Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
ACTRN12612001190897
Ethics application status
Approved
Date submitted
6/11/2012
Date registered
13/11/2012
Date last updated
13/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving the Informed Consent Process for Elective Surgery using an Informed Consent Curriculum
Scientific title
Among patients about to have elective surgery, can standardised operation-specific instructional tools improve knowledge more than current informed consent practices
Secondary ID [1] 281503 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knowledge of Surgery for Informed Consent 287773 0
Condition category
Condition code
Surgery 288121 288121 0 0
Other surgery
Public Health 288125 288125 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Validated Standardised Operation-Specific Instructional Tool
Both tools (Total Hip Replacement and Operative Laparoscopy) are multimedia based, linear in format, and require about 15 minutes to view on a computer. They require simple user interaction (mouse click) to progress through, and allow users to review previously received information, but not to skip forward.
Participants only view the tool relevant to their surgery once during the trial.
The timing of the use of these tools was not regulated during the trial. Participants were recruited in surgeons rooms, outpatient clinics, and pre-admission clinics, and the information was delivered when participants were available.
Intervention code [1] 286018 0
Other interventions
Comparator / control treatment
No treatment (standard practice)
All participating surgeons educated their patients in their usual way. No effort was made to catalogue the various methods, though a verbal discussion is the standard way of disclosing such information. Some surgeons also provide college endorsed brochures to augment this discussion.
Control group
Active

Outcomes
Primary outcome [1] 288325 0
Knowledge Score measured using newly developed operation-specific knowledge questionnaire
Timepoint [1] 288325 0
Pre and post intervention
Secondary outcome [1] 299858 0
Nil
Timepoint [1] 299858 0
Nil

Eligibility
Key inclusion criteria
Awaiting total hip replacement surgery or an operative laparoscopy for investigation of pelvic pain
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-English Speaking

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)
Patients about to undergo one of the two elective procedures being studied were either invited by their surgeon, or approached by a research assistant, to participate.

Patients were stratified by surgeon before being randomised to treatment arm. Allocation was not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Ccomputer generated randomisation schedules were created for each surgeon
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Pre Post test
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/02/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5960 0
3050
Recruitment postcode(s) [2] 5961 0
3002
Recruitment postcode(s) [3] 5962 0
3121
Recruitment postcode(s) [4] 5963 0
3144

Funding & Sponsors
Funding source category [1] 286284 0
Charities/Societies/Foundations
Name [1] 286284 0
Medical Research Foundation for Women and Babies
Country [1] 286284 0
Australia
Primary sponsor type
Individual
Name
Dr Damian Claydon-Platt
Address
70 Newry St
Fitzroy North
Victoria 3968
Country
Australia
Secondary sponsor category [1] 285079 0
None
Name [1] 285079 0
Address [1] 285079 0
Country [1] 285079 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288358 0
Royal Melbourne Hospital
Ethics committee address [1] 288358 0
Grattan St
Parkville
Victoria 3050
Ethics committee country [1] 288358 0
Australia
Date submitted for ethics approval [1] 288358 0
05/11/2003
Approval date [1] 288358 0
10/12/2003
Ethics approval number [1] 288358 0
HREC 2003.230

Summary
Brief summary
Currently all patients about to undergo elective surgery in common law countries are required to give their informed consent to proceed. However, the literature suggests that many participants are not well informed when they give their consent. The aim of this study is to assess baseline knoweldge of elective procedures. The secondary aim is to see if baseline knowledge can then be improved through the use of an operation-specific instructional tool
Trial website
Trial related presentations / publications
May 2007 Presentation at Annual meeting of Australian Gynaecological Endoscopy Society
June 2008 Presentation at Annual Congress of the International Society for Cygnaecologic Endoscopy
23/10/08 Presentation to Biomedical Multimedia Unit, University of Melbourne
29/10/09 Presentation to Staff of Australia and New Zealand College Anaesthetists
Public notes

Contacts
Principal investigator
Name 34924 0
Address 34924 0
Country 34924 0
Phone 34924 0
Fax 34924 0
Email 34924 0
Contact person for public queries
Name 18171 0
Damian Claydon-Platt
Address 18171 0
70 Newry St
Fitzroy North
Victoria 3068
Country 18171 0
Australia
Phone 18171 0
+61394863943
Fax 18171 0
Email 18171 0
[email protected]
Contact person for scientific queries
Name 9099 0
Damian Claydon-Platt
Address 9099 0
70 Newry St
Fitzroy North
Victoria 3068
Country 9099 0
Australia
Phone 9099 0
+61394863943
Fax 9099 0
Email 9099 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.