Physiologic stress is being needlessly inflicted on patients because, despite their education and expertise, some doctors are reluctant to shed traditions. But any hospital, regardless of size or budget, can do better to promote healing.

Being an inpatient is already stressful enough, for obvious reasons.

Yet, many hospitals make the experience worse— and potentially dangerous—by needlessly subjecting patients to longstanding, but outmoded protocols that can result in food and sleep deprivation.

Martin Makary, MD, a medical researcher and surgical director at Johns Hopkins Multidisciplinary Pancreas Clinic, says it's time for hospital leaders to re-examine these hidebound practices.

"My patients were telling me that this was an issue," Makary told me. "Any doctor will tell you that patients routinely talk about sleep interruptions, difficulty sleeping, and asking when they can eat."

Although feeding patients and allowing them to rest seem obvious, Makary says these basic needs can be overlooked in hospital patient safety programs that focus on reducing adverse events. In addition, sleep and food deprivation can be hard to spot because they are dynamic and can vary greatly from patient to patient.

Add Empathy, Improve Patient Experience

"Traditional medicine has never really measured physiologic stress," Makary says. "Nobody has measured the complication rate in a normal body versus the complication rate in a fatigued, starved body. Is that complication rated doubled? Quadrupled? No one knows."

The variability between patients and the fact that food and sleep deprivation can't be well measured, has kept the issue "off the radar," Makary says. "It's off the radar because physicians like things that are actionable—things that we can fix."

Despite their education and expertise, some doctors are reluctant to shed traditions, no matter how outdated.

Refuting Dogma
"Doctors have been frustrated by the strong traditions in medicine that govern patient care that are even stronger than the science," Makary says. "For example, we have a tradition in surgery that patients should not eat anything eight hours before an operation. That is dogma. It's a tradition, and it's considered a standard of care. If we really ask where that number came from, it was haphazardly chosen in the wisdom of the doctors of that era, who thought it was a safe period which would allow someone to empty their stomach and reduce the risk of aspiration."

The timeframe was debunked by science more than a decade ago, Makary says, and the rule of thumb now is that patients shouldn't eat within six hours or drink within two hours of an operation. "We are learning that if we actually feed the patients high-carbohydrate drinks two hours before the operation they feel better going in and they're less-starved coming out," he says.

Makary says hospitals must examine their protocols because the ramifications of sleep and food deprivation can be severe. Even a younger, relatively healthy person at home and without illness can become physiologically stressed and immunocompromised after 24-hours of fasting and a poor night's sleep.

In older, frail patients, already stressed by a hospital stay, food and sleep deprivation can worsen complications and overwhelm a patient's physiological reserves.

"Coming out of surgery, not only has your body undergone a physiological stress, now your body, if it's been without food, is in a vulnerable state, even without surgery," he says. "So, when we scratch our heads and ask 'how can we lower our infection rates' or 'how can we improve patient satisfaction?' Well, we know patients are happier and healthier when they're eating and sleeping."

On the subject of sleep deprivation, Makary once again listened to his patients.

Archaic Protocols Amidst a Cacophony
"One thing the patients told me at Johns Hopkins—and I have seen this at every hospital I have worked at— is 'they come in at 2AM and stick a needle in me and draw my labs,'" he says. "The people ordering the labs say they have to do that because they need the lab results before 5AM, which is when the youngest residents come in and pre-route and get all the information together to pass on to the chief resident. Then the chief resident uses all the information from their 6:30AM rounds and passes it on to the head surgeon at 7:30AM. So, there is this communication cascade that is archaic, burdensome, and technologically immature that results in patients' sleep getting interrupted at night."

Beyond the early morning wake-up calls, hospitals are a cacophony of sound, with overhead pages, phones ringing, loud conversations, and monitors beeping. Makary says Johns Hopkins has eliminated overhead pages on clinical units, ended overnight lab draws, and provides private rooms for most patients.

"We are learning more and more that many of these labs are not needed, and we can work with the patients to learn when they're planning on going to bed and do the labs just beforehand," he says. "We got rid of overhead pages after recognizing that there are better technological forms of communicating that do not need to wake up or alarm patients."

Makary also suggests that hospitals provide patients with eye masks, pipe in soft music, and display artwork that encourages relaxation and sleep.

Every Hospital Can Do Better
Makary's recommendations are particularly appealing because every hospital can do it, regardless of size or budget. There really is no excuse not to.

"Hospital leaders are having great success putting together groups of doctors and nurses who are asking how they can reduce noise, how they can change the time for lab testing, and how can they insure that patients are given better information about eating and drinking before surgery," he says.

A renewed emphasis on the importance of rest is overdue.

"We're supposed to promote health, but we create these hostile environments," Makary says. "There is a long tradition in medicine that rest is still good medicine. That's been under-represented in the litany of treatments that we have memorized and compartmentalized as doctors."

"We in medicine often don't have the methods and vehicles to study treatments because every patient is different and studies are labor intensive," he says. "As a result, we rely heavily on tradition. We rely heavily on consensus wisdom. And that reliance is so strong that even when there is science, it can't overcome the tradition."

This is not the first alert directed at falls, which are described as a "complex, chronic problem." The alert is directed at healthcare facilities in general, not only inpatient settings.

Despite widespread prevention efforts, patient falls remain a dogged and dangerous problem in healthcare settings, The Joint Commission says.

In a Sentinel Event Alert issued last week, The Joint Commission noted that patient falls with serious injury are among the top 10 sentinel events reported to its database, which has received 465 reports of patient falls with injuries since 2009. Of those falls, 63% resulted in death.

Erin DuPree, the Chief Medical Officer and Vice President for The Joint Commission Center for Transforming Healthcare says that this latest sentinel alert is not the first directed at falls, which have proved vexing for many providers.

"It's a complex, chronic problem and with the complexity of healthcare organizations today it is why we are still dealing with falls," she says.

"Ultimately, a lot of the falls work has been around identifying who is at risk and who are the high-risk patients. Really, especially in the hospital setting or any healthcare setting, all patients are at risk at some level. It's a different approach when you look at it from that lens."

The Joint Commission defines a sentinel event as a patient safety event not primarily related to the natural course of the patient's illness or underlying condition that reaches a patient and results in death, permanent harm, or severe temporary harm where intervention is required to sustain life.

Although the majority of falls reported to The Joint Commission occurred in hospitals, the ECRI Institute also reports a significant number of falls occurring in non-hospital settings such as long-term care facilities. 

"This alert is about healthcare facilities in general," DuPree says. "A lot of the understanding around falls has come from the inpatient setting, but this alert is targeted to healthcare facilities in general."

The sentinel event alert cites these common contributing factors for falls:

• Inadequate assessment
• Communication failures
• Lack of adherence to protocols and safety practices
• Inadequate staff orientation, supervision, staffing levels, or skill mix
• Deficiencies in the physical environment
• Lack of leadership

DuPree says provider leaders have to ask themselves some tough questions about fall prevention strategies in their organizations.

"The first things leaders need to ask themselves is are they just trying to meet compliance with CMS or are they committed to preventing falls in their organizations, which would require them to understand their outcomes and their aims."

"Are they really aiming to prevent falls for every single patient? Then, look at how other staff and management teams are approaching the problem. Are they approaching it in a systematic, data-driven way? Are they using robust process improvement, or are they just throwing every solution set at the wall and hoping it works?"

DuPree says consistency across the entire organization is also a challenge.

"Everyone says 'oh yeah we have a falls risk assessment. We put that in our EMR,'" she says. "But when they drill down in a systematic data-driven way, they find that it's not implemented consistently or well. Every nurse has their own definition of what different aspects of the assessment mean and maybe it's not built into their orientation and so the new nurses don't even know and they learn through osmosis. So, the implementation and delivery of these preventive measures are done inconsistently."

DuPree says it is also important that every healthcare organization understand its own specific challenges and not rely on a one-size-fits-all approach.

"It's very important that they discover what their issues are to target solutions to their unique needs. That is at the heart of these tough, chronic issues in healthcare today," she says. "The approach to improvement is usually far too basic for the complexity of these problems. That is what we find in healthcare today. One size does not fit all, but that is the approach used by a majority of healthcare organizations today. We will not improve or transform in healthcare using that approach."

The presence of people with academic affiliations on the boards of for-profit healthcare companies is not necessarily illegitimate, but does pose questions about conflict of interest or the appearance of it, researchers say.

Conflict-of-interest regulations have removed drug company pens and note pads from physicians' offices, but they haven't addressed the propriety of academic leaders and researchers serving on the boards of for-profit healthcare companies, a new study suggests.

Researchers from the University of Pittsburgh School of Medicine found that nearly 10% of for-profit healthcare company board positions they examined were held by people with academic affiliations. The findings, which appear in the current issue of The BMJ, found that these board members were compensated an average of $193,000 in 2013, and that many of them also held stock in the companies.

Study co-author Timothy Anderson, MD, chief medical resident in Pitt's Department of Internal Medicine, says the findings show that academic leaders and professors may have relationships with for-profit companies that fall outside the parameters of the Physician Payments Sunshine Act.

"Often when we talk about conflicts of interest in medicine, we are talking about physicians receiving pens and meals from sales representatives," Anderson says. "The stakes are much higher for the board members in our study."

The Pitt researchers analyzed public disclosures of all publicly traded U.S. healthcare companies listed on the NASDAQ exchange and New York Stock Exchange in January 2014 that specialized in pharmaceuticals, biotechnology, medical equipment, and providing healthcare services.

Of the 442 companies with publicly accessible disclosures on boards of directors, 180 (41%) had one or more academically affiliated directors in 2013. These individuals included professors, trustees, CEOs, vice presidents, presidents, provosts, chancellors and deans from 85 non-profit academic research and healthcare institutions. The 279 academically affiliated board members received annual compensation totaling over $54 million and owned more than 59 million shares of company stock.

Questions About Conflict of Interest
Anderson says the presence of academics on for-profit company boards is not necessarily illegitimate, but it does pose legitimate questions about conflict of interest or the appearance of it.

"Our view is not to pass judgment," he says. "We wanted to paint that landscape of how diverse these sorts of relationships are. Some may be quite beneficial and some might be quite concerning, but until we really understand what relationships exist, it is hard for the medical and academic community to have a good discussion about what we should do to minimize the risks and maximize the benefits of these collaborations."

"We do not expect a one-size-fits-all approach would work in managing these relationships, but we risk undermining the public's trust if these conflicts of interest are not addressed openly," he says.

The researchers did not disclose the names of the academically affiliated board members in their analysis. Anderson says the goal is to highlight the issue, not the individuals.

The Sunshine Act requires nearly all payments to physicians and academic medical centers be reported annually by pharmaceutical and medical device companies. The act does not require separate reporting of payments for serving as a company director.

Anderson says the problem could be larger than what his research uncovered.

"The Sunshine Act is limited to looking only at physicians and not people who aren't docs," he says. "It is also only subject to companies that currently sell a product that Medicare pays for. It will cover someone who covers drugs or medical devices but perhaps not a company that is still in development."

Anderson says sitting on a for-profit company board poses particular conflict-of-interest concerns for academics because it can split their loyalties. As academics, they have a primary duty to their patients, their colleagues, their research, and their academic institutions. As paid members of a for-profit board, they have a fiduciary obligation to act in the best interests of shareholders.

"Sometimes those two sets of responsibilities may overlap and sometimes they may not," he says.

"We know if someone is helping run a clinical trial there is some risk, but there is also some benefit from the knowledge gained in a clinical trial. It is a little less clear whether running a company from the board room is something that is going to benefit patients or research."

Anderson and his colleagues hope their study will spark a discussion.

"Some commentators have proposed just not allowing it; telling faculty 'we are comfortable with you participating with the research within the industry or other endeavors, but not leading a company because we feel that would be too great a conflict,'" he says.

"Other commentators recommend limiting how much reimbursement or time their faculty can spend in these roles. We talk about the dollar figures in this paper, but we don't have data for how much money is an influencing amount versus how much is appropriate for reimbursing services. A lot of folks have pointed out that there is not any evidence that this helps or harms individuals or companies, so future research should probably try to determine if there is any benefit or harm to these relationships."

Relying only on risk-adjustment characteristics approved by Medicare—age, sex, and diagnosis—puts safety net hospitals in line for significant financial penalties for higher readmissions rates, researchers say.

More research is suggesting that a hospital's patient mix has a direct bearing on readmissions rates.

The latest evidence comes from Harvard researchers, who published a study this month in JAMA Internal Medicine that factors race, education level, poverty, disability and other socio-economic factors when measuring hospital readmissions.  

Study lead author Michael L. Barnett, MD, a fellow in general internal medicine and primary care at Harvard Medical School and Brigham and Women's Hospital, says that relying only on risk-adjustment characteristics approved by Medicare—age, sex, and diagnosis—puts safety net hospitals in line for significant financial penalties for higher readmissions rates.

Barnett recently spoke with HealthLeaders Media about his study findings and offered some recommendations that could level the playing field for hospitals with more challenging patient demographics. The following is an edited transcript.

