The study, involving 476 patients recruited through 18 health systems, was done on a completely virtual platform, with researchers communicating with and collecting data from patients through an mHealth app and online portal. It may serve as a model for future clinical studies.
Researchers at Henry Ford Health are celebrating the results of a multi-institutional heart failure study that was conducted entirely on a virtual care platform, saying it could be the model for future clinical studies.
Some 476 patients were enrolled in the study through 18 participating health systems between March 2020 and February 2021 – during the height of the pandemic, when every effort was being made to reduce in-person treatments. Researchers connected with study participants through an mHealth app and online portal, where they communicated with patients and collected data from surveys and Fitbit devices. Medications used in the study were mailed to the participant's home.
“What this study demonstrated is that you can execute a virtual clinical trial with greater efficiency than a traditional, in-person trial,” David Lanfear, MD, an advanced heart failure specialist at Henry Ford Health and one of eight authors of a report on the study recently published in Nature Medicine, said in a press release. “This could lead to more people getting involved in medical research because of the convenience of participating from home and the potential for lower costs and faster results.”
The study sought to test the value of a sodium-glucose co-transporter 2 inhibitor (SGLT2i), a newer class of drugs used in heart failure treatment and shown to improve clinical outcomes. It also looked at how these drugs could be applied to patients at home, how it might affect their quality of life, how patients could report their own data and observations through a connected health channel, and how patient-reported outcomes might affect treatment and results.
"The costs of conducting clinical trials have risen substantially over time, leading to calls for novel study designs to generate the evidence needed to guide care," Lanfear and his colleagues said in the report. "A large component (up to 50%) of these costs is the burden of data collection on sites, which have nearly quadrupled from 1990 to 2010. The ongoing Coronavirus Disease 2019 (COVID-19) global pandemic further highlighted the challenges of traditional study designs that depend on in-person visits and resource-intense data acquisition and verification. In response to the growing demands to make clinical trials more pragmatic, novel study designs have been implemented, from leveraging existing registries for data collection to the use of electronic health records to identify, enroll, randomize and follow-up eligible patients. Although the innovation of eliminating in-person clinical trial visits has been proposed, it has not, to our knowledge, been tested on a large scale."
Lanfear and his colleagues said the virtual study may have been "the first randomized drug study of its kind in cardiology." It could also set the bar for clinical studies by eliminating geographical barriers to patient recruitment, allowing healthcare organizations to find the right participants no matter where they live. And the platform allows researchers to better understand how patients are affected at home, and in their daily lives and routines, while gathering biometric and other data in real time.
“Improving symptom burden is one of our main goals for managing heart failure patients,” he said in the press release. “Clearly, what this study showed is that these agents have meaningful impact on patients within just weeks of starting treatment, which we were able to prove using a virtual research approach.”
The platform also reduces barriers to participation for patients. Lanfear noted enrollment for this study was roughly five times faster that in traditional in-person heart failure clinical trials.
The Illinois-based health system created the innovative program during the pandemic to identify patients infected with COVID-19 and steer them to the right resources. Now it's expanding the platform to help identify underserved populations and the resources they need to improve health and wellness.
OSF Healthcare is expanding an innovative data platform developed during the pandemic to help health clinics, primary care providers and others identify Medicaid members at risk of poor health outcomes and the resources they need to improve their health.
The Peoria, Illinois-based not-for-profit Catholic healthcare system is making OSF Community Connect available to a wider range of providers in an effort to tackle social determinants of health that affect residents in surrounding communities. The tool was developed by the OSF Innovation Data Science and Advanced Informatics Lab to "help the ministry prioritize care and resources for the most affected communities."
“The solution was born out of the pandemic as a way to support OSF community health workers (CHWs) who were digitally connecting with COVID-19 patients to assess their conditions, provide education and refer them to a provider when needed,” Roopa Foulger, OSF's director of the data lab and vice president of digital innovation development, said in a recent press release. “We discovered it could also be a way to reach out and maintain relationships with under-resourced communities.”
The program is representative of the efforts of healthcare organizations across the country to address barriers to healthcare access and outcomes, especially those with non-clinical origins. They include home and family life, job status, food resources, transportation and geography, cultural norms, even digital literacy, which can impact access to telehealth.
