Informed consent video for flexor tendon repair surgery
Research type
Research Study
Full title
Informed consent in plastic surgery: a pilot study evaluating the effect of using a patient information video as part of the informed consent process for flexor tendon repair surgery
IRAS ID
256273
Contact name
Dimitris Reissis
Contact email
Sponsor organisation
Research and Development Office, Mid Essex NHS Trust
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
0 years, 2 months, 1 days
Research summary
Consenting patients for surgery is performed to varying standards between units and between individual doctors and patients. Doctors all have varied levels of training and experience in each specific procedure being consented for. Patients have varied levels of prior knowledge and understanding regarding their surgical procedure before discussing with their surgeon and signing their consent form. They currently have limited resources to help them fully understand and become reliably informed of the potential risks and benefits of the surgery before signing the consent form.
NHS hospitals and departments must continuously reflect on their performance and save money where possible within the tight budget available. ‘Failure to warn’ of potential risks and complications is directly linked to 86.1% litigation claims in surgery processed by the NHSLA annually. The NHSLA pays out a total of £1.2billion in litigation costs each year, which represents a significant financial burden to the NHS as a whole, of which a significant part is related to poor consent practice.
This study will use a specifically designed animated video for informing patients about their flexor tendon repair surgery. They will be given access to the video online and be able to watch this an unlimited number of times in the time between their injury/decision for surgical treatment, and the surgery itself. They will also be able to note down questions that arise as they watch the video and ask these to their surgeon before providing their consent. Time usually spent in person discussing the generic risks in a varied, paternalistic and generic manner, often soon before the operation itself, will instead be freed up for more detailed and personalised discussion between the patient and doctor regarding their specific concerns, based on their prior understanding and questions from the video.
We will assess patient’s understanding and satisfaction with their consent process and overall care, in direct comparison to a group of ‘controls’ who will be consented as per normal standard practice in our Plastic Surgery department.
The results will inform further development of our ability to provide and support patients with the information they need to fully understand and be informed of their surgery, and become actively involved in their decision making, when providing their consent.
REC name
East of England - Essex Research Ethics Committee
REC reference
19/EE/0028
Date of REC Opinion
9 Jan 2019
REC opinion
Unfavourable Opinion