On-the-Ground Learning in a Pandemic

VP&S Response Ranged From a New Critical Care Staffing Model to Speedy Clinical Trials to Cross-Disciplinary Consultations
By Alexander Gelfand

Among the many lessons learned during the COVID-19 pandemic was the rapid pace of evolving strategies needed to treat patients infected by a new virus. The speed at which the pandemic swept over the hospital made one intensivist say this on-the-job training made every doctor an ICU specialist. 

The unprecedented pandemic was matched by an unprecedented response by physicians who had to adapt to evolving—and shifting—situations. Two VP&S graduates—Magdalena Sobieszczyk’98 and Roy Gulick’86—found themselves front and center of the ever-changing patient care environment from those first days. As infectious diseases chiefs at Columbia (Dr. Sobieszczyk) and Weill Cornell (Dr. Gulick), they collaborated closely to develop new treatment guidelines and strategies.

It was on-the-job training, in a sense, in a specialty many had not pursued or imagined, says another VP&S graduate, Natalie Yip’03, associate director of medical intensive care units and medical critical care service at NewYork-Presbyterian. “It wasn’t like they had to go through fellowship and learn the breadth of what we do as intensivists,” Dr. Yip says, “but they essentially became specialists in COVID ICU care.”

Dr. Yip worked hand-in-hand with a multidisciplinary group of colleagues at NYP/Columbia and Weill Cornell to develop an innovative staffing model while Drs. Sobieszczyk and Gulick aligned research activity and treatment guidelines at their respective schools. 

The resulting protocols and guidelines not only saved lives during the initial surge, but also ensured that clinicians a year later are in a much better position to treat COVID-19 than they were when SARS-CoV-2 first emerged.

“We have learned an awful lot,” says Dr. Gulick. “And it translates to lower mortality rates.”


Early Days

Dr. Yip vividly remembers what it was like trying to manage the first patients who arrived at NYP/Columbia in March 2020 suffering from a highly transmissible—and still highly mysterious—respiratory disease.

“How do we go in and out of the room? What does it look like to perform CPR?” she and her colleagues wondered. “We were literally rethinking how to provide care from tip to toe.”

Her colleagues in the division of infectious diseases found themselves in similarly uncharted waters, unable to recommend anything beyond supportive care. At the time, no proven treatments were available for SARS-CoV-2.

The clinical trials system was aligned between Columbia and Cornell, and the speed with which the trials were implemented was unprecedented. “The important thing was that none of the steps were skipped,” says Dr. Sobieszczyk.

One potential antiviral candidate drug was remdesivir, an experimental drug that had been studied as a potential treatment for Ebola but had not been approved for use in patients. After securing FDA permission to administer it to one patient, the care team anxiously waited for the drug to be delivered to the CUIMC Research Pharmacy, unsure if it would have any effect—and whether it would help or harm the patient.

“The uncertainty was unsettling, but the significance of this patient’s outcome sharpened everyone’s focus,” Dr. Sobieszczyk recalls.

The patient eventually recovered. And as the influx of COVID-19 cases quickly became a surge—by mid-April 2020, the NYP hospital system admitted more than 7,600 COVID-19 patients—Drs. Yip, Sobieszczyk, Gulick, and their colleagues helped create an infrastructure for treating them.

They restructured how ICUs were organized, staffed, and managed. They developed treatment guidelines that continued to evolve as they learned more about the virus and the drugs that could alter its course—knowledge that was gained in part through their own data collection and clinical trials.


Reimagining Critical Care

As the number of severely ill patients requiring unusually long ICU stays continued to rise, patient bed-flow and ICU capacity quickly became pressing issues.

Ordinarily, Milstein Hospital maintains 117 ICU beds, including 24 medical ICU beds. By mid-April, however, the number of ICU beds had risen to approximately 300—a feat that Dr. Yip and her colleagues accomplished by converting all available spaces into surge ICUs.

With many services suspended, pop-up ICUs were constructed in settings from operating rooms to cardiac catheterization labs. Intensivists began repurposing OR anesthesia machines and prepared to split ventilators between multiple patients. And they began using telemedicine internally to preserve personal protective equipment and minimize exposure to the virus.

Staffing up to deal with a massive influx of critically ill patients presented another challenge, with the principal issue being the shortage of personnel with critical care expertise. As ORs shut down and health care professionals arrived from around the country to volunteer their services, plenty of personnel were available but not enough with medical ICU experience. Even those familiar with cardiac and surgical ICUs were not necessarily prepared to deal with COVID-19 patients, who often suffered from a wide range of complications and had complex ventilation requirements.

Dr. Yip and a multidisciplinary working group of critical care experts responded by developing a pyramid-shaped staffing model. At the very top stood ICU physicians with complex ventilator management skills who supervised from 20 to 50 patients. Just beneath them were ICU leads—physicians who did not normally work in the ICU but were considered critical-care capable (surgeons, pulmonologists, anesthesiologists) and who could round on patients with the support of an intensivist. The “first call” or front-line roles were occupied by residents, nurse practitioners, and physician assistants from many different specialties. 

Despite the varying degrees of critical care expertise among team members, the model succeeded in part because everyone focused on a single disease. Rather than having to train an entire cohort of full-fledged intensivists, says Dr. Yip, everybody in the pyramid took on roles as COVID ICU specialists.

In addition, Dr. Yip and her colleagues created specialized teams that could bring critical-care skills wherever they were needed. Airway teams of attending anesthesiologists performed all intubations. Procedure teams of surgical specialists and interventional radiologists were available to perform central line and chest tube insertions. And physical and occupational therapists were trained by medical ICU staff to prone patients with acute respiratory distress syndrome.

They also built a new dedicated palliative care unit for patients whose families had decided to withdraw life support or forgo aggressive care. The unit offered a peaceful environment for patients and grief support for their families while simultaneously freeing up space in the ICU for incoming patients.


Trials and Guidelines

While Dr. Yip and her fellow intensivists were reinventing how critical care was delivered, colleagues in the division of infectious diseases were mounting their own pandemic response.

Much of their energy went toward two intersecting initiatives: one focused on conducting clinical trials to determine the most promising treatments, the other devoted to developing clinical guidelines for physicians in the emergency department and the ICU.

Roy Gulick and Magdalena Sobieszczyk. Photograph by Jörg Meyer.

Both initiatives were complicated by the blizzard of information that accompanied the pandemic. This included not only peer-reviewed studies on potential therapies that were published at breakneck speed and sometimes later retracted, but also preprints, press releases, and even tweets about treatments ranging from convalescent plasma to the antimalarial drug hydroxychloroquine.

“There was a lot of noise,” says Dr. Sobieszczyk, “but we tried to be as data-driven as possible and to do no harm.”

Protocols and guidelines during the initial surge ensured that clinicians a year later were better equipped to treat COVID-19 than they were when SARS-CoV-2 first emerged. “We have learned an awful lot,” says Dr. Gulick. “And it translates to lower mortality rates.”

Dr. Sobieszczyk and her Columbia colleagues developed a database to collect information on patients’ clinical parameters, the care they received, and their outcomes. These data-collection efforts were harmonized with a similar initiative at Weill Cornell so that both groups of clinicians could learn from each other’s experiences. The goal was to create an internal data set that could inform the development of evidence-based clinical protocols for physicians on the ground: what labs to draw, what treatments to administer, and when. These data also provided the basis for many interdisciplinary publications.

At the same time, Dr. Sobieszczyk, Dr. Gulick, and their teams joined or initiated clinical trials on what appeared to be the most promising therapeutic candidates—a small pool that included remdesivir, hydroxychloroquine, convalescent plasma, and sarilumab, an immunomodulating drug used to treat rheumatoid arthritis. The inpatient trial process was aligned across NYP and between the two institutions under an executive committee chaired by 1983 VP&S graduate Donald Landry, MD, PhD, chair of medicine at VP&S, and Anthony Hollenberg, MD, Weill Cornell’s chair of medicine, with the participation of Dr. Sobieszczyk and Dr. Gulick.

