Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001114538
Ethics application status
Approved
Date submitted
26/08/2024
Date registered
16/09/2024
Date last updated
16/09/2024
Date data sharing statement initially provided
16/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Translated information to improve consent for surgery in non-English speaking patients: a randomised controlled trial
Scientific title
Evaluating the efficacy of a Google-translated patient education website on informed consent for surgery in Orthopaedic patients with limited English: a randomised controlled trial
Secondary ID [1] 312352 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Surgical consent Optimisation; Linguistically Inclusive and Diverse – a Randomised Controlled Trial (SOLID-RCT)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Informed Consent for Surgery 334207 0
Surgical consent in non-English speaking patients 334208 0
Condition category
Condition code
Surgery 330798 330798 0 0
Other surgery
Musculoskeletal 330799 330799 0 0
Other muscular and skeletal disorders
Musculoskeletal 330847 330847 0 0
Osteoarthritis
Public Health 330872 330872 0 0
Health promotion/education
Public Health 331524 331524 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will evaluate the use of a Google-Translated patient education website following standard informed consent for surgery process, to assess if it can improve non-English-speaking patient knowledge compared to the standard surgical consent process.

The intervention will be the use of a Google-translated patient education website (orthoanswer.org). The researcher will provide participants in the intervention group with access to the Orthoanswer web page with information specific to their operation (total hip or knee replacement) translated in their preferred language using a Google Translate widget. The content provided on the patient education website includes information on diagnosis, alternative interventions, benefits of surgical intervention, post-operative expectations, potential risks and complications, what to expect before, during and after surgery and recovery and rehabilitation,

Participants will be given up to 30 minutes to read the content. Patients will have an interpreter present and available for any questions that may arise. In order to monitor adherence to the intervention, patients will be supervised by research staff and a timer set to 30minutes will be used to track the period of reading and viewing the content.
Intervention code [1] 328856 0
Treatment: Other
Comparator / control treatment
Current standard practice at our institution for surgical consent for non-English speaking patients is a discussion between the surgeon and the patient with an interpreter. No additional patient education resources (i.e. Google-translated patient education website: orthoanswer.org) are routinely provided.
Control group
Active

Outcomes
Primary outcome [1] 338580 0
Patient knowledge
Timepoint [1] 338580 0
Assessed post-consent/post-control
Secondary outcome [1] 436497 0
Patient satisfaction
Timepoint [1] 436497 0
Assessed post-consent/post-control.

Eligibility
Key inclusion criteria
- waitlisted for a total knee replacement or total hip replacement
- adult patient, aged 18 and over
- have limited or no English proficiency, requiring an interpreter for surgical consent
- have an interpreter and Google Translate available for their preferred language
- have not used the Orthoanswer website to read translated information about their planned procedure in their preferred language
- have self-reported ability to read and understand basic medical information in their preferred language.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- unable to or not willing to consent to research
- have self-reported inability to read basic medical information in their preferred language
- are unable to participate fully in the trial procedures

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 concealment will be performed by central randomisation via computer on REDCAP software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple random sampling, with a randomisation list generated by an independent biostatistician.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The statistical analysis will consist of descriptive statistics such as mean, median, standard deviations, frequencies, proportions etc. to describe the results and graphical representations can be made were applicable to assist in visualizing aspects of the data.
Inferential investigations may include tests like the Chi-squared test to compare the results, between the Control and Intervention arms, for the categorical outcomes. Numerical outcomes will be investigated for normality and may include tests like the independent t-test or the Mann Whitney U test (the nonparametric alternative). Additional regression models may be considered to adjust for certain baseline characteristics (such as age, language, education level and operation). All significance tests will be performed at a 5% level of significance.

Using information from a similar study (Fraval, et al., 2015), which also measured the patient knowledge score on a relatively similar subset of patients and showed a large effect size of 1.36 (intervention arm had an average score of 69.25 [SD 14.91] with the control arm 47.38 [SD 17.11]), a sample size calculation using G*Power Version 3.1.9.6 (24, 25), testing at a 5% level of significance and a power of 80%, showed that at least 8 participants will be required per group. Data will be collected for a 12-month period, with a minimum number of participants being collected per group set at 18 (total of 36). A slightly larger sample of participants will be collected to account for the slight differences between the study sample and those of the study. This slightly larger sample will also account for any dropouts even though this is expected to be very small due to the nature in which the data will be collected.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/10/2024
Actual
Date of last participant enrolment
Anticipated
19/09/2025
Actual
Date of last data collection
Anticipated
19/09/2025
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26700 0
Western Hospital - Footscray - Footscray
Recruitment postcode(s) [1] 42738 0
3011 - Footscray

Funding & Sponsors
Funding source category [1] 316760 0
Hospital
Name [1] 316760 0
Western Health (Footscray Hospital) Orthopaedic Department Special Purpose Fund
Country [1] 316760 0
Australia
Funding source category [2] 317230 0
Charities/Societies/Foundations
Name [2] 317230 0
Western Health Foundation - BankVic Research Grant
Country [2] 317230 0
Australia
Primary sponsor type
Hospital
Name
Western Health - Orthopaedic Unit
Address
Country
Australia
Secondary sponsor category [1] 319509 0
None
Name [1] 319509 0
Address [1] 319509 0
Country [1] 319509 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315561 0
Western Health Low Risk Ethics Panel
Ethics committee address [1] 315561 0
Ethics committee country [1] 315561 0
Australia
Date submitted for ethics approval [1] 315561 0
04/04/2024
Approval date [1] 315561 0
03/07/2024
Ethics approval number [1] 315561 0
107617

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134974 0
Prof Phong Tran
Address 134974 0
Head of Unit, Department of Orthopaedics, Level 1, Footscray Hospital, 160 Gordon St, Footscray, VIC 3011
Country 134974 0
Australia
Phone 134974 0
+61 03 8345 5757
Fax 134974 0
Email 134974 0
[email protected]
Contact person for public queries
Name 134975 0
Dr Quoc Toan Phu
Address 134975 0
Department of Orthopaedics, Western Health Western Hospital Level 1 South, 160 Gordon St Footscray, VIC 3011
Country 134975 0
Australia
Phone 134975 0
+61469726217
Fax 134975 0
Email 134975 0
[email protected]
Contact person for scientific queries
Name 134976 0
Dr Quoc Toan Phu
Address 134976 0
Department of Orthopaedics, Western Health Western Hospital Level 1 South, 160 Gordon St Footscray, VIC 3011
Country 134976 0
Australia
Phone 134976 0
+61469726217
Fax 134976 0
Email 134976 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.