Is Healthcare IT Ready for its Big Coming Out Party?

In 2001, when my colleagues and I ranked nearly 100 patient safety practices on the strength of their supporting evidence (for an AHRQ report), healthcare IT didn’t make the top 25. We took a lot of heat for, as one prominent patient safety advocate chided me, “slowing down the momentum.” Some called us Luddites.

Although we hated to be skunks at the IT party, we felt that the facts spoke for themselves. While decent computerized provider order entry (CPOE) systems did catch significant numbers of prescribing errors, we found no studies documenting improved hard outcomes (death, morbidity). More concerning, virtually all the research touting the benefits of HIT was conducted on a handful of home-grown systems (most notably, by David Bates’s superb group at Brigham and Women’s Hospital), leaving us concerned about the paucity of evidence that a vendor-developed system airlifted into a hospital would make the world a better place.

Since that time, there have been lots of studies regarding the impact of HIT on safety and, while many of them are positive, many others are not. In fact, beginning about 5 years ago a literature documenting new classes of errors caused by clunky IT systems began to emerge. A study from Pittsburgh Children’s Hospital found a significant increase in mortality after implementation of the Cerner system – a study that was criticized by IT advocates on methodologic grounds, and because “they didn’t implement the system properly.” Studies by Ross Koppel of Penn and Joan Ash of Oregon (such as here and here) chronicled the unintended consequences of IT systems, and urged caution before plunging headfirst into the HIT pool. I raised similar concerns in a 2006 JAMA article, and also recounted the iconic story of Cedars-Sinai’s 2003 IT implementation disaster, where a poorly designed interface, combined with physician resistance to overly intrusive decision support, led the plug to be pulled on the $50 million CPOE system only a few weeks after it was turned on.

A new story line was emerging, and its theme was that implementing an effective HIT system is harder than it looks. And yet one could not deny the political attractiveness of computerization – during the last presidential campaign, the need for HIT was the only thing that McCain and Obama seemed to agree on, and a prominent proponent of a Manhattan Project-like push for HIT has been none other than Newt Gingrich, not exactly a freewheeling spender.

These politics led to $19 billion being included in February’s stimulus package to support HIT implementation in American hospitals and clinics. Once federal HIT Czar David Blumenthal figures out how to divvy up the money (it hinges on coming up with a workable definition of “meaningful use” of HIT, which would unlock the door to the federal vault), HIT will have its big Coming Out Party. Cue the balloons and streamers!

It’s all pretty exciting… if the systems work.

Fast forward to today’s Washington Post, where an article describes a new crusade by Iowa Senator Charles Grassley to confront HIT vendors who sell defective products. Grassley, who has taken on the role of keeping professions honest (including scrutinizing physician relationships with pharma and device companies, attention that is long-past due), has raised a number of concerns about the safety of store-bought IT systems, and has sent a letter of inquiry to one of the companies (Cerner) that looks a lot like a prelude to a Senate subpoena.

Interestingly, many of the issues raised in the Grassley letter mirror an argument advanced by Penn sociologist Ross Koppel in JAMA earlier this year (for which he was vilified by the IT community – both implementers and vendors). Ross (who is a friend) noted that most of today’s IT implementation contracts insist on gag clauses for clinicians who identify errors caused by faulty software, and virtually all contain hold-harmless clauses for the vendors in the event that an IT-related error leads to patient harm. The vendors’ case seems like a version of the “guns don’t kill people…” argument: there is nothing wrong with the software, the errors reflect poor implementation practices or screw-ups by users, yada yada. This is certainly true at times, but Ross and others have documented scores of errors that are absolutely inevitable given clunky software and poor user interfaces. It seems right that the vendors would at least share responsibility if patients were harmed in such circumstances. 

