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

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.

Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

© 2021 Published by Elsevier Ltd.

Figures

Fig. 1
Fig. 1
Trial Workflow and Clinical Trial Informatics Solution (CTIS) Components (A) Generalized depiction of the trial workflow with colors denoting each corresponding, custom developed, support tool. (B) Modular CTIS components numbered 1–6 were all accessible via a VHA workstation. Clinicians utilized the Computerized Patient Record System (CPRS) user interface to view and enter patient data into VistA. All VHA patient data in VistA is stored nightly in the Corporate Data Warehouse (CDW) where it resides for research use. Custom developed (B1) Eligibility Screening and (B2) Consent Tracking forms were embedded within the EHR via CPRS. The Consent Tracking form links to the (B3) Randomizer application which was used to assign trial treatment strategy. Patient EHR data was extracted nightly from the CDW into the (B4) Trial DB. Within the Trial DB custom developed ‘Informatics Tables’ were used to facilitate data consumption and auditing. (B5) Patient Outcomes and Adverse Event tracking were used to collate data entered via chart review for regulatory reporting and used by the study statistician use to periodically update the randomization schedule. These data were also validated via EHR data extracts. Data from all CTIS components were combined with relevant EHR data in the Trial DB and (B6) real-time enrollment as well as scheduled reports were generated. . (For interpretation of the references to color in this figure legend, the reader is referred to the Web version of this article.)
Fig. 2
Fig. 2
Randomizer Application GUI The Randomizer Application was used to determine and track patient treatment arm. Specifically, clinicians entered patient identifiers (solid red arrows) including name, SSN, date-of-birth, inpatient site, and the application returned a treatment assignment (dashed dark blue arrow), e.g., Standard-of-Care (SOC) or SOC with Sarilumab (Active). . (For interpretation of the references to color in this figure legend, the reader is referred to the Web version of this article.)
Fig. 3
Fig. 3
Outcome and Adverse Event Tracking GUIs The CTIS includes customized GUIs to facilitate outcome and adverse event reporting via clinician chart review. (A) The Outcome Report GUI (top panel) allows selection of relevant primary/secondary study outcomes and date of occurrence as well as space for additional details as free text (red arrows). Multiple outcomes may be entered. These standardized outcome data were used by study statisticians to update treatment strategy as part of the overarching adaptive randomization design. (B) Adverse Event (AE) Report GUI (bottom panel) also includes dropdown menus and free-text boxes for detailed data entry (orange arrows). . (For interpretation of the references to color in this figure legend, the reader is referred to the Web version of this article.)

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