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Trial registered on ANZCTR


Registration number
ACTRN12619001169134
Ethics application status
Approved
Date submitted
14/07/2019
Date registered
20/08/2019
Date last updated
11/02/2021
Date data sharing statement initially provided
20/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
An observational study of general surgery models in Australia
Scientific title
An Australian observational study of general surgery models of care for emergency patients, including Traditional, Hybrid and Acute Surgical Unit models.
Secondary ID [1] 298735 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emergency general surgery model 313663 0
Condition category
Condition code
Surgery 312078 312078 0 0
Other surgery
Public Health 312168 312168 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational study of the model of care used by general surgical departments for the care of emergency aka non-elective patients. The exposure assessed will be the type of emergency general surgery model in place at each hospital.
Acute Surgical Units were defined as those with a surgeon dedicated solely to EGS patients for greater than 50% of business hours. A Hybrid model lacked such surgeon allocation, but provided a registrar rostered solely to EGS patients for greater than 50% of business hours, or two or more half-day protected EGS theatre lists per week. Hospitals with a Traditional model had none of these features.
Data will be gained by staff questionnaires. Emergency departments are not part of this study.
Intervention code [1] 315000 0
Not applicable
Comparator / control treatment
Use of the Traditional model of structuring care for emergency general surgery patients.
Acute Surgical Units were defined as those with a surgeon dedicated solely to EGS patients for greater than 50% of business hours. A Hybrid model lacked such surgeon allocation, but provided a registrar rostered solely to EGS patients for greater than 50% of business hours, or two or more half-day protected EGS theatre lists per week. Hospitals with a Traditional model had none of these features.
Control group
Active

Outcomes
Primary outcome [1] 320715 0
Proportion of Australian medium- to large-sized hospitals using each emergency general surgery model.
This outcome will be assessed by inviting surgical staff at all such hospitals to complete a questionnaire, and reporting the proportion of hospitals utilising each model.
Timepoint [1] 320715 0
This data will be collected once only for each hospital. Surgical staff will be invited to complete the questionnaire in March-April 2019. There is no baseline time, as hospitals may have changed to the Acute Surgical Unit model (or another model) many years prior. This study is intended as a snapshot of current practice.
Secondary outcome [1] 372592 0
Bed number of hospitals utilising each emergency general surgery model, as assessed by study specific staff questionnaire, combined with freely available data on hospital characteristics from the Australian Institute of Health and Welfare.
This questionnaire has not been externally validated, and was designed specifically for this study.
Categorical measures will be summarized as proportions and assessed with Pearson’s chi-square test. All tests will be two-tailed and significance assessed at the 5% alpha level.
Timepoint [1] 372592 0
This data will be collected once only for each hospital. Surgical staff will be invited to complete the questionnaire in March-April 2019. There is no baseline time, as hospitals may have changed to the Acute Surgical Unit model (or another model) many years prior. This study is intended as a snapshot of current practice.
Secondary outcome [2] 372593 0
Secondary study outcomes will include reporting average subjective staff satisfaction amongst involved general surgery consultants and registrars, of hospitals utilising each emergency general surgery model, as assessed by study specific staff questionnaire.

Categorical data will be compared with Pearson’s chi-square test, or the Fisher exact test when zero values are encountered. Continuous data will be compared using either the Mann-Whitney U test for continuous data in two categories, or the Kruskal Wallis test for continuous data in three or more categories. All statistical tests will be two-tailed. The 5% alpha level will be used to assess significance.
Timepoint [2] 372593 0
This data will be collected once only for each hospital. Surgical staff will be invited to complete the questionnaire in March-April 2019. There is no baseline time, as hospitals may have changed to the Acute Surgical Unit model (or another model) many years prior. This study is intended as a snapshot of current practice.
Secondary outcome [3] 373022 0
Mean number of general surgeons in hospitals utilising each emergency general surgery model, as assessed by study specific staff questionnaire. This questionnaire has not been externally validated, and was designed specifically for this study.
Categorical measures will be summarized as proportions and assessed with Pearson’s chi-square test. All tests will be two-tailed and significance assessed at the 5% alpha level.
Timepoint [3] 373022 0
This data will be collected once only for each hospital. Surgical staff will be invited to complete the questionnaire in March-April 2019. There is no baseline time, as hospitals may have changed to the Acute Surgical Unit model (or another model) many years prior. This study is intended as a snapshot of current practice.
Secondary outcome [4] 373023 0
Trauma service sophistication in hospitals utilising each emergency general surgery model. Data will be obtained by study specific staff questionnaire, combined with freely available data on hospital characteristics from the Australian Institute of Health and Welfare.
This questionnaire has not been externally validated, and was designed specifically for this study.
Categorical measures will be summarized as proportions and assessed with Pearson’s chi-square test. All tests will be two-tailed and significance assessed at the 5% alpha level.
Timepoint [4] 373023 0
This data will be collected once only for each hospital. Surgical staff will be invited to complete the questionnaire in March-April 2019. There is no baseline time, as hospitals may have changed to the Acute Surgical Unit model (or another model) many years prior. This study is intended as a snapshot of current practice.

