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

Active, not recruiting

• Conditions: Penicillin Allergy

• Registration Number: NCT06528106
• Lead Sponsor: Royal Cornwall Hospitals Trust

Brief Summary

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.

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 Timeline

• Status Verified: 2024-06
• Study Start: 2024-06-18
• Study First Submitted: 2024-07-25
• Study First Submitted QC: 2024-07-25
• Last Update Submitted: 2024-07-25
• Study First Posted: 2024-07-30
• Last Update Posted: 2024-07-30
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Royal Cornwall Hospital; 🇬🇧 Truro, Cornwall, United Kingdom