None listed
Conditions
Brief summary
Approximately one in ten adults in Australia have chronic kidney disease (CKD). In advanced CKD, the kidneys fail to remove waste from the blood, leading to symptoms that reduce quality of life and contribute to >1,700 deaths per year in Australia. Once the kidneys fail, patients can opt for life-extending treatment, such as haemodialysis (HD). However, the process of obtaining consent for HD is not consistently implemented across most Australian healthcare facilities. We hypothesise that quality informed consent improves decision-making and is key to better preparing patients for HD. This project aims to empower patients with advanced CKD to make informed decisions about HD by collaboratively developing a digital information interface called eConsent HD, co-designed with consumers, to present information in a user-friendly manner, catering to diverse backgrounds, languages, and health literacy levels. The effectiveness of eConsent HD will be evaluated through a randomized controlled trial comparing it to the current informed consent practice. Furthermore, an implementation strategy will be assessed using implementation science frameworks, aiming to identify facilitators and barriers to adopting eConsent HD into clinical practice. The project's ultimate goals are to improve patient outcomes, reduce treatment withdrawal rates, and standardize the HD consent process across Australia. The team involved in the project includes a diverse and skilled group of clinicians, researchers, and an industry partner specializing in digital capabilities. The research findings are expected to generate new knowledge, improve health literacy, and deliver a market-ready product to improve the patient experience in decision-making for HD. The project will address the disparities in consent practices, particularly for culturally and linguistically diverse populations, and contribute to evidence-based policies and practices in kidney care.
Interventions
Participants assigned to the intervention group will be coached to navigate the online digital eConsent HD. The consent animation will be a user-friendly animation featuring human figures role-playing an interaction between a patient and a doctor. The audio narrative will guide participants through the content presented in the video, while written subtitles and captions will further enhance the visual content. The script will cover various topics including treatment options for advanced kidney d
Participants assigned to the intervention group will be coached to navigate the online digital eConsent HD. The consent animation will be a user-friendly animation featuring human figures role-playing an interaction between a patient and a doctor. The audio narrative will guide participants through the content presented in the video, while written subtitles and captions will further enhance the visual content. The script will cover various topics including treatment options for advanced kidney disease; what HD involves, its potential benefits and risks, likely survival with or without HD, and the process of making an informed choice about HD. The animation will be co-designed with consumers (patients, family, carers, and kidney patient advocates). eConsent HD places control of uptake of information and consent with the participant. At the start of the animation participants will select language and literacy level. Participants can alter the speed of navigation through the animation at any time. Participants will complete teach-back exercises, a cyclic process to assess and reinforce understanding, and will have the option to go back and revisit specific points in the animation. The process finishes with signing of the electronic consent form which is date- and time-stamped and is compliant with international requirements for electronic signatures (i.e., the U.S. Food and Drug Administration Code of Federal Regulations Part 11 eSignature requirements). It is anticipated that navigation through the animation and questions will take up to 15 minutes.
Sponsors
Pedro Henrique Franca Gois
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
All consecutive incident haemodialysis patients will receive information about the study and be invited to participate. Prevalent haemodialysis patients, who have not been consented in the last 12 months, will also be invited to participate. Those that agree will be required to sign written informed consent to proceed into the study.
Exclusion criteria
< 18 years of age. Individuals not competent to consent or refuse to consent to medical treatment. Legally blindness (defined as having corrected acuity of no better than 6/60 and/or a vision field of no more than 10 degrees).
Outcome results
None listed