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Kidney Week

Abstract: PO1071

Patient Navigators and Study Coordinators: A Team Approach Towards Patient Support in Decentralized Clinical Trials

Session Information

  • Educational Research
    November 04, 2021 | Location: On-Demand, Virtual Only
    Abstract Time: 10:00 AM - 12:00 PM

Category: Educational Research

  • 800 Educational Research


  • D'Alessandri-Silva, Cynthia J., Connecticut Children's Medical Center, Hartford, Connecticut, United States
  • Cranstoun, Kimberley D., Advicenne Inc., Ardmore, Pennsylvania, United States
  • Klochak, Anna, Children's Hospital Colorado, Aurora, Colorado, United States

COVID-19 related restrictions have accelerated adoption of decentralized clinical trials(DCT). DCTs offer increased patient flexibility via online study platforms, telemedicine and home-based nursing. DCTs reduce travel, hospitalization and in-person interactions, all problematic under COVID. Potential drawbacks exist for both patients and study coordinators, however. In DCTs, removal of study-site visits may leave patients feeling confused, unsafe, disempowered and disengaged, potentially increasing drop-out risk. While DCTs may mean increased enrollment for sites, management of novel patient pathways may prove more time-consuming for study coordinators. Crucial protocol driven events or patient concerns/questions may be missed due to complex patient tracking.


The role of the patient navigator(PN) was developed to support both patients and study coordinators in DCTs. PNs will provide culturally-appropriate psychosocial education to ensure patients feel safe, informed, and supported. PNs serve as conduits between the patient and the study site, ensuring bi-directional communication of patient progress. This unique approach is being trialed in ARENA2, a pediatric Phase III study in primary distal renal tubular acidosis, a rare renal disease.


A multi-lingual team with unique educational and counseling experience was recruited and trained on the protocol and disease. The team will provide weekly check-ins with patients to foster engagement as well as identify any concerns the patient may be having in home healthcare. This role will offer around the clock patient support which will increase accessibility and decrease burden experienced by study coordinators with heavy caseloads. PNs have also developed educational videos in target languages using lay-friendly terminology to ensure patient understanding. Topics include clinical trials, ARENA2 and research in rare diseases. The study website contains additional resources including written articles that help set expectations and provide subjects with strategies for success as they go through ARENA2.


The concept of sponsor-driven PN team services in DCTs will offer both patients and study sites the added benefits of support.


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