Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000080820
Ethics application status
Not yet submitted
Date submitted
21/12/2011
Date registered
16/01/2012
Date last updated
16/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Using multimedia to enhance patient education when obtaining informed consent in an orthopaedic foot and ankle practice
Scientific title
To determine the efficacy of the use of multimedia patient education technology when obtaining informed consent in an orthopaedic foot and ankle practice.
Secondary ID [1] 279643 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obtaining informed consent from patient undergoing surgical procedures that are treated by the surgeons at the Victorian Orthopaedic Foot and Ankle Clinic. 285441 0
Condition category
Condition code
Surgery 285626 285626 0 0
Surgical techniques
Public Health 285785 285785 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients participating in the study will be given the opportunity to watch a multimedia patient education module (approximately 20 minutes in length) on the surgical procedure applicable to their All patient will be asked to complete a knowledge questionnaire after a discussion with their treating surgeon. Patients participating in the trial will then be asked to watch the multi media which the risks and benefits of the surgical procedure applicable to their condition. They will then be asked to complete the same knowledge questionnaire. in order to obtain informed consent.
Intervention code [1] 283927 0
Treatment: Surgery
Intervention code [2] 284041 0
Other interventions
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286184 0
The aim of this study is to evaluate the effect of a computer-based, patient controlled, interactive multimedia educational tool on knowledge transfer and patient learning in a foot and ankle private practice clinical setting. This will be accomplished by identifying consecutive patients that are suitable candidates for hallux valgus correction, lateral ligament reconstruction, first metatarsal phalangeal fusion, morton's neuroma excision, or ankle arthroscopy surgery
Timepoint [1] 286184 0
the outcome will be assessed immediately after information delivery
Secondary outcome [1] 295330 0
Nil
Timepoint [1] 295330 0
Nil

Eligibility
Key inclusion criteria
Inclusion Criteria
Primary language is English
Able to hear the spoken word
Able to read English
Has basic computer skills
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria
Unable to read
Hearing impaired
Non-English speaking
Lacks basic computer skills

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 was not concealed. Patients who fit the inclusion criteria will be identified by their treating surgeon. The surgeon will explain the study and instruct patients to confirm their willingness to participate in the trial during thier consultation at the Victorian Orthopaedic foot and ankle clinic. After a discussion with the surgeon the patient will be asked to complete a knowledge questionnaire. They will then be asked to watch the multimedia module and again complete the same questionnaire.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284420 0
Charities/Societies/Foundations
Name [1] 284420 0
Epworth Foundation - Foot and Ankle Research Fund
Country [1] 284420 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Epworth Foundation - Foot and Ankle Research Fund
Address
32 Erin Street
Richmond
Vic 3121
Country
Australia
Secondary sponsor category [1] 283348 0
None
Name [1] 283348 0
Address [1] 283348 0
Country [1] 283348 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286394 0
Epworth Healthcare
Ethics committee address [1] 286394 0
89 Bridge Road
Richmond
Victoria
3121
Ethics committee country [1] 286394 0
Australia
Date submitted for ethics approval [1] 286394 0
01/02/2012
Approval date [1] 286394 0
Ethics approval number [1] 286394 0
TBA

Summary
Brief summary
We hypothesise that multimedia patient education technology is superior to the traditional surgeon patient verbal process of obtaining informed consent for a variety of orthopaedic procedures including lateral ligament reconstruction, hallux valgus deformity correction, first metatarsal phalangeal fusion, Morton’s neuroma resection, and ankle arthroscopy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33562 0
Address 33562 0
Country 33562 0
Phone 33562 0
Fax 33562 0
Email 33562 0
Contact person for public queries
Name 16809 0
Kate Claxton
Address 16809 0
Epworth Centre
Suite 6.3, Level 6
32 Erin Street
Richmond
Vic 3121
Country 16809 0
Australia
Phone 16809 0
+61 3 9428 9944
Fax 16809 0
+61 3 9428 3444
Email 16809 0
[email protected]
Contact person for scientific queries
Name 7737 0
Kate Claxton
Address 7737 0
Epworth Centre
Suite 6.3, Level 6
32 Erin Street
Richmond
Vic 3121
Country 7737 0
Australia
Phone 7737 0
+61 3 9428 9944
Fax 7737 0
+61 3 9428 3444
Email 7737 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.