- The lengthy, convoluted process of industry-wide electronic health record (EHR) adoption has produced a large number of concerns about how this new technology will impact patient safety, especially in the hospital setting, where a patient’s life may depend on the smallest of actions.
While EHR systems are intended to standardize data collection, deliver critical safety alerts, provide clinical decision support, and facilitate communication between members of the care team, real-world experience has shown that healthcare providers are having a tough time adapting to the workflow changes, technical quirks, and unavoidable glitches that are part of any new IT installation.
The question of whether or not these shortfalls seriously impact the safe delivery of patient care has colored regulatory discussions since the very beginning of the EHR Incentive Programs, but there has been little more than anecdotal evidence to support theories on both sides of the argument.
Authors of a new Harvard Medical School study published in the BMJ note that EHRs don’t always have the best reputation when it comes to workflow improvements and better patient care, pointing out that one hospital even reported twice as many patient deaths in the wake of CPOE implementation.
"Physicians' tremendous frustration in switching to new electronic health records can spill over into concerns that patient care is actually worse because of these systems," said lead author Michael Barnett, a primary care physician at Brigham and Women’s Hospital and a professor at the Harvard T.H. Chan School of Public Health.
While Barnett and his team initially theorized that EHRs would produce a spike in negative patient safety outcomes, the study actually adds data to the pro-EHR camp.
The researchers found that electronic health record adoption did not produce significant short-term changes in the amount of reported patient safety events or mortality rates in 17 hospitals.
The study included hospitals with both comprehensive and basic EHR systems, organizations with brand new EHRs, and those that had transitioned between technology vendors. Using 30-day mortality, 30-day readmissions, and the AHRQ’s PSI-90 patient safety composite score as indicators of quality, the study reported no substantial changes in any of the major measures across the study population.
“We hypothesized that implementation of electronic health records (EHRs) would have a negative association with short term patient outcomes owing to disruptions in clinical workflow,” the authors explained.
“Contrary to that hypothesis, we found that before and after a discrete ‘go live’ date for EHR implementation across 17 hospitals, there was no evidence of a significant or consistent negative association between EHR implementation and short term mortality, readmissions, or adverse events.”
Barnett and his team added that the outcomes may seem surprising, especially in light of other research that indicates small changes in the hospital environment, such as lower levels of staffing on the weekends or the summer slump known as the “July effect,” do produce significant variation in patient safety events.
But after controlling for these variables, the EHR implementation process itself did not appear to make a significant difference.
"Having recently witnessed firsthand how disruptive an EHR implementation can be, it is reassuring to know that hospital safeguards prevent patients from being harmed," said Anupam Jena, senior author of the study and the Ruth L. Newhouse Associate Professor of Health Care Policy at HMS.
The results of the may be encouraging, but they do not necessarily tell the whole story. The authors do point out they could not fully explore the relationship of EHR adoption and inpatient outcomes due to a lack of data about the hospitals’ EHR adoption preparation programs, staff training procedures, and any other simultaneous organizational changes.
Even more significant, perhaps, is the fact that many patient safety events do not necessarily make it into research datasets at all. Patient safety errors are rarely volunteered as primary causes of death in medical records, and healthcare providers may be reluctant to record and report their mistakes due to a fear of punitive action, said a separate BMJ study published in May.
While patient safety events and medical errors are currently the third leading cause of death in the United States, the estimate that 250,000 patients die each year form preventable errors may be a massive understatement.
"Incidence rates for deaths directly attributable to medical care gone awry haven't been recognized in any standardized method for collecting national statistics," said Martin Makary, professor of surgery at the Johns Hopkins University School of Medicine. "The medical coding system was designed to maximize billing for physician services, not to collect national health statistics, as it is currently being used."
Electronic health records consistently top industry lists of patient safety hazards, creating hard-to-catch risks ranging from patient identification errors to outdated or incomplete medication and diagnosis data.
“After the implementation [of new technologies], people continue to do things the same way and really don’t adjust the health IT system or their workflow,” said Robert C. Giannini, NHA, CHTS-IM/CP, patient safety analyst and consultant, ECRI Institute.
The 2016 ECRI Institute patient safety risk list includes five EHR-related entries, including patient identification problems, inadequate follow-up on electronic test results, inability to create a culture of safety across the healthcare organization, and insufficient electronic monitoring of patients on high-risk medications.
EHR alarm fatigue due to an excessive number of alerts, pop-ups, and warnings is also frequently identified as a major risk to patient safety and clinical productivity, and providers have spent years wondering why many EHR clinical decision support features are so frustratingly ineffective.
“Clinically inconsequential” alerts and alarms may sap more than hour of time from a typical provider’s daily routine, a JAMA Internal Medicine study found earlier this year, as clinicians try to click their way through a maze of supposedly helpful notifications.
The cognitive fatigue, confusion, and distraction that results from these actions may lead to a variety of patient safety errors and clinical decision missteps, leaving providers to wonder if the data they are receiving from their EHRs is doing more harm than good.
Overall, however, patient safety has been improving at an astonishing rate. Since 2010, the number of hospital-acquired conditions has plummeted by 17 percent thanks to a general movement to prioritize patient safety in the inpatient setting. The looming threat of financial penalties, paired with the positive aspects of EHR adoption, may be responsible for the fact that fewer patients are being injured or dying in the hospital due to preventable circumstances.
Adverse drug events, catheter and central line infections, pressure ulcers, and ventilator-associated pneumonia have all dropped significantly, producing savings for hospitals and improved outcomes for patients.
Researchers have not been able to definitively say whether or not these gains are directly related to the rise in EHR adoption over the past decade, but the strong correlation could certainly be convincing for those who believe that EHRs may help more than they hurt.
As the healthcare industry continues to stress the importance of patient safety, especially in the emerging era of value-based care, researchers will likely continue to examine the question of whether or not electronic health records can produce significant improvements in the quality of safe and effective patient care.