HLM: What prompted you to do this study?

Barnett: The hospital readmissions reduction program is very much top of mind for hospitals across the country. The third round of penalties was just announced and almost 2,600 hospitals face penalties of $420 million for excess readmissions and 90% of those hospitals were penalized last year.

It appears that hospitals that serve disproportionate numbers of safety net patients get higher penalties and are disproportionately penalized more severely than other hospitals. There has been an active debate to what extent should the readmissions reduction program—which does not take into account any factors other than age, sex and diagnoses—account for other social and clinical factors.

HLM: How did you compile your study, and what did you find?

Barnett: We used a national representative survey of Medicare patients admitted to the hospital from 2009 to 2012. From this survey, we abstracted a very comprehensive set of 29 different characteristics encompassing a lot of social and clinical factors that CMS currently doesn't account for, including illness, disability, race, poverty, and social supports. We asked to what extent all of these characteristics that are not currently used by Medicare are associated with the risk of readmission after we account for everything that Medicare accounts for.

We found that a majority of them were significantly associated with readmission risks—obvious stuff like education, income, race, and disability. Then we asked which patients are admitted to hospitals with high versus low publicly reported readmission rates, and to what extent are these characteristics distributed differently across these hospitals.

For instance, are hospitals that have high publicly reported readmission rates more likely to have patients with lower education, lower income, more disability, or more illnesses? That is what is going to determine whether or not adjusting to those factors will change the hospitals' expected readmission rate.

We took all these factors we collected and we added them into the factors that Medicare adjusts for in a model to predict readmission rates. We found that incorporating all these characteristics would decrease the difference in the readmission rates between the highest and lowest performers by 48%.

When we adjusted for everything that Medicare uses, we found that the top and bottom quintile hospitals readmission rates were 4.4 percentage points apart. When we incorporated everything that we found in our study we shrunk that difference down to 2.3 percentage points. Even though the numbers seem small, the magnitude of the penalty is directly tied to how far off your readmission rates are from the national average.

So any adjustment that is going to change your readmission rate relative to the national average is going to affect your penalty. Our analysis suggests that the penalty is being disproportionately leveled on hospitals serving those who are at a higher risk of admission and readmission, [and those who are sicker] and poorer.

HLM: Were you able to put a dollar figure on the cost of these penalties for safety net hospitals?

Barnett: It is something we wanted to do and a lot of people have asked for it. Unfortunately, our data is a national representative survey. We don't have a big sample in any individual hospital, so we can't tie a dollar amount to it.

HLM: Why is CMS reluctant to make concessions for socio-economic factors in patient populations?

Barnett: CMS's position has been that adjusting for socio-economic factors potentially holds hospitals that are serving disadvantaged populations to a lower standard. The concern is that it could dis-incentivize hospitals to address healthcare disparities.  

What we propose is a more sophisticated risk adjustment and program design that can lead to a program where you can address disparities and incentivize quality.

There are a number of pieces of legislation recently passed and currently in Congress addressing this issue. There is the IMPACT Act passed in 2014 which directs HHS to examine the effects of socio-economic status on quality and resource use for Medicare patients. If those studies find a relationship between those factors and quality measures, they require the Secretary to make recommendations for how Medicare can adjust for them.

HLM: What can be done to ensure more balanced risk adjustment?

Barnett: We have a couple of suggestions. We acknowledge that risk adjustment is difficult. We have to accept that the data we access isn't the sort of stuff you can gather for every single patient on Medicare. One or our recommendations is based on an alternative payment models like global payments that preserve incentives for hospitals to reduce readmissions without unfairly penalizing them based on their patient populations.

Of course, those kinds of programs require some sort of risk adjustment for how much you pay the hospital.

Another model we put forward is inspired by the ACO program, where ACOs are rewarded based on their improvement versus their historical average, which in the case of the ACO program is based on prior cost growth. We would have to come up with a different kind of metric for something like readmissions, but we want to incentivize improvement at each hospital, and what the readmissions reduction program does is compare every hospital to a national average.

There is an incentive for every hospital to improve, but to have every hospital held to a similar standard. We think that it could be better to incentivize improvement based on prior performance and come up with a new system where the benchmark you are performing against is either held constant or gradually increases over time so hospitals have an incentive to improve and maintain improvements. But we are also not holding them to an unrealistic standard. It's not like every hospital can improve readmissions every year. That's not possible.