ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12614000687695

Ethics application status

Approved

Date submitted

16/06/2014

Date registered

30/06/2014

Date last updated

30/06/2014

Type of registration

Prospectively registered

Titles & IDs

Public title

Comparison of two pre-operative information delivery techniques (video versus standard verbal communication) on levels of satisfaction and understanding in patients who present to Gosford Hospital and are identified as requiring cystoscopy and ureteric stent.

Scientific title

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1158-1002

Trial acronym

Linked study record

Health condition

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

Kidney Stone

Condition category

Condition code

Surgery

Surgical techniques

Renal and Urogenital

Kidney disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This randomised control trial will allocate patients on a 1:1 basis to either video consent or standard verbal consent. Patients will be recruited as those patients presenting in the acute setting through the Emergency Department, requiring a cystoscopy and insertion of ureteric stent, in a public hospital setting.

A crossover will then be performed at 30min.

The video consent will comprise of short video (6.5min) including preoperative information,
1. Indications for cystoscopy and ureteric stent insertion
2. How the cystoscopy is performed
3. Risks and benefits
4. Post procedure care and follow up

The period of recruitment will be 3 months.

Intervention code [1]

Behaviour

Comparator / control treatment

At the start of the trial, participants undergoing an emergency cystoscopy will be randomised in a simple 1:1 randomisation scheme to two study groups
Group A: portable video media consent group
Group B: standard verbal consent group

Control group

Active

Outcomes

Primary outcome [1]

Degree of patient satisfaction post information delivery method.

A validated questionnaire CSQ-8 will be used to assess patient’s satisfaction.

Timepoint [1]

Questionnaire will be completed post delivery method.

Crossover will then be performed at 30min

Questionnaire will be completed post both delivery methods

Primary outcome [2]

Level of understanding/knowledge.

Level of understanding will be assessed with a multi-choice ‘true’, ‘false’ questionnaire developed by urologists and urology registrars which will measure understanding and complications of cystoscopy and stent insertion.

Timepoint [2]

Questionnaire will be completed post delivery method.

Crossover will then be performed at 30min

Questionnaire will be completed post both delivery methods

Secondary outcome [1]

Nil

Timepoint [1]

Nil

Eligibility

Key inclusion criteria

Age >18 years
Able to read and speak in English (not necessarily as first language)
Able to give consent
Identified by Urology Registrar as requiring cystoscopy

Minimum age

18 Years

Maximum age

99 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Age < 18 years
Unable to read or speak in English.
Unable to give consent

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)

The participant will be enrolled into the study after the informed consent process has been completed and the participant has met all inclusion criteria and none of the exclusion criteria. The participant will receive a study enrolment number and this will be documented in the participant’s medical record and on all study documents. Following enrolment the patient will be randomised to either video or verbal consent first and then crossed over to the opposite medium.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation will be performed on appropriate randomisation software. The randomised group allocation sequence will be kept sealed in envelopes until each participant is ready to be randomised

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Mann–Whitney test will be used to compare results between the groups, and the Wilcoxon signed-rank test used to compare results within groups on crossover.

Sample size will be restricted by availability of patients through clinical presentation and time available of the investigators

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/07/2014

Actual

Date of last participant enrolment

Anticipated

2/02/2015

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Gosford Hospital - Gosford

Recruitment postcode(s) [1]

2250 - Gosford

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Individual

Name

Dr Matthew Winter

Address

Gosford Hospital
Holden Street
Gosford 2250
NSW

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Dr Mark Louie-Johnsun

Address [1]

Gosford Hospital
Holden Street
Gosford 2250
NSW

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Sydney Local Health District (NSLHD)

Ethics committee address [1]

Royal North Shore Hospital
Reserve Rd
St Leonards NSW 2065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/04/2014

Approval date [1]

11/06/2014

Ethics approval number [1]

LNR/14/HAWKE/64

Summary

Brief summary

Although informed consent for surgical procedures is a well-established practice between the surgeon and patient, if often fails to meet its purpose. The procedure to obtain consent must ensure that the patient understands the nature of his or her condition, the risks and benefits of the proposed treatment, its alternatives and agrees to it voluntarily.  In a busy surgical setting including outpatient clinics, emergency departments or private rooms, this process is often time limited.  The process can be inadequate and inconsistent, resulting in poorer health outcomes for such patients . Furthermore, patients have varying degrees of cultural backgrounds and educational levels that also influence patient comprehension and understanding. It has been demonstrated that patient comprehension highly correlates with patient care and postoperative complication.

The aim of this study is to conduct a randomised controlled trial to determine if video based education delivered through a portable video media (PVM) enabled device improves patient knowledge and satisfaction regarding the consent process for cystoscopy compared with conventional standard verbal consent (SVC).

Primary Objective
To determine if video based education delivered through a portable video media enabled device improves patient knowledge and satisfaction regarding the consent process for cystoscopy compared with conventional verbal consent.

Secondary Objectives
To improve the patient education and consent process and provide new ways to communicate risks and benefits of procedures 

At the start of the trial, participants undergoing an emergency cystoscopy will be randomised in a simple 1:1  randomisation scheme to two study groups
Group A: portable video media consent group
Group B: standard verbal consent group

Randomisation will be performed on appropriate randomisation software. The randomised group allocation sequence will be kept sealed in envelopes until each participant is ready to be randomised. In the video group, surgeons obtained informed consent using an education video. Participants will view this video on a portable video device (iPad). A cross-over will then be performed.   At the conclusion of both the SVC and PVM patients will be given the opportunity to ask questions.

Main outcome measures are differences in knowledge acquisition and degree of patient satisfaction comparing SVC to PVM consent.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/366547-Letter - LNR FINAL Approval - HREC Exec Meeting 11 June 2014 - RESP 14 45.pdf

Attachments [2]

/AnzctrAttachments/366547-Protocol v2.doc

Attachments [3]

/AnzctrAttachments/366547-NHMRC_PISCF_Non-Interventional_for_Selfv2.docx

Contacts

Principal investigator

Name

Dr Matthew Winter

Address

Gosford Hospital
Holden Street
Gosford 2250
NSW

Country

Australia

Phone

+61 423 411 433

Fax

drmatthewwinter@gmail.com

Contact person for public queries

Name

Matthew Winter

Address

Gosford Hospital
Holden Street
Gosford 2250
NSW

Country

Australia

Phone

+61 423 411 433

Fax

drmatthewwinter@gmail.com

Contact person for scientific queries

Name

Matthew Winter

Address

Gosford Hospital
Holden Street
Gosford 2250
NSW

Country

Australia

Phone

+61 423 411 433

Fax

drmatthewwinter@gmail.com

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

Source	Title	Year of Publication	DOI
Dimensions AI	The use of portable video media vs standard verbal communication in the urological consent process: a multicentre, randomised controlled, crossover trial	2016	https://doi.org/10.1111/bju.13595

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically