The Kansas City health system has launched an innovative alliance that uses predictive analytics and digital technology to create new care management programs for young adults living with diabetes.
Children's Mercy Kansas City has launched a new program that uses predictive analytics and digital health technologies to help young patients living with diabetes manage their health and address concerns before they become serious.
Called the Rising T1DE Alliance, the program brings together clinicians, patients, caregivers, and researchers to harness the data being gathered throughout the healthcare experience and use it to predict and improve health outcomes.
"Predicting outcomes through analytics is great, but at the end of the day, you still have to do something with it," says Mark Clements, MD, PhD, a pediatric endocrinologist, professor of pediatrics, and the Rick and Cathy Baier Family Endowed Chair in Endocrinology at the health system.
Financed by a $8.5 million grant from the Leona M. and Harry B. Helmsley Charitable Trust, the program seeks to improve care management through simple, personalized steps. The alliance selects an outcome —such as lowering one's A1C level, reducing insulin use or even reducing weight—and creates a model that will use technology to reach that outcome. The model, called a Change Package+, includes guidance on how to predict outcomes, collect and track data, and make changes to improve performance.
Clements says the interventions are designed to be simple and targeted, to get clinicians out of the mindset that new ideas need to go through trials and pilot projects before being used. They also take advantage of the latest in digital health technology that allows the patient to be an active part of the process, rather than just a test subject. And they're also designed to move healthcare out of the clinic or doctor's office and closer to the patient.
"The person with diabetes … knows what's best for them, and we clinicians should be listening more to them," he says.
The programs address Type 1 diabetes, an as-yet uncurable chronic disease that affects some 1.6 million Americans, including some 200,000 people under the age of 20. Those numbers are rising steadily, projected to hit 5 million Americans and 600,000 young adults by 2050. Also increasing are the costs associated with treating diabetes, which the American Diabetes Association estimates at $16 billion per year.
All that attention has also fueled innovation, particularly in digital health. Wireless devices can now measure one's blood glucose level on demand, transmitting that data to a wearable or smartphone app, and then on to caregivers. Devices can also store, measure, and even administer insulin, either manually or through digital commands, while telehealth platforms allow those with diabetes to access resources or connect with caregivers at any time.
That's where the Rising T1DE Alliance comes into play.
"Type 1 diabetes is something that patients and their families live with 24/7," Leonard D'Avolio, PhD, an assistant professor at Harvard Medical School and Mass General Brigham and CEO of digital health company Cyft, said in a November 2021 press release announcing the new program. "It's one of the few diseases that asks patients to self-administer variable doses of a potentially deadly drug on a daily basis, yet most patients speak with their clinician once every three months if they're lucky. It's the perfect opportunity to put data to work to better support patients and their families."
The program uses Cyft's predictive analytics technology as the backbone for its treatments, which use data and technology to predict outcomes and map out the protocols to reach those goals. Among the interventions being developed through Rising T1DE are a remote patient monitoring platform that allows patients to connect with their care providers to share data and hold virtual visits, a virtual program called PEEPS (Patients Encouraging and Engaging Peer Support) that pairs teen with young adults for mentoring, and an mHealth platform that delivers personalized "nudges" through one's mobile phone to support positive habits and goals.
Clements says many of the programs use data to drill down to the direct point in which technology can affect an outcome, and then create just-in-time interventions to create those outcomes. This, in turn, would lead to better outcomes over time, a healthier lifestyle, improved self-management, reduced healthcare costs, and fewer hospitalizations.
"We have spent about 15 months creating the landscape and looking at these interventions," says Clements, adding the organization will make these models available to other health systems in time. "We're trying to understand how to break out from the (traditional lab-based approach) and start learning from these examples. That's going to involve more partnerships."
He says the program can also expand, using digital health tools and platforms to understand how the social determinants of health—from transportation to diet and exercise to financial resources and employments—have an impact on care management.
"It takes a lot of bringing people along to see what is possible," he says. "Leaders in healthcare still need to be convinced."
Long the second fiddle to Epic and losing ground, Cerner will get a much-needed innovation infusion when it's acquired by Oracle, and could give a much-needed boost to the EHR landscape.
Oracle’s pending acquisition of Cerner may have caught many by surprise, but it falls in line with the thought that the EHR market needs to embrace innovation to evolve.
Long the second fiddle to Epic – Cerner had 25% of the EHR market in 2020, compared to Epic’s 31%, according to KLAS Research - the Kansas City-based company had been losing business to its competitor in recent years and was struggling to fulfill contracts with the US Department of Defense and Veterans Affairs. And while the company was securing contracts with smaller health systems who liked the price, critics said the platform wasn’t meeting expectations on the back end, particularly in revenue cycle services.
In Oracle, Cerner is getting a partner with a strong background in finance and operations, and one that wants to make an impact in the busy clinical market. This could shore up the company’s platform and make it more attractive, particularly in the smaller markets and overseas.
In addition, Austin-based Oracle brings expertise in new technologies that will strongly impact the EHR market, including AI, machine learning, data management and cloud computing. Those features could also form the backbone of a more compelling and effective telemedicine offering, with tools in place to develop remote patient monitoring capabilities.
“The future of enterprise software is being able to engage with industry segments,” Bob Parker, an analyst at IDC, recently told The New York Times. “And this puts Oracle deeply into a key part of the healthcare business.”
"With Oracle's resources, infrastructure and cloud capabilities, Cerner will accelerate the pace of product and technology development to enable more connected, high-quality and efficient care," the two companies said in a December 20 press release announcing the deal. "Oracle's focus on usability and voice-enabled user interfaces will dramatically reduce the amount of time that medical providers spend dealing with systems."
“With this acquisition, Oracle’s corporate mission expands to assume the responsibility to provide our overworked medical professionals with a new generation of easier-to-use digital tools that enable access to information via a hands-free voice interface to secure cloud applications,” Oracle Chairman and Chief Technology Officer Larry Ellison added. “This new generation of medical information systems promises to lower the administrative workload burdening our medical professionals, improve patient privacy and outcomes, and lower overall healthcare costs.”
Those functions are important as healthcare looks to move beyond the dark days of the pandemic and adapt to a hybrid care environment that supports both in-person and virtual services. Healthcare providers will need an EHR platform that can seamlessly adjust from one modality to the other, as well as one that can support new digital health tools aimed at reducing workload pressures on providers and funneling data into the medical record.
“Cerner has been a leader in helping digitize medical care and now it’s time to realize the real promise of that work with the care delivery tools that get information to the right caregivers at the right time,” Cerner President and Chief Executive Officer David Feinberg said in the press release. “Joining Oracle as a dedicated Industry Business Unit provides an unprecedented opportunity to accelerate our work modernizing electronic health records (EHR), improving the caregiver experience, and enabling more connected, high-quality and efficient patient care.”
Beyond the flowery language of the press release, however, the healthcare industry will wait and see if this merger can back up with words with actions.
Honda and Children's Health of Orange County have partnered to create a customized electric vehicle that can transport the hospital's young patients around in style.
Children’s Health of Orange County (CHOC) is giving its young patients a new means of traveling around the hospital.
The Los Angeles-based hospital has introduced Shogo, a custom-made electronic vehicle developed by Honda that’s specifically designed to transport patients throughout the hospital. The vehicle, based on the Japanese word for “soaring into the future,” features a steering wheel with a stop/go button, can travel up to 5 mph, and is remotely controlled by a nurse or caregiver. It includes an IV holder, toy bucket, cup holders, a horn with different sound options and a license plate that can be customized to feature the rider’s name.
Honda engineers worked with hospital staff to design the vehicle, part of the company’s “Project Courage” initiative.
"As someone who spent time in the hospital as a young child, I really wanted the number one objective of our Honda team in developing Shogo to ease the hardship of a hospital stay by providing kids a lasting positive memory about that experience," Randall Smock, a senior designed with American Honda who played a significant role in designing Shogo, said in a press release. "Every element of Shogo was designed to accommodate different needs of young children, making it as easy as possible to get in and out, simple to drive, and for the entire experience to leave them a bit happier."
Honda and CHOC have partnered in the past on innovative tools for pediatric patients. They include a “Candy Cane Lane” VR program, accessed through Oculus headsets, in 2016, a VR-based virtual snow globe and AR-based “Ultimate Get Well Card” in 2017, and a VR-based “Magic Snow Globe” in 2018.