Eligibility
Key inclusion criteria
Eligible centres were Australian public hospitals offering elective general surgery, medium (>2,000 patient separations per-annum) or greater peer group, who offered an emergency general surgery service.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Centres were excluded if they were located outside Australia, private hospitals, did not offer both elective and emergency general surgery services or declined to participate.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Hospitals were grouped based on EGS structure as Traditional versus Hybrid or ASU. Categorical data were displayed as proportions and compared with Pearson’s chi-square test, or the Fisher exact test when zero values were encountered. Continuous data were reported as means. Given their expected non-normal distribution, these were compared using either the Mann-Whitney U test for continuous data in two categories, or the Kruskal Wallis test for continuous data in three or more categories. All statistical tests were two-tailed. The 5% alpha level was used to assess significance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/03/2019
Date of last participant enrolment
Anticipated
Actual
19/04/2019
Date of last data collection
Anticipated
Actual
19/04/2019
Sample size
Target
120
Accrual to date
Final
119
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 303288 0
Government body
Name [1] 303288 0
National Health and Medical Research Council
Country [1] 303288 0
Australia
Funding source category [2] 303289 0
University
Name [2] 303289 0
University of Adelaide post-graduate scholarship
Country [2] 303289 0
Australia
Funding source category [3] 303290 0
Charities/Societies/Foundations
Name [3] 303290 0
The Hospital Research Foundation
Country [3] 303290 0
Australia
Primary sponsor type
Individual
Name
Dr Ned Kinnear
Address
University of Adelaide
North Tce, University of Adelaide SA 5005
Country
Australia
Secondary sponsor category [1] 303309 0
University
Name [1] 303309 0
University of Adelaide
Address [1] 303309 0
North Tce, University of Adelaide SA 5005
Country [1] 303309 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303824 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 303824 0
Ethics committee country [1] 303824 0
Australia
Date submitted for ethics approval [1] 303824 0
12/08/2018
Approval date [1] 303824 0
20/11/2018
Ethics approval number [1] 303824 0
HREC/18/CALHN/529

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

Contacts
Principal investigator
Name 94938 0
Dr Ned Kinnear
Address 94938 0
Western Health, 160 Gordon St, Footscray VIC 3011
Country 94938 0
Australia
Phone 94938 0
+61 3 9496 5000
Fax 94938 0
Email 94938 0
ned.kinnear@adelaide.edu.au
Contact person for public queries
Name 94939 0
James Moore
Address 94939 0
Royal Adelaide Hospital
North Tce, Adelaide SA 5000
Country 94939 0
Australia
Phone 94939 0
+61 8 7074 2315
Fax 94939 0
Email 94939 0
James.Moore@sa.gov.au
Contact person for scientific queries
Name 94940 0
Ned Kinnear
Address 94940 0
Western Health, 160 Gordon St, Footscray VIC 3011
Country 94940 0
Australia
Phone 94940 0
+61 3 9496 5000
Fax 94940 0
Email 94940 0
ned.kinnear@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Informed consent of study participants included data confidentiality.
Additionally, ethics approval did not include data sharing.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3060Study protocol    377970-(Uploaded-07-05-2020-11-56-27)-Study-related document.docx



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.