Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2025-12-27 @ 2:37 AM
Study NCT ID:
NCT05272592
Status:
UNKNOWN
Last Update Posted:
2022-10-17
First Post:
2022-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protocol for CAMUS Nurse Delphi Study
Sponsor:
Melbourne Health
Organization:
Study Overview
Official Title:
Protocol for CAMUS Nurse Delphi Study: Active Involvement of Nursing Staff in Reporting and Grading Complication-Intervention Events - An Approach to Improve Patient Safety and Quality of Surgical Care
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
ENROLLING_BY_INVITATION
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:
Multi-staged, international Nurse Delphi study that aims to validate the newly proposed CAMUS System and CAMUS CCI in an experienced nursing staff population.
Detailed Description:
Background: Comprehensive and reproducible assessment of post-operative complications are essential for reliable evaluation of quality of care and subsequent reformation of hospital safety infrastructure. At present, significant discrepancies exist in complication reporting and grading, and current complication systems lack holistic assessment of patient care by failing to consider and incorporate nursing insight and perception of patient burden.
Objective: To gain experienced nursing perspective on current and future complication reporting and grading in Urology, validate the CAMUS-CCI, and quality control the use of the CDC in nurses.
Design, Setting, and Participants: The 12 part REDCap-based Delphi survey was developed in conjunction with methodologist review, experienced nursing and urologist opinion. Certified local and international inpatient and outpatient nurses specialised in urology, perioperative nurses, and urology-specific advanced practice nurses/nurse practitioners will be included. A minimum sample size of 250 participants is targeted.
Outcome Measurements and Statistical Analysis: The survey assesses participant demographics, nursing experience and opinion on complication reporting and the proposed CAMUS reporting recommendations, grading of intervention events using the existing Clavien-Dindo Classification and the proposed CAMUS Classification, and rating various clinical scenarios. Consensus will be defined as ≥75% agreement. If consensus is not reached, subsequent Delphi rounds will be performed under Steering Committee guidance.
Objective: To gain experienced nursing perspective on current and future complication reporting and grading in Urology, validate the CAMUS-CCI, and quality control the use of the CDC in nurses.
Design, Setting, and Participants: The 12 part REDCap-based Delphi survey was developed in conjunction with methodologist review, experienced nursing and urologist opinion. Certified local and international inpatient and outpatient nurses specialised in urology, perioperative nurses, and urology-specific advanced practice nurses/nurse practitioners will be included. A minimum sample size of 250 participants is targeted.
Outcome Measurements and Statistical Analysis: The survey assesses participant demographics, nursing experience and opinion on complication reporting and the proposed CAMUS reporting recommendations, grading of intervention events using the existing Clavien-Dindo Classification and the proposed CAMUS Classification, and rating various clinical scenarios. Consensus will be defined as ≥75% agreement. If consensus is not reached, subsequent Delphi rounds will be performed under Steering Committee guidance.
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?: