D C Classen

University of Utah, Salt Lake City, Utah, United States

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Publications (96)789.38 Total impact

  • [Show abstract] [Hide abstract]
    ABSTRACT: An efficient and reliable process for measuring harm due to medical care is needed to advance pediatric patient safety. Several pediatric studies have assessed the use of trigger tools in varying inpatient environments. Using the Institute for Healthcare Improvement's adult-focused Global Trigger Tool as a model, we developed and pilot tested a trigger tool that would identify the most common causes of harm in pediatric inpatient environments. After formal training, 6 academic children's hospitals used this novel pediatric trigger tool to review 100 randomly selected inpatient records per site from patients discharged during the month of February 2012. From the 600 patient charts evaluated, 240 harmful events ("harms") were identified, resulting in a rate of 40 harms per 100 patients admitted and 54.9 harms per 1000 patient days across the 6 hospitals. At least 1 harm was identified in 146 patients (24.3% of patients). Of the 240 total events, 108 (45.0%) were assessed to have been potentially or definitely preventable. The most common patient harms were intravenous catheter infiltrations/burns, respiratory distress, constipation, pain, and surgical complications. Consistent with earlier rates of all-cause harm in adult hospitals, harm occurs at high rates in hospitalized children. Availability and use of an all-cause harm identification tool will establish the epidemiology of harm and will provide a consistent approach to assessing the effect of interventions on harms in hospitalized children. Copyright © 2015 by the American Academy of Pediatrics.
    PEDIATRICS 05/2015; 135(6). DOI:10.1542/peds.2014-2152 · 5.47 Impact Factor
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    Dean F Sittig · David C Classen · Hardeep Singh
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    Dean F Sittig · David C Classen · Hardeep Singh
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    ABSTRACT: The Office of the National Coordinator for Health Information Technology is expected to oversee creation of a Health Information Technology (HIT) Safety Center. While its functions are still being defined, the center is envisioned as a public-private entity focusing on promotion of HIT related patient safety. We propose that the HIT Safety Center leverages its unique position to work with key administrative and policy stakeholders, healthcare organizations (HCOs), and HIT vendors to achieve four goals: (1) facilitate creation of a nationwide 'post-marketing' surveillance system to monitor HIT related safety events; (2) develop methods and governance structures to support investigation of major HIT related safety events; (3) create the infrastructure and methods needed to carry out random assessments of HIT related safety in complex HCOs; and (4) advocate for HIT safety with government and private entities. The convening ability of a federally supported HIT Safety Center could be critically important to our transformation to a safe and effective HIT enabled healthcare system.
    Journal of the American Medical Informatics Association 10/2014; 22(2). DOI:10.1136/amiajnl-2014-002988 · 3.50 Impact Factor
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    ABSTRACT: Objectives: To have impact on reducing harm in pediatric inpatients, an efficient and reliable process for harm detection is needed. This work describes the first step toward the development of a pediatric all-cause harm measurement tool by recognized experts in the field. Methods: An international group of leaders in pediatric patient safety and informatics were charged with developing a comprehensive pediatric inpatient all-cause harm measurement tool using a modified Delphi technique. The process was conducted in 5 distinct steps: (1) literature review of triggers (elements from a medical record that assist in identifying patient harm) for inclusion; (2) translation of triggers to likely associated harm, improving the ability for expert prioritization; (3) 2 applications of a modified Delphi selection approach with consensus criteria using severity and frequency of harm as well as detectability of the associated trigger as criteria to rate each trigger and associated harm; (4) developing specific trigger logic and relevant values when applicable; and (5) final vetting of the entire trigger list for pilot testing. Results: Literature and expert panel review identified 108 triggers and associated harms suitable for consideration (steps 1 and 2). This list was pared to 64 triggers and their associated harms after the first of the 2 independent expert reviews. The second independent expert review led to further refinement of the trigger package, resulting in 46 items for inclusion (step 3). Adding in specific trigger logic expanded the list. Final review and voting resulted in a list of 51 triggers (steps 4 and 5). Conclusions: Application of a modified Delphi method on an expert-constructed list of 108 triggers, focusing on severity and frequency of harms as well as detectability of triggers in an electronic medical record, resulted in a final list of 51 pediatric triggers. Pilot testing this list of pediatric triggers to identify all-cause harm for pediatric inpatients is the next step to establish the appropriateness of each trigger for inclusion in a global pediatric safety measurement tool.
