Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Jan:148:107744.
doi: 10.1016/j.cct.2024.107744. Epub 2024 Nov 17.

Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials

Keith A Marsolo  1 , Andrea Cheville  2 , Edward R Melnick  3 , Jeffrey G Jarvik  4 , Gregory E Simon  5 , Kathleen A Sluka  6 , Leslie J Crofford  7 , Karen L Staman  8 , Rachel L Richesson  9 , Judith M Schlaeger  10 , Lesley H Curtis  11
Affiliations

Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials

Keith A Marsolo et al. Contemp Clin Trials. 2025 Jan.

Abstract

The NIH Pragmatic Trials Collaboratory supports the design and conduct of 32 embedded pragmatic clinical trials, and many of these trials rely on data from the electronic health record (EHR) to monitor outcomes and/or use functionality provided by the EHR platform to deliver the intervention. Given the complexity and dynamic nature of EHR systems, study teams have encountered challenges in use of the EHR for these purposes, including challenges related to local implementation of trial interventions, rapid technology evolution, EHR updates, and transitions in EHR systems. In this article, we share case examples and lessons learned, and suggest that teams need to be aware of-and perhaps proactively investigate- possible changes to EHR systems and data that will affect the delivery of interventions and the integrity and safety of pragmatic clinical trials.

Keywords: Electronic health record; Health systems research; Monitoring; Pragmatic trials.

PubMed Disclaimer

Conflict of interest statement

Declaration of competing interest KM has no disclosures relevant to the manuscript and reports that he is a Co-inventor of Hive Networks, Inc. and his salary is funded in part through research contracts from Bayer, BMS, BI, Amgen, Novartis, Seqirus, and Genentech. JGJ: Dr. Jarvik was supported by the University of Washington Clinical Learning, Evidence, And Research (CLEAR) Center for Musculoskeletal Disorders, Administrative, Methodologic Cores and NIAMS/NIH grant P30AR072572. Dr. Jarvik r has no disclosures relevant to the manuscript but reports royalties as a book co-editor from Springer Publishing and travel reimbursement for Faculty Board of Review from GE-Association of University Radiologists Radiology Research Academic Fellowship (GERRAF) and royalties as a chapter author from Wolters Kluwer/UpToDate.

References

    1. Richesson RL, Green BB, Laws R, Puro J, Kahn MG, Bauck A, Smerek M, Van Eaton EG, Zozus M, Ed Hammond W, Stephens KA, Simon GE, Pragmatic (trial) informatics: a perspective from the NIH Health Care Systems Research Collaboratory, Journal of the American Medical Informatics Association; 24 (2017) 996–1001. 10.1093/jamia/ocx016. - DOI - PMC - PubMed
    1. Raman SR, O’Brien EC, Hammill BG, Nelson AJ, Fish LJ, Curtis LH, Marsolo K, Evaluating fitness-for-use of electronic health records in pragmatic clinical trials: reported practices and recommendations, Journal of the American Medical Informatics Association; 29 (2022) 798–804. 10.1093/jamia/ocac004. - DOI - PMC - PubMed
    1. Weinfurt KP, Hernandez AF, Coronado GD, DeBar LL, Dember LM, Green BB, Heagerty PJ, Huang SS, James KT, Jarvik JG, Larson EB, Mor V, Platt R, Rosenthal GE, Septimus EJ, Simon GE, Staman KL, Sugarman J, Vazquez M, Zatzick D, Curtis LH, Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory, BMC Med Res Methodol 17 (2017) 144. 10.1186/s12874-017-0420-7. - DOI - PMC - PubMed
    1. Richesson RL, Marsolo KS, Douthit BJ, Staman K, Ho PM, Dailey D, Boyd AD, McTigue KM, Ezenwa MO, Schlaeger JM, Patil CL, Faurot KR, Tuzzio L, Larson EB, O’Brien EC, Zigler CK, Lakin JR, Pressman AR, Braciszewski JM, Grudzen C, Fiol GD, Enhancing the use of EHR systems for pragmatic embedded research: lessons from the NIH Health Care Systems Research Collaboratory, Journal of the American Medical Informatics Association; 28 (2021) 2626–2640. 10.1093/jamia/ocab202. - DOI - PMC - PubMed
    1. Richesson RL, Hammond WE, Nahm M, Wixted D, Simon GE, Robinson JG, Bauck AE, Cifelli D, Smerek MM, Dickerson J, Laws RL, Madigan RA, Rusincovitch SA, Kluchar C, Califf RM, Electronic health records based phenotyping in next-generation clinical trials: a perspective from the NIH Health Care Systems Collaboratory, J Am Med Inform Assoc 20 (2013) e226–231. 10.1136/amiajnl-2013-001926. - DOI - PMC - PubMed

LinkOut - more resources