To make sure Shogo could navigate the hospital, Honda worked with the hospital to replicate a hospital hallway at the company’s research & development facility and tested the vehicle with children and parents.
"Our team greatly appreciates Honda bringing innovative solutions that support our ongoing commitment to providing an exceptional patient experience and infusing joy into a patient's stay," Brianne Ortiz, manager of the Cherese Mari Laulhere Child Life Department at CHOC, said in the press release. "We were impressed from the beginning when we first saw Shogo, and by the Honda team's dedication in collaborating with our staff to ensure a vehicle that is perfect – and safe – for our young patients."
The Nevada-based health system is looking to build its remote patient monitoring program slowly and steadily, using an innovative, wearable patch that captures relevant data.
While healthcare organizations often look at remote patient monitoring (RPM) as a means of caring for patients at home, Renown Health has launched a pilot project aimed at helping a rural hospital improve inpatient care.
And the Nevada health system's president and CEO sees this as the first step in a much larger journey toward integrated care no matter where the patient is located.
"This isn't just about monitoring a patient," says Anthony Slonim, MD, DPH, who has helmed Renown since 2014. "It's about system design. We have to be very thoughtful about how we approach [RPM], and make sure we have the infrastructure in place to support what we want to do."
Many healthcare organizations pivoted to telehealth during the pandemic to shift in-person services onto virtual platforms, and RPM programs soon followed that trajectory. The idea behind RPM is that a health system can track and care for patients in their home by capturing key data, such as vital signs, through either connected devices or by having the patient collect that data.
Anthony Slonim, MD, DPH, president and CEo of Renown Health. Photo courtesy Renown Health.
COVID-19 offered a good opportunity for health systems to test out that strategy, and many adopted the platform on the fly, launching a program with whatever they had at hand to care for infected patients at home and planning only for the short term. Others, though, look at RPM as a long-term project, capable of providing care management for many populations, from patients recently discharged from the hospital to those with ongoing chronic care needs.
For that strategy to work, however, it must be planned out carefully. And Slonim says he wants to take it one step at a time.
Starting Small and Scaling Up
Reno-based Renown Health, includes a trauma center, two acute care hospitals, a children's hospital, a rehabilitation hospital, a medical group, and a nonprofit insurance company, recently partnered with Denver-based BioIntelliSense to pilot its first RPM program in Renown South Meadows Medical Center. Patients admitted to the hospital are equipped with a wearable patch that captures vital signs and other biometric data.
That information is transmitted back to the Renown Transfer & Operations Center (RTOC), a state-of-the-art command center opened in August and equipped with roughly 30 large monitors. Slonim likens the new center to an air traffic control hub, monitoring patient rooms and other locations throughout the health system and allowing officials to keep track of rooms and the patients in them.
These command centers are becoming common in health systems across the country—Intermountain Health in Salt Lake City and Mercy Virtual in Kansas City feature them—as health systems look to gather the data coming in from technology platforms and connected devices in one place. From here, they can quickly determine which rooms are empty, in need of cleaning or ready for new patients; they can check on patients, answer patient requests, and monitor patient health.
Many of these rooms sit on a telemedicine platform that allows the health system to pull data from connected devices in the hospital room, tracking vital signs and other information. From that one room, care teams can monitor vital signs of patients throughout the hospital or health system, spotting trends that indicate a health concern and acting quickly.
This is the first step in Slonim's RPM strategy. And it begins with a small patch attached to the patient that monitors skin temperature, resting heart rate and respiratory rate, step, gait, sleep, activity levels, even infection-like symptoms that can support COVID-19 monitoring.
"This little half-dollar-sized device can revolutionize how we deliver care," he says.
Patients wear the patch during their hospital stay and can keep it on when they're discharged, allowing care teams to monitor them at home as well. That, of course, is a later phase of an RPM program that many healthcare organizations have already launched.
Pick the Right Signals From the Noise
But Renown is taking things slowly, starting inside the hospital. Slonim says he wants to get the framework down first, making sure that the program is tracking the right things and that his care teams are getting the information they need to improve outcomes.
"There's a lot of noise out there, and we have to pick the right signals from the noise," he says. By starting small and including all patients, his care teams have an opportunity to develop their own workflows and protocols, establishing guidelines that work for them and use the resources they have at hand. They'll map out what data is important for patients with specific health concerns, then determine how and when to shift from passive monitoring to a phone call or telehealth visit, and when in-person or emergency care is needed.
"Don't think of this as an isolated piece of equipment," Slonim says, fingering the patch he keeps on his desk at all times. "This is part of a much bigger series of programs."
To that end, Slonim's RPM strategy involves short, targeted pilot projects. The inpatient program will end at the end of this month, at which point they'll look to try out the program in the emergency department, as well as a rural location. Down the road they'll be launching pilot programs with skilled nursing facilities or assisted living complexes, and eventually they'll move this platform into the patient's home.
Slonim sees Renown Health as the ideal testbed for a long-term RPM strategy. The health system is in northern Nevada, a decidedly rural part of the country, covering a 100,000-square-mile area and serving roughly a million people as the only network between Salt Lake City and Sacramento. Healthcare here is local, and a trip to a specialist might take several hours. Care providers must have the resources at hand —physically or virtually—to provide patients with the care they need.
That formula has changed as well in recent years. Slonim, who was appointed by then-Nevada Governor Steve Sisolak in 2018 as a commissioner on the Patient Protection Commission, a statewide task force focused on improving healthcare access, affordability, and quality, wants to move beyond the episodic-based healthcare model to one that embraces population health and wellness. RPM fits that model by giving care providers the opportunity to collaborate with patients on their care, addressing needs as they come up, and promoting lifestyles and habits that improve overall health.
"We can't think of it as encounter-based care anymore," he says, "because it's a public health approach."
Looking Beyond Data Collection
It's also part of an integrated model of care, he adds, that encompasses "pre-acute care," or services delivered to people before they become sick enough to require a trip to the doctor's office, clinic, or hospital. RPM's one big selling point so far is that it can help health systems prevent hospitalizations, especially for preventable health issues, for which hospitals can be penalized.
Slonim also wants to ensure that all the pieces are in place for scalability and sustainability. While the potential for RPM is clear, the process must be tied into measurable improvements, be they reduced costs or better clinical outcomes. And it takes a while for RPM programs to gather that data and prove the premise.
That's also why the Centers for Medicare & Medicaid Services has been slow to recognize and offer reimbursement for RPM: the agency first offered CPT codes for "remote physiological monitoring" in 2019 and has only recently proposed additional codes for what it calls "remote therapeutic monitoring." Advocates expect the coverage will increase as health systems issue studies and reports on how their RPM programs have worked over a period of time.
Slonim sees his short, focused RPM pilots as ideal for gathering that data. And he's not interested in waiting for proof of value.
"At some point, I can sit and wait for CMS to make the change to deliver funding for me," he says. "Or I can go ahead and do all the right work and show them the value add."
So, this is just the first step on the journey, one that Slonim expects will expand up and out as his health system experiments with and finds new uses for the technology. These tiny, coin-sized patches, he says, will open new pathways to patient care, giving patients and their care providers more opportunities to connect and collaborate beyond the traditional visit to the doctor's office.
The US Food & Drug Administration will permanently allow people to receive abortion-causing medications by mail, as long as they've first had a telehealth examination by a doctor.
The US Food & Drug Administration has announced it will permanently allow patients to receive abortion-causing medications by mail following a telehealth examination.
The agency’s action expands access to abortion services for women who face barriers to in-person care, and places telehealth squarely in the middle of the ongoing abortion debate. It comes as the Supreme Court reviews abortion laws and conservative states move to make it illegal.
The FCC had expanded access to the abortion-caused drug mifepristone during the pandemic, allowing care providers to meet with patients via telehealth instead of in person, then issue prescriptions via mail. The US Supreme Court blocked that measure in March 2021, putting back into place FDA guidelines that required doctors and patients to meet in person before any medications could be prescribed.
This past April, the Biden administration announced it would lift its restrictions on the use of mifepristone by changing the way the drug is classified. Mifepristone was approved for use in 2000, but shortly afterward was placed on the FDA’s Risk Evaluations and Mitigation Strategies (REMS) protocol, which requires that drugs determined to be risky be dispensed in a healthcare setting under the direct supervision of a certified care provider, and that patients be advised of the drug’s dangers. This week’s ruling now lists the drug as “safe and effective when used to terminate a pregnancy in accordance with the revised labeling.”
Demand for medication abortions had been growing, due to aggressive efforts to shut down clinics and outlaw the procedure and the stresses placed in in-person care by the pandemic. According to the Guttmacher Institute, almost 40 percent of all abortions were conducted with medication in 2017, up from only 5 percent in 2001.
Telehealth advocates and pro-abortion rights groups like Planned Parenthood have long argued that telehealth should be a part of abortion care, by allowing providers to conduct medication abortions and remotely monitor patients, because many women in underserved and rural areas don’t have access to in-person treatments.
A partnership between a telehealth company specializing in mental healthcare and a biotech company will use remote patient monitoring to monitor patients with mental healthcare needs and develop new treatments for them.
Two digital health companies are launching an ambitious remote patient monitoring program aimed at monitoring people with mental health concerns at home and developing new medications to help treat them.
Cerebral, a telehealth company focused on mental health services, is partnering with biotech company Alto Neurosciences on a “precision psychiatry” program that aims to improve how medications and other treatments are tested and developed for patients. The two plan to launch a series of home-based clinical trials next year that use telehealth and mHealth tools to monitor participants, then tailor new medications or treatments based on the data they receive.
“Our goal is to identify who is responsive to our investigational medicines to move quickly towards registration supportive studies,” Adam Savitz, MD, PhD, chief medical officer of Los Altos, CA-based Alto Neuroscience, said in a press release. “Ultimately, this accelerates our ability to develop targeted medicines more efficiently and help patients get better faster. This partnership represents the beginning of upending the nature of mental health clinical trials moving forward as we work to better serve a greater breadth of patients at an unprecedented speed.”
“Delivering accessible, cutting-edge care is of utmost importance to us and we’re proud to offer our members at-home access to clinical research,” added David Mou, MD, MBA, chief medical officer of San Francisco-based Cerebral. “Working to match each member with the right medication for their unique biology is completely novel in psychiatry, and if successful, this precision approach will completely disrupt the current treatment paradigm in mental healthcare. As one of the largest mental health providers in the world, we look forward to bridging the gap between innovative drug discovery and commercial scalability in order to help millions suffering from mental illnesses.”
The partnership takes advantage of the fast-growing RPM field, which healthcare organizations and companies have been embracing over the past few years in a bid to shift both healthcare and research out of the hospital, clinic and lab and into the home. The platform allows organizations to treat patients where they are and access a larger, decentralized pool of people for clinical tests.
Officials say the programs will enroll 200 to 300 participants from Cerebral’s network and use a mobile electroencephalography (EEG)) device to measure brain activity, as well as other wearables to monitor cognitive and emotional functions, sleep and activity and genetics. Virtual visits will also be scheduled with the participants before and after the trials.
The first trial, slated to begin in January 2022, will focus on people who have failed at least one prior treatment for major depressive disorder and will focus on the ALTO-300 drug developed by Alto Neurosciences. Subsequent studies will focus on other treatments and mental health concerns, such as PTSD.
“In addition to the brain biomarker evaluations, patients will also be assessed on clinical outcomes, such as depression or PTSD scales, to evaluate the overall improvements,” officials said in the joint press release. “Alto will leverage their analytical approach to predicting patient outcomes to determine whether a certain biomarker best identifies patients who are most likely to benefit from the drug candidate being evaluated. The results from these studies are expected to inform the design and implementation of studies that will potentially support FDA approval of novel psychiatric medications and companion biomarker diagnostics.”
Healthcare management software provider Kronos has notified clients, including those in healthcare, that a Dec. 11 cyberattack knocked down several platforms.
Kronos has advised clients that a ransomware attack has disabled several of its cloud-based platforms, including its UKG Workforce Central, UKG TeleStaff, Healthcare Extensions, and Banking Scheduling solutions.
In a Dec. 13 blog, officials at the Massachusetts-based provider of workforce and healthcare management software said the attack was first noticed on Dec. 11.