    Journal of Patient Safety 08/2014; Publish Ahead of Print. DOI:10.1097/PTS.0000000000000139 · 1.49 Impact Factor
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    ABSTRACT: We will provide a context to health information technology systems (HIT) safety hazards discussions, describe how electronic health record-computer prescriber order entry (EHR-CPOE) simulation has already identified unrecognized hazards in HIT on a national scale, helping make EHR-CPOE systems safer, and we make the case for all stakeholders to leverage proven methods and teams in HIT performance verification. A national poll of safety, quality improvement, and health-care administrative leaders identified health information technology safety as the hazard of greatest concern for 2013. Quality, HIT, and safety leaders are very concerned about technology performance risks as addressed in the Health Information Technology and Patient Safety report of the Institute of Medicine; and these are being addressed by the Office of the National Coordinator of HIT of the U.S. Dept. of Human Services in their proposed plans. We describe the evolution of postdeployment testing of HIT performance, including the results of national deployment of Texas Medical Institute of Technology's electronic health record computer prescriber order entry (TMIT EHR-CPOE) Flight Simulator verification test that is addressed in these 2 reports, and the safety hazards of concern to leaders. A global webinar for health-care leaders addressed the top patient safety hazards in the areas of leadership, practices, and technologies. A poll of 76 of the 221 organizations participating in the webinar revealed that HIT hazards were the participants' greatest concern of all 30 hazards presented. Of those polled, 89% rated HIT patient/data mismatches in EHRs and HIT systems as a 9 or 10 on a scale of 1 to 10 as a hazard of great concern. Review of a key study of postdeployment testing of the safety performance of operational EHR systems with CPOE implemented in 62 hospitals, using the TMIT EHR-CPOE simulation tool, showed that only 53% of the medication orders that could have resulted in fatalities were detected. The study also showed significant variability in the performance of specific EHR vendor systems, with the same vendor product scoring as high as a 75% detection score in one health-care organization, and the same vendor system scoring below 10% in another health-care organization. HIT safety hazards should be taken very seriously, and the need for proven, robust, and regular postdeployment performance verification measurement of EHR system operations in every health-care organization is critical to ensure that these systems are safe for every patient. The TMIT EHR-CPOE flight simulator is a well-tested and scalable tool that can be used to identify performance gaps in EHR and other HIT systems. It is critical that suppliers, providers, and purchasers of health-care partner with HIT stakeholders and leverage the existing body of work, as well as expert teams and collaborative networks to make care safer; and public-private partnerships to accelerate safety in HIT. A global collaborative is already underway incorporating a "trust but verify" philosophy.
    Journal of Patient Safety 12/2013; 9(4):177-189. DOI:10.1097/PTS.0b013e3182a8c2b2 · 1.49 Impact Factor
  • David C Classen · Roger K Resar
    Joint Commission journal on quality and patient safety / Joint Commission Resources 07/2013; 39(7):291.
  • David C. Classen · Roger K. Resar
    Joint Commission journal on quality and patient safety / Joint Commission Resources 01/2013; 39(7).
  • Greg Christian · David Classen · Frances A Griffin
    Journal of Patient Safety 07/2012; 8(3):144-8. DOI:10.1097/PTS.0b013e318258ca5b · 1.49 Impact Factor
  • Matthew K Wynia · David C Classen
    JAMA The Journal of the American Medical Association 12/2011; 306(22):2504-5. DOI:10.1001/jama.2011.1820 · 35.29 Impact Factor
  • Ashish K Jha · David C Classen
    New England Journal of Medicine 11/2011; 365(19):1756-8. DOI:10.1056/NEJMp1109398 · 55.87 Impact Factor
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    Hardeep Singh · David C Classen · Dean F Sittig
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    ABSTRACT: Electronic health records (EHRs) have potential quality and safety benefits. However, reports of EHR-related safety hazards are now emerging. The Office of the National Coordinator for Health Information Technology recently sponsored an Institute of Medicine committee to evaluate how health information technology use affects patient safety. In this article, we propose the creation of a national EHR oversight program to provide dedicated surveillance of EHR-related safety hazards and to promote learning from identified errors, close calls, and adverse events. The program calls for data gathering, investigation/analysis, and regulatory components. The first 2 functions will depend on institution-level EHR safety committees that will investigate all known EHR-related adverse events and near-misses and report them nationally using standardized methods. These committees should also perform routine safety self-assessments to proactively identify new risks. Nationally, we propose the long-term creation of a centralized, nonpartisan board with an appropriate legal and regulatory infrastructure to ensure the safety of EHRs. We discuss the rationale of the proposed oversight program and its potential organizational components and functions. These include mechanisms for robust data collection and analyses of all safety concerns using multiple methods that extend beyond reporting, multidisciplinary investigation of selected high-risk safety events, and enhanced coordination with other national agencies to facilitate broad dissemination of hazards information. Implementation of this proposed infrastructure can facilitate identification of EHR-related adverse events and errors and potentially create a safer and more effective EHR-based health care delivery system.