The platform not only combs data to identify patients facing these difficulties, but looks for resources that can help them, such as remote patient monitoring, screening programs, local food banks, credit and family counseling, transportation networks and community centers.
“We’ve essentially built an electronic community health record to integrate data from multiple places,” Foulger said in the press release. “With OSF Community Connect, it should be much easier for us as a healthcare system to identify people in most need of our help, monitor progress and intervene when necessary. We shouldn’t have anyone falling through the cracks because of their social or economic status.”
Supported by a state award, OSF OnCall Digital Health has adapted the program to look for more than just COIVID-19 patients and resources, thus making it sustainable beyond the pandemic. It will also be used to support federally qualified health centers (FQHCs), which will work with CHWs to reach out to underserved communities and populations who often don't seek the care they need or follow up after their primary care visit.
“The possibilities are endless,” Nick Heuermann, a strategic program manager with OSF Innovation, said in the press release. “Users can customize workflows in the platform to identify any patient group they want to focus on. From there, they can use the same tool to positively impact an entire population.”
Health system executives taking part in the recent HealthLeaders Healthcare Workforce of the Future event cite the challenges to staffing an IT department and the rewards in advancing new ideas.
Workforce shortages in healthcare aren't limited to the clinical ranks. Healthcare organizations are also seeing challenges in keeping their IT departments staffed.
Due in part to the pandemic, health systems are adopting (and adapting to) much more technology than they have in the past, from complex electronic health record and imaging platforms to digital health and telehealth tools. They're now facing much more competition than they've seen in the past, including stand-alone clinics, telehealth and virtual health vendors, retail giants like Amazon, Google, and Walmart, and other health systems looking to take their patients.
But executives taking part in the recent HealthLeaders HealthCare Workforce of the Future roundtable, noted there are advantages that make working in healthcare IT an attractive career.
"When we look at talent, we look for those who are wanting to have the culture that we offer, are wanting to work in person, or have a hybrid model because no matter what we offer," said William Manzie, administrative director of telehealth and telehealth strategy at the Memorial Healthcare System in Florida. "If a millennial or someone who just came out of college wants to work from home and make over $200,000 a year, then we're just not the organization for you. We're doing everything right in terms of promoting our culture, promoting growth, promoting opportunities to potential applicants, and that has allowed us to bring in additional talent, but also use our existing talent and grow them for the positions that we're hiring for."
Richert pointed out that as the healthcare industry evolves, IT departments have evolved as well, from helping staff with simple installations and downloads to maintaining an integrated technical platform capable of scaling up and out as needed.
"We're … shifting that mindset from order-taker into a solution partner, and really guiding the organization through a digital roadmap that would help them understand how we're going to scale differently and how we're going to be able to provide care without so much labor in the past," he said. "I think we're now setting a vision for what's possible with digital and partnering more with the organization. That's brought different types of people and skill sets into my organization."
Richardville said the pandemic has highlighted the value of being able to work remotely, even from home. This means he can look a lot farther out for IT talent.
"I think it's here to stay," he said of the hybrid work environment. "And I think that provides a great opportunity … because we could even recruit from around the country, and in some cases around the globe, for talent."
But that can work both ways.
"We have to watch it," Richert said. "With all of our Epic expertise, there's a hospital in New York City that found four of my good Epic people and said, 'We'll pay New York City wages and [you can] just sit in your Missouri home and you'll be fine. So that dimension is there, [and] we have to be aware of it, but we also have to make sure that we take advantage of it ourselves."
Richert pointed out that working in healthcare is different than working in retail, and that culture may help in securing IT talent.
"We're a faith-based organization, and I know the impact of walking amongst the caregivers and being in the hospital lobby and seeing neighbors come through," he said. "It really bonds me to the mission of the organization and the fact that a lot of … our IT coworkers came through the healthcare career path. And so, their identity is with the Mercy organization, [even if] there are other places to make more money than in our organization. We've always had a real strong culture."
"For me, it's probably more about being a professional parent and telling people I'm here to grow and develop you," Richardville said. "[I'm going] to give you challenges and if you're with me for a year, two years, three years, I'm here to grow your résumé, to make you more valuable, hopefully to me, but if not to me, to somebody else."
