iCompare Trial:  Unethical Work-Hour Limit Study Being Performed at Hospitals Putting Patients and Doctors at Risk

…Shhhhh it’s just putting everyone at risk, no one has to know.

Fueled by greed and profits, the most recent attempt by the healthcare and insurance lobby has berthed a new egregiously unethical study that forces physician residents at 63 randomly chosen hospital facilities across the country to participate in a trial which pushes them to work inhumane hours, while caring for patients in the supposed name of “improving” the patient care experience.

The iCompare Trial is a $9 million research project partly funded by the National Institute of Health which was supposedly designed to determine the best way to train novice physicians while maintaining patient care by forcing intern physicians and senior residents to work 30-hour-plus shifts. Oddly, It was only five years ago, and again in the name of “improving” patient care and preventing resident burnout that the Accreditation Council for Graduate Medical Education set the current regimen of work duty restrictions.  These restrictions mandated maximum resident shift lengths of 16 hours for interns and 24 hours for more senior residents with a maximum for all of 80 hours per week.

“The arrangement is reviving one of the oldest debates in the education of physicians: whether they learn best when subjected to brutally long and difficult working conditions, whether their patients have a right to know about it, and whether physicians and patients can be kept safe.” states NPR news.

The trial’s backers claim they are hopeful that the results of the extended duty hours will be favorable so as to remedy what has proven to be a problematic issue that occurs due impart to the current work-duty restrictions (wherein residents work less hours more frequently). The study’s supporters say under the current guidelines, multiple shift changes coupled with poor training can lead to inefficient transitions cause a breakdown in communication which then can lead lapses in patient care.

The studies major flaw:  Solving a problem by creating a problem

Though these transitional issues are a huge problem at US hospitals across the country, we believe the idea that working residents harder and longer could possibly be the solution to this issue is like trying to heal a wound with a dirty Band-Aid.

Our view point is shared by Washington Post guest writers Jeffrey Clark and David Harari.  Both men are resident physicians at the University of Washington specializing in psychiatry and participating in the iCompare Trial.

“These studies err in assuming that the dangers of sleep deprivation must be traded for the dangers of shared patient care. Such a zero-sum framework won’t help us improve patient care or ensure the well-being of resident physicians…. There is no reason to believe that 80-hour workweeks and shifts longer than 16 hours are associated with optimal patient or resident health. Adequate sleep is a fundamental physiological need. No amount of caffeine, prescription stimulants (as some physician leaders have advocated for) or ‘alertness management strategies’ can adequately compensate for acute and chronic sleep deprivation.”

After being told that the study presented only “minimal risk” to doctors and patients, it was the decision of the institutional review boards from two universities responsible for human research protection to waive the requirement for obtaining informed consent for all subjects, both the doctors and the patients.  This means that patients are not being made aware that they are in the study or given the right to reasonably opt out, nor can residents reject the grueling 30-hour-plus work day trial schedule without being removed from their residency training program. This puts not only a patient’s care at risk but also puts the residents at risk by expecting them to make life-altering decisions regarding patient care and to conduct procedures while being forced to work superhuman hours without adequate sleep and time off.

More specifically, it is our stance that trial investigators at Northwestern University (FIRST) and the University of Pennsylvania (iCompare) who are conducting and overseeing the study are exposing residents to well-documented increased risks of motor vehicle accidents, needle-stick injuries, injuries involving intravenous lines wound suturing that could potentially heighten spread of blood-borne or hospital-borne diseases to themselves and their patients.  Harari and Clark also have good reason to believe the long hours and lack of sleep are contributing to a widespread epidemic of chronic depression among residents at study sites.

Exhausted physicians can make mistakes that cost lives

Michael Carome, MD is the director of Public Citizen’s Health Research Group and is an expert on issues of drug and medical device safety, pharmacy compounding, Food and Drug Administration oversight, healthcare policy, and the protection of human research subjects.

Dr. Carome, who has spearheaded the fight against this study and what follows in its wake, explained that before there were work-hour restrictions for pilots in the commercial airlines industry, pilots were required to work as long and as much as the airlines demanded.  But as history dictates, we can now easily see that this type of routine over-extension of the human body is unacceptable because it has led to catastrophic plane crashes. Why then, Carome argues, would this be acceptable in the medical profession where human lives are at stake?

Dr. Carome believes there is only one true reason why this study is happening:  Loosening work hour restrictions saves hospitals money.  According to Carome, They might be selling it to the Accreditation Council for Graduate Medical Evaluation as a more “flexible” schedule that centers on patient care but the reality is that keeping less physicians on for longer hours puts money back into the hospital’s pockets.

Critics can’t understand why a medical culture in the US which encourages severely sleep-deprived, impaired physicians to take care of others is being perpetuated and in such an unethical way that flies in the face of what physicians are taught.

