Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-30 @ 4:05 PM
Study NCT ID:
NCT06528106
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-30
First Post:
2024-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Removal of Erroneous Penicillin Allergy Labels: Implementation Study (REPeAL)
Sponsor:
Royal Cornwall Hospitals Trust
Organization:
Study Overview
Official Title:
Removal of Erroneous Penicillin Allergy Labels: Implementation Study (REPeAL)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REPeAL
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: