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Abstract: TH-PO312

Utilization of Extended Training Decay Periods to Evaluate Training Effectiveness in Home Dialysis Devices

Session Information

  • Home Dialysis - I
    November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category: Dialysis

  • 802 Dialysis: Home Dialysis and Peritoneal Dialysis

Authors

  • Lim, Brittany, Outset Medical, San Jose, California, United States
  • Sureshbabu, Keertana, Outset Medical, San Jose, California, United States
  • Edson, Elise, Outset Medical, San Jose, California, United States
  • Wazny, Jarnet Han, Outset Medical, San Jose, California, United States
  • D'Alessandri-Silva, Cynthia J., Outset Medical, San Jose, California, United States
  • Aragon, Michael A., Outset Medical, San Jose, California, United States
Background

When conducting medical device usability testing, users perform tasks under representative use conditions. A “training decay” in the study is a defined time period between user training and user testing to allow for representative memory decay. FDA 2016 guidance emphasizes the training provided to test participants should approximate the training that actual users would receive including training decay. In practice, medical device manufacturers typically utilize a 1-hour training decay to simplify scheduling logistics. Real-world training decay for home hemodialysis (HHD) patients ranges from several hours up to nine days before their first-time independent use. Here we present the results of a usability validation study evaluating extended training decay on the safe and effective use of the Tablo Hemodialysis System.

Methods

A human factors (HF) protocol was implemented with recruitment of 16 patient/care partner pairs (PCP) and 17 health care professionals (HCP). The PCP arm included 10 pairs without any prior HHD experience, and the HCP arm was composed of dialysis nurses and technicians. Each participant completed standard Tablo training, after which they experienced extended training decay periods ranging from 1 to 4 weeks. All participants then performed a simulated dialysis treatment (treatment setup, monitoring, and tear down) on Tablo. Task performance (use errors, close calls, and difficulties), subjective interviews and knowledge task assessments were recorded.

Results

The training decay averaged 16 days (min = 9 days, max = 28 days) for HCPs and 13 days (min = 6 days, max = 25 days) for patient/care partner pairs. Participants were able to complete all necessary tasks with minimal use error rates (0.32% and 0.65%), for HCPs and PCPs, respectively. Post testing, 100% of participants reported confidence in being able to use Tablo safely and effectively.

Conclusion

Objective evidence of effective training through HF validation is critical to ensuring safe use of home dialysis devices. Task performance from this study demonstrates the effectiveness of standard Tablo training in scenarios of extended training decay including and beyond actual use (up to 28 days). These results extend prior data on the usability and ease of learning Tablo for patients performing home hemodialysis.

Funding

  • Commercial Support – Outset Medical