The argument for the study

A proponent of the clinical trial, Dr. David Asch, director of the Center for Health Care Innovation at the University of Pennsylvania’s school of medicine and the study’s lead researcher, says that it’s what patients want.

When given the choice, Dr. Asch says it’s the patients who have said that they prefer to have only doctor and deal with only one doctor over a period of a day and a half (especially within the first 36 hours of critical care) than deal with several, he explained to Full Measure news in its June 5 broadcast.  “The new doctor taking care of you never knows you as well as the doctor who was taking care of you before,” Asch says. Information handoffs are “like in a relay race, where the baton gets dropped between two runners. And it’s known as a critical point where medical errors are common.”

However, if you’re collecting opinions from patients on what they’d rather have after only divulging the information which benefits your cause like Asch claims he has done, then of course anyone would agree with him.  But if it was proposed to these “patients” that they’re actually going to be under the care of a severely sleep-deprived resident for 30 plus hours rather than one that has only worked up to 16 hours (within current federal regulations), is the their answer really going to be the same Dr. Asch?  We think not.  And for the record Dr. Asch, since when are biased and uniformed patient opinions what should determine the course of action the medical community takes in providing safe and consistent care?  Not to mention the fact that said patients won’t be made aware that they’re part of the study or given the opportunity to decline the being involved in such a potentially dangerous human circus— testing the limits of the body and brain to the debt of the patient and the resident physician.

Despite a ban against 30-hour-plus shifts in 2011 due to fears that inexperienced, sleep-deprived physicians might jeopardize patients and outcry and objection from Carome’s Public Citizen’s Health Research Group and the American Medical Student Association, which represents medical students, the study has continued without interruption.

To add injury to insult, Asch also maintains that it isn’t practical to get consent from all the doctors and patients in the study and that some “independent” bioethicists (likely paid for by the study’s benefactors) agree with him on that point.

Bioethicists like, Mildred Solomon, president of the Hastings Center, a nonpartisan research institute that studies ethical questions in health care.  Solomon strongly endorsed the research. “We haven’t really studied whether [restrictions on work hours] made a difference or not, not in this kind of rigorous way,” she said. “And I think we need to find out.”

Sorry Mildred, we disagree.  We believe there are significant ethical and regulatory problems with these trials. Conducting this research without the informed consent of residents and patients violates the basic ethical principle of respect for persons.  And you don’t have to be a doctor or a bioethicist or even a high school graduate to understand that tired people do not perform at an optimal level and errors will happen, people will get hurt whether it’s during the workday or after, and lives will be lost if this study’s exhausting work duty regimen becomes the new mandate.

Is there a devious master plan afoot?

The healthcare and insurance lobby is continually tightening its grip on patient rights.  Earlier this year, Rocky McElhaney was up at Tennessee’s Capitol Hill fighting a Bill that, if passed, took away a government dependent (Tenncare/Medicare or Indigent Program) patient’s rights to take legal action and seek damages against negligent government-contracted doctors and hospitals for disastrous and debilitating injuries and death.

So hypothetically speaking you could have over-taxed, sleep deprived doctors working longer hours than anyone should ever work treating low-income patients with a new law on their side that says if they screw up and hurt someone neither they, nor their employer can be found liable. If this happens, hospitals and their insurance companies will be cleaning up never having to pay out to deserving injury victims on their medical negligence and wrongful death claims, and they’ll be saving an additional nugget or two by running physician residents ragged rather than affording the logistical costs associated with more frequent shift changes.

A law firm that stands up for your rights

This is an issue near and dear to my heart, personally.  My sister-in-law is finishing up her third year of medical school this spring, and I’ve seen how exhausting 80 hour work weeks have been as she has done her third year rotations.  She’s going to be a great doctor (in my slightly biased opinion), but I would hate to see her make a mental mistake due to working a 30 hour shift when she clearly should have been off work and recharging hours before.  In our jobs here as attorneys, we certainly don’t want to see people getting injured by doctors, but we also don’t want doctors having to deal with such grueling hours and hurting themselves or their careers just so hospitals can push their employees as far as possible to test the boundaries of what they can get out of them.

It’s a scary world in which we live.  It can seem like there is no way to get the justice you deserve.  But as the old adage goes, “Where there is a will, there is a way,” and the Rocky McElhaney Law Firm has the will to give notorious big business offenders, negligent doctors and hospitals, and insurance companies a run for their money. We go to bat against big opponents to take home fair financial recoveries for real- hard working people that have been injured due to a person or company’s negligence.

We’ve been successfully serving injury victims across Tennessee and the Southeast for years and are a force to be reckoned with in the industry.  Insurance companies know when you hire Rocky Law Firm, that they’re in for a fight: a fight for the maximum, a fight for justice, a fight for you!  Don’t settle for less.  Call us today at (615) 425-2500 for a free consultation.