Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000870257
Ethics application status
Approved
Date submitted
18/05/2018
Date registered
22/05/2018
Date last updated
27/09/2019
Date data sharing statement initially provided
27/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of video media in informed consent in patients undergoing emergency appendicectomy
Scientific title
The use of video media in informed consent for emergency appendicectomy: a randomised controlled, crossover trial
Secondary ID [1] 294902 0
Nil known
Universal Trial Number (UTN)
U1111-1214-1421
Trial acronym
VAC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Appendicitis 307863 0
Condition category
Condition code
Surgery 306909 306909 0 0
Other surgery
Public Health 306981 306981 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be a six minute video detailing the condition of appendicitis, appendicectomy and it's alternatives, the common and serious but rare risks of the procedures, and the expected post-operative recovery. The video will be presented to the individual participant on a tablet device, and adherence will be monitored by direct observation by study personnel. The control consent method will be presented immediately after the knowledge test and CSQ-8 have been assessed for the intervention method, and vice-versa.
Intervention code [1] 301213 0
Other interventions
Comparator / control treatment
Standard face-to-face conset for an appendicectomy will be delivered by the surgical senior resident or registrar caring for the patient.
Control group
Active

Outcomes
Primary outcome [1] 305896 0
Knowledge test score, developed specifically for this study. Recall and comprehension of the information delivered during both control and intervention arms will bee assessed.
Timepoint [1] 305896 0
Immediately after intervention and standard consent methods
Secondary outcome [1] 346962 0
Client satisfaction questionnaire (CSQ-8) score, a validated measure of satisfaction
Timepoint [1] 346962 0
Immediately after intervention and standard consent method
Secondary outcome [2] 346963 0
Mean overall preference between intervention and standard consent method, assessed using a 100=point sliding visual analogue scale.
Timepoint [2] 346963 0
After delivery of both intervention and standard consent methods

Eligibility
Key inclusion criteria
Age > 16 years
Able to read and write in English
Able to give consent
Able to watch a video
Clinically indicated for appendicectomy or diagnostic laparoscopy, as determined by treating surgical team
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients requiring an urgent operation, and conducting the study would prolong the patient's time to the operating theatre.
Patients with significant pain which would impede completion of the questionnaires.

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)
Yes. Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table generated by computer softward
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We aim to recruit 88 patients in order to be able to detect a difference of 1.5 points in knowledge test scores between groups, with an estimated standard deviation of 5 points, with power set at 0.8 and significance level at 0.05,

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/10/2018
Actual
4/10/2018
Date of last participant enrolment
Anticipated
2/02/2020
Actual
Date of last data collection
Anticipated
2/02/2020
Actual
Sample size
Target
100
Accrual to date
36
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10900 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 10901 0
Wyong Public Hospital - Hamlyn Terrace
Recruitment hospital [3] 10902 0
Gosford Hospital - Gosford
Recruitment postcode(s) [1] 22666 0
2305 - New Lambton
Recruitment postcode(s) [2] 22667 0
2259 - Hamlyn Terrace
Recruitment postcode(s) [3] 22668 0
2250 - Gosford

Funding & Sponsors
Funding source category [1] 299483 0
University
Name [1] 299483 0
University of Newcastle
Country [1] 299483 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
Teaching and Research Unit
Gosford Hospital
PO Box 361
Gosford NSW 2250
Country
Australia
Secondary sponsor category [1] 298806 0
None
Name [1] 298806 0
Address [1] 298806 0
Country [1] 298806 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300391 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 300391 0
Hunter New England Research Ethics & Governance Office
Locked Bag No 1
New Lambton NSW 2305
Ethics committee country [1] 300391 0
Australia
Date submitted for ethics approval [1] 300391 0
20/09/2017
Approval date [1] 300391 0
23/10/2017
Ethics approval number [1] 300391 0
17/10/18/5.05

Summary
Brief summary
Informed consent is an not only an essential part of preparing a patient for surgery, but also a legal requirement. Surgeons typically explain the condition, procedure, risks and benefits and expected recovery of the intended treatment. This didactic method of information delivery can often miss out important components, and patients may not retain much knowledge from these discussions. Audio-video presentations have already been shown to be a promising medium to aid patient understanding and increase satisfaction during the consent process.

This project will investigate the role of video media in providing a better informed consent process for patients undergoing emergency appendicectomy, as compared with standard face-­to-­face verbal consent between doctor and patient. Patients who require this operation will be invited to participate in the study. When enrolled, participants will be randomised to receive either the intervention (video media) or standard method of consent first. A short knowledge test and consumer satisfaction questionnaire will be completed, and then the process repeated for the opposite consent method. At the conclusion, the participant's preference between video media or standard face-to-face consent will be recorded.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83502 0
Dr Amanda Dawson
Address 83502 0
Teaching and Research Unit
Gosford Hospital
PO Box 361
Gosford NSW 2250
Country 83502 0
Australia
Phone 83502 0
+61243205572
Fax 83502 0
Email 83502 0
[email protected]
Contact person for public queries
Name 83503 0
Brayden March
Address 83503 0
Division of Surgery
John Hunter Hospital
Locked Bag No 1
Hunter Region Mail Centre NSW 2310
Country 83503 0
Australia
Phone 83503 0
+61249213000
Fax 83503 0
Email 83503 0
[email protected]
Contact person for scientific queries
Name 83504 0
Brayden March
Address 83504 0
Division of Surgery
John Hunter Hospital
Locked Bag No 1
Hunter Region Mail Centre NSW 2310
Country 83504 0
Australia
Phone 83504 0
+61249213000
Fax 83504 0
Email 83504 0
[email protected]

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.