Patient randomised controlled trial of technology enabled strategies to promote treatment adherence in liver transplantation: rationale and design of the TEST trial

Abstract

Background and aimsLiver transplantation is a life-saving procedure for end-stage liver disease. However, post-transplant medication regimens are complex and non-adherence is common. Post-transplant medication non-adherence is associated with graft rejection, which can have long-term adverse consequences. Transplant centres are equipped with clinical staff that monitor patients post-transplant; however, digital health tools and proactive immunosuppression adherence monitoring has potential to improve outcomes.Methods and analysisThis is a patient-randomised prospective clinical trial at three transplant centres in the Northeast, Midwest and South to investigate the effects of a remotely administered adherence programme compared with usual care. The programme monitors potential non-adherence largely levering text message prompts and phenotypes the nature of the non-adhere as cognitive, psychological, medical, social or economic. Additional reminders for medications, clinical appointments and routine self-management support are incorporated to promote adherence to the entire medical regimen. The primary study outcome is medication adherence via 24-hour recall; secondary outcomes include additional medication adherence (ASK-12 self-reported scale, regimen knowledge scales, tacrolimus values), quality of life, functional health status and clinical outcomes (eg, days hospitalised). Study implementation, acceptability, feasibility, costs and potential cost-effectiveness will also be evaluated.Ethics and disseminationThe University of Pennsylvania Review Board has approved the study as the single IRB of record (protocol # 849575, V.1.4). Results will be published in peer-reviewed journals and summaries will be provided to study funders.Trial registration numberNCT05260268.

Design, implementation, and impact of a cirrhosis-specific remote patient monitoring program

“…[8] While studies have demonstrated promise in the use of digital tools to manage cirrhosis, it is essential to determine the feasibility and effectiveness of a comprehensive cirrhosis-specific RPM before widespread implementation of this technology. [9][10][11] In this project, we aimed to: (1) design and implement a cirrhosis-specific RPM (CiRPM) program, as well as (2) show its utility through measurement of potential clinical benefit, patient satisfaction, and patient adherence. We hope this can serve as a roadmap for other personalized remote monitoring programs for patients with cirrhosis.…”

“…RPM is becoming increasingly popular, and its use will likely continue to increase in the near future due to recent changes in Medicare establishing a billing code for RPM 8 . While studies have demonstrated promise in the use of digital tools to manage cirrhosis, it is essential to determine the feasibility and effectiveness of a comprehensive cirrhosis-specific RPM before widespread implementation of this technology 9–11 . In this project, we aimed to: (1) design and implement a cirrhosis-specific RPM (CiRPM) program, as well as (2) show its utility through measurement of potential clinical benefit, patient satisfaction, and patient adherence.…”