Protocol for CAMUS Nurse Delphi Study

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

Multi-staged, international Nurse Delphi study that aims to validate the newly proposed CAMUS System and CAMUS CCI in an experienced nursing staff population.

Study Overview

• Status: Enrolling by invitation
• Conditions: Urologic Diseases; Perioperative/Postoperative Complications

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.

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia
      • The Royal Melbourne Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Certified local-and-international inpatient-and-outpatient nurses specialised in urology, perioperative nurses, and urology-specific advanced practice nurses/nurse practitioners will be included.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Nursing staff; Certified local-and-international inpatient-and-outpatient nurses specialised in urology, perioperative nurses, and urology-specific advanced practice nurses/nurse practitioners will be included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Validation of the newly proposed CAMUS System and CAMUS CCI in an experienced nursing staff population	6 months

Collaborators and Investigators

• Sponsor: Melbourne Health
• Investigators: Principal Investigator: Marc Furrer, MD, Melbourne Health

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: February 18, 2022
• First Submitted That Met QC Criteria: February 28, 2022
• First Posted (Actual): March 9, 2022

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 14, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Urologic Diseases
• Other Study ID Numbers: 2022.046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No