Protocol for CAMUS Nurse Delphi Study | NCT05272592

Studies
Protocol for CAMUS Nurse Delphi Study

NCT05272592

Sponsor

Melbourne Health

Status

Unknown status

Last Update Posted

Oct 17, 2022Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Perioperative/Postoperative Complications
Urologic Diseases

Interventions

Not provided

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 9, 2021Actual

Primary Completion Date

Jun 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Feb 18, 2022

First Submission Date that Met QC Criteria

Feb 28, 2022

First Posted Date

Mar 9, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2022

Last Update Posted Date

Oct 17, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc Furrer, MD	Melbourne Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Royal Melbourne Hospital		Melbourne	Victoria		Australia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011183	Postoperative Complications
D014570	Urologic Diseases

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

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