Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000135819
Ethics application status
Approved
Date submitted
26/01/2012
Date registered
31/01/2012
Date last updated
29/03/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of compliance and quality in administration of the WHO Surgical Safety Checklist in two Auckland hospitals.
Scientific title
An audit at two Auckland hospitals of the compliance and quality of WHO Surgical Safety Checklist administration
Secondary ID [1] 279800 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Administration of, and compliance with, the WHO Surgical Safety Checklist 285681 0
Condition category
Condition code
Surgery 285867 285867 0 0
Other surgery
Anaesthesiology 285868 285868 0 0
Other anaesthesiology
Public Health 285899 285899 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational audit only - no intervention in this study. We will observe a random selection of operations at both hospitals from November 2011 until 200 cases have been observed (estimated 2 months from actual study start). Observers will rate compliance with, and operating room team engagement during administration of the Checklist. A sample of 100 operative procedures at each hospital will be observed. Data will be collected using a standardised assessement tool developed for this use.
Intervention code [1] 284125 0
Not applicable
Comparator / control treatment
Comparison of compliance and quality of WHO Surgical Safety Checklist use between two Auckland Hospitals
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286365 0
Compliance with the administration of the checklist domains.
Timepoint [1] 286365 0
At the end of data collection (N=200)
Secondary outcome [1] 295691 0
Timing of the checklist administration
Timepoint [1] 295691 0
At the end of data collection (N=200)
Secondary outcome [2] 295692 0
Engagement of operating teams during checklist administration
Timepoint [2] 295692 0
At the end of data collection (N=200)

Eligibility
Key inclusion criteria
All cases that involve all three operating room teams (1. Nursing, 2. Aneasthesia, 3. Surgery) will be eligible.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
N/A. We are not auditing patients / participants; only the operating team as a whole.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 4085 0
New Zealand
State/province [1] 4085 0

Funding & Sponsors
Funding source category [1] 284577 0
University
Name [1] 284577 0
University of Auckland
Country [1] 284577 0
New Zealand
Primary sponsor type
University
Name
Dept of Anaesthiology, University of Auckland
Address
L12 Auckland City Hospital
2 Park Road
Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 283494 0
None
Name [1] 283494 0
None
Address [1] 283494 0
Country [1] 283494 0
New Zealand
Other collaborator category [1] 260477 0
University
Name [1] 260477 0
Dept of Surgery, University of Auckland
Address [1] 260477 0
L12 Auckland City Hospital
2 Park Road
Grafton
Auckland 1023
Country [1] 260477 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286564 0
Northern Y Regional Ethics Committe
Ethics committee address [1] 286564 0
C/o Ministry of Health
PO Box 1031
Hamilton 3240
Ethics committee country [1] 286564 0
New Zealand
Date submitted for ethics approval [1] 286564 0
14/09/2011
Approval date [1] 286564 0
31/10/2011
Ethics approval number [1] 286564 0
NTY/11/EXP/075

Summary
Brief summary
The World Health Organisation (WHO) has developed an airline cockpit-style checklist to make surgery safer by reducing errors and improving team work in the operating room. A study from eight centres world-wide showed that the Checklist reduced patient harm and actually saved lives. In 2010 a tool was developed to allow an independant observer to record compliance and quality in administration of the checklist during an episode of surgery. We received expedited ethics approval to use this tool to audit 100 surgical cases at a large Auckland hospital. Compliance proved to be good in administering some items of the checklist, and poor with respect to others. It was also determined that there was considerable potential to improve engagement by theatre teams during the process of administration.
Anecdotally (observations by surgeons who work at other large Auckland hospitals) there may be better compliance and engagement associated with different methods of administration. Therefore we propose to observe a random selection of operations at two large hospitals using exactly the same methodology as our previous study. Agreement will be obtained from all relevant clinical teams. 100 operative procedures will be audited at each hospital. This study will inform a process of continuous quality improvement aimed at enhancing safety in the operating room. No information that will identifies any staff or patients from the audited surgical cases will be gathered.
Trial website
N/A
Trial related presentations / publications
N Z Med J. 2011 Sep 9;124(1342):48-58."Compliance and quality in administration of a Surgical Safety Checklist in a tertiary New Zealand hospital." Vogts N, Hannam JA, Merry AF, Mitchell SJ.
Public notes

Contacts
Principal investigator
Name 33685 0
Address 33685 0
Country 33685 0
Phone 33685 0
Fax 33685 0
Email 33685 0
Contact person for public queries
Name 16932 0
Jacqui Hannam
Address 16932 0
Dept of Anaesthesiology
University of Auckland
L12 Auckland City Hospital
Auckland 1023
Country 16932 0
New Zealand
Phone 16932 0
+64 9 3737 599 ext 81143
Fax 16932 0
Email 16932 0
j.hannam@auckland.ac.nz
Contact person for scientific queries
Name 7860 0
Jacqui Hannam
Address 7860 0
Dept of Anaesthesiology
University of Auckland
L12 Auckland City Hospital
Auckland 1023
Country 7860 0
New Zealand
Phone 7860 0
+64 9 3737 599 ext 81143
Fax 7860 0
Email 7860 0
j.hannam@auckland.ac.nz

No information has been provided regarding IPD availability


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.