"I've got 12 CIOs or CDOs in the industry that used to work for me, and I'm just privileged that those people have grown," he added. "It's really [about saying] 'I'll give you the challenge, I'll grow your résumé, I'll make you more valuable to the market, and if I'm able to keep you I'll just continue that. But if there are other opportunities somewhere else, I'm here to help you capture those as well so you can fulfill your life goals.'"
Manzie, like the others, also pointed out that the IT department is changing as the healthcare industry moves from testing and adoption of new technology to scaling and sustaining the best platforms and services. And part of the process is in helping clinical staff understand and embrace these new tools.
"We don't just jump right into a new technology or jump right into the next shiny thing that comes out on the market," he said. "Actually, sadly, it takes us a long time to make a change and be innovative. [Adopting] new telehealth and virtual technologies happens at a slower pace, which allows the existing staff to learn that new skill set, drive some of that change, and manage some of the tasks or the people involved with that change."
"To me that feels like a whole different partnership [and] engagement model with the organization," Richert added. "We're finding key challenges and key areas within the healthcare operations that are embracing that, saying 'this is great, let's do more.' I'm excited over the next few years that we're going to be able to bring those kinds of skills."
"I think it continues to mature and evolve," Richardville said. "We are here to serve and those that we serve are those on the business side and the clinical side. From that standpoint, we've got to make sure that we understand that we aren't doing technology because it's cool, and it's fancy, and it's kind of neat, but we actually have measurable outcomes that are happening at the end and we're helping our caregivers provide a higher quality product, a better patient experience, at maybe a more efficient, effective way."
"And that's what we're here to do," he concluded. "I think that part of our job is to continue to educate so that people know that those things are out there and aren't threatened. We need to engage, make that part of us, with more ideas and thought leadership. It can't just come out of technology; it's got to come out of the people that are actually doing the work."
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The Association for Community Affiliated Plans, which represents 74 not-for-profit Safety Net Health Plans serving 22 million people across the country, is highlighting innovative research and programs aimed at addressing the non-clinical barriers to healthcare access and outcomes.
The Association for Community Affiliated Plans (ACAP) has launched a new resource aimed at helping not-for-profit Safety Net Health Plans understand and take on non-clinical challenges and barriers to healthcare access and outcomes.
The ACAP Center for Social Determinants of Health Innovation offers resources, including policy reports, research and educational events, to help the nation's 74 health plans, who serve more than 22 million low-income people with complex healthcare needs through Medicare, Medicaid, marketplaces and other health coverage programs.
“Longstanding racial inequities cannot improve without meaningfully addressing the social factors underlying them,” Margaret A. Murray, ACAP's chief executive officer, said in a press release. “Safety Net Health Plans have worked in communities across the United States to address factors that shape their members’ health for decades."
Studies have shown that roughly 60% of health outcomes are caused by non-clinical factors, including physical and social environment, cultural concerns, economic and family issues and access to housing and health food.
"This new center creates unique opportunities to showcase what works, share that knowledge with others, and support a healthier future for people with low incomes, whose wellbeing has too often been held back by their environment,” Murray said.
An initiative launched in 2021 out of the University of Chicago Health Labs has released recommendations aimed at upgrading the nation's 54-year-old 911 Emergency Response System, including developing technology and training standards and creating a Cabinet-level post to oversee the network.
A collection of healthcare stakeholders has released a policy blueprint aimed at updating and improving the nation's 911 Emergency Response System, with recommendations that range from establishing a Cabinet-level position to setting standards for new and innovative technology.
Transform911, an initiative launched in 2021 with more than $1 million in funding, led by the University of Chicago Health Lab and comprised of more than 100 stakeholders, has unveiled six key recommendations, the result of 18 months of meetings and research into the 54-year-old emergency response network.
“It’s clear that the times call for the most comprehensive overhaul of the nation’s 911 system ever, to ensure that the right professional responds to an emergency call at the right time,” S. Rebecca Neusteter, PhD, executive director of the University of Chicago Health Lab and principal investigator of Transform911, said in a press release. “Recent events highlight that policymakers at all levels of government must identify, debate, and implement changes to the emergency response system. It’s a matter of life or death.”
