Point of Care Peritoneal Dialysis System Early Evaluation Study

POC-PDEE will utilise different methodologies to establish the safety, efficacy and usability of the Ellen Medical - Point of Care (EM-POC) peritoneal dialysis (PD) system with Australian dialysis patients. This study comprises three inter-linked components: (1) a series of human factors usability assessments, (2) a shadow study testing the reliability of the chemical composition and sterility of PD fluid produced by the EM-POC system when used by dialysis patients or their carers independently at the point-of-care and (3) semi-structured interviews to assess patient perspectives regarding the EM-POC system, it’s usability and the training provided prior to using the EM-POC system. (1) Human Factors Assessment. A mixed methods study to collect observational and interview data from patient and clinician participants, who will be asked to complete specified tasks through simulated use testing, using: photographs, computer aided design (CAD) models, foam models and functional prototypes of the EM-POC system to identify potential human factors risk, use errors and possible improvements to the design of the system. The system prototypes used in these evaluations will not provide medical therapy. Assessments will be conducted individually with around 23 participants (approximately 20 patients and 3 clinicians) and will be conducted in patient participants’ homes or in the peritoneal dialysis unit. Assessments will be conducted by a human factors expert with over 20 years of experience in medical device product development and will last approximately 90 minutes. (2) Shadow Study. An open label in-vitro interventional study to test the chemical composition and sterility of PD fluid produced by patient participants using the EM-POC system at home. EM-POC PD fluid will NOT be used for dialysis in any participants. Instead, five patient participants will prepare four bags of PD fluid each day for five days at home using the EM-POC system. The filled PD bags will be collected and sent for testing of chemical composition and sterility. Participants will be trained to use the EM-POC system by a peritoneal dialysis clinical nurse specialist. Adherence will be monitored by daily visits to participants’ homes and collection of filled dialysis bags. (3) Patient Perspectives. A qualitative research study collecting data through semi-structured interviews from all five participants in the Shadow Study regarding their expectations, experiences and training with the EM-POC system. Daily participant experience will also be collected using a brief questionnaire. All interviews will be conducted via videoconference by an interviewer with extensive experience in qualitative research methods and patient partnership. Interviews will be recorded using videoconference software and transcribed to facilitate data analysis. Interviews will be conducted once with each participant, between one-three weeks following completion of the Shadow Study and take less than 60 minutes.