In the television game show “Deal or No Deal,” contestants are asked to make a choice between the known and the unknown.
They are asked to stay with what they have or take a chance on something that might be better. When patients enter the CREST (Carotid Revascularization Endarterectomy vs. Stenting Trials) research study, they face a similar scenario.
They agree to join a group of patients who will receive one of two treatments – a known and accepted treatment (Carotid Revascularization Endarterectomy) or a known, but not commonly used treatment for their specific medical problem (stenting). The choice for patients is not which treatment to choose. Because they are randomly assigned to either group, the choice lies in whether to join the study.
“It can be a difficult choice for patients, and as a research coordinator and a patient advocate, I need to make sure that patients are properly screened, that they fit the criteria for the study, that they are properly informed and [have consented], and that they are able to make the commitment to the full duration of the study,” says Cheryl Meehan, RN, BA, Clinical Research Coordinator at St. Michael’s Medical Center in Newark, N.J.
And when it comes to research, commitment is certainly a key factor. “In a study like the CREST trial, the actual procedure may take only an hour or so, but we are asking patients to make a four-year commitment to follow-up visits,” she adds.
The CREST study that Meehan refers to is a randomized clinical trial to compare the outcomes of carotid endarterectomy, the surgical approach to carotid revascularization, and carotid artery stenting, a minimally invasive procedure where a meshlike metal device is threaded through the femoral artery and is placed in the narrowed part of the artery to hold it open.
The carotid artery surgery is currently considered the standard of care for carotid stenosis, while carotid artery stenting, which is a relatively new procedure, is only currently approved by the Food and Drug Administration (FDA) for patients who are considered too high risk for surgery.
“Robert W. Hobson, MD, professor of Surgery and director of the Division of Vascular Surgery at the University of Medicine and Dentistry (UMDNJ) in Newark, N.J., is the principal investigator of the CREST study,” explains Susan Hughes, RN, BSN, senior Clinical Research Associate at UMDNJ. “The study, sponsored by the National Institute of Neurological Disorders and Stroke and the National Institutes of Health (NIH), was originally proposed to the FDA by Hobson in 1997, but didn’t begin enrolling patients until 2003.”
“The process was slow in the beginning for several reasons,” Hughes explains. “First, there were problems with getting the financial approval for carotid stenting from the Centers for Medicare and Medicaid Services (CMS), and the researchers had to make sure that the procedures were safe.”
The researchers found that the initial stenting procedure provided no distal protection for patients. “Plaque could be dislodged during the stenting procedure and potentially travel to the brain, causing a stroke,” Hughes adds. “With this in mind, Guidant designed a device that is able to capture and extract the plaque that is loosened during the stenting procedure.”
“We have enrolled 1,844 randomized participants (1,021 symptomatic and 823 asymptomatic) and 1,546 lead-in participants (409 symptomatic and 1,137 asymptomatic) so far, and with our current rate of 60 new participants [randomizations] each month, we anticipate reaching our 2,500 participant target by the middle of next year,” says Hughes.
Overall, the study has a recruitment target of 40% women and 12% minorities (currently at 35.8% and 9.2%, respectively for randomized participants), and the data will be examined within these groups, as well as for particular comorbidities, including diabetes and hypertension.
While UMDNJ is the originator of the CREST study, St. Michael’s Medical Center is the only CREST site in New Jersey, and the study is led by the site investigator, Zafir Jamil, MD, acting chief of Vascular Surgery.
“The reason the CREST study is so important is because it gives us the chance to determine the best management for patients who need treatment for carotid artery disease,” says Jamil.
When the CREST trial began, it was conducted only on symptomatic patients, but in 2005, the study was opened up to patients who had not yet developed symptoms. Currently, more than two-thirds of the carotid endarterectomies in the U.S. are performed on patients who do not have symptoms of carotid stenosis.
