Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001319268
Ethics application status
Approved
Date submitted
24/07/2018
Date registered
6/08/2018
Date last updated
11/11/2020
Date data sharing statement initially provided
11/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing information for consent for orthopaedic 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 informed consent to traditional informed consent for orthopaedic procedures to assess patient knowledge and satisfaction
Secondary ID [1] 295639 0
Nil known
Universal Trial Number (UTN)
U1111-1217-9545
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 308973 0
Hallux valgus 308974 0
Meniscal tear 308975 0
Arthritis 308976 0
Cartilage disorders 308977 0
Bone disease 308978 0
Joint injury 308979 0
Condition category
Condition code
Musculoskeletal 307872 307872 0 0
Osteoarthritis
Musculoskeletal 307873 307873 0 0
Other muscular and skeletal disorders
Surgery 307874 307874 0 0
Other surgery
Injuries and Accidents 308021 308021 0 0
Other injuries and accidents

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 orthopaedic procedures.
Arm 1 (video-assisted consent)
Arm 2 (usual care)
The intervention is a short video animation (approximately 5 minutes) that discusses the risks, benefits and alternatives of orthopaedic procedures, and will be watched on a computer or tablet computer in the doctors office. The animations are narrated by a voiceover artist from a script constructed by orthopaedic specialists. There are separate animations for each orthopaedic procedure that will be undertaken e.g. knee and hip arthroplasty, knee arthroscopy etc. These videos have bee designed specifically for the study. The animation will be watched by the patient and the research assistant will supervise to try and ensure that the video is completely watched 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.
Intervention code [1] 301958 0
Behaviour
Comparator / control treatment
The comparator group is informed medical consent provided by the orthopaedic surgeon, which is usual / standard care.
Control group
Active

Outcomes
Primary outcome [1] 306850 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] 306850 0
Measured immediately after informed consent has been undertaken.
Primary outcome [2] 306851 0
Patient satisfaction recorded on a likert scale.
Timepoint [2] 306851 0
Measured immediately after the consent has been undertaken
Secondary outcome [1] 349938 0
Physician satisfaction recorded on a likert scale.
Timepoint [1] 349938 0
Measured immediately after the consent has been undertaken
Secondary outcome [2] 349939 0
Time per consent measured using a stopwatch
Timepoint [2] 349939 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 an orthopaedic 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
Recruiting
Date of first participant enrolment
Anticipated
10/08/2018
Actual
6/05/2019
Date of last participant enrolment
Anticipated
30/06/2021
Actual
Date of last data collection
Anticipated
30/06/2021
Actual
Sample size
Target
152
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11497 0
Campbelltown Private Hospital - Campbelltown
Recruitment postcode(s) [1] 23521 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 300221 0
Other
Name [1] 300221 0
AVANT DIT Grant
Country [1] 300221 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] 299634 0
None
Name [1] 299634 0
Address [1] 299634 0
Country [1] 299634 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301043 0
Nepean Blue Mountains Local Health District Human Research Ethics Committee
Ethics committee address [1] 301043 0
Ethics committee country [1] 301043 0
Australia
Date submitted for ethics approval [1] 301043 0
22/05/2018
Approval date [1] 301043 0
18/07/2018
Ethics approval number [1] 301043 0
HREC/18/Nepean/78

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

Contacts
Principal investigator
Name 85686 0
Dr Rebecca Saunderson
Address 85686 0
Department of Dermatology
Royal North Shore Hospital
Reserve Road
St Leonards
NSW 2065
Country 85686 0
Australia
Phone 85686 0
+61 2 9926 7111
Fax 85686 0
Email 85686 0
rebecca.saunderson@consentic.com
Contact person for public queries
Name 85687 0
Rebecca Saunderson
Address 85687 0
Department of Dermatology
Reserve Road
St Leonards
NSW 2065
Country 85687 0
Australia
Phone 85687 0
+61 2 9926 7111
Fax 85687 0
Email 85687 0
rebecca.saunderson@consentic.com
Contact person for scientific queries
Name 85688 0
Rebecca Saunderson
Address 85688 0
Department of Dermatology
Reserve Road
St Leonards
NSW 2065
Country 85688 0
Australia
Phone 85688 0
+61 2 9926 7111
Fax 85688 0
Email 85688 0
rebecca.saunderson@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


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.