Journal article
Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials
Contemporary clinical trials, Vol.148, 107744
01/2025
DOI: 10.1016/j.cct.2024.107744
PMCID: PMC11831575
PMID: 39561918
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.
Details
- Title: Subtitle
- Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials
- Creators
- Keith A. Marsolo - Duke UniversityAndrea Cheville - Mayo Clinic in FloridaEdward R. Melnick - Yale UniversityJeffrey G. Jarvik - University of WashingtonGregory E. Simon - Kaiser Permanente Washington Health Research InstituteKathleen A. Sluka - University of IowaLeslie J. Crofford - Vanderbilt University Medical CenterKaren L. Staman - Duke UniversityRachel L. Richesson - University of MichiganJudith M. Schlaeger - University of Illinois Urbana-ChampaignLesley H. Curtis - Duke University
- Resource Type
- Journal article
- Publication Details
- Contemporary clinical trials, Vol.148, 107744
- DOI
- 10.1016/j.cct.2024.107744
- PMID
- 39561918
- PMCID
- PMC11831575
- NLM abbreviation
- Contemp Clin Trials
- ISSN
- 1551-7144
- eISSN
- 1559-2030
- Publisher
- Elsevier Inc
- Grant note
- NIH Office of Behavioral and Social Sciences Research (OBSSR)NIH Office of Disease Prevention (ODP)NIH through the NIH HEAL Initiative: U24AT010961 NIH: UG3DA047003, UH3DA047003, UG3AR076387, UH3AR076387, UG3AT011265, UH3AT011265, UH2AT007766, UH3AR066795, UG3AG067593, UH3AG067593, UH2AT007755, UH3MH007755 NIANHLBI
This work was supported within the National Institutes of Health (NIH) Pragmatic Trials Collaboratory through cooperative agreement U24AT009676 from the National Center for Complementary and Integrative Health (NCCIH) , the National Institute of Allergy and Infectious Diseases (NIAID) , the National Cancer Institute (NCI) , the National Institute on Aging (NIA) , the National Heart, Lung, and Blood Institute (NHLBI) , the National Institute of Nursing Research (NINR) , the National Institute of Minority Health and Health Disparities (NIMHD) , the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) , the NIH Office of Behavioral and Social Sciences Research (OBSSR) , and the NIH Office of Disease Prevention (ODP) . This work was also supported by the NIH through the NIH HEAL Initiative under award number U24AT010961. Demonstration Projects within the NIH Pragmatic Trials Collaboratory were supported by the following cooperative agreements with NIH Institutes: EMBED (UG3DA047003, UH3DA047003) , FM-TIPS (UG3AR076387, UH3AR076387) , GRACE (UG3AT011265, UH3AT011265) , LIRE (UH2AT007766, UH3AR066795) , NOHARM (UG3AG067593, UH3AG067593) , and SPOT (UH2AT007755, UH3MH007755) . The content is solely the responsibility of the authors and does not necessarily represent the official views of the NCCIH, NIAID, NCI, NIA, NHLBI, NINR, NIMHD, NIAMS, OBSSR, or ODP, or the NIH or its HEAL Initiative.r (NIAMS) , the NIH Office of Behavioral and Social Sciences Research (OBSSR) , and the NIH Office of Disease Prevention (ODP) . This work was also supported by the NIH through the NIH HEAL Initiative under award number U24AT010961. Demonstration Projects within the NIH Pragmatic Trials Collaboratory were supported by the following coop-erative agreements with NIH Institutes: EMBED (UG3DA047003, UH3DA047003) , FM-TIPS (UG3AR076387, UH3AR076387) , GRACE (UG3AT011265, UH3AT011265) , LIRE (UH2AT007766, UH3AR066795) , NOHARM (UG3AG067593, UH3AG067593) , and SPOT (UH2AT007755, UH3MH007755) . The content is solely the re-sponsibility of the authors and does not necessarily represent the official views of the NCCIH, NIAID, NCI, NIA, NHLBI, NINR, NIMHD, NIAMS, OBSSR, or ODP, or the NIH or its HEAL Initiative.
- Language
- English
- Electronic publication date
- 11/17/2024
- Date published
- 01/2025
- Academic Unit
- Iowa Neuroscience Institute; Nursing; Physical Therapy and Rehabilitation Science; Neuroscience and Pharmacology
- Record Identifier
- 9984749734402771
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