Grant: Planning and Dissemination Grant - Institute Community Support

Patients receiving hemodialysis (HD) suffer from poor quality of life and markedly shortened life span compared with the general population. Currently, there is a knowledge gap on the optimal HD prescriptions that would improve patient outcomes. The aim of the current proposal is to bring together key stakeholders to explore how clinical trials may be more feasibly conducted in this population in order to determine the optimal treatment parameters. We propose that randomly allocating HD units to one or more HD prescription options (cluster randomized trial - CRT) to determine the optimal prescription would be a more natural, better study design than randomly allocating individual patients, as the latter has proven infeasible. However, the practical advantages, barriers, and ethics of CRTs need to be explored. We will hold a national in-person workshop with dialysis clinical researchers, HD unit directors, HD charge nurses, research coordinators, ethicists and patient representatives in order to: 1) discuss the advantages and gauge current enthusiasm to conduct CRTs evaluating HD prescription in Canada; 2) identify barriers and solutions to feasibly such conduct cluster RCTs in Canada; 3) explore whether it is ethical to waive the need for patient-level informed consent for cluster RCTs of standard of care HD prescription interventions. Through this worksop, we will lay the foundation for the first-ever cluster RCT evaluating HD prescription. Involvement of key stakeholders will ensure the resulting protocol addresses a clinically important question, and has a high likelihood of funding, completion, and translation into practice. Finally, the multi-displinary collaborations and network created through this workshop will be key to conducting future trials in HD Canada and continue to advance knowledge in this field.