My father died 2 months ago and now with a bit of distance from that emotional event, it’s time to further reflect on technology to support patients and families in ICUs.
BIDMC has been speaking with a major foundation about creating a cross-disciplinary, multi-institutional, open source application to turn critical care data into wisdom for patients and families.
How might it work? Let me use my father as an example.
My father had multiple sclerosis for 23 years, myelodysplastic syndrome for 2 years, and 3 myocardial infarctions since 2009.
When I arrived at his ICU bedside in early March, I spoke with all his clinicians to create a mental dashboard of his progress. It looked something like this
Cardiac – history of 2 previous myocardial infarctions treated with 5 stents. New myocardial infarction resulting in apical hypokinesis and an ejection fraction of 25%. No further stent placement possible, maximal medical therapy already given.
Pulmonary – New congestive heart failure post recent myocardial infarction treated with diuretics, nitroglycerine drip, afterload reduction, upright position, and maximal oxygenation via bilevel positive airway pressure. O2 saturation in the 90s and falling despite maximal therapy (other than intubation)
Hematologic – failing bone marrow resulting in a white count of 1, a platelet count of 30, and a hematocrit of 20
Neurologic – significant increase in muscle spasticity, resulting in constant agitation. Pain medication requirements escalating. Consciousness fading.
Renal – Creatinine rising
Although I did not have realtime access to his records, I gathered enough data from my conversations to turn this dashboard into a scorecard green, yellow and red indicators.
Cardiac – Red due to irreversible low ejection fraction
Pulmonary – Red due to the combination of falling O2 saturation despite aggressive therapy
Hematologic – Red due to lack of treatment options available for myelodysplastic syndrome and an inability to transfuse given the low ejection fraction and congestive heart failure
Neurologic – Yellow due to the potential for successful symptom control with pain medications
Renal – Yellow due to treatment options available for renal failure
My father had expressed his wishes in a durable power of attorney for healthcare – do not intubate, do not resuscitate, no pressors, no feeding tubes, and no heroic measures.
From the combination of the dashboard, scorecard, and his end of life wishes, it was clear that hospice was the best course of action.
I’m a physician with 20 years of practice experience. I’m a CIO with 30 years of data analysis experience. I’m a decision maker with 35 years leading teams.
Making the hospice decision required all of my skills.
Ideally, patients and families should have the tools needed to make such decisions regardless of their medical sophistication.
Our proposed project is an automated ICU dashboard/scorecard for patients and families updated in realtime based on data aggegrated from the medical record and patient connected telemetry. The architecture will be a decision support web service , Hospitals send data in and the web service returns the wisdom of a graphical display.
The project is ambitious and will bring together patients, providers, and IT experts. We look forward to the challenge of creating a patient and family friendly dashboard for ICUs. My healthcare navigator service to my father would have been empowered with such a resource.
What if the next time you step into your doctor’s office for an examination, she reaches into her white coat pocket and pulls out an iPhone instead of a stethoscope? That’s the idea behind The Smartphone Physical, a re-imagination of the physical exam using only smartphones and a few devices that connect to them. These include a weight scale, blood pressure cuff, pulse oximeter, ophthalmoscope, otoscope, spirometer, ECG, stethoscope, and ultrasound. Want to know more? I’ve answered some questions here for THCB. And have a few myself.
What are the pros and cons of using smartphones for clinical data collection?
Smartphone penetration in virtually every market has exceeded expectations, and healthcare is no exception. More than 80% of physicians in the US have smartphones, and of those three-quarters use them at work. Much of this is currently personal communication, but increasingly physicians are using smartphones as reference tools; between 30-40% report using their smartphones for clinical decision support. It seems like a logical next step to go beyond reference apps and to start using peripheral devices, such as cases that convert the smartphone into an ECG or otoscope as well as peripherals such as pulse oximeters and ultrasound probes, for easy and reliable data collection.
At TEDMED we found that using our smartphones and the clinical devices actually improved our ability to engage with the “patient,” because we were able to share and explain the physical exam findings directly at the point of care. We could take a quick snapshot of the carotid arteries and tympanic membrane and, for the first time ever, show the patient what theirs looked like and field any questions they may have. Ideally in the near future we’d be able to go one step further and upload this data to the patient record. That is one of the most powerful aspects of the Smartphone Physical because we will be able to establish baselines for individuals. For example, instead of the current model of a primary care ophthalmologic exam, where a physician will write “W.N.L” or “unremarkable” for a patient without a concerning optic disc finding, we will be able to take and store an actual image of what the patient’s optic disc looked like at an earlier time-point. This may be particularly useful for patients who present years later with concerning visual changes.
Furthermore, smartphone-based collection of clinically-relevant data will help patients become their own data collectors. This may abstract away the mundane and standardize the unreliable aspects of the physical exam, and allow for trending data that needs to be taken in context and not just at once-yearly visits (e.g. blood pressure, temperature, etc).
Those are a few examples of the benefits that may be achieved through the integration of smartphones into the clinic. There are, of course, potential drawbacks. One of the most obvious concerns affecting the whole BYOD (Bring Your Own Device) movement is that of patient safety. Most physicians use their personal smartphones and would thus be collecting and storing potentially sensitive data on their phones. There would certainly be issues were these to be compromised. This is an issue facing other industries as well and some smartphone-makers, such as Blackberry, have responded by separating the hard drives- one for personal use and the other for business use, which is encrypted and can be scrubbed on a daily basis. Another workaround is to have a devoted smartphone or tablet for the clinic to collect data. A second potential negative of the integration of smartphones into the clinic is that it may distract from the patient-clinician relationship, especially if the clinician is not used to such devices. This is common to almost every form of technology and may be overcome with appropriate training and practice.
How can the Smartphone Physical be applied in medical education?
I think medical education may be the first to benefit from the devices we included in The Smartphone Physical. This applies not only to how we educate our future clinicians, but also to how we educate and engage our patients. If a patient can easily correlate their blood pressure, for example, to their salt intake they may be more likely to change their diets – especially if the smartphone has an alert system if one’s blood pressure has been trending upwards.
Back to medical school, when students first learn the clinical exam there’s a lot of “see one, do one, teach one” going on. The issue with some of the physical exam maneuvers, particularly those that involve seeing or listening asynchronously with the instructor, is that the student may not fully comprehend how to perform the exam. A fourth year medical student told me that he had never actually gotten a good visualization of an optic disc until he used the smartphone ophthalmoscope, and that’s a common theme. At Hopkins I brought the device to clinic and had a very productive training session with an ophthalmologist who was able to get a good image and teach both me and the patient about the fundus. I’m looking forward to seeing more of these devices integrated into schools.
I’m personally very interested in devices that can be carried around by clinicians. Most of the devices we included in The Smartphone Physical are small enough, and in particular there are a few that serve dual functions as clinical data collectors and protective cases for the phone. For example, the smartphone ECG and the smartphone otoscope are both in the form factor of an iPhone case. This allows clinicians to always be ready if the need arises, e.g. in the case of the ECG if someone complains of chest pain or faints at a public event (if only we also had a smartphone defibrillator, which I’m positive someone somewhere is working on). I’m also excited about devices that will empower and engage patients so they can connect with and understand their own bodies. One caveat is that this may lead to a small minority of patients to go overboard, e.g. I’m concerned in particular if the smartphone ultrasound ever becomes available to the broad public that some helicopter-parents-to-be will purchase or lease a unit and expose their babies to repeated sonograms. Proper education and device regulation should help circumvent this.
What’s next for the Smartphone Physical?
I will continue curating additional devices that may be added to the Smartphone Physical. These can be found on our website, Smartphone Physical, and already may include a smartphone-based glucometer, breathalyzer, thermometer, and even a thermocycler/PCR! My team is working with device manufacturers to make these more available for medical education and global health purposes as well. In terms of studies of these devices, there are many pilots going on that are being run by independent parties as well as the device manufacturers and we will be paying close attention to these results to see if outcomes are improved and/or costs are reduced. As with any technology, the cost-benefit analysis needs to be done to make sure we are making progress and not simply falling into a tech trap. In terms of patient training, to my knowledge there have not been formal programs set up, but there will certainly be a need for this that will likely be filled by the device manufacturers who want to get their tools into the hands of patients. We’ll be sure to update you if any major announcements come up.
The Smartphone Physical and You (Feel free to add responses in the comments thread.)
1-Are you currently using any smartphone-based clinical devices, or are you planning to incorporate them into your practice/home?
2-Do you have suggestions for other devices that should be included?
Q: Have hospitals improved since the first Hospital Safety Score last year?
A: We saw an incremental improvement in the scores, though it is not as rapid or as dramatic as we would like. For the Spring 2013 Hospital Safety Score, there were more than 2,500 general hospitals scored, including 780 “As,” 638 “Bs,” 932 “Cs,” 148 “Ds” and 16 “Fs.” Those hospitals that lowered their grades demonstrate how patient safety can be seriously impacted when hospitals don’t stay vigilant. Safety is a 24/7, 365-day effort with all hands on deck; there is no time for excuses when it comes to preventing errors, injuries and harm. On the other hand, hospitals that showed improvement should be celebrating. They have clearly accepted the challenge to improve and have proven that any institution can make significant advances in patient safety over a short period of time. Now, they need to work on sustaining that achievement into the future.
Q: How is the Hospital Safety Score different from other hospital ratings?
A: The Hospital Safety Score is the standard assessment of how well hospitals perform at protecting patients from accidents, errors and injuries. The Score is 100-percent transparent, and the only hospital safety assessment to be (favorably) peer-reviewed in the Journal of Patient Safety. Unlike any other rating, you can see all the data that was applied to every scored hospital, as well as the entire methodology. Also unlike many other ratings, the Hospital Safety Score highlights both the best and poorest performers on safety in an effort to educate consumers on the hospitals they rely on for care.
The Hospital Safety Score assesses hospitals strictly on patient safety. Each “A,” “B,” “C,” “D,” or “F” score assigned to a hospital comes from expert analysis of infections, injuries, and medical and medication errors that frequently cause harm or death during a hospital stay.
Q: Why did some hospitals not receive a score?
A: The Leapfrog Group has strict criteria about which hospitals are eligible to receive a Hospital Safety Score. Hospitals must qualify as general acute care hospitals and must have enough publicly reported data to meet the threshold for scoring. Specialty hospitals (such as children’s or surgical) are excluded, as are hospitals in Maryland, Guam, and Puerto Rico, which are exempt from public reporting requirements. In some cases, hospitals that meet the standard during one iteration of the Hospital Safety Score will not receive a score in the next round, or vice versa, due to a change in the amount of publicly available data.
Q: Should patients be advised against going to hospitals that scored a “C,” “D” or “F?”
A: The Hospital Safety Score should be used as one important piece of information patients use to choose a hospital and as a tool to for them to raise questions with their doctors or hospital administrators. We advise consumers to never refuse care in an emergency because of the Hospital Safety Score, but rather, to use the Hospital Safety Score as a guide for planned events and a research tool for potential emergencies. Safety is the first thing that should be examined about a hospital, but it’s also important to take into account quality and procedure-specific metrics like those available from Consumer Reports or Hospital Compare.
Q: How can you fairly compare hospitals that are large, academic medical centers with a high-risk population to small, community hospitals?
A: Any hospital can afford to be safe. We were very pleased to see a wide range of hospitals serving all patient populations score an “A” on the Hospital Safety Score. These included academic medical centers, rural, urban, and suburban hospitals; safety net hospitals; community hospitals; and nonprofit and for-profit hospitals.
The Hospital Safety Score uses data publicly available at the national level. Where applicable, measures were risk-adjusted. Most of the data is not risk-adjusted, however, because it measures issues that should apply regardless of the frailty, economic hardship or other special characteristics of the patient. For instance, objects should never be left in after surgery, all hospitals should have a policy that employees must wash their hands, and hospital leadership should always place a priority on safety. Any hospital can earn an “A” Hospital Safety Score, and we look forward to the day when all hospitals practice this level of safety excellence.
To learn more about the Spring 2013 Hospital Safety Score release, visit the website or download the Hospital Safety Score app, available on the website.
Leah Binder is the CEO of The Leapfrog Group, a voluntary program aimed at mobilizing employer purchasing power to alert America’s health industry that big leaps in health care safety, quality and customer value will be recognized and rewarded.
A woman’s mother dies at age 56. A blood test is done. The woman finds out she has a genetic pre-disposition to cancer. She takes what action she thinks she needs to take. A familiar story repeated over and over again every day. I’ve met many women who have made this choice. While not “normal”, it is a familiar situation. These women’s difficult choices go unheralded. But not Angelina. She has a voice and she’s not afraid to use it.
I am of two minds about Ms. Jolie’s announcement. Unlike double mastectomies for ductal carcinoma in situ (DCIS), which isn’t necessarily a cancer and can be treated with a lumpectomy, BRCA1 gene mutations can’t be treated any other way. Unless I hear differently from my breast surgeon friends, I’d say she probably did the right thing. Her decision to talk about it is probably encouraging to women who have or will have to make that choice. It raises awareness of the gene mutation. It puts breast cancer on the front page of the New York Times. Again.
Here’s my problem: double mastectomy is not a benign procedure. Ms. Jolie seems to have had a remarkably easy time of it. Yes, she says she was right back to her normal life soon after, but since Jolie’s life is not normal that’s hard to generalize. The truth is there is significant pain involved, a long period of waiting while the tissue expanders do their work, then there’s further procedures for the implants, which can develop capsules around them, or rupture, or get infected. If Angelina had chosen breast reconstructive surgery there would be the risk of the flap losing blood flow, multiple drains, overnight stays in recovery rooms or ICUs, and many many surgeries for revision, nipple creation, etc. And the results are not always beautiful. I understand that it is not Ms. Jolie’s role to scare people, but to encourage them. I would just warn against falsely rosy expectations.
I am not trying to discourage double mastectomy. Sometimes it is necessary. I do think that people who have extraordinary access to public attention must pay extraordinary attention to what they say. I wish Angelina all the best for a complete, and beautiful, recovery.
Shirie Leng, MD is a practicing anesthesiologist at Beth Israel Deaconess Medical Center in Boston. She blogs regularly at medicine for real.
The Leapfrog Group has just released its latest report grading the safety of hundreds of individual hospitals, but the real news isn’t the“incremental progress.” It’s how a group started by some of the most powerful corporations in America has quietly devolved into just one more organization hoping press releases produce change.
Amid the current enthusiasm for “value-based purchasing” by employers and possible privatization of Medicare, it is worth examining why Leapfrog’s initial notion that corporations would spearhead a crackdown on crummy care failed and what we can learn from that publicly unacknowledged failure.
Leapfrog was launched with the hoopla of a high-powered initiative. A widely publicized 1999 report by the Institute of Medicine declared that up to 98,000 patients die every year in hospitals from preventable errors and more than one million are injured. In November, 2000, the newly formed Leapfrog Group announced three targeted “leaps” in patient safety that promised to save some 58,000 lives, prevent a half million medication errors and (in calculations that came later) save billions of dollars.
“The number of tragic deaths brought about by preventable medical errors is too striking for those of us in the business community to ignore,” declared Lewis Campbell, chairman and CEO of Textron TXT -0.29%, at the group’s launch.
Campbell was head of a health care task force of the Business Roundtable, an elite group of corporate leaders that sponsored Leapfrog. Wielding the power of the checkbook to enforce “aggressive but feasible target dates” was “a straightforward business approach to tackling a complex problem,” Campbell explained.
As someone who played a small part in that launch, I shared in the optimism of the “Founding Frogs” from big companies like General Electric and GTE, a predecessor to Verizon. But real change requires a sustained commitment to keep up the pressure. Let’s look at what happened to Leapfrog’s three original “leaps”:
Leap No. 1: “Computer physician order entry (CPOE).” Using computers to check the type of medication and dosage before it reached the patient was said at Leapfrog’s launch to reduce prescribing errors in hospitals by “more than 50 percent.” While that may have been true, the cost to hospitals of adopting CPOE turned out to be much higher than anticipated. Corporate America might have been able to force hospitals to become more efficient, but it didn’t.
Although CPOE has finally begun to take hold, even Leapfrog CEO Leah Binder acknowledges it’s because of the government’s “meaningful use” rules, which came I the wake of the 2009 federal stimulus bill giving out billions to hospitals and doctors to buy computers. In return, they had to show they were using the equipment for clinically meaningful improvements, such as safer care.
In other words, the government “carrot” of massive subsidies (bribery) trumped the “stick” of Leapfrog (we’ll tell our health plan to possibly not contract with you).
Leap No. 2: “Evidence-based hospital referral.” Patients should be sent to hospitals whose doctors performed a high volume of a procedure, said Leapfrog, thereby reducing a patient’s risk of dying by “more than 30 percent.” Unfortunately, that volume-outcome link turned out to be more complicated as more research was done. As one review of the medical literature concluded, the relationship between a hospital’s volume and mortality “appears largely to be specific to the procedure being studied.”
In any event, the business community never got serious about “evidence-based” contracting. Whatever the public pronouncements, the private message to health plans remained, “Give us a low price.” And, by the way, don’t stop contracting with any hospital our employees like to use.
Leap No. 3: “Intensive care unit (ICU) staffing by physicians trained in critical care medicine.”
Let’s think about this goal for a moment. At the time it was announced, “virtually no ICU met the Leapfrog standards.” While some research strongly supported the standard, other research found “weak or no scientific evidence.”Even ICU directors who overwhelmingly endorsed it pointed to implementation barriers such as “loss of control, loss of income, and increased cost to hospital administration.”
For Leapfrog to have succeeded, you’d have to believe that top business executives would order mid-level benefits managers to second-guess doctors about a life-and-death staffing decision.
In reality, the Business Roundtable quietly began backing away almost immediately. Worried that if they certified a hospital for being safe, an employee who was the victim of a medical error could sue them, the Roundtable decided to fund Leapfrog for a while but to sever any official affiliation.
And maybe they were right. The federal government has far more purchasing clout than any business coalition can dream of and, with far more at stake both financially and in human terms for its “constituents,” is much readier to wield that influence. The elderly on Medicare and the poor on Medicaid use more medical services, and therefore are at greater risk for poor care, than the working-age population. Big corporations have enough challenges without picking fights with local hospitals often seen as pillars of their communities.
Fortunately, as corporate America copped out, the American government stepped in – not as evil regulator but as savvy purchaser. Beginning under President George W. Bush and continuing under President Obama, the feds have set “aggressive but feasible target dates,” as Textron’s CEO put it, for hospitals to either improve care and eliminate “never events” or watch their reimbursement cut. Leapfrog deserves credit for helping push the federal government in that direction, but it was the government that eventually led the way for reasons that made eminent economic sense.
Private insurers followed in the government’s wake, one told me, because of market forces: if they tried to tell a prominent hospital they wouldn’t pay for care related to an error, the hospital could threaten to not sign a contract. But no hospital could afford to drop Medicare; ergo, the big “leaps” in patient safety came from government pressure.
Michael L. Millenson is president of Health Quality Advisors LLC in Highland Park, IL; the Mervin Shalowitz, MD Visiting Scholar at the Kellogg School of Management; and a board member of the Society for Participatory Medicine. This post originally appeared at the Medicare News Group.
It seems to have taken awhile, but organized medicine seems to finally be recognizing that today’s commercial health IT is not quite the revolutionizing, transformative, plug-and-play panacea to healthcare’s ills it is often touted as:
May 15, 2013
AMA board chair: HHS should address EHR usability issues immediately
The government needs to act quickly to remedy the impaired usability of electronic health records (EHR) if the technology’s touted benefits are to be realized, AMA Board of Trustees Chair Steven J. Stack, MD (left), told officials during a federal hearing last week.
“The AMA and most physicians believe that, done well, EHRs have the potential to improve patient care,” Dr. Stack, an emergency physician in Lexington, Ky., said during his 30-minute testimony. “At present, however, these EHRs present substantial challenges to the physicians and other clinicians now required to use them.”
He emphasized that many of today’s EHR systems require significant changes before they can deliver the promised outcomes. Referring to Medicare’s meaningful use program, he pointed to undesired consequences of pushing EHR systems on physicians before the technology was completely ready for prime time.
“Immediately” is strong language.
I note that the phrase “health IT done well” is a term I’ve been using since 1998 at my now-Drexel-based health IT teaching website at http://www.ischool.drexel.edu/faculty/ssilverstein/cases, as well as at this blog.
Penned by me at my aforementioned Drexel graduate teaching site, originally housed on AOL, in 1998 and still appearing in its main essay:
… While clinical IT is now potentially capable of achieving many of the benefits long claimed for it such as improved medical quality and efficiency, reduced costs, better medical research and drugs, earlier disease detection, and so forth, there is a major caveat and essential precondition: the benefits will be realized only if clinical IT is done well. For if clinical IT is not done well, as often occurs in today’s environment of medical quick fixes and seemingly unquestioning exuberance about IT, the technology can be injurious to medical practice and biomedical R&D, and highly wasteful of scarce healthcare capital and resources.
Those two short words “done well” mask an underlying, profound, and, as yet, largely unrecognized (or ignored) complexity. This website is about the meaning of “done well” in the context of clinical computing, a computing subspecialty with issues and required expertise quite distinct from traditional MIS (management information systems, or business-related) computing.
(I have more recently switched to the easier-to-parse terminology of “good health IT” vs. “bad health IT” after discussions with Dr Jon Patrick at U. Sydney during my visit Down Under last summer, http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html.)
I’ve also heard “not ready for prime time” before. It is a phrase I used in speaking with a New York Times reporter that then appeared in the Oct. 8, 2012 NYT article “The Ups and Downs of Electronic Medical Records” (http://www.nytimes.com/2012/10/09/health/the-ups-and-downs-of-electronic-medical-records-the-digital-doctor.html?pagewanted=2) by Milt Freudenheim, October 8, 2012, where I am quoted and this blog cited:
… Critics are deeply skeptical that electronic records are ready for prime time. “The technology is being pushed, with no good scientific basis,” said Dr. Scot M. Silverstein, a health I.T. expert at Drexel University who reports on medical records problems on the blog Health Care Renewal. He says testing these systems on patients without their consent “raises ethical questions.”
The AMA Board chair went on to opine:
“Attempting to transform the entire health system in such a rapid and proscriptive manner has compelled providers to purchase tools not yet optimized to the end-user’s needs and that often impeded, rather than enable, efficient clinical care,” he said.
He noted that physicians are “prolific technology adopters” but that adoption of EHR systems has required federal incentives because the technology still is “at an immature stage of development.”
My near-exact terminology has been that the technology is still experimental.
“EHRs have been and largely remain clunky, confusing and complex,” he said.
Perhaps he read my ten-part series on the health IT mission hostile user experience at this blog, at http://www.tinyurl.com/hostileuserexper.
According to a recent survey by AmericanEHR Partners, physician dissatisfaction with EHR systems has increased. Nearly one-third of those surveyed in 2012 said they were “very dissatisfied” with their system, and 39 percent said they would not recommend their EHR system to a colleague—up from 24 percent in 2010.
A survey I posted about in Jan. 2010 is here: “An Honest Physician Survey on EHR’s“, http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html
Dr. Stack spoke at a “listening session” hosted by the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC), a division of the U.S. Department of Health and Human Services (HHS). The agencies coordinated the session to examine how a marked increase in code levels billed for some Medicare services might be tied to the increased use of EHRs.
Dr. Stack noted that some Medicare carriers have begun denying payment for charts that are too similar to other records.
“In this instance, even when clinicians are appropriately using the EHR, a tool with which they are frustrated and the use of which the federal government has mandated under threat of financial penalty, they are now being accused of inappropriate behavior, being economically penalized, and being instructed ‘de facto’ to re‐engineer non‐value‐added variation into their clinical notes,” he said. “This is an appalling Catch‐22 for physicians.”
“Mandated under threat of financial penalty” has been one of my stated “cart before the horse” issues with HITECH (e.g., http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html).
Dr. Stack advised officials that three key actions are necessary to rectify these issues with EHR systems:
- The ONC promptly should address EHR usability concerns raised by physicians and add usability criteria to the EHR certification process.
- CMS should provide clear and direct guidance to physicians concerning use of EHRs for documentation, coding and billing.
- Stage 2 of the meaningful use program should allow more flexibility for physicians to meet requirements as EHR systems are improved.
The AMA will continue to work with federal agencies to improve EHR systems and the Medicare meaningful use program.
I’ve been calling for usability evaluation to be added to the certification process, including in comments during public comment periods to HHS, for some time.
What the AMA Board Chair is apparently missing, though, is health IT safety. They should perhaps read my post on the recent ECRI Institute Deep Dive Study on health IT risk – itself based on a report in their own AMNews (amednews.com) publication (“Peering Underneath the Iceberg’s Water Level: AMNews on the New ECRI Deep Dive Study of Health IT Events“, http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html).
I don’t think any prudent person would consider a 9-week study of 36 hospitals with volunteered reports of 171 health information technology-related problems, where eight of the incidents reported involved patient harm and three may have contributed to patient deaths, information to ignore.
Health Care Renewal
Of course, the ever-present euphemism for life-threatening EHR malfunctions and defects, i.e., “glitches” are the cause (http://hcrenewal.blogspot.com/search/label/glitch):
Marin General Hospital nurses warn that new computer system is causing errors, call for time out
By Richard Halstead
Marin Independent Journal
Posted: 05/15/2013 04:07:49 PM PDT
Nurses at Marin General Hospital have asked administrators to put implementation of a new computerized physician order entry system on hold until glitches can be worked out and more training provided to nurses and doctors who use it.
Nearly a dozen nurses attended the regularly scheduled meeting of the Marin Healthcare District board Tuesday night at Marin General to voice their concerns. The district board oversees Marin General, but it does not involve itself in the hospital’s day-to-day operations.
“Orders are being inadvertently passed to the wrong patients. People have gotten meds when they’ve been allergic to them. This is dangerous,” said Barbara Ryan, a Marin General registered nurse, who works in pediatrics and the intensive care nursery. “We’re not asking you to get rid of it. We’re asking you to place it on hold.”
Orders passed to wrong patients? No problem, just a glitch! Meds people are allergic to? Just a glitch. Dangerous? No way. It’s just a glitch!
But Lee Domanico, who serves as the CEO of both Marin General and the Marin Healthcare District, said, “I’m confident that in spite of the implementation issues, we have a system today that is safer for patients than our old paper system, and it will get even safer as we gain experience with it and work to fix some of the glitches we’ve experienced.”
Where’s the data backing up that assertion, I ask? The actual risks of paper records don’t seem to be robustly documented anywhere.
Ryan, who serves as the California Nurses Association/National Nurses United representative, was one of four Marin General nurses who spoke during the public comment portion of the meeting. Ryan said the nurses warned in advance of the system’s roll-out on May 7 that nurses and doctors had insufficient knowledge of the system. Ryan said due to problems with the software nurses had been unable to open the program at home to practice using it.
And yet the rollout happened anyway? That seems to me to be reckless indifference to the concerns of clinicians.
“Lo and behold the problems that we were worried about have happened,” Ryan said. “We’re looking at two-hour preps for surgery and two- to three-hour discharges; skilled nursing facilities calling back saying, this really doesn’t make sense; the wrong meds ordered on the wrong patients and then given to the wrong patients; the inability for nurses to be able to see what the doctor ordered and double-check it.”
Of course, I might add, patient safety was not compromised, the other common refrain of EHR glitch-excusers … see below.
Ryan said nurses have and will continue to file “assignment despite objection” forms due to the system. Nurses file the forms to document formal objections to what they consider an unsafe, or potentially unsafe, patient care assignment.
“We will take patients but we will object to the assignment because it is unsafe,” Ryan said. “This system is making it unsafe.”
These will be exceptionally helpful in court to any patients injured or killed as a result of these “glitches” and EHR rollout that occurred despite direct warnings from clinical experts.
Marin General nurse Susan Degan said, “This is not about resistance to change. It’s about accountability. My most important role is that of patient advocate. I am held accountable when errors are made.”
Domanico acknowledged there have been some technical problems with the Paragon system, including making it possible for nurses to open from home. And he said the software is not faster than the old paper system. [Considering it's acknowledged all the way up to the highest levels of HHS that current EHR's slow physicians down, one wonders if anyone in this organization thought an EHR would actually increase speed? - ed.]
About the “resistance to change” canard, see my essay “Doctors and EHRs: Reframing the ‘Modernists v. Luddites’ Canard to The Accurate ‘Ardent Technophiles vs. Pragmatists’ Reality” at http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html .
“So yes,” Domanico said, “it is causing stress for nurses who have heavy workloads, who are learning how to use it, particularly in areas where we need to speed up the computer.”
What? “Speed up the computer?” They’ve spent tens if not hundreds of millions for an EHR, and the computer’s too slow?
Actually, I think what this CEO in an obvious display of health IT ignorance is trying to say is that we have to do something about the system’s poor usability, which sort of mimics what the Board Chair of the American Medical Assocation just said (http://hcrenewal.blogspot.com/2013/05/ama-finally-on-board-with-ehr-views.html).
Also – clinician stress promotes error.
But Domanico challenged the suggestion that patient safety at Marin General had been compromised.
In fact, there is no way the issues described above cannot be compromising patient safety, on its face. (http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised).
“I would have no hesitation about entering this hospital tonight,” he said.
As a VIP, of course, this CEO would get special treatment. Thanks a lot.
I would NOT want to be a patient there under these conditions, unless perhaps I had a 24×7 medically-skilled advocate/bodyguard.
Board member Ann Sparkman, who previously served as in-house counsel at Kaiser Permanente, said nurses at Kaiser struggled at first when a new computer system was introduced there.
Sparkman said, “It’s just to be expected.”
This seems a rather bizarre appeal to common practice (http://www.nizkor.org/features/fallacies/appeal-to-common-practice.html).
The stunning ignorance of this board member about proper mission-critical IT safety testing and implementation, such as performed in pharma, aerospace, etc. is, quite frankly, shocking.
Further, an attitude that life-threatening “glitches” are “just to be expected” by a member of the Board of Directors, with fiduciary responsibilities regarding hospital operations, is grossly negligent in my opinion, and completely ignores patient’s rights.
One wonders if any formally-trained medical informatics experts were in leadership roles in this project.
Health Care Renewal
Last week, CMS unilaterally released chargemaster data from 300 hospitals around the country. As David Dranove summed up well in his recent piece, this is an old hat. Yes, there are big variations in hospitals’ chargemasters. And yes, there is a lot of buzz around consumer price shopping.
Hospitals are now reimbursed a capitated amount according to each patient’s diagnostic-related group. Capitated payment means, essentially, that the hospital receives a set amount of dollars for each patient that walks through its doors with a given diagnosis — say, $ X for a patient with pneumonia or $ Y for a patient with MI. Regardless of how many drugs, tests, or scans the hospital uses for the patient, it will still get the same compensation from the insurance company.
I have seen firsthand the motivation for this, as pay-for-performance model is beginning to take over with my own practice. Gone are the days where doctors’ salaries are unhitched to the cost-effectiveness of care. Everyone is now in the same boat.As a neurologist, I want to share a few examples regarding stroke care that illustrate the potential savings available from educating physicians regarding cost, and also some pitfalls to avoid that could compromise patient care.
CTA and MRA are two imaging methods of diagnosing clogged arteries in acute stroke patients. CTA can be used in most cases, and is more timely and detailed in showing arterial status than the roughly equivalent MRA. This makes it preferable as a diagnostic tool in acute stroke cases. However, MRA provides similar information and is frequently ordered in conjunction with an MRI since it utilizes the same machine, and the MRI test is being done anyway to obtain different and necessary data.
The piece of information that physicians do not often consider is that CTAs are thousands of dollars cheaper for the health system than MRAs. This saving holds true even if an MRI is done and then a CTA is done separately. Having a comparison price tag at the point of ordering informs the physician to think twice about the routine selection of a vastly more expensive test, and leads to savings for all stakeholders, including the health system.
Likewise, in treating hemorrhagic stroke, doctors frequently order Factor VIIA to control bleeding which not only costs $ 10,000 a dose, much more than the alternative — fresh frozen plasma — but also carries a higher risk of clotting complications. There are specific indications for preferred use of Factor VIIA, but 97% of the time it is used inappropriately.
The good news is that physicians are getting on board with the new model. I know this from my own experience as a stroke director for a hospital administering “Get With the Guidelines”, a nationwide computerized tracking program of stroke care that includes a physician-accountability component. This initiative has led to dramatic improvement in the screening and treatment of elevated cholesterol in the acute stroke patient.
At the same time, we must be careful of being penny-wise and pound-foolish. For instance, TPA is an anticoagulant that is used to treat stroke shortly after it occurs. Although it is very expensive, TPA is critical for post-stroke care, and discouraging its use due to its cost would be inappropriate. Not to mention, it would actually raise overall costs because the hospital would have to deal with sicker patients for longer.
Whether it is prescribing pricey Plavix instead of the equally effective aspirin, giving redundant blood tests, or ordering hypercoaguable workups in older patients, there is so much room for improvement. The trick is in large part to inform physicians — the ones whom the burden of value is being put on in the post-reform world — at the point of care about the relative prices and value of their options, enabling them to make optimal medical decisions, while not sacrificing quality. We are already seeing the impact of putting price transparency in the doctor’s hands in studies emerging form Johns Hopkins (FN) and other leading thought leaders such as University of Pennsylvania Health System and CHOP, where price transparency is being brought not to patients’ iPhones, but to the point of order.
