Removal of Erroneous Penicillin Allergy Labels: Implementation Study (REPeAL) (REPeAL)

To test the implementation of penicillin allergy de-labelling delivered by the responsible clinical teams and the antimicrobial stewardship teams across all medical, surgical and critical care specialities in a UK hospital using the developed toolkit and a validated penicillin allergy decision support tool.

Study Overview

• Status: Active, not recruiting
• Conditions: Penicillin Allergy

Detailed Description

Aim:

To test implementation of the penicillin allergy de-labelling complex intervention in surgical, medical and critical care patient pathway.

Objectives:

• To use the Institute for Health Improvement (IHI) Model for Improvement methodology to implement the penicillin allergy de-labelling complex intervention in each setting (surgery, medicine, critical care)
• To measure the number of patients meeting inclusion criteria (>16 with a penA not prescribed first line antibiotics) who have had their penicillin allergy record assessed by the wider clinical teams and separately by the AMS team.
• To measure the patient uptake of penicillin allergy record removal (i.e. the rate of patient declining de-label / DOC).

To interview 10-15 patients and 10-15 healthcare workers to gain insight into the penicillin allergy de labelling process.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• United Kingdom
  • Cornwall
    • Truro, Cornwall, United Kingdom, TR1 3LJ
      • Royal Cornwall Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All adult (>16) patients admitted to hospital over the study period with a penicillin allergy record preventing first line antibiotic use.

Description

Inclusion Criteria:

All adult (>16) patients admitted to hospital over the study period with a penicillin allergy record preventing first line antibiotic use.

Exclusion Criteria:

None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients admitted to adult medical, surgical and critical care specialities with a penicillin allergy record, where the allergy record is preventing first line antibiotic therapy, that are safely de-labelled.	1 year

Collaborators and Investigators

• Sponsor: Royal Cornwall Hospitals Trust

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: July 25, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Immune System Diseases; Drug-Related Side Effects and Adverse Reactions; Hypersensitivity; Drug Hypersensitivity
• Other Study ID Numbers: 2324.RCHT.66; 335337 (Other Identifier: IRAS); NIHR300542 (Other Grant/Funding Number: NIHR)

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