“As we previously communicated, late on Saturday, December 11, 2021, we became aware of unusual activity impacting UKG solutions using Kronos Private Cloud,” the blog reads. “We took immediate action to investigate and mitigate the issue, and have determined that this is a ransomware incident affecting the Kronos Private Cloud—the portion of our business where UKG Workforce Central, UKG TeleStaff, Healthcare Extensions, and Banking Scheduling Solutions are deployed. At this time, we are not aware of an impact to UKG Pro, UKG Ready, UKG Dimensions, or any other UKG products or solutions, which are housed in separate environments and not in the Kronos Private Cloud.”
“While we are working diligently, our Kronos Private Cloud solutions are currently unavailable,” the notice continues. “Given that it may take up to several weeks to restore system availability, we strongly recommend that you evaluate and implement alternative business continuity protocols related to the affected UKG solutions. Support is available via our UKG Kronos Community and via our UKG Customer Support Team to provide input on your business continuity plans.”
Kronos has many clients in the healthcare sector, as noted by the American Hospital Association.
“A lack of the availability of those services could be quite disruptive for healthcare providers, many of whom are experiencing surges of COVID-19 and flu patients,” John Riggi, senior advisor for cybersecurity and risk, said in an AHA press release. “We have received several reports from the field indicating that some hospitals and health systems have been impacted by this ransomware attack against Kronos.”
“This attack once again highlights the need for robust third-party risk management programs that identify mission-critical dependencies and downtime preparedness,” he added. “If mission-critical third-party services are made unavailable due to a cyberattack, it may result in disruptions to hospital operations. As such, we urge all third-party providers that serve the healthcare community to examine their cyber readiness, response and resiliency capabilities.”
When the pandemic hindered care for their ICU patients living with diabetes, nurses in an Ohio health system took advantage of new technology and a federal waiver to solve the problem.
With COVID-19 reducing contact with patients in the ICU, nurses at The Ohio State University Wexner Medical Center found they couldn't manage daily care for their charges living with diabetes. So, they got creative.
Nurses in the medical ICU (MICU) at the Columbus health system partnered with diabetes nurse practitioners to create a digital health-based process that allows nurses to monitor patients' blood glucose levels and administer insulin from outside the patients' rooms.
In doing so, they took advantage of two fast-growing segments of the healthcare innovation space: a booming industry in digital health tools and devices for chronic care management, and a population on the front lines of healthcare in desperate need of new technologies and workflows to improve patient care.
"Nurses are innately innovative," says Hunter Jefferis, MSN, RN, CCRN-K, MICU nurse manager at The Ohio State University Wexner Medical Center. "At the onset of the pandemic, [the] crisis accelerated innovation, driven by a need to protect and support our critical care nursing teams. Through collaboration with our endocrinology team, we seized the opportunity presented by the FDA to develop a hybrid protocol for continuous glucose monitoring for our COVID+ hyperglycemic patients in the ICU setting."
The process recently earned the health system’s University Hospital and nearby Ross Heart Hospital the 2021 Magnet Prize from the American Nurses Credentialing Center (ANCC). As a result, the nurses are in the midst of a multi-site, retrospective study with other health systems that are using the protocol.
"It is truly a testament to our profession that despite the challenges we all face with the COVID-19 pandemic, we are able to remain resilient and create innovative solutions to enhance the care for our patients," Jacalyn Buck, chief nursing officer at Ohio State Wexner Medical Center, said in a press release announcing the award. "This groundbreaking innovation designed by my team has made a lasting impact on the care for COVID-19 patients with hyperglycemia and will continue to improve care for many more."
In creating this new treatment plan, the nurses drew upon home-based blood glucose monitoring tools and platforms that have been in use for years. The consumer-facing digital health market has created a vast number of devices and mHealth apps that allow those living with diabetes to monitor their blood glucose levels—in some cases without invasive finger pricks—and deliver insulin, sometimes through devices attached to the skin.
Laureen Jones, a clinical nurse specialist at the health system, says those continuous glucose monitoring (CGM) systems have only been permitted by the U.S. Food and Drug Administration for outpatient use. However, with the pandemic affecting workflows within hospitals, the FDA issued a statement in April 2020 allowing CGM use in the inpatient setting for the duration of the public health emergency.
