None listed
Conditions
Brief summary
The INFORM trial is a large study taking place across multiple hospitals to find out whether a short, easy-to-understand educational video can improve the consent process for people having a coronary angiogram. The video was created together with patients and doctors to make sure it explains the procedure clearly, covers important risks, and answers common questions. We want to know whether patients who watch the video feel more satisfied with the consent process and have a better understanding of what the procedure involves, compared with those who receive the usual consent process. Improving consent is important because it helps patients feel informed, confident, and involved in decisions about their care. A video could make complex information easier to understand and ensure everyone receives the same clear message. This will be the first large Australian study to test whether a patient-designed video can improve the consent experience for coronary angiography.
Interventions
We aim to conduct a two-arm open-label randomised trial comparing patient education video assisted informed consent against the usual consent process in patients undergoing elective coronary angiography.
Participants allocated to the intervention arm will receive the same consent process as the control group, including a
verbal explanation of the coronary angiogram procedure and risks by an interventional cardiologist, followed by the completion of a standard consent form for procedure.
In ad
We aim to conduct a two-arm open-label randomised trial comparing patient education video assisted informed consent against the usual consent process in patients undergoing elective coronary angiography. Participants allocated to the intervention arm will receive the same consent process as the control group, including a verbal explanation of the coronary angiogram procedure and risks by an interventional cardiologist, followed by the completion of a standard consent form for procedure. In addition to these processes of usual care, participants in the intervention arm will view a pre-developed 5-minute patient education video on an electronic tablet provided by research staff. The viewing of the video will take place in the procedural waiting room prior to undergoing the angiogram and after usual care consent is performed and signed. The video will be played once, without pause or interruption under the direct supervision of research staff. The patient educational video was developed specifically for the study with consumer partnership and comprises of narrated animations detailing in an easily understandable manner the sequence of events of the procedure, its expected benefits, common and serious risks, and steps of preparation.
Sponsors
Sydney Adventist Hospital (SAN)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Informed consent • Age greater than or equal to 18 years • Undergoing coronary angiogram • English speaking
Exclusion criteria
• Unable to give informed consent e.g. severe dementia, severe psychiatric illness • Procedures carried out under general anesthesia • Participants deemed not to be suitable by treating doctor • Patients who had video assisted consent with an alternate video
Outcome results
None listed