The birthers, it turns out, aren’t the only ones with wacky conspiracy theories; evidently a lot of people out there really think there are cures “They” don’t want you to know about.
In particular, there seems to be a surprisingly pervasive belief that drug companies aren’t working on cures for disease because it’s far more profitable to chronically maintain patients on medication. This also explains (so the reasoning goes) why drug companies offer so many incremental therapeutics, and so few revolutionary treatments.
If only this explanation were true.
Drug companies, in fact, are desperate to identify radically improved treatments for dreadful disease. Even if you don’t accept (as I’ve recently argued) that most industry researchers I know aspire to create such profoundly effective medicines, imagine the economic value of a drug that cured Parkinson’s Disease or pancreatic cancer – consider what such a therapy would be worth.
Exhibit A is the explosion of pharmaceutical interest in hepatitis C. How do you explain the billions of dollars in investment– including an eye-popping $ 10.8B acquisition — if companies weren’t looking to cure patients? The entire premise of this field has been coming up with approaches to cure more patients faster.
Of course, progress in HCV has been exceptional; by and large, medicine has seen mostly incremental gains, and has witnessed few transformative therapies. Why?
The unfortunate truth is that drug companies really want to cure disease, but rarely know how. Medical science simply isn’t up to the challenge. Most diseases aren’t well enough understood to enable the rational development of truly transformative treatments.
When high-profile pharma studies fail – such as the slew of recent Phase 3 Alzheimer’s Disease trials – it’s fashionable to characterize them as yet another industry failure. There’s some truth to this: the proximal cause may well be a poor decision to continue the development of a questionable drug. But the root cause is likely insufficient understanding of disease pathophysiology.
We should also be careful about dismissing the value of incremental advances– a reflex I know I still have, although I’ve recognized the value of seemingly small tweaks from the time I was a resident. Even today, when I critique (as derivative) formulation plays like liquid Ritalin, I’m glad to be reminded of the kids who stand to benefit from just such a medication.
As the healthcare system looks more critically at value – demanding more evidence of effectiveness from providers and products alike – drug companies will be faced with two options.
The best choice, of course, would be to figure out how to come up with truly revolutionary treatments. Perhaps unexpected insights will emerge from big data and the integration of phenotypic and genotypic information, in the framework of system biology; maybe a new therapeutic modality will arrive on the scene. It’s possible intensified collaboration between academic and industry researchers will eventually yield something useful, or that open-data approaches (as championed by organizations like Sage Bionetworks [disclosure: I served as a founding advisor]) will achieve critical mass, and deliver impactful insights. But unless something substantial changes, progress is likely to remain slow and stochastic, and truly game-changing novel therapeutics will continue to be the exceptions rather than the rule.
Screening for and aggressive treatment of prostate cancer has become an enormously lucrative business, if not necessarily a life-saving medical strategy. The minimal media coverage of a recent settlement suggests that at least to some degree, it has been fueled by some questionable practices.
The CR Bard Settlement
As reported by the Atlanta Journal Constitution,
A medical device company on Monday agreed to pay a $ 48.2 million settlement to resolve claims by a Georgia employee that it paid kickbacks to doctors and customers who bought radiation treatment for prostate cancer.
C.R. Bard Inc., which is headquartered in New Jersey and has offices in Covington, resolved a whistle-blower suit filed by the employee in 2006. The suit alleged that the company paid off doctors and hospitals to induce them to prescribe brachytherapy seeds, which are implanted in the prostate and deliver a dose of radiation to cancer cells.
Another brief report in the Macon (GA) Telegraph gave a tiny bit more detail about what was given to physicians to get them to use Bard’s radiation therapy products,
Customers could order the seeds, used in brachytherapy to deliver a prescribed dose of radiation directly to cancer cells, from multiple companies. But Bard allegedly offered doctors grant money, rebates, free medical equipment and advertising campaigns to entice them to buy their product at inflated prices, according to a news release issued by [whistle-blower Julie] Darity’s legal team….
The Usual Elements of Legal Settlements of Allegations of Health Care Corporate Bad Behavior
The story, briefly told as it was, included many of the usual elements of stories of legal settlements of wrong-doing by large health care corporations.
The settlement, hence justice, as it were, took a long time, about 7 years since the most recent behavior, and 15 years since its start. Per the AJC,
Bard employed its kickback scheme from 1998 to 2006, federal prosecutors said.
Penalties Not as Big as They Appeared
The penalties were not as big as they seemed. There was the seemingly large fine, $ 48.2 million dollars. However, that should be compared to the company’s net sales of over $ 2.95 billion and net income of $ 530 million in 2012, according to the company’s annual report. It should also be compared to the total compensation of the company’s chairman and CEO in 2012, over $ 8.7 million, and to that of its president and chief operating officer, over $ 6.0 million, according to the company’s 2012 proxy statement. Apparently, the fine came out of the company’s treasury, so its impact was diffused among all shareholders, employees, customers, and patients, not directed to those who may have authorized, directed or implemented the kickbacks to physicians.
No Penalties for Individuals, No Acknowledgement of Wrong-Doing
The settlement did not involve any sort of direct penalties to those who authorized, directed, or implemented the kickbacks.
The corporation did not even acknowledge any bad behavior. As per the AJC,
Bard is pleased to settle the claims, Scott Lowry, a company spokesman, said in a statement.
‘This resolution allows the company to put this matter behind it and continue to focus on delivering life-enhancing medical devices and technologies to patients around the world,’ he said. ‘We remain committed to continuously enhancing and improving our compliance programs in accordance with industry standards.’