Within a month, she says, the health system had created a multidisciplinary team and developed the workflow to replace the traditional process of finger sticks every hour and insulin administered based on those readings. The first patient received a device on May 12, 2020.
"The nurse places a sensor and transmitter on the patient, which emits a signal to a receiver that is placed outside of the patient's room that continually displays a blood glucose reading," Jones explains. "This, along with an externalized IV pump, allows the nurse to assess and treat the patient with hourly IV insulin without having to make an unnecessary trip into the room. This saves the nurse exposure and conserves personal protective equipment as the required trips into the room to treat the patient with insulin is reduced from 24 times to four times a day."
"As we have developed a hybrid protocol, the device is initially validated with every patient and allows for continued validation every six hours with a point-of-care blood glucose to confirm its accuracy," she adds. "This protocol has mitigated any risk that would be associated with device capabilities and has proven to be safe for the patient."
Officials noted the FDA hadn't—and still hasn't—approved CGM for inpatient use because of concerns about the reliability of the data coming from those devices. If that information isn't accurate, a patient might get too much insulin, resulting in hypoglycemia, or the patient might not get enough insulin, which leaders to hyperglycemia. In both cases, the patient could slip into a coma and die.
"In order to ensure safety, we worked with a multidisciplinary team to create a hybrid protocol that ensured the CGM accuracy was validated initially using fingerstick in each patient, and then accuracy was assessed with finger sticks every six hours," says Eileen Faulds, PhD, MS, RN, FNP-BC, CDCES, an associate professor at The Ohio State University College of Nursing and diabetes practitioner at the hospital. "This allowed us to greatly reduce the frequency of nursing contact while ensuring patient safety."
"These outpatient CGM systems transmit data from a transmitter that is connected to a sensor worn on the patient's skin," she says. "The transmitter sends data to a receiver, which can be a small, free-standing device or the Dexcom app on a mobile phone. While the manufacturer says the devices will transmit data up to 20 feet, the team had concerns about the system's ability to transmit data through MICU walls and glass enclosures. The team tested the radius of transmission and any physical barriers ahead of launching the system. When the phones were used to capture and display glucose data, the data could be transmitted to a cloud-based server that allowed the diabetes team to view the data remotely."
"In order to protect patient identity, dummy or anonymous accounts were created and authenticated with dummy emails for each patient," she adds. "This created a unique anonymous data stream for each patient. Additionally, we asked nurses to annotate 'CGM' in the electronic medical record when they documented a CGM glucose value, so we could distinguish finger stick point-of-care from CGM glucose values."
According to Faulds, nurses reported that the new technology helped to improve workflows and efficiency. They also liked that the platform continuously monitored patients' blood glucose levels, displayed trends for each patient, and was set to issue alarms if those trends were dangerous. This, in turn, reduced stress on the nurses.
The FDA action to allow inpatient CGM treatment is one of hundreds taken by state and federal regulators during the pandemic to expand the use of and coverage for telehealth and mHealth tools and platforms. Many of those measures will stop with the end of the public health emergency, which is now expected to take place in 2023.
Health system executives worry that unless these measures are made permanent, hospitals will have to shut down telehealth programs, forcing providers to go back to the old way of doing things and leaving patients struggling to adapt to new and less effective care. With that in mind, telehealth advocates—including organizations like the American Telemedicine Association and Alliance for Connected Care, telehealth vendors and a number of large health systems—are lobbying both Congress and agencies like the FDA and Centers for Medicare & Medicaid Services to make those emergency measures permanent.
Philadelphia's Jefferson Health is one of many healthcare organizations using mHealth platforms and virtual visits to address the soaring rate of stress, anxiety, depression and burnout among staff and employees.
A Philadelphia-based university and health system is launching a digital health platform to help students and staff access behavioral health and self-care resources.
Thomas Jefferson University and Jefferson Health announced earlier this month that it would make the NeuroFlow mHealth app and platform available to “employees, faculty and students across Jefferson’s university, clinical and corporate services settings.” The platform developed by NeuroFlow, a Philadelphia-based startup, offers digital access to surveys, reminders, symptom trackers, exercises and other tailored content aimed at helping people dealing with behavioral health concerns.
