In March 2014, the San Antonio, Tx.-based mobility solutions vendor AirStrip announced that it acquired the assets of wireless monitoring startup Sense4Baby and licensed the associated technology that the startup was founded on from research from the Gary and Mary West Health Institute. The Sense4Baby system is used to perform remote maternal and fetal monitoring including for high-risk pregnancies.
Then, just a few months ago, the Food and Drug Administration (FDA) cleared the Sense4Baby wireless maternal/fetal monitoring system to be marketed for use in the U.S. by pregnant patients to self-administer non-stress tests (NSTs) or for use accompanied by medical professionals. Examples of these types of tests can include babies’ heart beats and mothers’ contractions in third trimester of pregnancies, as the technology tries to detect fetuses that are at high risk of stillbirth.
For both the obstetrics and gynecology world, as well as the health IT industry, the impact of this news is another sign towards taking clinical care out of the hospital and moving it into remote locations. "Patients may need to travel for extended periods of time, multiple times per week, in order to receive these tests," says Erin Clark, M.D., assistant professor of maternal/fetal medicine in the Department of Obstetrics and Gynecology at University of Utah Health Sciences. "At-home fetal monitoring may allow patients to save time and money related to travel for NSTs, and may also increase the capacity and flexibility of health systems to conduct NSTs,” Clark says.
In additional to her clinical medicine work, Clark is also associate director of University of Utah’s Obstetrics and Gynecology research department. She notes that a lot of her research focuses on genetic and environmental factors that contribute to preterm birth, but says she has spent increasing amounts of time focusing on developing novel and innovative strategies for administering prenatal care. That’s how the door opened for a new study at the university, which will test Sense4Baby in high-risk populations. “University of Utah [has become] very interested in innovative strategies for providing care with focus on value in clinical outcomes, cost effectiveness, and patient satisfaction,” Clark says.
“How do we provide the highest value of care in all these different areas? When it comes to providing prenatal care, we have done it pretty much the same way for the last 100 years,” she says. “We know that prenatal care, in its current format, which is about 15 face-to-face on site. There is no question that the care saves lives and is effective, but no one really knows what the best strategy is for providing this care,” she says. Clark notes that questions such as how many visits should there be, how many should be on site, and should stress tests in particular have to be in person all have been posed to shoe in the field. “Can we think about this in a new way that’s innovative with the same outcomes in a more cost-effective manner with potentially more satisfaction for providers and patients?” Clark asks.
The technology involved, says Clark, who admits she’s not the biggest “techie,” is essentially a small suitcase that contains the same monitoring equipment that is used in traditional prenatal monitoring, meaning it has a monitor in place that detects fetal heart rate, and also a monitor for contractions. The signal is then sent over an internet connection to a HIPAA-compliant web-based cloud that the care team could see, she explains. “The technology is not so different than what clinics use to send tracings to a doctor in another location to read. It’s very easy, once doctors see how easy it is to log in and see those tracings, they become converted quite quickly,” she says, adding that the monitoring provides an additional layer of protection compared to technology such as Skype.
Erin Clark, M.D.
As such, the study in which the University of Utah and AirStrip are participating in is focused on the administration of these non-stress tests. Clark says there are characteristics of the fetal heart rate tracing that can give clinicians clues that a baby is not doing as well in regards to oxygenation, for instance. “Hopefully we can then intervene and provide a better outcome,” she says. This has become a standard of care in obstetrics, and for women with high risk pregnancies, these tests have typically been administered once or twice a week, sometimes in a free-standing clinic or facility affiliated with the hospital, Clark notes.
The main question, Clark continues, became, could this could be accomplished in a way that made it feasible for a healthcare center? “We had faith in the technology, so feasibility was our primary question. We knew we could establish clinical algorithms to establish a safe practice to do these at home or off-site in general, but could we integrate it into the healthcare system? By integration, we mean can we schedule these tests, interpret them, bill them, and come up with these clinical algorithms that everyone finds acceptable? Can we build this into a system? Clark asks.
What’s more, Clark says she has been asked questions about why she is motivated to do these tests for women at home or off-site. “I think there are several compelling reasons why,” she says. “For one, these tests are not accessible to everyone, so people who are in rural or remote populations might not have access to a stress test without driving a long way. I have people who drive two to three hours to a medical center, then wait in waiting room and sit in a chair for the test for 30-60 minutes, wait for interpretation of test, and then go home. Even for someone who lives next door to the facility, it’s at least a one hour process that can be made more efficient for patients, as well as being more cost effective, with the same potential benefits.
The pilot study enrolled 30 patients in the third trimester who already have a physician order for twice weekly non-stress tests. The pilot has just started; the first patient was enrolled in mid-June, says Clark. “Our experience thus far is that patients have been really enthusiastic—they are less scared by change than physicians are. The ability and flexibility to take one of these monitoring units with them to home to work to another location and be able for us to still see those tracings is an enormous advantage.” Indeed, Clark admits that getting physicians on board can prove challenging. “Whenever I get up and talk to a group of doctors about the prospect of changing the standard way we have been administering care, this is this dogma. And I tell people that the dogma lives inside an obstetrician’s chest, and if you try to deviate from it, they get chest pains. Acceptance from providers isn’t insurmountable, but it has to be acknowledged,” she says.
Clark says that for those physicians who are hesitant, the strategy has been to educate and be with them during any technology change. Some clinicians also show concern that if a test that is not interpretable or gives a concerning result about a patient in a remote location, what should they do in those situations? “We respond that it’s not really any different than if the patient is sitting in a clinic and we are reading his or her strip from 30 miles away,” Clark says. “So we educate the physicians and all of the care providers associated with administering these tests that the same care algorithms apply, so people could get rapid attention to care if they need it.”
Clark says she emphasizes to people that despite their misgivings about change, all of the components of prenatal care as we know will inevitably change due to the newfound emphasis on cost effectiveness, quality, and satisfaction. “It means that we are inevitably going to take a look at alternatives that are superior to what we already have,” she says. My goal at the end [of the pilot] is that we would like to finish studies like this one and say, ‘We have a viable alternative.’ Maybe it won’t replace the current system completely, but we have an alternative that doctors and patients are happy with that has potential for better cost effectiveness and at least equal quality. That’s what we’re shooting for. We are taking baby steps forward, and having all parties accept will be a big step,” she says.