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

Marina Serper*, Alexander Burdzy, Douglas E. Schaubel, Richard Mason, Arpita Banerjee, David S. Goldberg, Eric F. Martin, Shivan J. Mehta, Louise B. Russell, Amanda C. Cheung, Daniela P. Ladner, Julia Yoshino Benavente, Michael S. Wolf

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

Background and aims Liver 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 analysis This 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 dissemination The 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 number NCT05260268.

Original languageEnglish (US)
Article number075172
JournalBMJ open
Volume13
Issue number9
DOIs
StatePublished - Sep 18 2023

Keywords

  • Clinical Trial
  • Hepatobiliary disease
  • Public health
  • TRANSPLANT SURGERY
  • Transplant medicine

ASJC Scopus subject areas

  • General Medicine

Fingerprint

Dive into the research topics of 'Patient randomised controlled trial of technology enabled strategies to promote treatment adherence in liver transplantation: rationale and design of the TEST trial'. Together they form a unique fingerprint.

Cite this