Trial Review

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
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
Secondary ID [1] 284813 0
Nil
Universal Trial Number (UTN)
U1111-1158-1002
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Stone
 292195 0
Condition category
Condition code
Surgery 292533 292533 0 0
Surgical techniques
Renal and Urogenital 292632 292632 0 0
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] 289604 0
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] 292391 0
Degree of patient satisfaction post information delivery method.

A validated questionnaire CSQ-8 will be used to assess patient’s satisfaction.
Timepoint [1] 292391 0
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] 292469 0
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] 292469 0
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] 309033 0
Nil
Timepoint [1] 309033 0
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?
No
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] 2638 0
Gosford Hospital - Gosford
Recruitment postcode(s) [1] 8295 0
2250 - Gosford

Funding & Sponsors
Funding source category [1] 289426 0
Self funded/Unfunded
Name [1] 289426 0
Country [1] 289426 0
Primary sponsor type
Individual
Name
Dr Matthew Winter
Address
Gosford Hospital
Holden Street
Gosford 2250
NSW
Country
Australia
Secondary sponsor category [1] 288113 0
Individual
Name [1] 288113 0
Dr Mark Louie-Johnsun
Address [1] 288113 0
Gosford Hospital
Holden Street
Gosford 2250
NSW
Country [1] 288113 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291182 0
Northern Sydney Local Health District (NSLHD)
Ethics committee address [1] 291182 0
Royal North Shore Hospital
Reserve Rd
St Leonards NSW 2065
Ethics committee country [1] 291182 0
Australia
Date submitted for ethics approval [1] 291182 0
01/04/2014
Approval date [1] 291182 0
11/06/2014
Ethics approval number [1] 291182 0
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] 85 85 0 0
/AnzctrAttachments/366547-Letter - LNR FINAL Approval - HREC Exec Meeting 11 June 2014 - RESP 14 45.pdf
Attachments [2] 86 86 0 0
/AnzctrAttachments/366547-Protocol v2.doc
Attachments [3] 87 87 0 0
/AnzctrAttachments/366547-NHMRC_PISCF_Non-Interventional_for_Selfv2.docx

Contacts
Principal investigator
Name 49246 0
Dr Matthew Winter
Address 49246 0
Gosford Hospital
Holden Street
Gosford 2250
NSW
Country 49246 0
Australia
Phone 49246 0
+61 423 411 433
Fax 49246 0
Email 49246 0
[email protected]
Contact person for public queries
Name 49247 0
Dr Matthew Winter
Address 49247 0
Gosford Hospital
Holden Street
Gosford 2250
NSW
Country 49247 0
Australia
Phone 49247 0
+61 423 411 433
Fax 49247 0
Email 49247 0
[email protected]
Contact person for scientific queries
Name 49248 0
Dr Matthew Winter
Address 49248 0
Gosford Hospital
Holden Street
Gosford 2250
NSW
Country 49248 0
Australia
Phone 49248 0
+61 423 411 433
Fax 49248 0
Email 49248 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
SourceTitleYear of PublicationDOI
Dimensions AIThe use of portable video media vs standard verbal communication in the urological consent process: a multicentre, randomised controlled, crossover trial2016https://doi.org/10.1111/bju.13595
N.B. These documents automatically identified may not have been verified by the study sponsor.