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Voice-over Internet phone system helps emergency CR
Five physicians are contacted at one time
Clinical research sites have many limitations imposed by federal and state regulations, as well as ethics review boards that help carry out federal requirements.
One limitation that can be particularly frustrating to principal investigators (PIs) involves obtaining informed consent in emergency situations.
There are a number of life-saving medical interventions that are not routinely adopted because of the lack of clinical trials proving their value. And one of the chief obstacles to obtaining these data is the difficulty CR sites have in obtaining informed consent during an emergency situation.
Now, a new study involving stroke patients shows that such emergency informed consent can be obtained in a way that meets regulatory and IRB requirements and which can be done fast enough to be practical. The solution is the use of simultaneous ring, voice-over-Internet phone system technology.1
Stroke is one of those emergency diseases where patients need to be treated very early, so there isn't time to wait until paramedics wheel them into the hospital to obtain informed consent, notes Nerses Sanossian, MD, an assistant professor of neurology and an associate director of the Stroke Center in the department of neurology at the University of Southern California in Los Angeles.
Investigators wanted to test the hypothesis that magnesium administered very soon after a person has a stroke can protect the human brain, Sanossian says.
Magnesium treatment showed protective potential in animal studies, but they needed to find a way to test it in clinical trials, and it would take too long to wait until patients were triaged in the hospital, he adds.
The key was to enroll patients in the study within two hours of the onset of their stroke.
"The earliest time we could enroll a stroke patient in clinical research was when they had paramedic contact," Sanossian says. "But paramedics won't wait for a page, and they won't wait more than 30 seconds to be connected with a physician."
So Sanossian and co-investigators designed a study in which paramedics would carry a kit with two bags. One contained 20 mg of magnesium, and the other had a salt water placebo.
When paramedics arrived a the home of a stroke victim, they would call an investigator physician via a virtual Internet phone number that simultaneously rings up to five physicians at one time, Sanossian explains.
The first physician to pick up the phone provides the informed consent. With this phone system, paramedics haven't had to wait more than 30 seconds for someone to answer the phone, he adds.
The key is for a number of physician investigators to carry phones at all time with the understanding that they will be called to conduct emergency clinical trial enrollment and informed consent.
"I just enrolled a patient earlier," Sanossian notes. "I was making rounds, and the phone rang four times; I won't let it ring five times, so during my hospital rounds I picked up the phone and spoke with the patient, getting permission and consent, and I enrolled the patient."
Altogether, the study has six physicians who are stroke specialists and researchers who can take these calls. Also, there's a dedicated line for Spanish-speaking patients, and three physicians are on the Spanish line while five are on the English-speaking line.
The investigators can remain on call for the study wherever they are because the calls go through the Internet.
"I was traveling in Estonia, and I was able to do enrollment from Estonia because all communication is online," Sanossian says.
While the Internet simultaneous phone ringing system made it possible to enroll patients within that two-hour critical window, there were other obstacles investigators had to overcome for the study.
One involved recruiting paramedics.
"We went to all Los Angeles county paramedic agencies," Sanossian says.
It took years of planning to obtain the necessary documentation, convince paramedics to assist with the study, and to obtain all regulatory approvals, he says.
"We had to do community education and have a dedicated person in charge of community education," he adds. "One-third of hospitals will allow us to enroll patients without explicit consent because we went to the community and showed how magnesium was safe and how the study will benefit society."
The study's target enrollment is 1,298, and investigators have enrolled more than two-thirds since first enrolling in the study in January, 2005, Sanossian says.
"We're only enrolling people with symptoms clearly showing an onset of less than two hours," he says. "We want to get to them before they're irreversibly damaged, and the faster we get to them the less likely there will be damage."
This study is the earliest stroke therapy trial ever attempted, Sanossian notes.
"This method has never been done before to our knowledge, and we did it because of necessity," Sanossian says. "We made a commitment to man our phones 24/7."
Investigators wanted to be connected to paramedics within five seconds of their call, and the simultaneous ring voice-over-Internet phone system was the best way to make this happen, he adds.
"If a paramedic is put on hold for 40 seconds, he won't call us back," Sanossian says. "The only way to get hold of a physician within five seconds is to have one person sit at a phone in an office or to use this system."
Since all of the investigators are busy stroke physicians with active clinical practices, the Internet phone system was their best option.
"This is a good model for future pre-hospital studies if you want to get on the phone with no delay," Sanossian says. "In one month of intense monitoring we were not able to identify any cases where they weren't able to reach us."
Three patients dropped out because of poor telephone reception, however, so the system has limitations, he says.
Forty percent of the calls from paramedics resulted in enrolled patients, Sanossian says.
"A lot of what we do is talk to paramedics and see if patients qualify for the study," he says. "Their patient could be a person with a brain tumor who doesn't qualify, or if the person has only two months to live he wouldn't qualify."
The point of the Internet phone system is to get the physician and paramedic talking as soon as possible, and so far it appears the paramedics involved are happy with the situation, Sanossian says.
"Rarely is there a situation where the paramedic is on the line a little longer than usual," he says. "I think this system could be useful in any kind of acute clinical situation, like someone having a heart attack, and it's ideal for stroke patients."