Evidence map›Paper›PMID 39561918›Full record

ArticleContemporary clinical trials2025

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

Keith A Marsolo, Andrea Cheville, Edward R Melnick, Jeffrey G Jarvik, Gregory E Simon, Kathleen A Sluka, Leslie J Crofford, Karen L Staman, Rachel L Richesson, Judith M Schlaeger and 1 more

Abstract read
In one paragraph

Article in Contemporary clinical trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Keith A MarsoloDuke University School of Medicine, Department of Population Health Sciences, Durham, NC, United States of America. Electronic address: keith.marsolo@duke.edu.
Andrea ChevilleMayo Clinic Comprehensive Cancer Center, Rochester, MN, United States of America.
Edward R MelnickYale School of Medicine, Department of Emergency Medicine, New Haven, CT, United States of America.
Jeffrey G JarvikDepartment of Radiology and Clinical Learning, Evidence, and Research (CLEAR) Center, University of Washington, School of Medicine, Seattle, WA, United States of America.
Gregory E SimonKaiser Permanente Washington Health Research Institute, Seattle, WA, United States of America.
Kathleen A SlukaUniversity of Iowa, Carver School of Medicine, Iowa City, IA, United States of America.
Leslie J CroffordVanderbilt University Medical Center Department of Medicine, Nashville, TN, United States of America.
Karen L StamanDuke Clinical Research Institute, Durham, NC, United States of America.
Rachel L RichessonDepartment of Learning Health Sciences, University of Michigan Medical School, Ann Arbor, MI, United States of America.
Judith M SchlaegerUniversity of Illinois Chicago, College of Nursing, Chicago, IL, United States of America.
Lesley H CurtisDuke University School of Medicine, Department of Population Health Sciences, Durham, NC, United States of America.

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NIH Health Care Systems Research Collaboratory-Coordinating Center (U24)U24AT009676 · NCCIH · DUKE UNIVERSITY · PI LESLEY H CURTIS, Adrian Hernandez · 2017 to 2026
$21.5M
Pragmatic Trial of Population-based Programs to Prevent Suicide AttemptUH3MH007755 · NIMH · KAISER FOUNDATION HEALTH PLAN OF WASHINGTON · PI SIMON, GREGORY E. · 2014 to 2018
$8.9M
UW Core Center for Clinical Research of Musculoskeletal ConditionsP30AR072572 · NIAMS · UNIVERSITY OF WASHINGTON · PI JEFFREY G JARVIK, Pradeep Suri · 2017 to 2026
$8.3M
Fibromyalgia TENS in Physical Therapy Study (TIPS): an embedded pragmatic clinical trial: Administrative SupplementUH3AR076387 · NIAMS · UNIVERSITY OF IOWA · PI CROFFORD, LESLIE J, SLUKA, KATHLEEN A · 2020 to 2023
$7.3M
EMBED: Pragmatic trial of user-centered clinical decision support to implement EMergency department-initiated BuprenorphinE for opioid use DisorderUH3DA047003 · NIDA · YALE UNIVERSITY · PI D'ONOFRIO, GAIL, MELNICK, EDWARD ROBERT · 2019 to 2022
$7.2M
HEAL Collaboratory Resource Coordinating Center (PRISM) (U24): Bioethics SupplementU24AT010961 · NCCIH · DUKE UNIVERSITY · PI CURTIS, LESLEY H, HERNANDEZ, ADRIAN · 2019 to 2021
$6.4M
Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease PainUH3AT011265 · NCCIH · UNIVERSITY OF ILLINOIS AT CHICAGO · PI DOORENBOS, ARDITH Z, EZENWA, MIRIAM OMELEBELE · 2021 to 2024
$6.4M
A Pragmatic Trial of Lumbar Image Reporting with Epidemiology (LIRE)UH3AR066795 · NIAMS · UNIVERSITY OF WASHINGTON · PI JARVIK, JEFFREY G · 2014 to 2017
$6.0M
Non-pharmacological Options in postoperative Hospital-based And Rehabilitation pain Management (NOHARM) pragmatic clinical trialUH3AG067593 · NIA · MAYO CLINIC ROCHESTER · PI CHEVILLE, ANDREA LYNNE, TILBURT, JON C · 2020 to 2023
$6.0M
A Pragmatic Trial of Lumbar Image Reporting with Epidemiology (LIRE)UH2AT007766 · NCCIH · UNIVERSITY OF WASHINGTON · PI JARVIK, JEFFREY G · 2012 to 2012
$838k
Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease PainUG3AT011265 · NCCIH · UNIVERSITY OF ILLINOIS AT CHICAGO · PI DOORENBOS, ARDITH Z, EZENWA, MIRIAM OMELEBELE · 2020 to 2020
$827k
NCATS NIH HHS UL1 TR001863NCCIH NIH HHS U24 AT009676NCCIH NIH HHS U24 AT010961NCCIH NIH HHS UG3 AT011265NCCIH NIH HHS UH2 AT007755NCCIH NIH HHS UH2 AT007766NCCIH NIH HHS UH3 AT011265NIAMS NIH HHS P30 AR072572NIAMS NIH HHS UG3 AR076387NIAMS NIH HHS UH3 AR066795NIAMS NIH HHS UH3 AR076387NIA NIH HHS UG3 AG067593NIA NIH HHS UH3 AG067593NIDA NIH HHS UG3 DA047003NIDA NIH HHS UH3 DA047003NIMH NIH HHS UH3 MH007755
6 · The paper itself

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.

Indexed as

Electronic Health RecordsPragmatic Clinical Trials as TopicHumansResearch DesignElectronic health recordHealth systems researchMonitoringPragmatic trials

Identifiers

PMID39561918
PMCPMC11831575

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.