Hospitals consider universal do-not-resuscitate orders for coronavirus patients

https://www.washingtonpost.com/health/2020/03/25/coronavirus-patients-do-not-resucitate/?utm_campaign=wp_post_most&utm_medium=email&utm_source=newsletter&wpisrc=nl_most

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Worry that ‘all hands’ responses may expose doctors and nurses to infection prompts debate about prioritizing the survival of the many over the one.

Hospitals on the front lines of the pandemic are engaged in a heated private debate over a calculation few have encountered in their lifetimes — how to weigh the “save at all costs” approach to resuscitating a dying patient against the real danger of exposing doctors and nurses to the contagion of coronavirus.

The conversations are driven by the realization that the risk to staff amid dwindling stores of protective equipment — such as masks, gowns and gloves — may be too great to justify the conventional response when a patient “codes,” and their heart or breathing stops.

Northwestern Memorial Hospital in Chicago has been discussing a do-not-resuscitate policy for infected patients, regardless of the wishes of the patient or their family members — a wrenching decision to prioritize the lives of the many over the one.

Richard Wunderink, one of Northwestern’s intensive-care medical directors, said hospital administrators would have to ask Illinois Gov. J.B. Pritzker for help in clarifying state law and whether it permits the policy shift.

“It’s a major concern for everyone,” he said. “This is something about which we have had lots of communication with families, and I think they are very aware of the grave circumstances.”

Officials at George Washington University Hospital in the District say they have had similar conversations, but for now will continue to resuscitate covid-19 patients using modified procedures, such as putting plastic sheeting over the patient to create a barrier. The University of Washington Medical Center in Seattle, one of the country’s major hot spots for infections, is dealing with the problem by severely limiting the number of responders to a contagious patient in cardiac or respiratory arrest.

Several large hospital systems — Atrium Health in the Carolinas, Geisinger in Pennsylvania and regional Kaiser Permanente networks — are looking at guidelines that would allow doctors to override the wishes of the coronavirus patient or family members on a case-by-case basis due to the risk to doctors and nurses, or a shortage of protective equipment, say ethicists and doctors involved in those conversations. But they would stop short of imposing a do-not-resuscitate order on every coronavirus patient. The companies declined to comment.

Lewis Kaplan, president of the Society of Critical Care Medicine and a University of Pennsylvania surgeon, described how colleagues at different institutions are sharing draft policies to address their changed reality.

“We are now on crisis footing,” he said. “What you take as first-come, first-served, no-holds-barred, everything-that-is-available-should-be-applied medicine is not where we are. We are now facing some difficult choices in how we apply medical resources — including staff.”

The new protocols are part of a larger rationing of lifesaving procedures and equipment — including ventilators — that is quickly becoming a reality here as in other parts of the world battling the virus. The concerns are not just about health-care workers getting sick but also about them potentially carrying the virus to other patients in the hospital.

R. Alta Charo, a University of Wisconsin-Madison bioethicist, said that while the idea of withholding treatments may be unsettling, especially in a country as wealthy as ours, it is pragmatic. “It doesn’t help anybody if our doctors and nurses are felled by this virus and not able to care for us,” she said. “The code process is one that puts them at an enhanced risk.”

Wunderink said all of the most critically ill patients in the 12 days since they had their first coronavirus case have experienced steady declines rather than a sudden crash. That allowed medical staff to talk with families about the risk to workers and how having to put on protective gear delays a response and decreases the chance of saving someone’s life.

A consequence of those conversations, he said, is that many family members are making the difficult choice to sign do-not-resuscitate orders.

Code blue

Health-care providers are bound by oath — and in some states, by law — to do everything they can within the bounds of modern technology to save a patient’s life, absent an order, such as a DNR, to do otherwise. But as cases mount amid a national shortage of personal protective equipment, or PPE, hospitals are beginning to implement emergency measures that will either minimize, modify or completely stop the use of certain procedures on patients with covid-19.

Some of the most anxiety-provoking minutes in a health-care worker’s day involve participating in procedures that send virus-laced droplets from a patient’s airways all over the room.

These include endoscopies, bronchoscopies and other procedures in which tubes or cameras are sent down the throat and are routine in ICUs to look for bleeds or examine the inside of the lungs.

Changing or eliminating those protocols is likely to decrease some patients’ chances for survival. But hospital administrators and doctors say the measures are necessary to save the most lives.

The most extreme of these situations is when a patient, in hospital lingo, “codes.”

When a code blue alarm is activated, it signals that a patient has gone into cardiopulmonary arrest and typically all available personnel — usually somewhere around eight but sometimes as many as 30 people — rush into the room to begin live-saving procedures without which the person would almost certainly perish.

“It’s extremely dangerous in terms of infection risk because it involves multiple bodily fluids,” explained one ICU physician in the Midwest, who did not want her name used because she was not authorized to speak by her hospital.

Fred Wyese, an ICU nurse in Muskegon, Mich., describes it like a storm:

A team of nurses and doctors, trading off every two minutes, begin the chest compressions that are part of cardiopulmonary resuscitation or CPR. Someone punctures the neck and arms to access blood vessels to put in new intravenous lines. Someone else grabs a “crash cart” stocked with a variety of lifesaving medications and equipment ranging from epinephrine injectors to a defibrillator to restart the heart.

As soon as possible, a breathing tube will be placed down the throat and the person will be hooked up to a mechanical ventilator. Even in the best of times, a patient who is coding presents an ethical maze; there’s often no clear cut answer for when there’s still hope and when it’s too late.

In the process, heaps of protective equipment is used — often many dozens of gloves, gowns, masks, and more.

Bruno Petinaux, chief medical officer at George Washington University Hospital, said the hospital has had a lot of discussion about how — and whether — to resuscitate covid-19 patients who are coding.

“From a safety perspective you can make the argument that the safest thing is to do nothing,” he said. “I don’t believe that is necessarily the right approach. So we have decided not to go in that direction. What we are doing is what can be done safely.”

However, he said, the decision comes down to a hospital’s resources and “every hospital has to assess and evaluate for themselves.” It’s still early in the outbreak in the Washington area, and GW still has sufficient equipment and manpower. Petinaux said he cannot rule out a change in protocol if things get worse.

GW’s procedure for responding to coronavirus patients who are coding includes using a machine called a Lucas device, which looks like a bumper, to deliver chest compressions. But the hospital has only two. If the Lucas devices are not readily accessible, doctors and nurses have been told to drape plastic sheeting — the 7-mil kind available at Home Depot or Lowe’s — over the patient’s body to minimize the spread of droplets and then proceed with chest compressions. Because the patient would presumably be on a ventilator, there is no risk of suffocation.

In Washington state which had the nation’s first covid-19 cases, UW Medicine’s chief medical officer, Tim Dellit, said the decision to send in fewer doctors and nurses to help a coding patient is about “minimizing use of PPE as we go into the surge.” He said the hospital is monitoring health-care workers’ health closely. So far, the percentage of infections among those tested is less than in the general population, which, he hopes, means their precautions are working.

‘It is a nightmare’

Bioethicist Scott Halpern at the University of Pennsylvania is the author of one widely circulated model guideline being considered by many hospitals. In an interview, he said a blanket stop to resuscitations for infected patients is too “draconian” and may end up sacrificing a young person who is otherwise in good health. However, health-care workers and limited protective equipment cannot be ignored.

“If we risk their well-being in service of one patient, we detract from the care of future patients, which is unfair,” he said.

Halpern’s document calls for two physicians, the one directly taking care of a patient and one who is not, to sign off on do-not-resuscitate orders. They must document the reason for the decision, and the family must be informed but does not have to agree.

Wyese, the Michigan ICU nurse, said his own hospital has been thinking about these issues for years but still is unprepared.

“They made us do all kinds of mandatory education and fittings and made it sound like they are prepared,” he said. “But when it hits the fan, they don’t have the supplies so the plans they had in place aren’t working.”

Over the weekend, Wyese said, a suspected covid-19 patient was rushed in and put into a negative pressure room to prevent the virus spread. In normal times, a nurse in full hazmat-type gear would sit with the patient to care for him, but there was little equipment to spare. So Wyese had to monitor him from the outside. Before he walked inside, he said, he would have to put on a face shield, N95 mask, and other equipment and slather antibacterial foam on his bald head as the hospital did not have any more head coverings. Only one powered air-purifying respirator or PAPR was available for the room and others nearby that could be used when performing an invasive procedure — but it was 150 feet away.

While he said his hospital’s policy still called for a full response to patients whose heart or breathing stopped, he worried any efforts would be challenging, if not futile.

“By the time you get all gowned up and double-gloved the patient is going to be dead,” he said. “We are going to be coding dead people. It is a nightmare.”

