Rapid implementation of a modular clinical trial informatics solution for COVID-19 research

Rupali Dhond; Ryan Acher; Sarah Leatherman; Sarah Page; Randolph Sanford; Danne Elbers; Frank Meng; Ryan Ferguson; Mary T Brophy; Nhan V Do

doi:10.1016/j.imu.2021.100788

Rapid implementation of a modular clinical trial informatics solution for COVID-19 research

Inform Med Unlocked. 2021:27:100788. doi: 10.1016/j.imu.2021.100788. Epub 2021 Nov 12.

Authors

Rupali Dhond^{1

2}, Ryan Acher¹, Sarah Leatherman¹, Sarah Page¹, Randolph Sanford¹, Danne Elbers^{1

3}, Frank Meng^{1

2}, Ryan Ferguson¹, Mary T Brophy^{1

2}, Nhan V Do^{1

2}

Affiliations

¹ VA Boston Healthcare System, Boston, MA, USA.
² Boston University School of Medicine, Boston, MA, USA.
³ University of Vermont, Burlington, VT, USA.

Abstract

Veterans Health Administration (VHA) services are most frequently used by patients 65 years and older, an age group that is disproportionally affected by COVID-19. Here we describe a modular Clinical Trial Informatics Solution (CTIS) that was rapidly developed and deployed to support a multi-hospital embedded pragmatic clinical trial in COVID-19 patients within the VHA. Our CTIS includes tools for patient eligibility screening, informed consent tracking, treatment randomization, EHR data transformation for reporting and interfaces for patient outcome and adverse event tracking. We hope our CTIS component descriptions and practical lessons learned will serve as a useful building block for others creating their own clinical trial tools and have made application and database code publicly available.

Keywords: Adaptive randomization; CDW; EHR; Electronic health record; Embedded pragmatic; Learning healthcare; VHA; Veterans.