The group has issued the following recommendations:
Create a Cabinet-level position within the US government to report to the President on urgent 911 improvements;
Create a federal task force to set standards for new technology, including digital health and telemedicine platforms and tools, and addressing such concerns as security and privacy of 911 calls and data;
Create protocols for training and access to technology to ensure that the nation's 911 workforce is well-resourced and trained;
Create a separate governance structure for 911 centers so that they're independent and equal to police, fire, EMS and other public safety entities, giving them the autonomy to address and report on public safety issues as they see fit;
Integrate community perspectives into 911 policies so that 911 centers can better understand and build relationships with different members of the community – especially minorities, who may not trust the system or believe it's equitable; and
Re-introduce the 911 network to the American public, with an awareness campaign that highlights the training and capabilities on 911 centers and tackles the misconception that "911 is a switchboard service staffed by operators."
According to the group, the nation's more than 6,000 911 centers function through a patchwork of governance structures over seen by local, state, and federal agencies. There are no common standards at present for how these centers select and train their staff, use technology, collect and report on data, or ensure quality and security. This also means there isn't that much federal support or funding to make improvements.
Much has changed in the half-century that 911 centers have operated, including recent efforts to better determine who should be dispatched to 911 calls (for example, replacing police as first responders with trained mental health crisis professionals or – in mobile integrated health programs - specially trained paramedics).
New technology is also improving the 911 process, through telemedicine platforms and digital health tools that enable 911 centers to coordinate emergency care through virtual channels, bypassing a trip to the ER when that's not the best option, or enable first responders to access resources and connect with healthcare specialists.
“The time to update and transform the emergency response model in the United States is now,” Walter Katz, vice president of criminal justice at Arnold Ventures, a philanthropy that is helping to finance Transform911, said in the press release. “Local communities and the country need a comprehensive, transparent, and innovative approach to strengthen the 911 system. These recommendations help establish a more effective, equitable, uniform emergency response that protects public health and safety.”
Along with Arnold Ventures, the group is supported by the Microsoft Justice Reform Initiative, the Sozosei Foundation, and the Wagner Foundation. Other partners in the project include Code For America, the Full Frame Initiative, the New York University School of Law's Policing Project, and the Research Triangle Institute (RTI) Center for Policing Research and Investigative Science.
The Delaware health system and two digital health companies have joined forces to create a digital health platform that will allow college students to access a wide range of services, including primary care, physical rehabilitation and mental health and substance abuse care, from their computer or mobile device.
ChristianaCare is launching a bundled virtual care program aimed at helping college-aged students easily access a wide range of healthcare services ranging from primary care and physical therapy through mental health and addiction treatment.
The Delaware health system is partnering with digital health providers PursueCare and SimpleTherapy to create the program, which offers a single digital portal, accessible via an mHealth app on mobile devices and computers, through which students can connect with internal and family medicine providers from ChristianaCare's Center for Virtual Health.
The platform will also allow students to access mental health, psychiatric and medication-assisted treatment providers affiliated with PursueCare and physical therapists affiliated with SimpleTherapy and specializing in musculoskeletal care, acute or chronic pain management, and strength and mobility training.
The new program targets students who have problems accessing healthcare, particularly for sensitive issues like mental health concerns are substance abuse. They may be far from home, unable to get in touch with their primary care provider and either too busy or hesitant to visit the health center on campus.
“When college students are able to access medical, behavioral health and musculoskeletal services through their phone or laptop, from their dorm room or a private space on campus, they’ll be more likely to get help when they need it," Sharon Anderson, MS, RN, FACHE, ChristianaCare’s chief virtual health officer and president of ChristianaCare’s Center for Virtual Health, said in a press release. "This is about delivering care to students on their terms, so that they can be healthy and supported with high-quality care throughout their college experience.”
The program also fits a need for colleges and universities who are struggling to address a nationwide surge in mental health and substance abuse cases, and an increase in student suicides. While many are beefing up services through their health center, digital health and telehealth partnerships with health systems and specialty care providers offer another avenue to improve access to care.
