ANZCTR - Registration

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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

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]

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

Condition category

Condition code

Anaesthesiology

Other anaesthesiology

Oral and Gastrointestinal

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

1 month after participants receive the survey

Secondary outcome [1]

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]

1 month after participants receive the survey

Secondary outcome [2]

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]

1 month after participants receive the survey

Secondary outcome [3]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [2]

Austin Health - Heidelberg Repatriation Hospital - Heidelberg West

Recruitment postcode(s) [1]

3084 - Heidelberg

Recruitment postcode(s) [2]

3081 - Heidelberg West

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Department of Anaesthesia, Austin Health

Address [1]

Department of Anaesthesia, 145 Studley Road Heidelberg VIC 3084 Australia

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

L8 Harold Stokes Building 145 Studley Road Heidelberg Victoria Australia 3084
PO Box 5555

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/05/2017

Approval date [1]

02/06/2017

Ethics approval number [1]

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

A/Prof Laurence Weinberg

Address

145 Studley Road Heidelberg VIC 3084
Department of Anaesthesia, Austin Health

Country

Australia

Phone

+61 3 94965000

Fax

+61 3 94596421

laurence.weinberg@austin.org.au

Contact person for public queries

Name

Laurence Weinberg

Address

145 Studley Road Heidelberg VIC 3084
Department of Anaesthesia, Austin Health

Country

Australia

Phone

+61 3 94965000

Fax

+61 3 94596421

laurence.weinberg@austin.org.au

Contact person for scientific queries

Name

Laurence Weinberg

Address

145 Studley Road Heidelberg VIC 3084
Department of Anaesthesia, Austin Health

Country

Australia

Phone

+61 3 94965000

Fax

+61 3 94596421

laurence.weinberg@austin.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
3026				laurence.weinberg@austin.org.au
3028	Ethical 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

Source	Title	Year of Publication	DOI
Embase	Attitudes of anesthetists towards an anesthesia-led nurse practitioner model for low-risk colonoscopy procedures: a cross-sectional survey.	2020	https://dx.doi.org/10.1186/s12960-020-0458-1

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

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