Suppression of Whistle-Blowing
It may not be part of all such settlements, but note that in this case there seemed to be an attempt to shut up the whistle-blower. So, there is reason to think that justice, such as it was, was delayed because the company seemingly tried to punish the whistle-blower, rather than listen to what she had to say. Per the Macon Telegraph,
Darity, 56, said she first reported what she suspected as questionable activities to her supervisors.
‘I did exactly what was outlined in the company ethics policy,’ she said. ‘I wanted to think things were being corrected.’
In time, she realized nothing had changed. She filed an internal whistle-blower complaint.
Her job was eliminated in November 2005, soon after an investigation was launched into her whistle-blower complaint, she said.
Darity had worked for Bard, which has an office in Covington, for more than 18 years. When her job was eliminated, she was a manager in the Brachytherapy Contracts Administration division.
Out of a job, Darity filed the lawsuit in U.S. District Court for the Northern District of Georgia in January 2006.
Nonetheless, the government seemingly trusted C R Bard to fix its own behavior going forward, per the Wall Street Journal,
As part of a non-prosecution agreement, C.R. Bard agreed to pay an additional $ 2.2 million and take remedial steps to enhance compliance. The company had said in a regulatory filing last year that it expected the settlement to include a corporate integrity agreement, which typically require companies to obey restrictions on their sales and marketing practices, but no such agreement was announced Monday.
Note that here we discussed a case in which an academic medical institution seemingly tried to punish faculty members who questioned that organization’s overly enthusiastic approach to prostate cancer.
Summary – the Profitable but Unsubstantiated Aggressive Approach to Prostate Cancer
So its just another day at the office. This was a typical settlement of allegations of unethical behavior by a large health care organization. A large health care company allegedly bribed doctors to use its products. It seemingly tried to shut up a whistle-blower. Seven years later, the company got a financial slap on the wrist, but no one directly involved in the alleged kickbacks, and no one whose compensation may have been enlarged due to such apparently unethical activity paid a price. Never mind that the alleged kickbacks may have induced doctors to use treatments that provided no overall benefit, but could have harmed patients.
Before ending with our usual fulmination, I should note that this case appears to be one small piece in the puzzle of our national infatuation with an aggressive approach to prostate cancer, despite a lack of essentially any good evidence that this approach does any good. Brachytherapy, the treatment pushed allegedly by kickbacks, is one kind of aggressive treatment for prostate cancer. Yet there is no good evidence from randomized controlled trials that is prolongs life. In fact, a recent (and the only major) randomized controlled trial of aggressive treatment of prostate cancer on initial diagnosis failed to show any overall survival benefit.(1) There has been a huge push to screen all men of a certain age for prostate cancer. Yet now two new trials also failed to show any overall survival benefit from screening.(2,3)
But the prostate cancer business is very lucrative. On the Reforming Health blog, a post summarized a lecture given by Dr Otis Brawley, chief medical officer of the American Cancer Society in which Dr Brawley described the financial scheme underlying the aggressive approach to prostate cancer,
Brawley recounts an experience he had on a site visit to a hospital in 1998 while an Assistant Director at the National Cancer Institute. During the visit a marketing executive explains to Brawley the publicity value and financial rewards of a free prostate screening program offered by the hospital at a local mall. The plan is to screen the first 1,000 men over 50 who come to the mall for testing. I’ve transcribed Brawley’s recollections from the video and they provide a great explanation for the profit-driven practices that continue to occur today, 14 years later:
‘If they screen 1,000 men they’re going to have 145 abnormals. They’re going to charge about $ 3,000 to figure out what is abnormal about these abnormals, that’s how they pay for the free screening. About 10 of the 145 won’t come to this hospital so that’s business for their competitors, but they’ll get 135 times $ 3,500 on average. Of the 135, 45 are going to die of prostate cancer and the other percentage are going to get radical prostatectomy at about $ 30-40,000 a case; there’s a percentage that’s going to get seeds at about $ 30,000 a case; a percentage were going to get radiation therapy that (at the time) was about $ 60,000. Then [the marketing executive’s] business plan goes further, he knows how many guys are going to have so much incontinence that diapers aren’t going to do it so he had in his business plan how many artificial sphincters urologists were going to implant. And then he was a little apologetic because there was this new thing called Viagra that screwed up his estimates for how many penile implants he was going to sell because guys were upset about impotence related to prostate cancer treatment.’
Brawley says, ‘this is 1998, I ask him, if you screen 1,000 people how many lives are you going to save? He took off his glasses and looked at me like I was some kind of fool and said, ‘Don’t you know, nobody’s ever shown that prostate cancer screening saves lives, I can’t give you an estimate on that.’’
Presumably because he was a marketing executive, the manager whom Brawley quoted did not have to feel doubt about all the men subjected to needless procedures, and who would be at risk of serious and unpleasant adverse effects of these procedures, all to make money but not to prolong their lives. Of course, not only the hospitals make money, but also quite obviously the companies that sell them the drugs and devices needed for all this medical aggression make money, as do the doctors who go along with it all.
Now we suspect that one small reason the doctors have gone along with it is that they may have gotten inducements from those companies.
Time to fulminate,…
We will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.
1. Wilt TJ, Brewer MK, Jones KM et al. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med 2012; 367: 203-13. [Link here]
2. Andriole GL, Crawford ED, Grubb RL et al. Mortality results from a randomized prostate-cancer screening trial. N Engl J Med 2009; 360: 1310-9. [Link here]
3. Schroder FH, Gugosson J, Roobl MJ et al. Screening and prostate-cancer mortality in a randomized European study. N Engl J Med 2009: 360: 1320-8.[Link here]