RecruitingACTRN12618001319268

Comparing information for consent for orthopaedic procedures given by a video, or by a doctor, to see if this improves patient understanding of a procedure.

A randomised controlled trial comparing video assisted informed consent to traditional informed consent for orthopaedic procedures to assess patient knowledge and satisfaction


Sponsor

Consentic

Enrollment

152 participants

Start Date

May 6, 2019

Study Type

Interventional

Conditions

Summary

Informed medical consent is often poorly done; it can be time consuming, there is no clear standard between different medical practitioners, and overwhelmingly, the literature provides support for standardised animations or video consent. Video animations have been shown to improve patient comprehension, take the same amount of time, or can even save time and in most cases there is an improvement in patient satisfaction and comprehension. Videos have been successfully used to consent for colonoscopy, knee arthroscopy, laparoscopic urological procedures, cataract surgery, intravenous fluorescent angiography, vascular procedures, coronary angiography, cardiac electrophysiology, urogynaecological surgery as well as for clinical trials. There are no studies evaluating video informed consent for orthopaedic procedures in Australia. Given the literature shows improvements in patient understanding and satisfaction, it is anticipated that the video informed consent will lead to enhanced clinical practice, including enhanced knowledge retention by patients, improved patient and physician satisfaction, improved recall of the procedure, as well as saving minutes per consultation. We aim to compare traditional doctor-patient informed consent to a video animation when consenting for orthopaedic procedures (e.g. total hip replacement, total knee replacement, shoulder reconstruction, joint arthroscopy, hallux valgus deformity and other procedures). We propose that the video consent will be superior to traditional doctor patient consent – patients will have better retention of information, comprehension and understanding and higher satisfaction.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for adult patients aged 18 and over who are scheduled for an orthopaedic (bone and joint) procedure — such as a hip or knee replacement, shoulder reconstruction, joint arthroscopy, or foot surgery — and need to give informed consent for the operation. Informed consent is an important process where the doctor explains the procedure, its risks, and alternatives so the patient can make a fully informed decision. However, research shows that patients often forget or misunderstand much of this information. This trial tests whether watching a video animation explaining the procedure is a better way to ensure patients understand what they are consenting to, compared with the standard doctor-patient conversation. After receiving consent information through one method or the other, participants complete a short questionnaire to test their understanding, recall, and satisfaction with the consent process. You may be eligible if you are 18 or older, are scheduled for an orthopaedic procedure at a participating site, and are able to provide your own consent. People with significant visual or hearing impairment, those from a non-English speaking background without strong English, or those who lack capacity to consent are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Patients will receive video-assisted consent or usual care when informed consent is undertaken for orthopaedic procedures. Arm 1 (video-assisted consent) Arm 2 (usual care) The intervention is a s

Patients will receive video-assisted consent or usual care when informed consent is undertaken for orthopaedic procedures. Arm 1 (video-assisted consent) Arm 2 (usual care) The intervention is a short video animation (approximately 5 minutes) that discusses the risks, benefits and alternatives of orthopaedic procedures, and will be watched on a computer or tablet computer in the doctors office. The animations are narrated by a voiceover artist from a script constructed by orthopaedic specialists. There are separate animations for each orthopaedic procedure that will be undertaken e.g. knee and hip arthroplasty, knee arthroscopy etc. These videos have bee designed specifically for the study. The animation will be watched by the patient and the research assistant will supervise to try and ensure that the video is completely watched by the patient. All participants will be offered the opportunity to ask questions after the video has been watched or after the doctor has undertaken informed consent.


Locations(1)

Campbelltown Private Hospital - Campbelltown

NSW, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12618001319268


Related Trials