 

 

 

 

Mixing medicine and money: Why the rise of health system VCs is raising ethical concerns

https://www.healthcaredive.com/news/mixing-medicine-money-hospital-vc-funding-device-ethical-concerns/549392/

Industry-leading nonprofit health systems like Ascension, Providence St. Joseph and Cedars-Sinai have launched affiliated venture capital firms with increasingly more cash to fund start-ups. But the mixture of medicine and financial investment presents the potential for ethical pitfalls.

Deals involving at least one healthcare provider-linked corporate VC fund totaled roughly $1.3 billion last year, a record high nearly triple the amount recorded five years prior, according to data provided to Healthcare Dive by PitchBook, a financial data firm.

Health systems defend their corporate VCs, noting a separation of clinical and investment decisions along with general policies designed to prevent improper influence. Yet the potential for conflicts of interest looms, ethicists said in interviews — particularly when a health system’s hospitals adopt products from companies staked with funds via the affiliated VC.

“If you have a venture program that is really gearing up with some serious investments and they are going to use those devices in their own institution, I would say that’s a matter of concern,” said Jeffrey Flier, dean of Harvard Medical School from 2007 to 2016, in an interview.

“That doesn’t mean it would be done dishonestly, it just means that maybe they should promote doing it elsewhere, not in their own institution.”

A mixture of medicine and finance

The case of Gauss Surgical, a private medical device startup, illustrates how some of these questions can play out in practice.

Corporate VCs affiliated with nine hospital systems have invested in the company since its founding in 2011. A majority of those VC funds were launched in the past five years. A tenth system, Memorial Hermann Health System, invested directly in Gauss. All 10 systems also use — to varying extent — Gauss’ flagship Triton device in clinical practice.

A software platform designed to process images, Triton is used to quantify blood loss, typically during childbirth. Studies have shown standard practices, such as visually estimating or weighing bloody materials, to be inaccurate, leaving an opening for an improvement.

Between the 10 health systems invested in Gauss, 16 of their hospitals use Triton, according to Gauss. Overall, more than 50 U.S. hospitals use the device today, the Los Altos, California-based startup said.

Those running the funds invested in Gauss acknowledge the need for full disclosure to avoid any real or perceived conflicts of interest, particularly when their hospitals are using the device.

“It’s fair to ask why nonprofit systems have venture funds,” said Darren Dworkin, managing director of Summation Health Ventures, a joint VC arm for Cedars-Sinai and MemorialCare that launched in 2014 and has invested in Gauss.

Still, Dworkin, also Cedars’ chief information officer, argued the fund helps fill an investment gap for businesses like Gauss with promising ideas that might not otherwise have received financial backing.

“If there was perfect liquidity in the capital markets for all great ideas, maybe the case can be made that focus can be in other areas,” the exec said in an interview.

Timeline of investments in Gauss

Along with adoption — some hospitals routinely use the device in newborn delivery — has come controversy, however.

At one of those hospitals, St. Joseph Hospital in Orange County, California, an investment by the parent system’s VC fund led to objections from some healthcare staff over the adoption of Triton. The hospital is owned by Providence St. Joseph, which invested in Gauss through its VC arm, Providence Ventures.

Last April, 10 physicians working at the hospital signed onto a letter sent to Scott Rusk, the hospital’s chief medical officer, airing doubts over whether Triton improved patient outcomes, and questioning if its use was influenced by the chain’s financial investment in Gauss.

“We suspect that their use has been mandated by the health system due to investments made by the Providence Venture Capital Fund, and that the insistence that they be used has more to do with ensuring a return on investments than with improving patient care,” the doctors wrote, according to a copy of the letter obtained by Healthcare Dive.

In a statement to Healthcare Dive, Providence St. Joseph said clinical adoption decisions are made exclusively by clinical and operational leadership review, and are not influenced by Providence Ventures. After that review, hospitals in the system decide on their own whether or not to use such products.

“There was no directive from PSJH or Providence Ventures to use the device,” the chain stated on the Orange County hospital. “The decision was made to fund and adopt the Gauss solution at the local hospital level.”

Only three of the system’s 51 hospitals use Triton today, the organization said, and the Orange County hospital made the decision to start using the device before the merger creating Providence St. Joseph completed in July 2016.

But the fund isn’t entirely walled off from the rest of the system, as its leader also serves as a C-suite executive for the health system. Aaron Martin is the managing general partner at Providence Ventures as well as an executive vice president and chief digital officer for the broader PSJH system.

In response to the letter, Gauss stated it is “statistically impossible for a single practitioner or small group of practitioners to personally observe the impact of a monitoring device on patient outcomes across an entire population,” noting hemorrhage is a low-volume, high-risk event.

Testing Triton

The Food and Drug Administration cleared the device in 2014 as an adjunct to blood loss estimation techniques based on two clinical studies, respectively testing 46 patients and 50 patients, as well as a series of non-clinical studies.

Still, several doctors and one nonprofit group question Triton’s proven clinical value.

“It’s in its infancy,” said Abdulla Al-Khan, a doctor at New Jersey’s Hackensack University Medical Center, which has been testing the device since 2015. “Is it 100% reliable? I don’t think so. Is it perhaps better than a physician’s guesstimation of blood loss? Yes, probably.”

Al-Khan, who is the hospital’s director for its Division of Maternal-Fetal Medicine & Surgery and the Center for Abnormal Placentation, said earlier Triton studies “clearly had their limitations,” and plans to soon begin a study comparing all methods of blood loss estimation.

Daniel Katz, director of obstetric anesthesiology research at Mount Sinai, said in an interview arranged by Gauss that Triton’s clinical value has been well-demonstrated, giving healthcare providers a standard way to measure and keep track of blood loss. While Mount Sinai has an equity investment in Gauss through its corporate VC arm, Katz said he has not received any compensation from Gauss.

In a statement, Gauss said it “believes Triton has proven clinical value,” supported by “robust accuracy data,” particularly highlighting research done following its 2014 FDA clearance.

“Subsequent studies, published in peer-reviewed, academic journals, have demonstrated superiority compared with alternative means to measure blood loss and significantly improved clinical outcomes following adoption of Triton,” the company stated.

Gauss also noted a hospital pays a fee per annual subscription for the software as a service, no matter how often the product is used. It said adoption of the product is independent and goes through the hospital’s regular procurement process in instances where the health system has invested in the company.

The company did not make its CEO Siddarth Satish available for a phone interview.

However, the ECRI Institute, an independent organization that analyzes new technologies for providers, payers and government agencies, reviewed at Healthcare Dive’s request the body of evidence supporting Triton and concluded the device’s clinical value was far from established.

Diane Robertson, the institute’s director of health technology assessment, said the studies done have been small and low quality, noting limitations on trial design for controls, blinding and randomization.

“There isn’t any moderate quality or higher quality evidence on clinical outcomes improvement in patients with how this device is used,” she said.

In response to ECRI’s assessment, Gauss stated that a randomized, controlled trial would be “ineffective, impractical and potentially unethical.” The company further defended Triton’s studies, saying they showed it was more accurate than other estimation methods and is widely supported by leading physicians and experts.

A broader issue

Triton’s adoption spurs broader questions for nonprofit systems that have established VC arms.

About a decade ago, deals involving hospital-affiliated VCs were few, mustering less than $50 million in total value in 2008 and 2009 combined, according to PitchBook. Activity has steadily risen, surpassing $500 million in annual value in 2014 and reaching nearly $1.3 billion in 2018.

Little analysis has come with that money. Several ethicists told Healthcare Dive they were unaware of any published or ongoing studies examining hospital-affiliated VCs and the unique questions such funds pose for medical technology adoption.

“That is an issue of institutional conflicts of interest, which is, frankly, completely unsolved in general in healthcare,” said Steven Joffe, a bioethicist at the University of Pennsylvania. “We don’t have clear-cut mechanisms to make sure institutional conflicts of interest are navigated well.”

Most of the hospital systems invested in Gauss via corporate VCs said they take conflicts of interest seriously and have policies in place to prevent such influence.

For instance, Mount Sinai, which launched its VC back in 2008, has a board of people not affiliated with the health system to analyze the investments and clinical use, a spokesperson said.

According to ethics experts, such an independent review is a critical step to mitigate the potential for decisions to be made, which could compromise a hospital’s patient-driven mission.

But even the appearance of conflict can bring risks to an organization. In the case of St. Joseph in Orange County, uncertainty over the relationship between the hospital’s use of Triton and Providence St. Joseph’s investment in Gauss through its venture arm was enough to motivate physicians to speak out.

One has to be very careful not to mix a medical practice with financial gain of an industry,” said Al-Khan, the doctor at Hackensack, which does not have such a VC arm.

The funds, though, appear to be here to stay.

In early 2019, Providence Ventures, which backed Gauss, literally doubled down, announcing its fund will expand from $150 million to $300 million. The fund targets companies just like Gauss: early-stage healthcare companies specializing in IT, medical devices and technology-enabled services.