Nurse researchers are playing a crucial role in a groundbreaking study underway in Los Angeles County to find an effective treatment for stroke. The goal of the FAST-MAG (Field Administration of Stroke Therapy-Magnesium) Phase 3 Clinical Trial is to determine if field-administered IV magnesium sulfate given within two hours of stroke symptom onset improves patients’ functional outcomes.
This is a unique position for nurses who have excellent clinical and analytical skills and who are looking for a different type of arena to practice in, says Anna Yanes, RN, BSN, MA, chief nurse coordinator for the FAST-MAG clinical trial, which is being funded by the National Institutes of Health (NIH). The trial is being performed by a consortium of 46 hospitals, 31 emergency medical services provider agencies, 16 full-time nurses, 2,200 paramedics, and 400 physicians in the county, with UCLA serving as the clinical coordinating center.
The blend of research and clinical responsibilities of the nurses include, among other things, teaching paramedics the stroke screening protocol, assessing enrolled patients’ functional status, and interacting with hospital staff to ensure regulatory compliance.
The innovative design of this clinical trial involves physicians obtaining consent from patients or their representatives by cell phone while the patients are in the field. Then paramedics deliver the magnesium or placebo to patients before they even reach the hospital.
This is the first ever trial to enroll every single patient in under two hours of stroke symptom onset, which has never in the history of stroke care been achieved, Yanes says. There have been millions, perhaps a billion, dollars spent previously on research trials for stroke [treatment other than tPA or magnesium]. The majority of patients in those studies were enrolled between three and 12 hours after symptom onset, and those studies have essentially been neutral, not showing any benefit of the different drugs they were studying. Our investigators believe it’s because the time window before drug administration was too long.
Expanding Treatment OptionsChief Nurse Coordinator Anna Yanes, RN, delivers a kit to Los Angeles Fire Department firefighter/paramedic Ryan Howes.
For the 790,000 people in the U.S. who suffer a stroke each year, treatment options are limited. The clot-busting drug tPA can help some of the roughly four out of five who suffer an ischemic infarction. But the drug must be administered within three hours of symptom onset and only after a CT scan rules out a hemorrhagic stroke. Because of those constraints, only about 1% to 3% of stroke patients actually receive tPA.
Since FAST-MAG requires no imaging before administration, paramedics can give the loading dose in the field, once a physician in the study has evaluated the patient over the phone and obtained the patient’s informed consent.
Experimental animal evidence shows that if magnesium is given within two hours of stroke symptom onset, there’s an approximate 50% reduction in final stroke size, Yanes notes. Obviously for human patients, saving brain tissue is going to translate into improved functional status. In our study, we are measuring the functional outcomes of patients 90 days after their stroke in the magnesium and placebo groups and comparing those two.
She emphasizes that being in the study does not preclude any other treatment options for patients. This is truly an add-on treatment. It does not replace anything. It does not take away any of the other treatments they might be getting in the emergency room, she says. In fact, so far, almost 22% of ischemic stroke patients enrolled in the FAST-MAG study also received tPA. The researchers expect the randomization process will equally distribute patients who receive tPA between the magnesium and placebo groups, which will allow the investigators to determine that if the magnesium group does better, it is because of the magnesium, not tPA.
Varied RolesFrom left: Ryan Howes, Anna Yanes, RN, Barbara Tone, RN, FAST-MAG nurse coordinators Rob Phoenix, RN, and Randy Sanoff, RN, and Carl Thurston.
The study is about halfway over, having enrolled just over 50% of the goal of 1,298 patients. Having all of the participating facilities in one county allows nurse researchers to dedicate themselves to one study, but play various roles. Each nurse is responsible for study operations at 18 paramedic stations and four receiving hospitals, training paramedics and hospital nursing staff, completing regulatory paperwork, and performing patient outcome assessments.
Most multi-center studies have sites across the country. But because of the county’s diversity and the uniqueness of enrolling patients before they even arrive at the hospital, the FAST-MAG design, with its distinctive role for nursing staff, was approved by the NIH.
One of the challenges is that what we are doing has never been done before — large-scale, pre-hospital research. The learning curve was steep, says Barbara Tone, RN. She has been a clinical research nurse with the study since its inception more than five years ago.
But she says those challenges have also made the job interesting. Each clinical research nurse is responsible for training all of the paramedics at about 20 fire stations in study procedures. The research nurses also do education and training at the participating hospitals and usher the study through the institutional review board.
Once patients are enrolled in the study, the nurse researcher on call meets them in the ED and evaluates their functional status. A nurse researcher measures the functional status again at 24, 48, and 96 hours after enrollment. The last two follow-up points are at 30 and 90 days.
With so many varied roles, no two days are alike. The most appealing thing still for me is the diversity of the job, Tone says. We get a little patient contact. We get to learn about research. I do some hospital regulatory work. On any given day, you may be doing four or five different things. I like that. Given my emergency nursing history, doing the same thing every day doesn’t interest me very much.
For nurse researcher Theresa Haley, RN, MSN, CCNS, the chance to be part of developing a novel design hooked her on the FAST-MAG position. The direct patient involvement was a strong selling point as well. Being able to maintain contact and hands-on working with the patients amidst doing something like a project manager type of role is very rewarding, she says. If you choose a path of going into project management, you don’t normally get to retain that contact with patients. I think most nurses would admit that it’s still very satisfying to at least have a component of your day or a component of your week where you’re able to interact with patients and their families directly.
Each nurse researcher understands the dire need for stroke treatment options. Although the investigators have no idea which patients received a placebo and which received the FAST-MAG, the researchers have seen the power of a stroke firsthand.
There are patients I’ve gone to see after 90 days and come away with tears in my eyes, because overnight your life can be so tremendously altered that it’s just devastating, Tone says. But being part of the study has helped temper that sadness. To be part of something that might in the future really have an impact on that makes me very happy.
For more information, visit www.fastmag.info.