None listed
Conditions
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.
Interventions
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 orthop
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.
Sponsors
A/Prof Sam Adie
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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
Outcome results
None listed