While clinical decision support tools have the potential to help physicians provide better care to patients, current CDS technology is not providing what clinicians need to aid their care delivery in an increasingly complex healthcare environment.

That’s the contention of Andrew Gettinger, MD, chief medical information officer in the Office of the National Coordinator for Health IT.

With the tsunami of data being generated by HIT systems and medical devices, as well as the body of medical knowledge that is growing exponentially, CDS advocates see the software as being critical for doctors to effectively use the information for the benefit of patients.

However, Gettinger, who is also executive director of the Office of Clinical Quality and Safety for ONC, says that as the knowledge base expands to include genomic and proteomic data as well as other content, it’s virtually impossible for CDS to keep up with the explosion in medical literature.

“CDS is very complicated and is very difficult to do,” Gettinger adds. “The only way that it’s going to be successful is if we really help to improve the CDS that’s out there right now. Much of the CDS, despite many really good people working on this for a long time, is not what clinicians need to help provide the care that they would like to.”

Also See: 10 top patient safety concerns in 2017

In a recent ranking by the ECRI Institute of the top 10 patient safety concerns for healthcare organizations, the implementation and use of CDS placed third. According to Robert Giannini, patient safety analyst and consultant for ECRI, CDS encompasses “tools that we use to ensure that the right information is presented at the right time within the workflow.” However, he notes that if use of the tools by clinicians is suboptimal, then “opportunities may be missed and patient harm—as well as disruption of clinical workflows and provider frustration—could result.”

Consequently, healthcare organizations must design CDS systems based on good judgment, ECRI recommends.

“End users must be trained in the proper use of CDS, as well as their roles and responsibilities, and have access to support structures,” states ECRI’s report. “On an ongoing basis, organizations should monitor the effectiveness and appropriateness of CDS alerts, evaluate the impact on workflow and review staff response to alerts. The tool should be redesigned as necessary.”

Likewise, Bradley Merrill Thompson, general counsel for the Clinical Decision Support Coalition, which represents software developers, healthcare payers, providers and medical device manufacturers, believes that the failure to use CDS at the “right time in the right way” translates into missed opportunities for clinicians to improve patient care.

“I think just about everyone now recognizes the value of using CDS to help and support human decision-making,” Thompson says. “I think there’s a growing recognition supported by evidence that CDS, properly used, improves outcomes.”

Nonetheless, he acknowledges that CDS, used in the wrong way, can also be harmful to patient safety.

“Certainly, if CDS creates confusion or delays decision-making because the technology gets in the way, bad outcomes can result,” adds Thompson. “So, the risks flow from both the failure to use CDS and the failure to use it properly. These are, after all, important clinical decisions that physicians and others are making, and if the software fails to help or gets in the way, we need to fix that.”

The CDS Coalition contends that what is required to ensure patient safety varies greatly, depending on the risk of particular software. “The risk associated with a body mass index calculator is not the same as with computer- aided diagnosis imaging software,” states the coalition’s website. “As a result, all CDS cannot be regulated the same way. In fact, many low-risk CDS products should not be actively regulated at all.”

Still, Thompson makes the case that providers need to constantly re-examine CDS tools that are used in clinical practices and make adjustments to improve their value for patient care.

The CDS Coalition will soon be releasing draft guidelines for public comment on how best to design CDS to “leave the human being in control,” according to Thompson. “The coalition believes it is important wherever possible to support, not supplant, the human making the decision.”

For its part, Congress in the 21st Century Cures Act has “offered the carrot that software which successfully leaves the healthcare professional in control by giving that professional the opportunity to review the basis for the recommendation will be unregulated by FDA,” he concludes.

As such, Thompson is encouraged by Section 3060 of the Cures Act which “incorporates the common sense notion that if a physician has access to all of the underlying information—such that the physician can double check the basis for any recommendation—then the software is really simply supporting the physician in his or her practice.”

Gettinger notes that ONC has funded and is working with the National Academy of Medicine and a “superb group of experts” to explore the opportunities and strategies necessary for improving CDS practices and adoption. “Some of the output of that is going to be reported out in the fall meeting from the American Medical Informatics Association.”

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