Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-29 @ 2:46 AM
Study NCT ID:
NCT04493866
Status:
COMPLETED
Last Update Posted:
2020-07-30
First Post:
2020-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality Improvement Study on Operative Consent Forms
Sponsor:
Barts & The London NHS Trust
Organization:
Study Overview
Official Title:
Delivering High Quality Documentation on Operative Consent Forms; A UK Major Trauma Centre Quality Improvement Study
Status:
COMPLETED
Status Verified Date:
2020-05
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:
None
Brief Summary:
A Quality Improvement Project was undertaken to improve the completion of operative consent forms within a UK hospital plastic surgery department. Four weekly interventions were made which were accompanied by four further data collection cycles.
Detailed Description:
Background Royal College of Surgeons guidelines exist on the importance of full, accurate and legible completion of consent forms as a key part of the process of gaining informed consent. In addition to this, consent forms serve as an important medico-legal document to protect clinicians and patients should problems arise. It is therefore in all parties' interests that they are correctly completed.
It was noted that consent forms within the Royal London Hospital Plastic Surgery department were often not correctly completed. A Quality Improvement Project was undertaken to improve the completion of consent forms within the department.
Materials and Methods Common problem areas on consent forms were identified and QI methodology was used to design the study including selection of appropriate outcome, process and balancing measures. Baseline information on completion of: 1) patient details, 2) consultant details, 3) legibility, 4) use of abbreviations in description of operation/complications, and 5) patient signatures was collected. Four weekly interventions were made which were accompanied by four further data collection cycles. A further re-audit took place 4 months following the completion of the project to establish whether improvements had been sustained.
It was noted that consent forms within the Royal London Hospital Plastic Surgery department were often not correctly completed. A Quality Improvement Project was undertaken to improve the completion of consent forms within the department.
Materials and Methods Common problem areas on consent forms were identified and QI methodology was used to design the study including selection of appropriate outcome, process and balancing measures. Baseline information on completion of: 1) patient details, 2) consultant details, 3) legibility, 4) use of abbreviations in description of operation/complications, and 5) patient signatures was collected. Four weekly interventions were made which were accompanied by four further data collection cycles. A further re-audit took place 4 months following the completion of the project to establish whether improvements had been sustained.
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?: