RecruitingACTRN12621000768897

eConsent for kidney biopsy: impact on the patient experience

The patient experience of kidney biopsy: A randomised controlled trial evaluating video-assisted consent versus standard consent for percutaneous ultrasound-guided kidney biopsy in adults


Sponsor

Pedro Henrique Franca Gois

Enrollment

120 participants

Start Date

Jul 21, 2021

Study Type

Interventional

Conditions

Summary

Informed medical consent is how clinicians communicate important information to patients about procedures/treatments they are recommending. The process of communication is highly individualised, time consuming and at a pace that is usually set by the healthcare worker. It is therefore not surprising that patients report variable and inconsistent comprehension and understanding of clinicians’ explanations of procedures/treatments. The literature demonstrates that audiovisual consent, when used to supplement current methods, improves the patient experience, including higher satisfaction, better comprehension and less anxiety. We will, for the first time in the procedure of kidney biopsies, evaluate patient reported benefits of video-assisted electronic consent compared to a conventional consent process, that being a clinician consenting the patient.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Before undergoing a medical procedure like a kidney biopsy, patients need to give informed consent — meaning they must understand what the procedure involves, its risks, and the alternatives. This consent process is usually conducted by a clinician in conversation with the patient, but the quality and consistency of that communication can vary widely, and many patients leave without fully understanding what they have agreed to. This study tests whether an audiovisual electronic consent process — where patients can watch a video explaining the procedure at their own pace before their appointment — improves understanding, reduces anxiety, and increases satisfaction compared to the traditional verbal consent process. Participants scheduled for a kidney biopsy are randomly assigned to either the standard clinician-led consent or the eConsent approach, and outcomes including comprehension and patient experience are measured. You may be eligible if you are 18 or over and are scheduled for a percutaneous kidney biopsy. People who lack legal capacity to consent to medical treatment, or who are legally blind, 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

Participants in the video-assisted (intervention) group will watch a 6 minute audiovisual consent animation describing the procedure of percutaneous kidney biopsy. This will be shown prior to the part

Participants in the video-assisted (intervention) group will watch a 6 minute audiovisual consent animation describing the procedure of percutaneous kidney biopsy. This will be shown prior to the participant's consultation with their doctor. Content of the animation video is based on the recently published national CARI guidelines and its translation into the kidney biopsy pathway, approved by the RBWH Forms Review Committee. The final video is structured into 10 sections: “reasons for kidney biopsy”, “preparing for kidney biopsy”, “the procedure”, “post-procedure”, “benefits”, “risks of not having a kidney biopsy”, “alternatives”, “risks of kidney biopsy”, “patients at increased risk of complications” and “conclusion”. The audio narrative steps the participant through what is displayed in the video. The visual content is augmented by written subtitles and captions.The patient-centric animation was developed in English and will be translated into five other commonly spoken languages (Vietnamese, Arabic, Mandarin, Cantonese and Spanish).


Locations(1)

Royal Brisbane & Womens Hospital - Herston

QLD, Australia

View Full Details on ANZCTR

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

Visit

ACTRN12621000768897