This is all acutely interesting to me right now, since my own hospital (UCSF Medical Center) recently entered the not-very-proud fraternity of hospitals who aborted their implementation after an IT system failed to live up to expectations. In our case, nearly a decade ago, we put our IT nickel (actually, more than a billion of them) down on a system built by a vendor named IDX. A few years later, when IDX became wobbly as a company, we were reassured when technology titan General Electric gobbled them up. “They’re GE,” we thought, “they’ll get this right.” We eagerly signed on to be development partners with GE and found ourselves in a world of missed deadlines and inadequate support; in short, neither product nor vendor seemed ready for prime time. After years of negotiations, hair-pulling, and prayer, we recently pulled the plug on our GE relationship. (I’ve been on the committee overseeing our transition, and won’t divulge any confidences, but all of this has now been reported in the media.) Just last week, our CEO Mark Laret publicly announced our intention to pursue an implementation with Epic, the Wisconsin company that appears to be emerging as the best of the breed. I’m hoping that this is the system we’ve been waiting for (the reviews from colleagues who are using Epic elsewhere are generally reassuring), and not, as my friend Jim Reinertsen sometimes quips, simply “The Cream of the Crap.”

Last year, I wrote about the Technology Hype Cycle, a predictable roller coaster in which new technologies are over-hyped (the “Peak of Inflated Expectations”), fail to live up to their expectations (the “Trough of Disillusionment”), and ultimately (if they’re any good) traverse their “Slope of Enlightenment” before reaching a “Plateau of Productivity.” CPOE, and HIT more generally, are clearly on this roller coaster – somewhere between the “Trough…” and the “Slope…” Since we are about to invest 19 billion tax dollars on nationwide implementation of these systems, let’s collectively hope it is the latter.

Obviously, we simply must computerize American healthcare: in 2009, how can we possibly improve our care and coordination when we document our work by writing in chicken scratch on pieces of dead trees? And there are healthcare organizations that have enjoyed successful implementations and are beginning to reap real benefits, in quality, safety, and efficiency.

But it is not a slam-dunk, and there are some crummy systems out there that have the capacity to cause harm. Having folks like Ross Koppel, and maybe even Senator Grassley, push the IT companies to do better and be accountable for their products is vital if we’re going to get this complex and crucial task right.

7 Responses to “Is Healthcare IT Ready for its Big Coming Out Party?”

  1. Brian Clay, MD October 26, 2009 at 6:42 am #

    IT implementation is absolutely NOT a slam-dunk. Our own Epic installation at UC San Diego is ongoing, now nearly completing our ambulatory clinic roll-out after the first ambulatory area (reproductive medicine) went live almost four years ago.

    It takes analysis, time, testing, and even some active thought about how a user not savvy with the new system could really cause some damage before ever bringing an area live — and that has to be done for every clinic, every time. You know the label on a hair dryer that warns you not to use it in the bathtub? I guarantee you that that label was not added for theoretical reasons only. Part of the analysis is trying to figure out what the least computer-literate user might do in any situation, and engineering the IT workflow to prevent it as much as possible.

    We turned our attention to the analysis and design for the inpatient Epic application early last year, with a probable total of 2 1/2 years of analysis, design, and build before going live next year inside the hospital. We are advantaged in that we’ve been on an older CPOE system for five years — we have seen any number of user workarounds and unintended consequences from CPOE, and we are using that knowledge in the design of the Epic installation.

    The key is to be able to work with your vendor — you know your hospitals and your clinics better than the vendor does, and, although launch of a new IT system is an opportunity to re-engineer long-standing suboptimal workflows, it is most definitely NOT a bludgeon to force nurses, physicians, and other health care workers to completely change how they’ve always done things just to fit how the application works “off the shelf.”

    I can’t overstate the incredible amount of groundwork that needs to be done to overlay an IT system (or a newer IT system) on the massively complex and interconnected system that is a hospital or clinic network. “Plug and play” does not apply here at all.

  2. menoalittle October 26, 2009 at 1:11 pm #

    Bob,

    Your report is timely and comprehensive. Had the vendors not (? deliberately) tried to avoid the legal approach (complying with the F D and C Act) to place a medical device in to the market place, there would be more accountability the vendors would have produced less injurious and difficult to use devices performing CPOE. That is why we have the law; to avoid VIOXX problems.

