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NCT05272592 Clinical Trial

Protocol for CAMUS Nurse Delphi Study

Perioperative/Postoperative Complications Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05272592
Other study ID # 2022.046
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date December 9, 2021
Est. completion date December 2023

Study information
Verified date October 2022
Source Melbourne Health
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 250
Est. completion date December 2023
Est. primary completion date June 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Certified nurses - Local or international nurses - Inpatient or outpatient nurses - Peri-operative nurses - Urology-specific advanced practice nurses/nurse practitioners Exclusion Criteria: - Under 18 years of age

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Australia The Royal Melbourne Hospital Melbourne Victoria

Sponsors (1)
Lead Sponsor Collaborator
Melbourne Health

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Validation of the newly proposed CAMUS System and CAMUS CCI in an experienced nursing staff population 6 months
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