ANZCTR - Registration

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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]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Informed consent

Total laparoscopic hysterectomy

Condition category

Condition code

Surgery

Other surgery

Reproductive Health and Childbirth

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]

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]

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]

Baseline, immediately after intervention (primary endpoint) and 4 weeks post-intervention

Secondary outcome [1]

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]

baseline, immediately after intervention and 4 weeks after intervention.

Secondary outcome [2]

patient satisfaction questionnaire which is a 3 question dichotomous survey

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Mercy Hospital for Women - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Avelyn Wong

Address [1]

Endosurgery Department
Mercy Hospital for Women
163 Studley Rd, Heidelberg VIC 3084

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Mercy Hospital Small Research Grants

Address [2]

Country [2]

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]

Individual

Name [1]

Emma Readman

Address [1]

Mercy Hospital for Women - 163 Studley Rd, Heidelberg VIC 3084

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mercy Health Human Research Ethics Committee

Ethics committee address [1]

Level 6 Administration
Mercy Hospital for Women
163 Studley Rd, Heidelberg VIC 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/07/2021

Approval date [1]

30/08/2021

Ethics approval number [1]

2021-049

Summary

Brief summary

We seek to determine whether the use of a multimedia video can enhance consent for patients undergoing a total laparoscopic hysterectomy. 

In the era of increasingly complex surgical procedures and focus on patient-centred decision-making, the responsibility on clinicians to provide quality informed consent has never been more critical. In the current surgical climate, the Coronavirus pandemic has meant less face-to-face appointments and further delays from the initial booking appointment to surgery. Various media sources are often informally accessed by patients but these risk misinformation and further confusion. The addition of multimedia videos to routine consent has been shown to increase patient understanding and recall which optimizes informed consent and healthcare outcomes. 

This is a randomised controlled trial. Participants will be patients currently on the waitlist for a total laparoscopic hysterectomy at the Mercy Hospital for Women who have already received routine consent with their doctor. 

Participants will be assessed on their baseline understanding of the procedure, baseline anxiety levels and health literacy. They will be randomised into two groups. Group 1 will receive additional routine verbal consent. Group 2 will receive additional routine verbal consent and then watch an 11 minute multimedia video. Both groups will complete a questionnaire afterwards to evaluate their understanding of their procedure, anxiety and satisfaction levels which is repeated at 4 weeks. The multimedia video uses animations and text to describe the procedure of a total laparoscopic hysterectomy as well as complications and post-operative recovery. 

Our hypothesis is that patients who watch the multimedia video will have a better understanding of their procedure which will be reflected in a higher score in the questionnaire, without a negative impact on their anxiety level.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Avelyn Wong

Address

Mercy Hospital for Women
163 Studley Rd, Heidelberg VIC 3084

Country

Australia

Phone

+61 412787737

Fax

avelynwong1@gmail.com

Contact person for public queries

Name

Avelyn Wong

Address

Mercy Hospital for Women
163 Studley Rd, Heidelberg VIC 3084

Country

Australia

Phone

+613 8458 4444

Fax

endosurgeryfellow@mercy.com.au

Contact person for scientific queries

Name

Avelyn Wong

Address

Mercy Hospital for Women
163 Studley Rd, Heidelberg VIC 3084

Country

Australia

Phone

+613 8458 4444

Fax

avelynwong1@gmail.com

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 endosurgeryfellow@mercy.com.au

What supporting documents are/will be available?

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

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