“Asymptomatic people have a narrowing of the carotid artery that is usually found during a physical exam,” Jamil says. “Although patients have not yet exhibited any of the neurological symptoms, it puts them at risk for stroke.”
When a patient is referred to or signs up for the CREST study, they are randomly assigned to one of the two procedures. “There is rigid credentialing for both the interventionalists who insert the stents and the surgeons who do the surgical procedures in the study,” says Hughes. “We want to make sure that we have a level playing field.” Jamil agrees.
“It is essential to the strength of the research that all of the physicians involved in the study are highly competent and experienced,” he says. “We want to ensure that there are no doubts about our results when we’re done.”
And while it may seem difficult for patients to agree to a random assignment, it is a critical aspect of the research. “The data is blinded in the randomization phase and submitted to the Data Safety Monitoring Board* (DSMB),” Hughes explains. “They review the data every six months and determine whether to stop the study because there is too much of a difference, or no difference between the procedures, or to continue the study because they see a reason to keep going. As research coordinators, it is very important for us to let people know that we do not know the benefits of one procedure over the other.”
When patients are interviewed for the study at St. Michael’s, they meet with the physician to discuss the procedures. “Patients are given verbal and written information,” explains Jamil.”They are told to take the information, read it, think about it, and talk to their families.”
They also meet with the CREST coordinator, Indu Kapadia, PA, who reviews the informed consent and answers any questions. “We never want to enroll anyone who isn’t completely aware of the benefits and risks, as well as the time commitment,” says Meehan. “We want to be sure that the patient understands all aspects of the study.”
The patients are also followed by a neurologist who monitors their neurological status throughout the study.
Research coordinators play an essential role in the research process, and there are important skills needed for the job. “You have to be very organized and very detailed,” says Hughes. “There are a limited number of patients in a trial and there is no room for sloppy data. Any error, any missed appointment, missed follow-up, or missed test can affect the data. You have to understand the importance of every piece of data.”
Hughes also finds that customer service is an essential aspect of the role.
“Your patients need to like you,” she explains. “Once they’ve had the procedure, they think that they are done, but it is the information that we collect afterwards –at the one-week, 30-day, and yearly intervals — that makes the study. A four-year follow-up takes commitment; the patients have to want to come back.”
Squeeze the ducky
Mara Bugayons, RN, BSN, has a special insight into the CREST study in her role as OR and Cardiac Cath Lab nurse at St. Michael’s.
“The surgical procedure (the carotid endarterectomy) is an open procedure where there is an incision in the neck to remove the plaque from the artery,” she says. “The stent is percutaneous, with a needle stick to the femoral artery. During the surgery, the patient is asleep, but during the stenting procedure, there is patient participation.”
That participation is not what you may expect during a high-tech interventional procedure. “The patient is awake and fully aware of the environment, so we can assess this or her neurological status throughout the procedure,” Bugayons adds. “If we are working on the right carotid, we will give the patient a rubber duck to hold in the left hand. At different stages of the procedure, we will ask the patient to ‘squeeze the ducky’ to assess the motor movement on the left side.”
Recovery time is similar for both patients, and in both circumstances the patient is typically discharged from the hospital the next day.
“Participants in the CREST trial, as well as in other research studies, play a role in shaping policy and healthcare practices,” says Hughes. “They are helping to decide which medications, procedures, and devices will get approval for use. The research will have a huge impact on future generations.”
And nursing plays a leading role, not only in direct patient care, but also in teaching and advocacy for the research participants. “The nurses are the backbone of the research process,” Jamil says. “As patient advocates, they have a communication and understanding with the patients that is essential to the research process.”
Editor’s note: The DSMB is an independent committee of medical doctors and/or statisticians who are appointed by the National Institute of Neurological Disorders and Stroke to oversee and monitor the conduct of the CREST trial. The board meets approximately twice a year and conducts periodic conference calls in the interim to review the performance, safety, and efficacy of the trial.
Carol Nelke Dunbar, APRN, is a contributing writer for Nursing Spectrum.