Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000853943
Ethics application status
Approved
Date submitted
22/05/2020
Date registered
27/08/2020
Date last updated
27/08/2020
Date data sharing statement initially provided
27/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title

Remote video auditing of surgical safety checklist compliance before and after feedback in the emergency operating theatre at the Royal Melbourne Hospital
Scientific title

Remote video auditing of hospital staff surgical safety checklist compliance before and after feedback in the emergency operating theatre at the Royal Melbourne Hospital
Secondary ID [1] 301351 0
nil
Universal Trial Number (UTN)
U1111-1252-4376
Trial acronym
nil
Linked study record
nil

Health condition
Health condition(s) or problem(s) studied:
Surgical safety checklist practice compliance 317567 0
Condition category
Condition code
Surgery 315652 315652 0 0
Other surgery
Public Health 316052 316052 0 0
Other public health
Surgery 316053 316053 0 0
Surgical techniques
Emergency medicine 316054 316054 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
During the observation period, participants will monitored for the entire duration of an individual surgery via remote video every day for 4 weeks without feedback, followed by 4 weeks of weekly feedback of performance reports to healthcare workers.

Two independent auditors will review and assess all the recorded video data. An event is defined as when a patient is having an operation in OR 2. “Passing” an event means healthcare workers have completed 3 phases of the checklist procedure. The criteria for “failing” an event is when any one of the 3 phases of the checklist procedure is not completed. The three phases of the checklist completion are: 1) before the induction of anaesthesia (“sign in”) and 2) before the incision of the skin (“time out”) and 3) before the patient leaves the operating room (“sign out”). This checklist is adhered to the World Health Organisation Surgical Safety Checklist: https://www.who.int/patientsafety/safesurgery/tools_resources/SSSL_Checklist_finalJun08.pdf?ua=1.

During the 4-week feedback period, a weekly performance report will be displayed in multiple areas of the perioperative department and will also be emailed weekly to all floor staff. In the case that a department meeting is held, performance reports will also be announced periodically. Feedback will be provided to all healthcare workers regardless of their involvement in this study.
Intervention code [1] 317645 0
Other interventions
Comparator / control treatment
4-week of no feedback
Control group
Active

Outcomes
Primary outcome [1] 323887 0
Compliance rate of surgical checklist completion. It is defined as the number of observed checklist items completed as a percentage of total number of checklist items that should be completed during the observation period.
Timepoint [1] 323887 0
Recorded videos will be reviewed daily for the duration of the 8 week study period.
Secondary outcome [1] 383251 0
Completion of each of the three phases of surgical checklist procedures. It is defined as the number of observed checklist items for each phase completed as a percentage of total number of checklist items that should be completed for each phase during the observation period.
Timepoint [1] 383251 0
Recorded videos will be reviewed daily for the duration of the 8 week study period.

Eligibility
Key inclusion criteria
All health care workers completing a surgical checklist in the emergency theatre
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any healthcare workers who do not work directly in the emergency theatre.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis of compliance rate before and after providing feedback will be calculated using paired t-test. A P value < 0.05 is considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/08/2020
Actual
Date of last participant enrolment
Anticipated
2/11/2020
Actual
Date of last data collection
Anticipated
2/11/2020
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 30343 0
3050 - Royal Melbourne Hospital

Funding & Sponsors
Funding source category [1] 305788 0
Hospital
Name [1] 305788 0
The Royal Melbourne Hospital
Country [1] 305788 0
Australia
Primary sponsor type
Hospital
Name
Department of Anaesthesia and Pain Management, Royal Melbourne Hospital
Address
300 Grattan St, Parkville, Victoria, 3050
Country
Australia
Secondary sponsor category [1] 306227 0
None
Name [1] 306227 0
Address [1] 306227 0
Country [1] 306227 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306062 0
The Melbourne Health Human Research Ethics Committee - Quality Assurance Committee
Ethics committee address [1] 306062 0
Ethics committee country [1] 306062 0
Australia
Date submitted for ethics approval [1] 306062 0
06/05/2020
Approval date [1] 306062 0
23/07/2020
Ethics approval number [1] 306062 0
QA2020080

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102562 0
Dr Irene Ng
Address 102562 0
Royal Melbourne Hospital, 300 Grattan St, Parkville, Victoria, 3050
Country 102562 0
Australia
Phone 102562 0
+613 9342 7540
Fax 102562 0
Email 102562 0
Irene.Ng@mh.org.au
Contact person for public queries
Name 102563 0
Irene Ng
Address 102563 0
Royal Melbourne Hospital, 300 Grattan St, Parkville, Victoria, 3050
Country 102563 0
Australia
Phone 102563 0
+613 9342 7540
Fax 102563 0
Email 102563 0
Irene.Ng@mh.org.au
Contact person for scientific queries
Name 102564 0
Irene Ng
Address 102564 0
Royal Melbourne Hospital, 300 Grattan St, Parkville, Victoria, 3050
Country 102564 0
Australia
Phone 102564 0
+613 9342 7540
Fax 102564 0
Email 102564 0
Irene.Ng@mh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.