“COVID-19 challenged healthcare workers across the world like we have never seen in our lifetimes,” Jefferson Health President Bruce A. Meyer, MD, MBA, said in a press release. “This was something our employees asked for, and we believe this partnership, in addition to an expanded program for prioritizing holistic health and well-being, can make a true difference whether on the job or at home with family members.”
With stress, depression, anxiety, and burnout surging across the country, especially in healthcare settings, healthcare organizations are beefing up their support services or launching new programs aimed at giving employees access to on-demand help, either in person or through virtual platforms. This might include virtual visits with behavioral health specialists, mHealth apps that connect to resources, even platforms that enable the user to manage his or her own care and connect to counselors when needed.
Jefferson Health deployed the NeuroFlow platform to patients in the 14-hospital system in 2019, and began making those services available to students this past summer. The health system also conducted a pilot program with some 1,000 employees, and found that participants were completing, on average, 20 activities during their first month.
Healthcare administrators say digital health tools not only allow staff to self-manage and move at their own pace, using resources tailored to their concerns, but also allow the organization to expand its reach and push resources where they’re most needed – either in terms of treatments needed or areas where employee stress and burnout is high.
A review of published studies by Canadian researchers finds that a video-based telehealth program offers similar clinical outcoes as in-person care, while improving efficiencies and boosting patient satisfaction.
In an analysis of 24 telehealth studies published between 1997 and 2020 in 10 countries, researchers from St. Michael’s Hospital of Unity Health in Toronto and the Ontario-based University Health Network found the telehealth has been used to effectively facilitate care for patients in various stages of CKD. More recently, they found that programs are using consumer-based technology and devices, including wearables, to improve access for people who have difficulties getting to a clinic or hospital.
According to the research, video-based telemedicine platforms not only produced comparable clinical outcomes to in-person care, but also improved workflows and increase patient satisfaction.
“This is encouraging, but as the latest technologies are streamlined into routine health care, the ‘digital divide’ will become more pronounced, negatively impacting those without access to broadband internet connections, video-capable devices, and those with limited technology literacy,” Stephanie W. Ong, BScPhm, MSc, of the University Health Network, said in a statement issued by the American Society of Nephrology. “This is an area that deserves further study.”
Many healthcare providers shifted from in-person care to virtual care during the pandemic to reduce stress on hospitals and clinics and cut down on chances of transmitting the COVID-19 virus. Providers often found themselves trying telehealth for the first time or experimenting with new platforms and tools during this time.
With healthcare organizations looking to resume in-person care as the pandemic wanes, many of those providers are asking to be allowed to continue using telemedicine, or to at least create hybrid platforms that can support both in-person and virtual care. Specialists, including nephrologists, are particularly keen on embracing telehealth to improve care management and coordination for patients who would prefer more services in the home.
“The nature of CKD care makes it particularly amenable to virtual care given that relevant history, review of laboratory investigations, and counselling can all be conducted via virtual platforms,” Ann Young, MD, PhD, of St. Michael’s Hospital of Unity Health, said in the ASN statement. “The main obstacle of virtual care is the lack of a physical exam. Virtual visits are a powerful tool, but in certain clinical settings, a physical exam is necessary. Finding the appropriate balance between virtual visits and in-person visits is key.”
In the study, Ong also cautioned that some patients might not have the resources to acquire telemedicine technology or the broadband to use it. She worried that too much of an emphasis on digital health tools could exacerbate the digital divide, further distancing patients from the care they need.
“This is an area that deserves further study,” she said.
An editorial written by physicians from George Washington University in Washington DC and a patient perspective authored by Julie Glennon of West Palm Beach, FL, accompanied the study. Both cited concerns for patients unfamiliar with the technology or who lack access to broadband or equipment, but felt that the benefits could outweigh the challenges.
“Patients can benefit from access to their care providers, receive multidisciplinary care, include distant relatives in visits, and have the convenience of staying at home,” GWU physicians Susie Lew, MD, and Neal Sikka, MD, wrote in their editorial. “For those that are skeptical about telehealth, we feel that a telehealth visit is better than no visit at all for a new or existing patient.”
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