Nurses in Clinical Trials

Geralyn Warfield (00:20)  

I’d like to welcome our audience to today's episode where we are going to have a discussion about improving diversity in clinical trials by increasing involvement by nurses across practice settings. And we have two great guests with us today and I'm going to let them introduce themselves to you. Dr. Erin Ferranti, could you please introduce yourself and then we'll have a nurse researcher Ellen Thomas do the same.  

Erin Poe Ferranti (00:43)  

Yes, absolutely. I'm Erin Ferranti. I'm an assistant professor at the School of Nursing at Emory University in Atlanta. I've been a nurse for about 26 years, and 16 of those years I've been a researcher. I got my PhD back in 2013 and have been running studies since then. I currently have four studies that I'm running, three of which are clinical trials. So excited to talk about that today.  

Ellen Thomas (01:07)  

Hi, I'm Ellen. I'm a registered nurse for the past 11 years. I worked in research for almost two years now. Before that, I was working in acute care from anything from orthopedics to cardiology. I did travel nursing for a bit, short stint in the ED, and I received my master's in public health in 2020 from George Washington University.  

Geralyn Warfield (01:28)  

Well, we are so grateful to you both for being on our podcast episode today. And in order for us to start out and kind of have a better sense of what your background is, I'd love to hear from each of you about how you got involved in trials or research. Ellen, maybe you could start us off.  

Ellen Thomas (01:44)  

Yeah, sure. So I got involved in research through my current job at Tulane University, their School of Public Health. I sort of fell into it. I was looking for something that could use my master's in public health and also something that was a little less direct patient care after having been a travel nurse throughout COVID, and for 10 years, it was time to transition. And so I found this job that was a public health study that was looking to reduce risk factors for heart disease and I have a background in cardiology so it was kind of a perfect mix for me. And that's how I came to it.  

Geralyn Warfield (02:19)  

Great. Erin, what was your trajectory into clinical research?  

Erin Poe Ferranti (02:24)  

I think largely the questions that I had and the frustrations that I had both in practice and as an educator. When I was practicing at the bedside, I worked with patients who were getting kidney transplants and a big reason for kidney failure was either poorly or mismanaged diabetes and hypertension. And then they had renal failure on top of that. And so they couldn't, they were really struggling with diet and nutrition. And so I didn't feel all that well equipped to guide them. And then, so that frustration kind of lingered with me. And then I went into nursing education and realized that we didn't have a lot of nutrition education in our curriculum. So I was like, well, somebody needs to go learn this. And I decided to go get a PhD and focus it in food and nutrition. So was just trying to answer questions and deal with the frustrations that I had in clinical practice and education. So a lot of my work now is in working with patients to mitigate cardiometabolic risk through diet and nutrition interventions.  

Geralyn Warfield (03:25)  

I am so grateful to both of you for sharing how you got started in clinical trials. And I recognize that everybody's journey is a little bit different and you have excellent examples there where sometimes it's based on personal interests, sometimes it's job related or opportunity related and I would highly encourage those that are listening or watching this episode to stay tuned for more information about kind of the kind of clinical trials that each of you are involved with. So Erin, I'm going to start with you. You said you had four studies that you were working on and three of them were clinical trials. Would you like to describe those a little bit more for us?  

Erin Poe Ferranti (04:01)  

Sure, yeah, I'd love to. So one of them, the one that has been going on the longest is a study funded by the American Heart Association. And it was out of the Research Goes Red area for focus on research in women and to mitigate hypertension risk and social determinants of health. So we are running a peer support intervention bringing women together who've had adverse pregnancy outcomes, cardiometabolic adverse pregnancy outcomes. Bringing them together in the postnatal timeframe to share and to talk about stress and to talk about Life’s Essential 8 to mitigate future cardiometabolic risk. So we know that women who've had adverse pregnancy outcomes are at very high risk for developing chronic hypertension, chronic diabetes later in life. And so the goal is to reduce that risk through addressing stress and education around Life’s Essential 8. So that's ongoing. We have nearly 60 women enrolled in that study.  

And then we are replicating that in a study that just got funded from the NIH in farm worker Latina women. So I have been working with the Latina farm worker community for a very long time clinically and recognize women, particularly farm worker women, were not engaged in research. And so we modified the study and we're using a community health worker intervention approach. But we'll be running these peer support groups just like we are with the AHA study, but we'll be doing those in person led by a community health worker, again tailored for that community.  

Another study that I'm working on is looking at pesticide exposure and its association with glucose dysregulation in pregnancy among farm worker women. So we know that women who are farm workers are exposed to high levels of pesticides and other toxicants. We also know that they have really high rates of gestational diabetes and it's not fully explained by genetics or family history or things like that. So I'm looking at the role that the expo zone plays in that.  

Geralyn Warfield (06:10)  

Thanks so very much for sharing that with us. That's a lot of different research that's happening. And Ellen, what kind of research do you have happening in your life right now?  

Ellen Thomas (06:19)  

So it's really cool to talk to Erin because actually my study has some similarities. We're also working with community health workers. So this study is aimed at reducing health disparities in the black population, specifically looking at heart disease and strokes. So we're trying to do health coaching with community health workers on Life's Essential 8 in community centers and churches. So we're trying to move this care and education outside of the traditional clinic setting and moving to more trusted community settings to get buy-in from the population. And so we have community health workers doing health coaching, we have education, and then we also have clinicians seeing participants in these centers.  

Geralyn Warfield (07:01)  

We are going to take a brief break and we will be right back.  

Welcome back to our discussion about nursing and clinical trials with Erin Ferranti and Ellen Thomas. We heard from each of you about your journeys in working with clinical trials and the roles that you have perhaps served in clinical research, but I know that there is more to that when it comes to nurses roles in clinical trials. And maybe Ellen, you could get us started kind of talking a little bit more about what other roles might be available for nurses.  

Ellen Thomas (07:29)  

Yeah, sure. So clinical research nursing was recognized as a specialty by the American Nurses Association in 2016. And there's a variety of roles that nurses can have in clinical trials. And the type of clinical trial sort of determines what you're doing too. So like, say, phase one clinical trials where they're testing novel drugs in human populations for the first time, monitoring for adverse effects would be, the nursing role could be more focused on a very small number of participants and sort of trying to capture and monitor what this drug effect is in this population for the first time. Then there are studies, public health studies like mine that's more implementation science and you're working with public health researchers who don't necessarily have as much clinical experience. And then also the research staff that is also not having as much medical or clinical experience and aren't licensed. So the nurse kind of plays this role of being a liaison between the researchers, the patient, and the other research staff and making sure patient safety and the trial is being implemented in a safe and feasible way.  

Geralyn Warfield (08:42)  

I suspect there's also the role of being a conduit of information for people who haven't ever thought about clinical trials before. Would you say that's an accurate assessment, Erin?  

Erin Poe Ferranti (08:52)  

For sure, I mean, nurses are one of the most trusted healthcare professionals out there, right? We're rated number one nearly every year. I think, you know, ways nurses can get involved is to know what trials are going on and to link people to trials when they are appropriate patients for those trials or, you know, community members for those trials. So yeah, a nurse plays an important role for sure.  

 So you can lead clinical trials. Go get a doctorate, either PhD or DNP, and run the clinical trials. So that's what I've been doing for the past 11 years, I guess, since I finished my PhD. So yeah, you get to write the questions and come up with the hypotheses and seek the funding and do the work that you really want to do. So that's been a really fun part of my job.  

Ellen Thomas (09:39)  

I would also add that as a clinical research nurse, one of things I find the most rewarding is that you do get to work on these projects from the beginning and before they're even implemented. So there is a lot of opportunity on that research coordination side also to help build this study in a way that the researchers had envisioned that is also practical and beneficial to the participants. So that was exciting for me to actually be able to work on a project coming from the inpatient world where you see your patients for the time that you're there with them and then the next day something completely different. This sort of gives you the ability to work on something longer term, which I really enjoy.  

Erin Poe Ferranti (10:18)  

And I would absolutely add to that that nurses have very practical ideas for how research really, it's the one thing how you write it in a grant and it's another thing how it actually runs. And so really writing the protocol that makes the most sense for implementation and makes the most sense for participants. Nurses are really great at real world, know, how's this really gonna work?  

Geralyn Warfield (10:42)  

I really appreciate the fact that there are a lot of opportunities. And for some of the nurses that are listening or watching this particular episode, what one key thing would you tell them in terms of things they need to consider in order to get involved? Erin, I know you had said to get an advanced degree, a PhD or a DNP would be a great place to start. Is there anything else that you would recommend for somebody who's considering dipping their toe in or jumping full force into the waters of clinical trials?  

Erin Poe Ferranti (11:12)  

Yeah, absolutely. I think, research articles, reading them can seem really dry and boring, but I would highly encourage, you know, we're all scientists if we're clinicians, practicing clinicians, we're really all scientists. So staying abreast of what's new in the field. If I remember correctly, I think it takes 17 years roughly from, you know, research findings to actually be implemented into practice. But I think we could accelerate that translation if more clinicians were involved in knowing what research out there, how we can implement it better in practice. So yeah, just being engaged, asking questions, you know, if there's research going on in your clinic, in your hospital. Finding out more about how to be involved, how to teach patients or participants more about it. I think those are all great options.  

 Ellen Thomas (11:59)  

Yeah, would say, think about your expertise as a nurse. If you're really looking to get into research, try to play to those strengths. So often researchers need nurses who have clinical experience in their field. So say you want to work in cardiology, find a study that's about cardiology, pediatrics, same thing, because nurses know how to work with these populations. They know what makes this population unique. So it really is beneficial to the team to have a nurse who is an expert in that population that they're trying to study for sure.  

Geralyn Warfield (12:33)  

I don't know if there's any way to synthesize what we've talked about in a single sentence or a single thought, but do you have one key takeaway from our conversation, Ellen, that you would like our listeners or those that are watching to walk away with?  

Ellen Thomas (12:46)  

I think the key takeaway for me is just that nurses belong in research. I think it's not always well understood, the role that nurses have in research and that it is an option for nurses to get involved in clinical trials and research, but really research is how we move forward in medicine and in nursing. And I think it's just really important to explore how nurses can be more involved.  

Erin Poe Ferranti (13:09)  

Yeah, I absolutely agree with that too Ellen. We need more PhD and DNP prepared nurses for sure. So we need more nurses directing these types of research. But again, as the most trusted professional, the only way to move medicine and nursing and health care forward is to research strategies for which to do that. And nurses are key in making that work.  

Geralyn Warfield (13:29)  

We are so incredibly grateful to our guests for taking time to share about their roles and their thoughts about nurses in clinical trials. You can find more information about clinical trials in other episodes in this mini-series, and you can also find out more at PCNA.net. We would also like to thank Cytokinetics Incorporated and Novartis Pharmaceuticals for their support of this particular podcast episode. This is your host, Geralyn Warfield, and we will see you next time.