Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001036101
Ethics application status
Approved
Date submitted
12/07/2019
Date registered
19/07/2019
Date last updated
19/07/2019
Date data sharing statement initially provided
19/07/2019
Date results information initially provided
19/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Attitudes of Anaesthetists regarding an anaesthesia led nurse sedation service model.
Scientific title
Attitudes of Anaesthetists regarding an anaesthesia led nurse sedation service model for low risk colonoscopy patients
Secondary ID [1] 298722 0
Nil known
Universal Trial Number (UTN)
U1111-1236-9277
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Procedural sedation for colonoscopy 313642 0
Condition category
Condition code
Anaesthesiology 312064 312064 0 0
Other anaesthesiology
Oral and Gastrointestinal 312065 312065 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A cross-sectional, mixed method survey of anaesthetists by using commercial software (Survey Monkey®). An invitation letter which includes objectives of the study, a brief summary of the study, information about consent and a link to the online survey will be distributed to consultant anaesthetists at a University teaching hospital. The email link will have an invitation letter that clearly informs the participants to complete the survey. The survey is voluntary and anonymous, and no email or website IP (internet protocol) address will be collected. It is estimated that the survey is take approximately 5 minutes to complete. The survey will be open for approximately one month.
Objectives of the study are to discover attitudes of consultant anaesthetists towards a anaesthesia-led nurse sedation model for adult patients undergoing elective colonoscopy.
Intervention code [1] 314984 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320694 0
To ascertain the attitudes of consultant anaesthetists towards an anaesthesia led nurse sedation model for adult patients undergoing elective colonoscopy at a university teaching hospital. This will be assessed by a purpose designed online survey and face to face interviews using a designed interview script.
Timepoint [1] 320694 0
1 month after participants receive the survey
Secondary outcome [1] 372542 0
The perceived safety of an anaesthesia led nurse sedation model for adult patients undergoing elective colonoscopy at a university teaching hospital. This will be assessed by a purpose designed online survey and face to face interviews using a designed interview script..
Timepoint [1] 372542 0
1 month after participants receive the survey
Secondary outcome [2] 372543 0
Whether anaesthetists would be prepared to act as a supervisor for nurses administering procedural sedation, including propofol in an anaesthesia led nurse sedation model for adult patients undergoing elective colonoscopy at a university teaching hospital. This will be assessed by a purpose designed online survey and face to face interviews using a designed interview script.
Timepoint [2] 372543 0
1 month after participants receive the survey
Secondary outcome [3] 372544 0
Whether anaesthetists would participate in the training of appropriate nurses for an anaesthesia led nurse sedation model for adult patients undergoing elective colonoscopy at a university teaching hospital. This will be assessed by a purpose designed online survey and face to face interviews using a designed interview script.
Timepoint [3] 372544 0
1 month after participants receive the survey

Eligibility
Key inclusion criteria
Consultant anaesthetists registered with the Australian New Zealand College of Anaesthetists (ANZCA) who work in a university teaching hospital in Australia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Trainees and anaesthestic students will be excluded.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
This study will employ the conventional 95% confidence level with margin of error of 7%. According to the University teaching hospital where the study will be conducted there are approximately 100 consultant anaesthetists employed. Assuming a desired confidence level of 95% i.e. we are confident that the value of any sample will fall in the range of the margin of error 95% of the time, with a realistic margin of error of +\- 5%, we would need 80 respondents. As for all surveys we are unable to predict exactly what response rate we will achieve. As there is excellent engagement from within the anaesthesia consultant group, even if we received a response rate 60%, which is still considered excellent by survey response standards, this accounts for a margin of error of 8.04%, which we consider acceptable.

Data will be presented as frequency counts, percentages, and mean or median as indicated. Associations of demographic, age, gender, public vs. private hospital, type of hospital and the area of practice will be examined and attitudinal responses evaluated by using multivariable ordered logistic regression. All analyses will be performed using Stata 10 (Stata Corp, College Station, TX).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/07/2017
Date of last participant enrolment
Anticipated
Actual
31/07/2017
Date of last data collection
Anticipated
Actual
31/08/2017
Sample size
Target
80
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14217 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 14219 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 27206 0
3084 - Heidelberg
Recruitment postcode(s) [2] 27207 0
3081 - Heidelberg West

Funding & Sponsors
Funding source category [1] 303274 0
Hospital
Name [1] 303274 0
Department of Anaesthesia, Austin Health
Country [1] 303274 0
Australia
Primary sponsor type
Hospital
Name
Department of Anaesthesia, Austin Health
Address
Department of Anaesthesia, 145 Studley Road Heidelberg VIC 3084 Australia
Country
Australia
Secondary sponsor category [1] 303291 0
None
Name [1] 303291 0
Address [1] 303291 0
Country [1] 303291 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303812 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 303812 0
L8 Harold Stokes Building 145 Studley Road Heidelberg Victoria Australia 3084
PO Box 5555
Ethics committee country [1] 303812 0
Australia
Date submitted for ethics approval [1] 303812 0
29/05/2017
Approval date [1] 303812 0
02/06/2017
Ethics approval number [1] 303812 0
LNR/17/Austin/224

Summary
Brief summary
The number of people needing a colonoscopy is going to increase in the future following the national rollout of the National Bowel Cancer Screening Program (NBCSP). The NBCSP was extended to include Australians 60 and 70 years in 2013 and 2015 respectively and biennial screening from 2017-18, meaning that the future demand for screening and surveillance endoscopy procedures is set to escalate, and the current service model will not meet demand.

This has prompted reconsideration of current models of service delivery. It is important to gauge how well a novel service model will be received before the development of a role can occur. This study aims to hypothetically test a general service model that has not been wholly defined. The level of agreement or disagreement with the statements will indicate, in general terms, the level of support such a role would garner from the Department of Anaesthesia. Participants will have the opportunity to discuss their support or concerns for the program. Themes identified in these discussions will be used to influence future decision making. The survey and face to face interviews have been designed to be completed quickly and pose no risk of harm to the participants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94898 0
A/Prof Laurence Weinberg
Address 94898 0
145 Studley Road Heidelberg VIC 3084
Department of Anaesthesia, Austin Health
Country 94898 0
Australia
Phone 94898 0
+61 3 94965000
Fax 94898 0
+61 3 94596421
Email 94898 0
[email protected]
Contact person for public queries
Name 94899 0
A/Prof Laurence Weinberg
Address 94899 0
145 Studley Road Heidelberg VIC 3084
Department of Anaesthesia, Austin Health
Country 94899 0
Australia
Phone 94899 0
+61 3 94965000
Fax 94899 0
+61 3 94596421
Email 94899 0
[email protected]
Contact person for scientific queries
Name 94900 0
A/Prof Laurence Weinberg
Address 94900 0
145 Studley Road Heidelberg VIC 3084
Department of Anaesthesia, Austin Health
Country 94900 0
Australia
Phone 94900 0
+61 3 94965000
Fax 94900 0
+61 3 94596421
Email 94900 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants have not consented for data sharing and all surveys collected are anonymous.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3026   [email protected]
3028Ethical approval    377960-(Uploaded-12-07-2019-12-30-03)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAttitudes of anesthetists towards an anesthesia-led nurse practitioner model for low-risk colonoscopy procedures: a cross-sectional survey.2020https://dx.doi.org/10.1186/s12960-020-0458-1
N.B. These documents automatically identified may not have been verified by the study sponsor.