RATIONALE AND DESIGN OF THE eCONSENT HD: A HYBRID EFFECTIVENESS-IMPLEMENTATION CLINICAL TRIAL EVALUATING VIDEO-ASSISTED ELECTRONIC CONSENT VS STANDARD CONSENT FOR PATIENTS UNDERGOING HAEMODIALYSIS
Pedro Henrique Franca Gois1, Rebecca B. Saunderson2, Marina Wainstein3, Chenlei-Kelly Li4, Matthew Damasiewicz5, Vera Y. Miao2, Martin Wolley6, Kirsten Hepburn6, Ann Bonner7, Helen G. Healy6 1The University of Queensland, QLD, Australia2University of Sydney, Sydney, NSW, Australia, 3West Moreton Hospital and Health Service, Ipswich, QLD, Australia, 4St George and Sutherland Hospitals, Kogarah, NSW, Australia, 5Monash Medical Centre, Clayton, VIC, Australia, 6Royal Brisbane and Women’s Hospital, Herston, QLD, Australia, 7School of Nursing and Midwifery, Griffith University, Gold Coast, QLD, Australia,
Abstract
Background/Aims
We hypothesise that quality informed consent improves decision-making and is key to better preparing patients for haemodialysis (HD). The aims of this study are to demonstrate that the use of audio-visual resources (intervention) compared to paper-based resources (control) to supplement informed consent improves the patient-reported experience with better understanding/comprehension, less anxiety, increased patient satisfaction, less decisional regret, and improved adherence to kidney care.
Methods
A two-armed, open-label, RCT will be conducted in four Australian centres in parallel to the implementation of informed consent for HD in two sites. Participants: Incident and prevalent adult HD patients will be randomly assigned to either the intervention or the control group. Intervention group: Participants will be coached to an online platform that delivers a simple-to-understand animation and teach back questions prior to signing an electronic consent form. The 10-minute animation, co-designed with consumers, will consist of human figures role-playing a doctor-patient interaction. Control group: Participants will be consented conventionally by a medical practitioner and sign a paper consent form. Both groups will have their questions answered by a clinician prior to signing the consent form. Primary outcomes: patient reported experience measure and patient comprehension. Secondary outcomes: decision regret scale, patient anxiety, patient satisfaction, adherence to renal care, dialysis withdrawal, time taken to consent and participants’ qualitative feedback.
Conclusion
Study outcomes directly address patient experiences in the complex decision-making processes required to commence and continue HD. It also standardises the content of complex health information, which may profoundly impact decision-making and quality of life. If video-assisted electronic consent is proven superior to the existing consent process, this RCT will serve as a proof-of-concept to drive changes in nephrology.
Biography
A/Prof Franca Gois is a young Nephrologist, whose medical training spans 3 continents, giving him a diversity of experience in both developed and developing health systems. He attended medical school in Heidelberg, Germany and subsequently carried out specialist training in Brazil. He completed PhD and post-doc at the University of Sao Paulo. He moved to Australia in 2017 and was awarded with the Fellowship of the RACP in 2018. He has already attracted >$372,000 in competitive research funding for investigator-initiated projects. He has published >49 peer-reviewed papers in high-tier journals, book chapters and abstracts in conference proceedings. He is a member/fellow of various societies and editor of two medical journals.