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Trial registered on ANZCTR


Registration number
ACTRN12621000852853
Ethics application status
Approved
Date submitted
18/04/2021
Date registered
1/07/2021
Date last updated
22/12/2021
Date data sharing statement initially provided
1/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised trial of detailed written consent compared to standard verbal consent in adults with routine orthopaedic trauma
Scientific title
A randomised trial of patient recall during detailed written consent compared to standard verbal consent in adults with routine orthopaedic trauma
Secondary ID [1] 303965 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Orthopaedic trauma 321582 0
Condition category
Condition code
Surgery 319322 319322 0 0
Other surgery
Public Health 319832 319832 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Detailed Method (Intervention Method)
This intervention will incorporate all the usual information and documentation required in the standard method of informed consent, which is required by the health service. In addition, it will also include the use of a detailed written information consent support tool, which has sufficient information on the procedure, including visual aids. The written information consent support tool utilised in this study will be adapted from the Queensland Health orthopaedic consent templates, including the: Fractured tibia, fractured forearm, fractured femur and fractured ankle informed consent templates. These consent forms are widely used within the Queensland healthcare system, and they are available online for reference and education. Furthermore, the visual aids utilised will be adapted from the Orthopaedic Trauma Association, an international education organisation, which strives to promote excellence in care to patients. Each written information consent support tool will be presented in patient friendly manner promoting patient engagement in the process. All modified written information consent support tools will include the following elements:
• The condition (e.g. distal radius fracture) with a visual aid to indicate injury location.
• The treatment (e.g. fixation with plates or nails) with a visual aid to give the patient a visualisation of how the injury will be managed.
• General risks and specific risks to be presented in dot point format to ensure the patient does not become overwhelmed with extensive reading. Figures of common risks, such as Deep Vein Thrombosis (DVT) and surgical site infections (SSIs), will be included so the patient is aware of foreseeable complications as a result of receiving the treatment.
• Alternative treatment options (e.g. stabilisation) with the use of a visual aid so the patient can distinguish the difference in these treatments.
• Risks of not receiving the treatment.
• Benefits of receiving this treatment.
• Declaration and patient authorisation to undergo treatment.
The treating surgeon will go through the written information consent support tool during the informed consent process (prior to surgery) with the patient, allowing ample time for the patient to read the form and comprehend the information. The patient will then be provided with the opportunity to ask questions regarding the procedure and the treating surgeon will address any concerns. The duration of this process is dependent on questions posed after and specificities of the particular surgery. It will approximately be between 5-15 mins. The patient will also be given a brief copy of the information to keep. The process will be supervised by a member of the research team.
Intervention code [1] 320276 0
Treatment: Other
Comparator / control treatment
Standard Method (Control Group)
The standard method of informed consent will be the usual standard of care given to routine orthopaedic trauma patients. Before undergoing surgery, the treating surgeon will provide a verbal explanation of the procedure including: surgical complications, potential benefits, details of the injury and surgical management. The patient will then be provided with an opportunity to ask any questions about the surgery. The duration of this process is dependent on questions posed after and specificities of the particular surgery. It will approximately be between 5-15 mins.
Control group
Active

Outcomes
Primary outcome [1] 327192 0
The primary outcome measure is patient recall on the information provided by the treating surgeon during consent (standard or detailed method). This measure was selected as the primary outcome because patient recall is important for determining patient education and effectiveness of informed consent methods. Patient recall will be assessed using interviewer-administered questionnaire developed by the research team. Any incorrect answers will be recorded, however will verbally corrected for the patient.
Timepoint [1] 327192 0
Post operative (72 hrs post surgery)
Secondary outcome [1] 394119 0
• Hospital Anxiety and Depression Scale (interviewer-administered, self-reported, validated questionnaire using a 4-point Likert scale) collected 24 hours pre-operation and at 72 hours post-operation. If the patient has been discharged prior to the 72 hours they will be contacted via phone.
Timepoint [1] 394119 0
Baseline (24hrs prior surgery) and Post operative (72 hrs post surgery)
Secondary outcome [2] 394120 0
• Patient Satisfaction Questionnaire Short Form (PSQ-18) (patient-administered, self-reported, validated questionnaire using a 7-point Likert scale) (Marshal) collected at 72 hours post-operation. If a patient is discharged prior to the 72 hours the patient will be contacted via phone.
Timepoint [2] 394120 0
Baseline (24hrs or less than 24hrs prior to surgery) and post operative (72 hrs post surgery)
Secondary outcome [3] 394121 0
Rate of recruitment of eligible patients into the study
Outcome assessed by dividing the number of patients consented to participate in the trial by the total number of patients approached.
Timepoint [3] 394121 0
Conclusion of study
Secondary outcome [4] 394122 0
Visual Analogue Scale (Pain score), a validated, self reported tool to measure a patients current pain level collected at 24 hours pre-operation and at 72 hours post-operation. Pain is rated on a scale of 0-10 where 0 is the no pain and 10 is extreme pain. If a patient is discharged prior to the 72 hours the patient will be contacted via phone.
Timepoint [4] 394122 0
Baseline (24hrs or less than 24hrs prior to surgery) and post operative (72 hrs post surgery).

