Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001969257p
Ethics application status
Submitted, not yet approved
Date submitted
13/11/2018
Date registered
5/12/2018
Date last updated
28/11/2019
Date data sharing statement initially provided
5/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing information for consent for cardiology procedures given by a video, or by a doctor, to see if this improves patient understanding of a procedure.
Scientific title
A randomised controlled trial comparing video-assisted medical consent with traditional doctor-patient informed consent for procedures in cardiology to assess patient knowledge and satisfaction
Secondary ID [1] 296588 0
Nil known
Universal Trial Number (UTN)
U1111-1223-8900
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischaemic heart disease 310396 0
Coronary artery disease 310397 0
Chest pain 310398 0
Condition category
Condition code
Cardiovascular 309114 309114 0 0
Coronary heart disease
Cardiovascular 309192 309192 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will receive video-assisted consent or usual care when informed consent is undertaken for cardiology procedures.
Arm 1 (video-assisted consent)
Arm 2 (usual care)
The intervention is one short video animation (approximately 5 minutes) that discusses the risks, benefits and alternatives of the cardiology procedure, and will be watched on a computer or tablet computer in the doctor's clinic or hospital. The animations are narrated by a voiceover artist from a script constructed by cardiology specialists. These videos have been designed specifically for the study. The animation will be watched by the patient and a research assistant will supervise to ensure that the video is watched in its entirety by the patient. All participants will be offered the opportunity to ask questions after the video has been watched or after the doctor has undertaken informed consent. Only one video is watched by the participant, and only one video is available for the procedure.
Intervention code [1] 312898 0
Behaviour
Comparator / control treatment
The comparator group is informed medical consent provided by the cardiologist, which is usual / standard care.
Control group
Active

Outcomes
Primary outcome [1] 308093 0
Knowledge recall on a knowledge assessment scored out of ten following consent.
The knowledge recall has been designed specifically for this study.
Timepoint [1] 308093 0
Measured immediately after informed consent has been undertaken.
Primary outcome [2] 308094 0
Patient satisfaction recorded on a likert scale.
Timepoint [2] 308094 0
Measured immediately after the consent has been undertaken
Secondary outcome [1] 353929 0
Physician satisfaction recorded on a likert scale.
Timepoint [1] 353929 0
Measured immediately after the consent has been undertaken
Secondary outcome [2] 353930 0
Time per consent measured using a stopwatch
Timepoint [2] 353930 0
Measured in minutes and seconds from the commencement of the consent, and finishing when there are no further questions from the patient

Eligibility
Key inclusion criteria
Patients aged greater than 18 years of age, who are undergoing a cardiology procedure, and who are able to provide informed medical consent will be invited to participate in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with visual impairment, hearing impairment, or who come from a non-English speaking background without a command of English, or do not have the capacity to consent will be excluded from participation.

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)
Allocation concealment will be undertaken by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation will be used to randomly allocate subjects into the different groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We calculated a sample size of 152 participants (76 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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/03/2020
Actual
Date of last participant enrolment
Anticipated
16/11/2020
Actual
Date of last data collection
Anticipated
16/11/2020
Actual
Sample size
Target
152
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12395 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 24662 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 301166 0
Charities/Societies/Foundations
Name [1] 301166 0
AVANT DIT Grant
Country [1] 301166 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Consentic
Address
PO Box 4118
Royal North Shore Hospital
NSW 2065
Country
Australia
Secondary sponsor category [1] 300788 0
None
Name [1] 300788 0
Address [1] 300788 0
Country [1] 300788 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301910 0
Austin Health Ethics Committee
Ethics committee address [1] 301910 0
Ethics committee country [1] 301910 0
Australia
Date submitted for ethics approval [1] 301910 0
14/11/2018
Approval date [1] 301910 0
Ethics approval number [1] 301910 0

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

Contacts
Principal investigator
Name 88526 0
Dr Julia Rhodes
Address 88526 0
Department of Dermatology
Alfred Hospital
55 Commercial Road
Melbourne
Victoria 3004
Australia
Country 88526 0
Australia
Phone 88526 0
+61 420902720
Fax 88526 0
Email 88526 0
julia.rhodes@consentic.com
Contact person for public queries
Name 88527 0
Julia Rhodes
Address 88527 0
Department of Dermatology
Alfred Hospital
55 Commercial Road
Melbourne
Victoria 3004
Australia
Country 88527 0
Australia
Phone 88527 0
+61 420902720
Fax 88527 0
Email 88527 0
julia.rhodes@consentic.com
Contact person for scientific queries
Name 88528 0
Julia Rhodes
Address 88528 0
Department of Dermatology
Alfred Hospital
55 Commercial Road
Melbourne
Victoria 3004
Australia
Country 88528 0
Australia
Phone 88528 0
+61 420902720
Fax 88528 0
Email 88528 0
julia.rhodes@consentic.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There are no plans to make individual participant data routinely publicly available. The only personal data to be collected is gender and age.


What supporting documents are/will be available?

No Supporting Document Provided



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.