Rapid implementation of a modular clinical trial informatics solution for COVID-19 research
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-hospita...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2021-01-01
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| Series: | Informatics in Medicine Unlocked |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2352914821002598 |
| _version_ | 1819004550051266560 |
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| author | Rupali Dhond Ryan Acher Sarah Leatherman Sarah Page Randolph Sanford Danne Elbers Frank Meng Ryan Ferguson Mary T. Brophy Nhan V. Do |
| author_facet | Rupali Dhond Ryan Acher Sarah Leatherman Sarah Page Randolph Sanford Danne Elbers Frank Meng Ryan Ferguson Mary T. Brophy Nhan V. Do |
| author_sort | Rupali Dhond |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-20T23:38:40Z |
| format | Article |
| id | doaj.art-4281157deaf14681b4f95214271e2b1f |
| institution | Directory Open Access Journal |
| issn | 2352-9148 |
| language | English |
| last_indexed | 2024-12-20T23:38:40Z |
| publishDate | 2021-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Informatics in Medicine Unlocked |
| spelling | doaj.art-4281157deaf14681b4f95214271e2b1f2022-12-21T19:23:09ZengElsevierInformatics in Medicine Unlocked2352-91482021-01-0127100788Rapid implementation of a modular clinical trial informatics solution for COVID-19 researchRupali Dhond0Ryan Acher1Sarah Leatherman2Sarah Page3Randolph Sanford4Danne Elbers5Frank Meng6Ryan Ferguson7Mary T. Brophy8Nhan V. Do9VA Boston Healthcare System, Boston, MA, USA; Boston University School of Medicine, Boston, MA, USA; Corresponding author. VA Boston Healthcare System, 150 S Huntington Ave, Boston, MA, 02130, USA.VA Boston Healthcare System, Boston, MA, USAVA Boston Healthcare System, Boston, MA, USAVA Boston Healthcare System, Boston, MA, USAVA Boston Healthcare System, Boston, MA, USAVA Boston Healthcare System, Boston, MA, USA; University of Vermont, Burlington, VT, USAVA Boston Healthcare System, Boston, MA, USA; Boston University School of Medicine, Boston, MA, USAVA Boston Healthcare System, Boston, MA, USAVA Boston Healthcare System, Boston, MA, USA; Boston University School of Medicine, Boston, MA, USAVA Boston Healthcare System, Boston, MA, USA; Boston University School of Medicine, Boston, MA, USAVeterans 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.http://www.sciencedirect.com/science/article/pii/S2352914821002598Electronic health recordEHRVeteransAdaptive randomizationVHACDW |
| spellingShingle | Rupali Dhond Ryan Acher Sarah Leatherman Sarah Page Randolph Sanford Danne Elbers Frank Meng Ryan Ferguson Mary T. Brophy Nhan V. Do Rapid implementation of a modular clinical trial informatics solution for COVID-19 research Informatics in Medicine Unlocked Electronic health record EHR Veterans Adaptive randomization VHA CDW |
| title | Rapid implementation of a modular clinical trial informatics solution for COVID-19 research |
| title_full | Rapid implementation of a modular clinical trial informatics solution for COVID-19 research |
| title_fullStr | Rapid implementation of a modular clinical trial informatics solution for COVID-19 research |
| title_full_unstemmed | Rapid implementation of a modular clinical trial informatics solution for COVID-19 research |
| title_short | Rapid implementation of a modular clinical trial informatics solution for COVID-19 research |
| title_sort | rapid implementation of a modular clinical trial informatics solution for covid 19 research |
| topic | Electronic health record EHR Veterans Adaptive randomization VHA CDW |
| url | http://www.sciencedirect.com/science/article/pii/S2352914821002598 |
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