NCT04827602

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
849

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

3 months

First QC Date

March 30, 2021

Last Update Submit

May 25, 2022

Conditions

Keywords

drug allergydrug allergy labelspenicillin allergy labels

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Degree of match between registered drug allergy labels

    Baseline

Other Outcomes (1)

  • Analysis of predictors for failure to update drug allergy labels

    Baseline

Study Arms (1)

Allergy tested group

Patients who have completed penicillin allergy testing

Other: Drug allergy label status in electronic health records

Interventions

Registered drug allergy labels in primary care and hospital electronic medical charts

Allergy tested group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allergy Clinic, Department of Dermato-Allergology, Copenhagen University Hospital

Copenhagen, 2900, Denmark

Location

Related 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.

  • 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.

MeSH Terms

Conditions

Drug Hypersensitivity

Interventions

Electronic Health Records

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Medical Records Systems, ComputerizedMedical RecordsRecordsData CollectionEpidemiologic MethodsInvestigative TechniquesOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Lene H. Garvey

    Allergy Clinic, Copenhagen University Hospital, Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D student

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 1, 2021

Study Start

April 15, 2021

Primary Completion

July 15, 2021

Study Completion

July 15, 2021

Last Updated

May 26, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations