What is involved in setting up a research trial involving new technology? A key part of the process is recruiting patients and, just as important, monitoring their success––and setbacks––during the trial.
Nurses can play an important role in helping to make clinical trials successful. We talked with Nancy Colobong Smith, MN, ARNP, CNN, a Renal and Transplant Clinical Nurse Specialist at the University of Washington Medical Center (UWMC) in Seattle, about her work on developing a wearable artificial kidney. Results from the first clinical trial were recently presented at the American Nephrology Nurses’ Association annual meeting in Louisville. The University of Washington and Kidney Research Institute partnered in the research.
NN&I: tell us your background. How did you get involved in kidney research? Are you also doing direct patient care at UW?
Nancy Colobong Smith, MN, ARNP, CNN: I started working at UWMC as a staff nurse on a medical surgical, liver and kidney transplant unit 20 years ago. The UWMC has a unique model where they train experienced staff nurses to provide primary care and dialysis for inpatients. I first trained in peritoneal dialysis and then hemodialysis and pheresis. I eventually became assistant nurse manager of the transplant unit, and then went back to school to earn my masters of nursing with a dual focus as an acute care nurse practitioner and clinical nurse specialist. I currently have a blended role where I oversee the dialysis program as a clinical nurse specialist (CNS) and consult on the management of post-transplant diabetes as a nurse practitioner. My current role involves more quality improvement, education, and training, although I do some direct patient care when I manage diabetes or assist with complex dialysis patients.
The UWMC is an academic medical center, meaning that there is research all around. My first exposure was as a staff nurse when inpatients were enrolled in a study. The research coordinators were available to support us in making sure that protocols were followed and the needed data collected. Later, when staff had clinical questions and we found limited evidence in the literature to support practice, we partnered with a researcher at the UW School of Nursing to develop our own study. From there projects developed organically from shared interest or expertise.
NN&I: How do you split those roles?
Smith: This is something that I have to manage with each new project – research or otherwise. There are always projects that are interesting and I am passionate about so I need to balance that with the everyday work that needs to get done. I am fortunate to have a supportive manager and colleagues. We help cover for each other when we can, and help each other problem solve when we can’t. For the WAK project, it was easier. It was a large, well known trial and everyone I worked with was happy to participate, even if that meant supporting me at times when I wasn’t always available.
NN&I: Do you think research is a growing field and offers rewards for renal nurses?
Smith: Absolutely! As the health care profession and the public focus more on quality, outcomes, and evidence-based care, research continues to grow. Research starts with a question, and there are still many questions that need answers. The rewards come with finding the answer, and knowing that you are providing better care or new options for patients.
NN&I: Give us a short overview of the WAK trial: its mission, the protocol, and accomplishments to date.
Smith: The first WAK trial in the United States was the third WAK trial overall.
The goal was to establish the ability of the WAK to deliver continuous dialysis safely for 24 hours, and to determine the clearance of urea and other electrolytes over the 24-hour period. The previous European WAK trials had subjects wear the device for 6-8 hours.
The protocol involved subjects coming to UWMC for a standard hemodialysis procedure, having a short break, and then wearing the WAK for 24 hours. During the time at UWMC, subjects were closely monitored (vital signs, labs, and telemetry). Subjects were also interviewed before and after using the WAK, and completed a dialysis modality satisfaction survey after standard dialysis at their outpatient dialysis center and after wearing the WAK.
Five subjects were able to wear the WAK for the complete 24 hours. Two subjects wore the WAK for less than 24 hours. One came off early due to clotting and the other one due to technical complications such as kinking and the inability of the bubble traps to keep up with the carbon dioxide production. Part of what makes the WAK portable is the device’s ability to regenerate dialysate utilizing sorbent cartridges. One of the natural byproducts of this process is carbon dioxide, which is safely trapped in the bubble trap and vented into the atmosphere. These complications were consistent with the European trials findings. In this stage in the trial, regulatory bodies required that we use the same device as the one used in the European trials.
After seven patients, we completed the trial. Overall we found that the WAK is safe and well tolerated. The subjects’ labs values were maintained despite very liberal diets. Subjects also reported greater treatment satisfaction with the WAK compared to conventional hemodialysis.
NN&I: What was your role in helping to recruit patients for the trial. Was it difficult? What were some of the characteristics you were looking for in each candidate? Did you reject some patients?
Smith: Since we were partnering with the Kidney Research Institute, we had amazing research coordinators who recruited patients for the trial.
The study had specific inclusion criteria which was sometimes challenging to meet. A total of 246 patients were screened in order to find 10 patients who met criteria and were able to be consented. In the end, 7 patients were enrolled in the trial and underwent therapy with the WAK.
NN&I: Nurses are excellent nurturers. Did you use those skills during the trial as patients worked to adhere to the protocols? How would you describe their mood and attitude during the trial? Were there some tough times to get through?
Smith: Nurses have many skills and roles that contribute to research. Some examples are patient advocate, mentor, educator, clinical expert, planner, leader, and nurturer. Overall the study participants were very excited to be the first people in the United States to wear the WAK.
It was fun to watch them enjoy foods that they are not usually able to eat because of their kidney disease. They would ask about their lab results and were so happy to see that their labs were stable, even though they were eating foods higher in potassium and phosphate.
We recognized that sometimes it was challenging to have 2-3 members of the research team with the patient for 24 hours. It was a group effort to keep engaged with the more social participants, and allow the ones who needed more quiet time the space to have that despite the labs and monitoring required by the protocol.
NN&I: What would you say was the most rewarding part of the trial for you as a nurse?
Smith: The last statistics I remember from the USRDS had approximately 650,000 in the US receiving dialysis, and 100,000 waiting for a kidney transplant.
The most rewarding part for me in the trial was knowing that we were giving people hope for a future with more options of dialysis modalities. These new options may allow people more normalized diets, and the chance to receive dialysis therapy while walking, dancing, and enjoying their lives more fully. The best moments were watching the patients take their first walk with the WAK, and order their meals. It really is the simple pleasures that are the best.
NN&I: What are the next steps for the device and follow-up trials?
Smith: The next steps include technical revisions to the WAK circuit to make it smaller, lighter, and more patient manageable. There are plans being made for follow up trials that extend the time that subjects are wearing the device, as well as taking the WAK out of the hospital and into the home setting.