Eligibility
Key inclusion criteria
The inclusion criteria for this study is: (i) 18 years of age or above; (ii) patients with confirmed distal radius, ankle, femoral shaft, tibial shaft (lower limb long bone fracture), distal femur or proximal tibia fractures; (iii) able to speak and read the English language; (iv) capacity to make health care decisions independently; and (v) willing to participate in the trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be deemed ineligible if they are: (i) medically diagnosed with cognitive impairment, including dementia; (ii) have limited literacy; (iii) poor or no understanding of the trial; (iv) in a critical medical condition; (v) require very urgent surgery (prioritised within 8 hours of presentation) vi) return to theatre for a surgical site infection

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation sequence will be put into sealed, sequentially numbered, opaque envelopes. The randomisation sequence will therefore be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computerised sequence generation
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
This study will be conducted by the intention-to-treat (ITT) principle. Missing data will be treated with a sensitivity analysis using multiple imputation. Means (±), standard deviation (SD) and confidence intervals (CI: 95%) will be used to present all continuous variables. A Mann-Whitney U test (p= < 0.05) will be calculated to determine difference between the control and intervention groups. Absolute numbers with percentages (%) will be used to present all binary variables. Chi-square test or Fisher’s exact test will be used to determine difference between the control and intervention groups. P-values of < 0.05 will be considered statistically significant. All analyses will be done in RStudio 1.2.1335.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/03/2021
Date of last participant enrolment
Anticipated
30/09/2021
Actual
30/09/2021
Date of last data collection
Anticipated
3/10/2021
Actual
3/10/2021
Sample size
Target
50
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19136 0
St George Hospital - Kogarah
Recruitment hospital [2] 19137 0
The Sutherland Hospital - Caringbah
Recruitment postcode(s) [1] 33695 0
2217 - Kogarah
Recruitment postcode(s) [2] 33696 0
2229 - Caringbah

Funding & Sponsors
Funding source category [1] 308346 0
Self funded/Unfunded
Name [1] 308346 0
A/Prof Sam Adie
Country [1] 308346 0
Australia
Primary sponsor type
Individual
Name
A/Prof Sam Adie
Address
Specialist Consulting Suites
Suite 201, Level 2
131 Princes Highway (entry via South St)
KOGARAH NSW 2217
Country
Australia
Secondary sponsor category [1] 309186 0
None
Name [1] 309186 0
None
Address [1] 309186 0
Country [1] 309186 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308319 0
SESLHD Human Research and Ethics Committee (HREC)
Ethics committee address [1] 308319 0
Locked Mail Bag 21
TAREN POINT NSW 2229
Ethics committee country [1] 308319 0
Australia
Date submitted for ethics approval [1] 308319 0
Approval date [1] 308319 0
16/12/2020
Ethics approval number [1] 308319 0
STE17276

Summary
Brief summary
standard method will include a verbal explanation of the procedure including: surgical complications, potential benefits, details of the injury and surgical management. The detailed method will include the same information as the standard but the process will be supplemented by a written tool, including procedural information and visual aids.
We hypothesise that the patients that are consented utilising the detailed method will have greater overall post-operative recall in comparison to the patients that receive the standard consent method.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110294 0
A/Prof Sam Adie
Address 110294 0
Specialist Consulting Suites
Suite 201, Level 2
131 Princes Highway (entry via South St)
KOGARAH NSW 2217
Country 110294 0
Australia
Phone 110294 0
+61 2 9587 4720
Fax 110294 0
+61 2 9587 6927
Email 110294 0
[email protected]
Contact person for public queries
Name 110295 0
Sam Adie
Address 110295 0
Specialist Consulting Suites
Suite 201, Level 2
131 Princes Highway (entry via South St)
KOGARAH NSW 2217
Country 110295 0
Australia
Phone 110295 0
+61 295876927
Fax 110295 0
+61 2 9587 6927
Email 110295 0
[email protected]
Contact person for scientific queries
Name 110296 0
Sam Adie
Address 110296 0
Specialist Consulting Suites
Suite 201, Level 2
131 Princes Highway (entry via South St)
KOGARAH NSW 2217
Country 110296 0
Australia
Phone 110296 0
+61 2 9587 4720
Fax 110296 0
+61 2 9587 6927
Email 110296 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11401Study protocol    381809-(Uploaded-17-04-2021-22-46-41)-Study-related document.docx



Results publications and other study-related documents

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