Removal of Erroneous Penicillin Allergy Labels: Implement... | NCT06528106

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

NCT06528106

Sponsor

Royal Cornwall Hospitals Trust

Status

Unknown status

Last Update Posted

Jul 30, 2024Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Penicillin Allergy

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
335337	Other Identifier	IRAS
NIHR300542	Other Grant/Funding Number	NIHR

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 18, 2024Actual

Primary Completion Date

Jun 2025Estimated

Completion Date

Jun 2025Estimated

First Submitted Date

Jul 25, 2024

First Submission Date that Met QC Criteria

Jul 25, 2024

First Posted Date

Jul 30, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2024

Last Update Posted Date

Jul 30, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Cornwall Hospital		Truro	Cornwall	TR1 3LJ	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided