Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001496808
Ethics application status
Approved
Date submitted
19/09/2021
Date registered
4/11/2021
Date last updated
15/04/2024
Date data sharing statement initially provided
4/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial evaluating the effect of a multimedia video on informed consent in patients undergoing total laparoscopic hysterectomy
Scientific title
A randomised controlled trial evaluating the effect of a multimedia video on informed consent in patients undergoing total laparoscopic hysterectomy
Secondary ID [1] 305343 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Informed consent 323675 0
Total laparoscopic hysterectomy 323981 0
Condition category
Condition code
Surgery 321214 321214 0 0
Other surgery
Reproductive Health and Childbirth 321482 321482 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The interventional group will receive routine consent and then watch a supplementary multimedia video describing their planned surgery which is the exposure.

Routine consent involves verbal consent with the surgeon or senior member of the research team, as usually performed when waitlisted for surgery, to describe indications for surgery and associated complications. It will take 5-10 minutes and be performed at recruitment.

The multimedia video will be delivered immediately after routine consent. The video is an 11 minute video which uses animations to depict and describe the relevant anatomy and indications for surgery, an explanation of the surgery, and the post-operative recovery. The video was not designed specifically for this study and is available for The Australasian Gynaecological Endoscopy and Surgery (AGES) Society members on the AGES website only. It is not available currently to the general public. There is one multimedia video for total laparoscopic hysterectomy and one for total laparoscopy hysterectomy with bilateral salpingo-oophrectomy. This will delivered via email link which will self-destruct.

Given the delays to surgery with the current global pandemic and ever-changing directions to the elective surgery waitlist in Victoria, Australia it will not be possible to know when this exposure will be in relation to the actual surgery. The trial is designed to assess change in outcomes immediately after the exposure and at 4 weeks.

A member of the research team will audit each participant to ensure consent forms are signed before proceeding to the next step of the study. We will use an automated program (REDCAPS) which allows for reminders to participants, and notifications to investigators until consent and questionnaires are completed. We will use email read receipts to check adherence to the intervention.
Intervention code [1] 321757 0
Behaviour
Comparator / control treatment
The control group will receive routine treatment which is routine consent only, as usually delivered to patients who are not in a study.

Routine consent involves verbal consent with the surgeon or senior member of the research team, as usually performed when waitlisted for surgery. It describes indications for surgery alternatives for surgery, expectations of surgery and associated complications. It will take 5-10 minutes and be performed at recruitment. As the consent is performed by the surgeon or a member of the research team, adherence will be recorded in the study database to confirm it has taken place.
Control group
Active

Outcomes
Primary outcome [1] 329001 0
knowledge scores in a questionnaire regarding the surgery .

This questionnaire has not been validated and was designed by the researchers specifically for this study, It has 15 questions and asks questions about the nature of the surgery, complications of the surgery and post-operative care after surgery.
Timepoint [1] 329001 0
Baseline, immediately after intervention (primary endpoint) and 4 weeks post-intervention
Secondary outcome [1] 401128 0
Anxiety scores in the State-Trait Anxiety Inventory (STAI) survey which is a well-validated and commonly used measure of anxiety. It was not developed specifically for this study.
Timepoint [1] 401128 0
baseline, immediately after intervention and 4 weeks after intervention.
Secondary outcome [2] 401129 0
patient satisfaction questionnaire which is a 3 question dichotomous survey
Timepoint [2] 401129 0
immediately after intervention and 4 weeks after intervention

Eligibility
Key inclusion criteria
1. Women requiring a total laparoscopic hysterectomy as determined and agreed to by both the surgeon and the participant.
2. Over 18 years of age at time of surgery.
3. Participants who understand the conditions of the study and are willing to participate for the duration of study including all follow-up.
4. Participants who are capable of, and have given, informed consent to their participation in the study.
5. Participants must have sufficient English reading and writing comprehension to complete the questionnaires
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Hysterectomy for malignant indications or under the gynae-oncology team

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 is not
concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created
by computer software (i.e. computerised sequence
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
Efficacy
Statistical methods / analysis
The expected number of participants is 34
The required sample size has been calculated using the two sample t test and based on a power test of 0.8 an assumed knowledge difference between groups of 5 and 10% the recommended sample size is 17 per group.
This is in keeping with previous studies published looking at improving informed consent with multimedia videos, which have shown statistically significant differences with sample sizes of 60, 56 and 31.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2022
Actual
25/07/2022
Date of last participant enrolment
Anticipated
Actual
1/12/2023
Date of last data collection
Anticipated
Actual
29/12/2023
Sample size
Target
34
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20552 0
Mercy Hospital for Women - Heidelberg
Recruitment postcode(s) [1] 35334 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 309714 0
Self funded/Unfunded
Name [1] 309714 0
Avelyn Wong
Country [1] 309714 0
Australia
Funding source category [2] 316305 0
Hospital
Name [2] 316305 0
Mercy Hospital Small Research Grants
Country [2] 316305 0
Australia
Primary sponsor type
Individual
Name
Avelyn Wong
Address
Endosurgery Department
Mercy Hospital for Women
163 Studley Rd, Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 310734 0
Individual
Name [1] 310734 0
Emma Readman
Address [1] 310734 0
Mercy Hospital for Women - 163 Studley Rd, Heidelberg VIC 3084
Country [1] 310734 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309477 0
Mercy Health Human Research Ethics Committee
Ethics committee address [1] 309477 0
Ethics committee country [1] 309477 0
Australia
Date submitted for ethics approval [1] 309477 0
25/07/2021
Approval date [1] 309477 0
30/08/2021
Ethics approval number [1] 309477 0
2021-049

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

Contacts
Principal investigator
Name 114278 0
Dr Avelyn Wong
Address 114278 0
Mercy Hospital for Women
163 Studley Rd, Heidelberg VIC 3084
Country 114278 0
Australia
Phone 114278 0
+61 412787737
Fax 114278 0
Email 114278 0
[email protected]
Contact person for public queries
Name 114279 0
Avelyn Wong
Address 114279 0
Mercy Hospital for Women
163 Studley Rd, Heidelberg VIC 3084
Country 114279 0
Australia
Phone 114279 0
+613 8458 4444
Fax 114279 0
Email 114279 0
[email protected]
Contact person for scientific queries
Name 114280 0
Avelyn Wong
Address 114280 0
Mercy Hospital for Women
163 Studley Rd, Heidelberg VIC 3084
Country 114280 0
Australia
Phone 114280 0
+613 8458 4444
Fax 114280 0
Email 114280 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
after de-identification;
individual participant data underlying published results only such as age, highest level of education obtained, previous surgeries, health literacy, knowledge questionnaire results, anxiety questionnaire results, patient satisfaction questionnaire results
When will data be available (start and end dates)?
Immediately following publication and ending 5 years following main results publication
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
only to achieve the aims in the approved proposal or for IPD meta-analyses,
How or where can data be obtained?
Data will be on a secure Database (REDCAPS) and also stored on paper in a locked office in the Endosurgery Unit of the hospital. Access will be subject to approval by Principal Investigator and data obtained by emailing the Principal investigator at [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13270Study protocol    382805-(Uploaded-19-09-2021-13-49-42)-Study-related document.docx
13271Informed consent form    382805-(Uploaded-19-09-2021-13-50-04)-Study-related document.doc
13272Ethical approval    382805-(Uploaded-19-09-2021-13-50-42)-Study-related document.pdf



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.