Clinical trial NCT05272592: Protocol for CAMUS Nurse Delphi Study
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perioperative/Postoperative Complications
Urologic Diseases
Lead sponsor: Melbourne Health
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Validation of the newly proposed CAMUS System and CAMUS CCI in an experienced nursing staff population
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
Study officials:
affiliation: Melbourne Health
name: Marc Furrer, MD
role: PRINCIPAL_INVESTIGATOR
References: