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Trial registered on ANZCTR


Registration number
ACTRN12618001185257
Ethics application status
Approved
Date submitted
12/07/2018
Date registered
17/07/2018
Date last updated
17/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Video or verbal consent? A randomised trial of the informed consent process prior to endoscopy
Scientific title
Video or verbal consent? A randomised trial of the informed consent process prior to endoscopy
Secondary ID [1] 295535 0
None
Universal Trial Number (UTN)
U1111-1198-1577
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Informed Consent
 308800 0
Condition category
Condition code
Oral and Gastrointestinal 307735 307735 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who came forward for either elective gastroscopy or colonoscopy were randomised to receive either standard verbal consent, or video assisted consent (intervention).
Two videos were created, professionally filmed and narrated by a nurse investigator. The videos were 3.5 minutes long and designed to cover all aspects of legal informed consent. Subtitles were included to highlight individual risks as they were mentioned.
The intervention was the demonstration of the video, played in the patient bed space and displayed on an A5-sized tablet with the use of earphones in order to minimise contamination bias with neighbouring patients. Patients who were scheduled for gastroscopy were shown the gastroscopy-specific video. Likewise for patients scheduled for colonoscopy. Patients who were scheduled to have both procedures were shown both videos.
Following the video, patients had the opportunity for further discussion and to ask questions. Patients where then asked to sign a standard hospital consent form, and fill out the questionnaire.
Intervention code [1] 301840 0
Behaviour
Comparator / control treatment
Patients who were randomised to the control group received standard verbal consent, given by endoscopy nurses who have been trained to perform legal informed consent specifically for gastroscopy and colonoscopy.
Control group
Active

Outcomes
Primary outcome [1] 306722 0
The primary outcome measured was the recollection of procedural risks. This was assessed by means of study specific questionnaire, completed by the patient at the end of the endoscopy procedure (sum of all correct answers for risk recall items).
Timepoint [1] 306722 0
Immediately following endoscopic procedures
Primary outcome [2] 306742 0
patient experience, recorded as “similar, better or worse” than the video or verbal explanation given.
Timepoint [2] 306742 0
Immediately following endoscopic procedures
Secondary outcome [1] 349352 0
Secondary outcomes included breakdown of individual risk recall items, assessed by means of study specific questionnaire with tick box options and pre-specified responses
Timepoint [1] 349352 0
Immediately following endoscopic procedures
Secondary outcome [2] 349416 0
patient perception about understanding and taking of informed consent, assessed by means of study specific questionnaire with tick box options and pre-specified responses.
Timepoint [2] 349416 0
immediately after endoscopic procedures
Secondary outcome [3] 349417 0
anxiety, assessed by means of study specific questionnaire with tick box options and pre-specified responses
Timepoint [3] 349417 0
immediately after endoscopic procedures

Eligibility
Key inclusion criteria
All consecutive patients aged 18 years or older scheduled for an outpatient gastroscopy, colonoscopy or both were considered for enrolment in the trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients were excluded if they were having a procedure other than colonoscopy or gastroscopy such as Endoscopic Retrograde Cholangiopancreatography (ERCP) or a planned therapeutic intervention such as dilatation or variceal banding. Further exclusions included patients who would ordinarily require a third party to sign consent (due to age, intellectual disability, lack of capacity, those visually or hearing impaired) and patients with a language barrier such that an interpreter was required.

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)
Via sealed envelopes pre-made by clerical staff not involved in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation procedure by shuffling the pre-made, sealed envelope in a large box.
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 aimed to detect an effect size in the sense of Cohen (proportion of the baseline pooled standard deviation) of 0.5 at 80% power for a False Discovery Rate-corrected significance level of 2.5%.24 To do so, we required 78 participants per arm; assuming 20% missing values, 98 participants per arm were required to meet these criteria. We therefore aimed to recruit 100 participants per arm, which also provided us with 80% power to detect a relative risk in dichotomised experience slightly larger than 1.5 (1.54; corresponding to an odds ratio of 2.10) assuming a base probability of 1/3 for an answer of “better”.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/09/2017
Date of last participant enrolment
Anticipated
Actual
1/12/2017
Date of last data collection
Anticipated
Actual
1/12/2017
Sample size
Target
200
Accrual to date
Final
200
Recruitment outside Australia
Country [1] 10641 0
New Zealand
State/province [1] 10641 0
Tauranga

Funding & Sponsors
Funding source category [1] 300115 0
Hospital
Name [1] 300115 0
Tauranga Hospital gastroenterology department
Country [1] 300115 0
New Zealand
Primary sponsor type
Hospital
Name
Tauranga Hospital gastroenterology department
Address
829 Cameron Rd, Tauranga South, Tauranga 3112
Country
New Zealand
Secondary sponsor category [1] 299515 0
None
Name [1] 299515 0
Address [1] 299515 0
Country [1] 299515 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300955 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 300955 0
Ethics committee country [1] 300955 0
New Zealand
Date submitted for ethics approval [1] 300955 0
12/09/2017
Approval date [1] 300955 0
21/09/2017
Ethics approval number [1] 300955 0
17NTB176

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

Contacts
Principal investigator
Name 85402 0
Dr Cameron Schauer
Address 85402 0
Tauranga Hospital, 829 Cameron Rd, Tauranga South, Tauranga 3112
Country 85402 0
New Zealand
Phone 85402 0
+64210368637
Fax 85402 0
Email 85402 0
[email protected]
Contact person for public queries
Name 85403 0
Cameron Schauer
Address 85403 0
Tauranga Hospital, 829 Cameron Rd, Tauranga South, Tauranga 3112
Country 85403 0
New Zealand
Phone 85403 0
+64210368637
Fax 85403 0
Email 85403 0
[email protected]
Contact person for scientific queries
Name 85404 0
Cameron Schauer
Address 85404 0
Tauranga Hospital, 829 Cameron Rd, Tauranga South, Tauranga 3112
Country 85404 0
New Zealand
Phone 85404 0
+64210368637
Fax 85404 0
Email 85404 0
[email protected]

No information has been provided regarding IPD availability


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.