Trial Review

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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
ACTRN12619000343101
Ethics application status
Approved
Date submitted
15/12/2018
Date registered
5/03/2019
Date last updated
5/03/2019
Date data sharing statement initially provided
5/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Patients' perception of qualitative and quantitative risk in preanaesthetic consent
Scientific title
Patients' perception of qualitative and quantitative risk in preanaesthetic consent
Secondary ID [1] 296886 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health Literacy 310820 0
Condition category
Condition code
Anaesthesiology 309495 309495 0 0
Anaesthetics
Public Health 309586 309586 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aim: To determine the relationship between quantitative and qualitative risk perceived by patients presenting for anaesthesia.
Participants > 18yrs will be recruited before their preanaesthetic consultation in the preadmission clinic.
Methods: All participants in this study will be asked the same questions. The order of questioning will be allocated as per the randomisation sequence.

All participants will be asked both sets of questions. Group A will be provided with a series of words describing risk such as 'rare, 'uncommon' 'common' 'frequent' and asked to choose which numerical descriptor eg 1:1000, 1:100 etc best applies to the verbal terms. Group B will be provided with the numerical descriptors of risk first and then asked the most appropriate word from a list best describing the meaning as per Group A. There will be no washout period.

The survey will take approximately 10 mins total.

All participants will be asked general demographic information and which method of describing risks they prefer (numerical or verbal) and whether they would like a discussion of risks to be included in the preanaesthetic consultation.

Expected Outcomes: to be able to correlate verbal descriptions of risk with numerical descriptions in order to develop a useful set of words that can be used to communicate risk more clearly when consenting patients for their anaesthetic.
Intervention code [1] 313848 0
Other interventions
Comparator / control treatment
Comparator number versus words
Control group
Active

Outcomes
Primary outcome [1] 308455 0
Where numbers are shown first, the primary outcome is the median/IQR/Range numerical score that are best represented by the words supplied as assessed by study-specific questionnaire
Timepoint [1] 308455 0
The time point is prior to anaesthesia consultation and informed consent for anaesthesia.
Primary outcome [2] 319333 0
Where the words are shown first, the primary outcome is the median/IQR/Range numerical score for each of the words supplied as assessed by study-specific questionnaire.
Timepoint [2] 319333 0
Prior to pre-anaesthesia patient review and informed consent
Secondary outcome [1] 365472 0
nil
Timepoint [1] 365472 0
nil

Eligibility
Key inclusion criteria
The eligibility criteria are patients over 18 years old who are presenting prior to their anaesthetic.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are those who are unable to consent for themselves or are under 18 years of age.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consecutively numbered opaque sealed envelopes containing the randomisation sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
100-200 patients will be studied. All data will be treated as non parametric and analysed accordingly. Descriptive statistics will also be presented,

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2019
Actual
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
3/01/2022
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13305 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 25879 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 301458 0
Self funded/Unfunded
Name [1] 301458 0
Nepean Hospital
Country [1] 301458 0
Australia
Primary sponsor type
Hospital
Name
Department of Anaesthesia and Pain Management
Address
Department of Anaesthesia and Pain Management, Nepean Hospital, Derby st, Kingswood, 2747, NSW
Country
Australia
Secondary sponsor category [1] 301148 0
None
Name [1] 301148 0
Address [1] 301148 0
Country [1] 301148 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302192 0
NEPEAN BLUE MOUNTAINS LOCAL HEALTH DISTRICT HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 302192 0
Ethics committee country [1] 302192 0
Australia
Date submitted for ethics approval [1] 302192 0
Approval date [1] 302192 0
12/06/2018
Ethics approval number [1] 302192 0
LNR/18/Nepean/53

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

Contacts
Principal investigator
Name 89426 0
Dr Rachel Smith
Address 89426 0
Department of Anaesthesia and Pain Management, Nepean Hospital, Derby st, Kingswood, 2747, NSW
Country 89426 0
Australia
Phone 89426 0
+61 423839001
Fax 89426 0
Email 89426 0
[email protected]
Contact person for public queries
Name 89427 0
Rachel Smith
Address 89427 0
Department of Anaesthesia and Pain Management, Nepean Hospital, Derby st, Kingswood, 2747, NSW
Country 89427 0
Australia
Phone 89427 0
+61 423839001
Fax 89427 0
Email 89427 0
[email protected]
Contact person for scientific queries
Name 89428 0
Rachel Smith
Address 89428 0
Department of Anaesthesia and Pain Management, Nepean Hospital, Derby st, Kingswood, 2747, NSW
Country 89428 0
Australia
Phone 89428 0
+61 423839001
Fax 89428 0
Email 89428 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• other researchers only

Conditions for requesting access:
• -

What individual participant data might be shared?
• Deidentified responses to the survey

What types of analyses could be done with individual participant data?
• deidentified analyses of all collected data

When can requests for individual participant data be made (start and end dates)?
From:
within 6 months of publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• by email and excel spreadsheet on request

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
802Ethical approval    Study-related document.pdf
803Study protocol    Study-related document.docx
804Other    Survey - Numerical Study-related document.pdf
805Other    Survey - Verbal Study-related document.pdf
806Other    Participant Information Sheet 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.