    Journal of Patient Safety 11/2011; 7(4):169-74. DOI:10.1097/PTS.0b013e31823d8df0 · 1.49 Impact Factor
  • David C Classen · David W Bates
    New England Journal of Medicine 09/2011; 365(9):855-8. DOI:10.1056/NEJMsb1103659 · 55.87 Impact Factor
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    ABSTRACT: Computerized physician order entry (CPOE) is the feature of electronic medical record (EMR) implementation that arguably offers the greatest quality and patient safety benefits. The gains are potentially greater for critically ill neonates, but the effect of CPOE on quality and safety is dependent upon local implementation decisions. OBJECTIVES: After completing this article, readers should be able to: Define the basic aspects of CPOE and clinical decision support (CDS) systems.Describe the potential benefits of implementing CPOE associated with CDS in a neonatal intensive care unit (NICU).
    NeoReviews 07/2011; 12(7):393-396. DOI:10.1542/neo.12-7-e393
  • David C Classen · Shobha Phansalkar · David W Bates
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    ABSTRACT: Medications represent the most common intervention in health care, despite their benefits; they also lead to an estimated 1.5 million adverse drug events and tens of thousands of hospital admissions each year. Although some are not preventable given what is known today, many types are, and one key cause which is preventable is drug-drug interactions (DDIs). Most electronic health record systems include programs that can check and prevent these types of interactions as a routine part of medication ordering. Studies suggest that these systems as implemented often do not effectively screen for these DDIs. A major reason for this deficiency is the lack of any national standard for the critical DDIs that should be routinely operationlized in these complex systems. We review the leading critical DDI lists from multiple sources including several leading health systems, a leading commercial content provider, the Leapfrog CPOE Testing Standard, and the new Office of the National Coordinator (ONC) DDI List. Implementation of strong DDI checking is one of the important steps in terms of realizing the benefits of electronic prescribing with respect to safety. Hopefully, the ONC list will make it easier for organizations to ensure they are including the most important interactions, and the Leapfrog List may help these organizations develop an operational DDI list that can be practically implemented. In addition, this review has identified 7 common DDIs that can be the starting point for all organizations in this area of medication safety.
    Journal of Patient Safety 06/2011; 7(2):61-5. DOI:10.1097/PTS.0b013e31821d6f6e · 1.49 Impact Factor
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    ABSTRACT: Identification and measurement of adverse medical events is central to patient safety, forming a foundation for accountability, prioritizing problems to work on, generating ideas for safer care, and testing which interventions work. We compared three methods to detect adverse events in hospitalized patients, using the same patient sample set from three leading hospitals. We found that the adverse event detection methods commonly used to track patient safety in the United States today-voluntary reporting and the Agency for Healthcare Research and Quality's Patient Safety Indicators-fared very poorly compared to other methods and missed 90 percent of the adverse events. The Institute for Healthcare Improvement's Global Trigger Tool found at least ten times more confirmed, serious events than these other methods. Overall, adverse events occurred in one-third of hospital admissions. Reliance on voluntary reporting and the Patient Safety Indicators could produce misleading conclusions about the current safety of care in the US health care system and misdirect efforts to improve patient safety.
    Health Affairs 04/2011; 30(4):581-9. DOI:10.1377/hlthaff.2011.0190 · 4.97 Impact Factor
  • Jane Metzger · David W. Bates · David C. Classen
    Health Affairs 07/2010; 29(7):1417-1417. DOI:10.1377/hlthaff.2010.0617 · 4.97 Impact Factor
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    ABSTRACT: Computerized physician order entry is a required feature for hospitals seeking to demonstrate meaningful use of electronic medical record systems and qualify for federal financial incentives. A national sample of sixty-two hospitals voluntarily used a simulation tool designed to assess how well safety decision support worked when applied to medication orders in computerized order entry. The simulation detected only 53 percent of the medication orders that would have resulted in fatalities and 10-82 percent of the test orders that would have caused serious adverse drug events. It is important to ascertain whether actual implementations of computerized physician order entry are achieving goals such as improved patient safety.
