Pandemic Perspectives: Research Nurse Pivots to COVID-19 Clinical Trials

Every unemployment filing, furlough, and closed business reflects a personal experience. As the statistics pile up, we’re committed to sharing stories of how COVID-19 continues to shape people’s lives and livelihoods—how they’ve coped, what they’ve learned during the crisis, and how they’re moving forward. 

Like many of her colleagues in the medical profession, Stephanie Toczylowski’s career was dramatically transformed with the emergence and surge of COVID-19. As a longtime nurse at Inova Fairfax Hospital in Falls Church, VA, Toczylowski was focused on cardiology research before being tasked—virtually overnight—with conducting COVID-19 clinical trials. As she continued to help fight the battle against the pandemic and delve into potential treatments for the virus, Toczylowski spoke with The Balance in July about the immediate change to her work, the many challenges she faced, and her biggest concerns. This interview has been edited for length. 

What was your professional life like prior to COVID-19?

I have a team of about 20 staff members that are research nurses, non-nurses, and laboratory staff. We were primarily focused on cardiology research, so everything from new drugs and device development for advanced heart failure, interventional cardiology, biomarker work, genomics, really everything related to the heart and vascular component of the body. So we were enrolling patients in our drug trials, doing device implantations, everything like that.

It was like a slow trickle at first. We saw our first COVID patient in March, and just almost all of a sudden, we—just like everywhere else—got overrun with COVID.

My team used to be up on an inpatient floor, a whole 24-bed unit dedicated to research where there was a lot of space for patients. Almost overnight, we had to move off of that floor to a different part of the hospital to turn that unit into a negative pressure unit for COVID patient overflow because we were running out of floor space in our previous ICU areas. And then the hospital essentially stopped all elective procedures, so that wiped out a huge portion of our research. They basically said no enrollment in clinical trials where the risk versus benefit ratio did not benefit the patient, and they didn't want to expose staff members. 

My team is now actively going down to the [emergency department (ED)]. We’re all fitted with the appropriate respirators and personal protective equipment to go down to the ED and go into patient rooms.

We're infusing them with some of the drugs that you hear on the news, like Regeneron and Gilead. There's a huge amount of research going into diagnostics. One of the biggest challenges was that with the nasal swabs, there wasn't enough reagent, and they're very uncomfortable to have done. So we are working with a number of diagnostic companies to basically figure out what is a better, easier, faster way to get samples and specimens from people.

That's currently what you're doing?

Yeah, and we also got approached by the Virginia Department of Health and one of its head epidemiologists, David Trump. He wanted to conduct what we're calling COVID in the Commonwealth. It is a collaboration between five different institutes to do serology testing in the community to get a sense of how many people that potentially were asymptomatic, actually have COVID, or had very light symptoms and thought it was allergies or whatever it may be.

So really, over the course of a couple of days, my team went completely into running around to all these different clinics and seeing all these different patients that are sick and doing nasal swabs and drawing blood and wearing PPE, just like everyone else. It stayed within research, but it is a very different type.

In terms of the job transition, did you have to learn a new skill set? 

I mean, research is research, right? If you're conducting research, you have to follow the same guidelines. But conducting research during a pandemic, you're worried about social distancing, and about actually contracting the virus yourself. Trying to explain it to someone who is sick and asking them to join a research study while I have my mask on and a shield over my face is very challenging.

What are some other current challenges?

We used to gain consent from everybody on paper, but we're not allowed to bring paper out of COVID patient rooms anymore because they don't know how long the virus can stay on the paper for. And so we had to learn how to—essentially within a week's time—turn all of our consent forms electronic. When the hospitals restricted visitors, in some research instances, people could consent to participate in research through their legally authorized representative. Traditionally, those things were done onsite. If someone's super sick in the hospital, they probably have someone there with them making decisions for them, but we couldn't let anybody in the hospital.

So the patient's intubated, on [extracorporeal membrane oxygenation (ECMO)], can't make a decision for themselves, and now the person that we would turn to isn't here at the hospital. They are at home scared for their loved one, and we're calling them to try and ask for consent from them for a research study. But unfortunately, [with] the population that the virus is impacting, a lot of them don't have access to things like smartphones or even email addresses. And so things that we would electronically send—like a link to a consent form—they don't have access to that.

There's also a huge issue around language barriers. Luckily, I have staff members on my team that are certified in Spanish. A consent form is hard enough to understand, let alone when it's in a completely different language. So we had to translate all of our consents, make them electronic, and just basically redo our whole process.

In addition to that, in clinical research, there's a lot of monitoring that goes on. The Food and Drug Administration requires that the sponsors, like the pharmaceutical or device companies, come in and monitor our work to make sure that we are enrolling the right people, that we are consenting them appropriately, following the protocol, and not putting people at risk. 

There are a lot of different processes when you work for a hospital. It's not as easy as working for a tech company that's used to just pivoting on a dime. Here, it's almost like moving the Titanic.

What have you learned as you navigate this whole process? 

From a research standpoint, it's been very interesting to see just how quickly we can actually do things if our feet are put against the fire. A lot of times in research, you hear—especially from the drug and device companies—how it's going to take many years to develop this drug and how much money. But now all of a sudden, all of these companies have a vested interest in trying to find a cure, trying to find something, and so things are moving at a much faster pace.

When you all have one common goal or enemy so to speak, people come together to try and fix the problem. It's been nice to see how we can pivot so quickly and just how adaptable we are to doing things in this way.

What is your biggest concern?

I think my biggest concern is that I have a staff of 25. We are the research department at the hospital, and research is always one of those things that's first looked at from a budgetary standpoint. It's a “nice to have,” but not always a “need to have” sort of thing. 

But when we look at these protocols and we look at these studies, something like COVID is the reason why all of us got into research. That being said, though, we all have families and my biggest fear is that someone on my team is going to get sick. I worry about sending my team down to the ED to go into the room of a COVID patient, or going out in the community and swabbing people and drawing blood from cars. It's the same fear that the more you expose yourself, the more likely it is that you're going to catch the virus.

What are your expectations moving forward? 

It’s hard. We're trying to figure out what the “new normal” is. What does that look like? Because from my standpoint, we are one of the only research teams that has the experience just doing the drug and device trials, so naturally this work came to us, but we also need to get back to doing some cardiology research. So it's like, how do you balance both? How do you manage all of that? We're all trying to look forward to the new normal, just figuring out what that is.

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