    To the extent that the vendors subverted the mechanisms to keep patients safe, by obtaining FDA approval and regulation that includes not experimenting on the patients or by not relying on the user to improve their device, there would appear to be justification for detailed investigation. Have they broken the law?

    The conspiracy involved a cast of characters that have redefined CPOE equipment and quasi deceptive regulatory programs (such as CCHIT certification) such that it flies under the radar of the FDA and Congress, and the President. Worse yet, they entice the intense desire to reduce mistakes, but as Dr. Koppel points out, CPOE devices cause numerous new dangerous ones.

    As others have advised, the FDA is interested in hearing of yours and your readers’ experiences with adverse events associated with the use of these devices.

    Write to Commissioner Hamburg or post on MedWatch (device section).

    Best regards,

    Menoalittle

  3. Chris Longhurst, MD October 28, 2009 at 6:53 pm #

    Interesting and insightful post, thanks. One notable correction however: Senator Grassley’s letter was sent to 10 vendors, including Eclipsys, Epic Systems, McKesson, Perot Systems and Philips Healthcare. For more information, see http://blogs.wsj.com/health/2009/10/26/chuck-grassley-has-a-few-questions-for-the-health-it-industry/

  4. Bob Wachter October 29, 2009 at 2:00 am #

    Thanks for the clarification, Chris. These seem like generic issues, so there is no reason that Cerner alone would be in the Senator’s cross-hairs.

  5. Kendall November 6, 2009 at 5:07 pm #

    Bob – this is a timely and excellent post. I chair the SHM IT Task Force and agree with your comments completely. While I strongly advocate for and believe that we must design and implement effective healthcare IT, the current health IT solutions are not adequate to meet our quality, safety, and efficiency goals (let alone ‘ease of practice.) Imagine if that 19 billion (actually closer to 40 million with expected ‘savings’ to net 19 billion) was instead earmarked for development and innovation in HIT instead of the just focusing on adoption. Physicians and hospitals would jump at the opportunity to purchase a product that made our lives easier and improved the care we provided patients, unfortunately that product does not yet exist. And now with the HITECH funding, we are in a position of being forced to purchase sub-standard IT that does not meet out needs, could harm our patients, and stifles vendors need to innovate and improve their products (they are guaranteed a customer base.) In addition to inadequate design, we lack the expertise in our field to guide effective implementations and to improve our workflows before going electronic. There is much work to be done.

    As a plug: Ross Koppel and I are giving a talk at the SHM Annual Meeting 2010 titled First Do No Harm: Dangers of CPOE Design and Implementation. Ross has recently been asked to speak at both the house and the senate – hopefully we are getting somewhere with this! If the relationship between providers and vendors changed we could begin making significant improvements to the products and not always receive the answer ‘that is a training issue’ when bringing up safety concerns.

    Kendall Rogers – University of New Mexico

  6. S Silverstein November 7, 2009 at 1:59 am #

    Bob,

    I’ve been expressing many of these concerns for over ten years now. It is good to see many others highlighting the fact that these systems are virtual clinical tools that happen to run on computers, not business systems that happen to be used by clinicians.

    See http://www.ischool.drexel.edu/faculty/ssilverstein/medinfo.htm

    Health IT is not as easy as it looks, in fact, it’s far, far harder than it looks, especially if one’s assumptions are incorrect. It’s actually impossible to “do HIT well” if one is wearing traditional management information systems-tinted glasses, as most of the HIT vendors do.

    As the National Research Council itself suggested in its Jan. 2009 report, no, HIT is not ready for its coming out party. Our current approaches are insufficient.

    As Mr. Scott said to Capt. Kirk about the revamped USS Enterprise, “it needs more work, sir…”

  7. wolandscat January 29, 2010 at 6:12 pm #

    I personally doubt that that the incumbent solutions are going to solve the problems of e-health in any systemic way. To do it properly, the right kind of system framework and semantics are needed. This partly rests on the idea of ‘standards’, and there is a huge problem in that area, see my blog articles at http://wolandscat.net/category/health-informatics/ . While large vendors ignore the issues discussed here, they will be limited to pretty screens, but very poor information integration, querying and added value services like true decision support.

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