Please note the ANZCTR will be unattended from Friday 20 December 2019 for the holidays. The Registry will re-open on Tuesday 07 January 2020. Submissions and updates will not be processed during that time.

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
ACTRN12619000647134
Ethics application status
Approved
Date submitted
21/04/2019
Date registered
1/05/2019
Date last updated
1/05/2019
Date data sharing statement initially provided
1/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial comparing video-assisted informed medical consent to traditional doctor patient consent for Mohs micrographic surgery.
Scientific title
A comparison of video assisted medical consent compared to traditional doctor-patient consent for medical procedures.
Secondary ID [1] 297983 0
Nil known
Universal Trial Number (UTN)
U1111-1231-7942
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Skin cancer 312396 0
Condition category
Condition code
Skin 310956 310956 0 0
Dermatological conditions
Surgery 311024 311024 0 0
Surgical techniques
Cancer 311098 311098 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will watch a 6 minute video describing Mohs micrographic surgery, including the method, risks, benefits, alternatives and aftercare. Following this, they will then see their doctor to address any personal questions or concerns, however, the procedure will not be explained to them again. Adherence will be ensured through direct observation of the participants by the study personnel.
Intervention code [1] 314200 0
Treatment: Other
Comparator / control treatment
Usual consent process of talking to their doctor as they normally would in standard practice.
Control group
Active

Outcomes
Primary outcome [1] 319765 0
Patient comprehension of the procedure, assessed using a 10-item knowledge questionnaire that was designed specifically for the study.
Timepoint [1] 319765 0
Immediately after the consent process
Secondary outcome [1] 369454 0
Patient satisfaction, as measured using a Likert scale satisfaction survey
Timepoint [1] 369454 0
Immediately after the consent process
Secondary outcome [2] 369456 0
Patient anxiety levels, as measured using the 6-item State-Trait Anxiety Inventory (STAI).
Timepoint [2] 369456 0
Immediately before and after the consent process
Secondary outcome [3] 369457 0
Time per consultation between patient and doctor, assessed by the study personnel using a stopwatch.
Timepoint [3] 369457 0
Time of consultation

Eligibility
Key inclusion criteria
Patients attending the Mohs micrographic surgery clinic at Royal North Shore Hospital or The Skin Hospital who will be consented for Mohs micrographic surgery.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those who are not able to provide informed medical consent for themselves. Also those who have a visual or hearing impairment.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation performed by computer generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
We calculated a sample size of 102 participants (51 per group) to detect a minimally clinically important difference of knowledge retention post consent as undertaken on a knowledge questionnaire with 80% power at 5% level of significance.

Continuous variables will be summarised using means and standard deviations, and Categorical variables will be summarised using frequencies and percentages.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13623 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 13640 0
The Skin Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 26290 0
2065 - St Leonards
Recruitment postcode(s) [2] 26310 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 302506 0
Charities/Societies/Foundations
Name [1] 302506 0
AVANT Doctors in training research grant
Address [1] 302506 0
AVANT Mutual Level 6 Tower 3/Darling Park, 201 Sussex St, Sydney NSW 2000
Country [1] 302506 0
Australia
Primary sponsor type
Individual
Name
Dr Rebecca Saunderson
Address
Department of Dermatology
Royal North Shore Hospital
Reserve Road,
St Leonards
NSW, 2065
Country
Australia
Secondary sponsor category [1] 302414 0
None
Name [1] 302414 0
Address [1] 302414 0
Country [1] 302414 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303162 0
Nepean Blue Mountains Local Health District Human Research Ethics Committee
Ethics committee address [1] 303162 0
PO Box 63, Penrith, NSW, 2751
Ethics committee country [1] 303162 0
Australia
Date submitted for ethics approval [1] 303162 0
12/06/2018
Approval date [1] 303162 0
18/07/2018
Ethics approval number [1] 303162 0
HREC/18/Nepean/78

Summary
Brief summary
The purpose of the study is to compare a new way of undertaking informed medical consent, that being with the aid of a video, to the regular way a doctor would tell you about the procedure (which is usually a conversation between the doctor and yourself).

Who is it for?
You may be eligible for this study if you are aged 18 or over and are attending Royal North Shore Hospital or The Skin Hospital (Darlinghurst) for Mohs micrographic surgery.

Study details
Participants will be randomised by chance into two groups. One group will first watch a 6 minute video about the procedure before talking with their doctor to address any questions. The other group will only talk with their doctor (usual practice). As part of this study, all participants will complete a number of questionnaires before and after the consent process.

It is hoped this research will show improved patient comprehension of the risks and benefits of the procedure, enhance patient satisfaction with the consent process, lower anxiety levels and save time.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92698 0
Dr Rebecca Saunderson
Address 92698 0
Department of Dermatology
Royal North Shore Hospital
Reserve Road,
St Leonards
NSW, 2065
Country 92698 0
Australia
Phone 92698 0
+61 2 9926 7111
Fax 92698 0
Email 92698 0
rebecca.saunderson@consentic.com
Contact person for public queries
Name 92699 0
Dr Rebecca Saunderson
Address 92699 0
Department of Dermatology
Royal North Shore Hospital
Reserve Road,
St Leonards
NSW, 2065
Country 92699 0
Australia
Phone 92699 0
+61 2 9926 7111
Fax 92699 0
Email 92699 0
rebecca.saunderson@consentic.com
Contact person for scientific queries
Name 92700 0
Dr Rebecca Saunderson
Address 92700 0
Department of Dermatology
Royal North Shore Hospital
Reserve Road,
St Leonards
NSW, 2065
Country 92700 0
Australia
Phone 92700 0
+61 2 99267111
Fax 92700 0
Email 92700 0
rebecca.saunderson@consentic.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified demographics of the participants
Time of consultation, knowledge scores, satisfaction and anxiety scores.
When will data be available (start and end dates)?
At the trial completion, no end date determined.
Available to whom?
To interested parties
Available for what types of analyses?
Meta analysis
How or where can data be obtained?
csv file with data points
What supporting documents are/will be available?
No other documents available
Summary results
No Results