Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001058662
Ethics application status
Approved
Date submitted
16/09/2014
Date registered
3/10/2014
Date last updated
3/10/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of an internet based patient education on informed consent for elective orthopaedic surgery: A randomized controlled trial
Scientific title
The effect of an internet based patient education on knowledge, satisfaction and anxiety relating to informed consent in patients for elective orthopaedic procedures.
Secondary ID [1] 285342 0
Nil
Universal Trial Number (UTN)
U1111-1161-7692
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Informed consent of elective orthopaedic procedures 293067 0
Condition category
Condition code
Surgery 293342 293342 0 0
Other surgery
Musculoskeletal 293438 293438 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Both control and intervention arms received the standard consent discussion as carried out by their treating surgeon. The experiment arm were facilitated to read the relevant section of the website, after having spoken to their surgeon about their planned operation. They were then directed to complete surveys relating to the outcome measures of this study.

The orthopaedic units’ website (www.orthoanswer.org) was utilised as the patient education tool. The website was built employing best practice principles for design of medical education websites. It is written at a basic English reading level catering for patients with a reading level of grade 5 or above. It is designed as a walkthrough overview of each procedure along the lines of diagnosis and indications for surgery, complications, pre-operative, intra-operative and post operative care. It has been formulated with multidisciplinary input taking 3 years to design and implement.

The website takes approximately 10 - 15 mins to read the relevant section.
Intervention code [1] 290258 0
Behaviour
Comparator / control treatment
Both control and intervention arms received the standard consent discussion as carried out by their treating surgeon. The control arm, completed surveys relating to the outcome measures of this study directly after their appointment with the surgeon.
Control group
Active

Outcomes
Primary outcome [1] 293173 0
The primary outcome measure was knowledge about their operation. This was assessed using an operation specific questionnaire, designed by the researchers.
Timepoint [1] 293173 0
Immediately after the intervention for those in the intervention arm and immediately after appointment with surgeon for those in the control arm.
Secondary outcome [1] 310505 0
Patient's satisfaction with the consent process is a secondary measures. This was assessed using a validated survey (CSQ-8) to assess patient satisfaction with a service provision.
Timepoint [1] 310505 0
Immediately after the intervention for those in the intervention arm and immediately after appointment with surgeon for those in the control arm.
Secondary outcome [2] 310687 0
Anxiety relating to their planned surgery. This was assessed using a validated survey to assess anxiety (State-Trait Anxiety Index).
Timepoint [2] 310687 0
Immediately after the intervention for those in the intervention arm and immediately after appointment with surgeon for those in the control arm.

Eligibility
Key inclusion criteria
All patients that were booked for five common orthopaedic procedures were eligible to participate in the trial. The operations included were total knee arthroplasty, total hip arthroplasty, knee arthroscopy, shoulder arthroscopy and ACL reconstruction.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with an English reading level of grade 5 or below were excluded from participating. A patient’s reading level was assessed using the Rapid Estimate of Adult Literacy in Medicine (REALM) screening tool

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 were recruited from the Western Health orthopaedic outpatient clinic. All patients that were booked for five common orthopaedic procedures were eligible to participate in the trial. Patients were allocated according to randomisation sequence using the sealed envelope method.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomisation was carried out by a random sequence generated by the STATA statistical software program.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Results were analysed with the STATA statistical software package. Continuous data such as survey scores and age of patients is reported in terms of the mean and 95% confidence interval. The mean of continuous data between intervention arms is compared using the T-test. Dichotomous data such as education is compared using z-test of two proportions. Age is compared using the chi-square test.
To detect an improvement of 15% in the primary outcome measure of knowledge in the experiment group, which is in keeping with the observed magnitude of similar trials conducted previously, with a two-sided 5% significance level and a power of 80%, a sample size of 100 patients per group was necessary.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/09/2013
Actual
13/09/2013
Date of last participant enrolment
Anticipated
Actual
31/05/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2983 0
Western Hospital - Footscray
Recruitment postcode(s) [1] 8705 0
3011 - Footscray

Funding & Sponsors
Funding source category [1] 289956 0
Self funded/Unfunded
Name [1] 289956 0
Country [1] 289956 0
Primary sponsor type
Individual
Name
Dr Andrew Fraval
Address
Western Health
Gordon St, Footscray VIC 3011
Country
Australia
Secondary sponsor category [1] 288646 0
None
Name [1] 288646 0
Address [1] 288646 0
Country [1] 288646 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291673 0
Western Health Low Risk Ethics Panel (LREP)
Ethics committee address [1] 291673 0
Office for Research
Level 3 Western Centre for Health, Research & Education (CHRE)
Sunshine Hospital
Furlong Road
St Albans VIC 3021
Ethics committee country [1] 291673 0
Australia
Date submitted for ethics approval [1] 291673 0
09/05/2013
Approval date [1] 291673 0
26/07/2013
Ethics approval number [1] 291673 0
HREC/13/WH/80

Summary
Brief summary
The research question
Does exposing patients to a website containing accurate, free and easily accessible information related to the operation to be performed as part of the consent process improve the informed consent attained? This will be measured by accessing 3 end points:
comprehension
satisfaction
anxiety

Hypothesis: The use of the Orthoanswer website, as an adjunct to standard consent procedures, significantly improves the satisfaction and comprehension of informed consent whilst decreasing anxiety levels concerning the operation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51458 0
Dr Andrew Fraval
Address 51458 0
Western Health
140 Gordon St
Footscray 3011
VIC
Country 51458 0
Australia
Phone 51458 0
+ 61 423 155 386
Fax 51458 0
Email 51458 0
[email protected]
Contact person for public queries
Name 51459 0
Dr Andrew Fraval
Address 51459 0
Western Health
140 Gordon St
Footscray 3011
VIC
Country 51459 0
Australia
Phone 51459 0
+ 61 423 155 386
Fax 51459 0
Email 51459 0
[email protected]
Contact person for scientific queries
Name 51460 0
Dr Andrew Fraval
Address 51460 0
Western Health
140 Gordon St
Footscray 3011
VIC
Country 51460 0
Australia
Phone 51460 0
+ 61 423 155 386
Fax 51460 0
Email 51460 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
EmbaseInternet based patient education improves informed consent for elective orthopaedic surgery: A randomized controlled trial.2015https://dx.doi.org/10.1186/s12891-015-0466-9
N.B. These documents automatically identified may not have been verified by the study sponsor.