Natalie Yip. Photograph by Jörg Meyer.

The speed with which the trials were implemented was unprecedented, with IRB approval from VP&S typically coming through within a week. “The important thing was that none of the steps were skipped,” Dr. Sobieszczyk says. “People just worked day and night.”

As data came in from both internal and external studies, clinical guidelines were modified accordingly: hydroxychloroquine and convalescent plasma, for instance, were eliminated, while remdesivir, which ultimately became the first drug to receive FDA approval as a treatment for COVID-19, survived. 

Other treatments were incorporated as warranted by the available evidence. When the British RECOVERY trial for COVID-19 treatments announced in June 2020 that steroids conferred a mortality benefit, “that became the standard of care in about a minute,” says Dr. Gulick, who also co-chairs the NIH’s COVID-19 treatment guidelines. The immunomodulator tocilizumab and the monoclonal antibody cocktails developed by Regeneron and Eli Lilly, meanwhile, were added to the list of potential therapeutics when they received emergency use authorization. 

Depending on a patient’s clinical state, the guidelines might recommend that the patient receive one or another drug, or some combination of them, through several different mechanisms. A patient presenting at the emergency department, for example, might be eligible for emergency use of a monoclonal antibody cocktail; if not, the patient might still be able to receive the drug by enrolling in a clinical trial. Alternatively, a patient might be able to gain access to certain treatments under expanded access or “compassionate use” guidelines issued by the FDA. 

Managing this complexity was a team effort. The pharmacists in the research pharmacy, who were familiar with both drug development and infectious diseases, played a vital role in weighing the pros and cons of the various treatments. So did specialists such as rheumatologists and oncologists who had prior experience with some of the immunomodulating agents on offer. And the infectious diseases division had all its clinicians on call to consult with the emergency department and ICU physicians as they put the evolving guidelines into practice.

“It was intensely complicated, and it required an all-hands-on deck approach,” says Dr. Sobieszczyk. 

It also involved difficult discussions between family members desperate for anything that might help their ailing loved ones and physicians who had to be careful not to overpromise when dealing with experimental drugs.

“We had lots of anguished conversations about what was available and what we could try,” says Dr. Gulick.


Lessons Learned

By the time the second wave arrived in New York City during the fall and winter of 2020, the clinicians of NYP/Columbia and Weill Cornell had significantly more treatment options than they had during the initial surge and a much better understanding of their adversary.

They now knew, for example, that COVID-19 was a multisystem, multistage disease that progressed from a viral phase to an inflammatory one and that the various drugs now at their disposal worked best either alone or in combination at different points in a patient’s trajectory—knowledge that was reflected in significantly lower mortality rates.

Similarly, while doctors favored intubation over noninvasive ventilation and high-flow nasal cannulae during the first wave due to concerns over aerosolization, they now knew that risk was much lower than they had initially suspected—and that once intubated, patients often stayed that way for weeks. As a result, intubations were less common during the second wave. Coupled with the new therapeutic options, that meant less demand for ICU beds and more need for stepdown or intermediate care beds.

Even when highly effective vaccines became widely available (following successful studies that both Columbia and Weill Cornell participated in) and case counts plunged in the spring of 2021, things did not go entirely back to normal. When the surge ICUs disappeared, for example, Dr. Yip and her colleagues remained vigilant: They have retained their expanded stepdown capacity and continue to train their staff to deliver more acute care should the situation worsen again.

Dr. Sobieszczyk and Dr. Gulick, meanwhile, continue to run clinical trials on new potential treatments: an oral antiviral, a new immunomodulator, cellular therapies to address later stages of inflammation as well as damage to the lungs and other organs.

“We cannot rest on our laurels,” Dr. Sobieszczyk says. “This virus is proven to be more formidable than many people expected.”