    Health Affairs 04/2010; 29(4):655-63. DOI:10.1377/hlthaff.2010.0160 · 4.97 Impact Factor
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    David Classen · David W Bates · Charles R Denham
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    ABSTRACT: It is the objective of this article to provide a guide to health care providers adopting computerized prescriber order entry (CPOE) and to explain recent developments of important concepts and initiatives such as "meaningful use" that will have significant impact on successful implementation of CPOE. The specific goals are to discuss key concepts relating to the NEW ARRA/HITECH-EHR meaningful use criteria and its relevance to CPOE Safe Practice and medication safety, summarize and update the recent scientific evidence evaluating CPOE, present the new 2010 CPOE safe practice, and suggest ways the CPOE safe practice may be expanded and harmonized with the new EHR meaningful use criteria. This article evaluates the latest published studies in the field of CPOE and reexamines the objectives, the requirements for achieving these objectives, and evidence of efficacy for this practice. It reviews relevant issues of medication safety, the likely impact of CPOE, the efficacy of CPOE in various studies, key measures of impact of the practice, and important implementation issues. The 2010 updates to the National Quality Forum CPOE practice are also reviewed with support from the evidentiary base. This paper has presented an update to the National Quality Forum Safe Practice on CPOE for 2010. Although the practice itself has not changed, the scientific evidence of the impact of CPOE on medication safety and quality of care continues to accumulate. However, the adoption of CPOE by hospitals in the United States remains very low, as low as 6% in 1 study. The adoption of CPOE has been low despite increasing evidence that hospital patients are still experiencing significant rates of preventable adverse drug events. This low adoption rate will likely be impacted by the new ARRA/HITECH legislation and the meaningful use concept.
    Journal of Patient Safety 03/2010; 6(1):15-23. DOI:10.1097/PTS.0b013e3181d108db · 1.49 Impact Factor
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    ABSTRACT: Selection of relevant patient safety interventions for the pediatric intensive care (PICU) requires identification of the types and severity of adverse events (AEs) and adverse drug events (ADEs) that occur in this setting. The study's objectives were to: 1) determine the rates of AEs/ADEs, including types, severity, and preventability, in PICU patients; 2) identify population characteristics associated with increased risk of AEs/ADEs; 3) develop and test a PICU specific trigger tool to facilitate identification of AEs/ADEs. Retrospective, cross-sectional, randomized review of 734 patient records who were discharged from 15 U.S. PICUs between September and December 2005. A novel PICU-focused trigger tool for AE/ADE detection. Sixty-two percent of PICU patients had at least one AE. A total of 1488 AEs, including 256 ADEs, were identified. This translates to a rate of 28.6 AEs and 4.9 ADEs per 100 patient-days. The most common types of AEs were catheter complications, uncontrolled pain, and endotracheal tube malposition. Ten percent of AEs were classified as life-threatening or permanent; 45% were deemed preventable. Higher adjusted rates of AEs were found in surgical patients (p = .02), patients intubated at some point during their PICU stay (p = .002), and patients who died (p < .001). Surgical patients had higher preventable adjusted AE (p = .01) and ADE rates (p = .02). The adjusted cumulative risk of an AE per PICU day was 5.3% and 1.6% for an ADE alone. There was a 4% increase in adjusted ADEs rates for every year increase in age. AEs and ADEs occur frequently in the PICU setting. These data provide areas of focus for evidence-based prevention strategies to decrease the substantial risk to this vulnerable pediatric population.
    Pediatric Critical Care Medicine 03/2010; 11(5):568-78. DOI:10.1097/PCC.0b013e3181d8e405 · 2.34 Impact Factor
  • Source
    Dean F Sittig · David C Classen
    JAMA The Journal of the American Medical Association 02/2010; 303(5):450-1. DOI:10.1001/jama.2010.61 · 35.29 Impact Factor

Publication Stats

8k Citations
789.38 Total Impact Points


  • 1988–2015
    • University of Utah
      • • Division of Infectious Diseases
      • • Department of Internal Medicine
      • • School of Medicine
      • • Division of Epidemiology
      Salt Lake City, Utah, United States
  • 2013
    • Cleveland Clinic
      Cleveland, Ohio, United States
  • 2008
    • University of Manitoba
      Winnipeg, Manitoba, Canada
    • Washington University in St. Louis
      San Luis, Missouri, United States
    • Duke University Medical Center
      Durham, North Carolina, United States
    • The Children's Hospital of Philadelphia
      Philadelphia, Pennsylvania, United States
    • Harvard Medical School
      Boston, Massachusetts, United States
  • 2006
    • Stanford University
      • Department of Pediatrics
      Palo Alto, California, United States
  • 1990–1998
    • Salt Lake City Community College
      Salt Lake City, Utah, United States