“For college and university student health services and administrators, this partnership offers a powerful new way to provide comprehensive, affordable health solutions that benefit students,” Anderson said. “In a highly competitive recruiting environment, these solutions are easy to implement and can add tremendous value."
The platform enables students to access digital health resources, assessments and virtual care modules at any time, as well as connecting via a telemedicine portal to care providers. They'll also be able to use the PursueCareRx portal for pharmacy services.
Participating colleges and universities will be able to offer the branded program to students for a flat fee, enabling them to access the portal whenever and as many times as they need help.
The program is currently licensed to operate in Delaware, New Jersey, Pennsylvania, and Maryland, with plans to expand to other states.
Henry Ford Innovations is partnering with digital health company Exo to apply digital health concepts to ultrasounds, with the goal of making them more portable and accessible to underserved populations.
Henry Ford Health is partnering with a digital health company to make ultrasounds more portable and accessible.
Henry Ford Innovations, the Michigan-based health system's innovation arm, is working with Exo, a California-based developer of point-of-care ultrasound (POCUS) technology with a connected software platform. The project aims to bring ultrasounds, which are traditionally conducted in hospitals and medical offices, out to remote and underserved communities, where they can tackle traditional barriers to care.
"We envision a future where handheld portable ultrasound is as ubiquitous as the stethoscope, only more accurate and more capable," Dan Siegel, MD, a musculoskeletal radiologist and vice chairman of radiology quality and informatics at Henry Ford Health, said in e-mail. The technology, he said, would be "able to provide quantitative data and faster, more automated assessment for our patients and providers."
"Through this partnership, we are focused on improving [three] things," he said. "The first is education and training, making sure that all users who have a handheld probe are appropriately trained and credentialed to do appropriate high-quality scans. The second is system-wide standardization, where any clinical scan is performed according to appropriate parameters, annotated and documented in a standardized high-quality method, and stored in a common environment that is easily accessible by any provider or the patient. And finally, to research advanced techniques using machine learning and AI to automate or accelerate the acquisition of images, quantitative assessment of those images, or the automated interpretation of those images to make the learning curve faster for novice users, or users in non-traditional environments [such as] home care and remote medicine."
Siegel said POCUS technology allows care providers to treat patients more comfortable and quickly and wherever patient and provider are located, speeding up the diagnosis and the care plan.
"Instead of having to wait for additional test results, providers can use what they have in their pocket to get near-instantaneous data that can inform clinical decisions right at the point of care," he said. "This is already happening with home care and the mobile integrated health program, helping decide at the point of care in patients' homes whether they are safe to stay at home or not."
"We really see this as just scratching the surface," he concluded. "Ultrasound is such a powerful tool, and the technology continues to get smaller, with higher image quality and less cost. We really do believe this will be the stethoscope of the future, and as more and more young and early-stage clinicians (and students) become familiar with the tool, we will see more and more research around what can be done in novel and unusual clinical settings. All of this will produce substantial benefits for our patients and providers, and for the system as a whole."
The Florida-based health system will use the wayfinding platform to create the foundation for a more extensive patient portal.
Being a kid, or a parent of a kid, in a hospital is an extremely stressful experience and pediatric hospitals are turning to innovative technology to reduce that tension.
At the Nicklaus Children's Health System in Miami, officials have introduced a wayfinding platform and accompanying app to help patients and visitors find their way around the 309-bed hospital and associated care sites, such as doctor's offices and urgent care centers. The resource not only maps their healthcare journey, but helps them locate such amenities as the cafeteria, gift shop, pharmacy, restrooms, and even ATMs.
Hospital leadership says the wayfinding platform is a first step—literally and figuratively—toward a much larger digital health experience.
"This is how we become a connected healthcare provider," says David Seo, MD, the health system's vice president and chief digital and information officer. "We have been wondering how can we use digital health technology to improve the experience for families, and this is our initial foray into that digital experience."
The health system is partnering with Atlanta-based Gozio Health on the platform, accessible through the MyNicklaus App. The platform uses digital health technology similar to a GPS system to give users turn-by-turn directions to their destination, whether it's down the hall or another building on the other side of the city.
While health systems try to make it as easy as possible to get around—think color-coded lines on the floor, maps, signs, and information booths—they can only do so much for what are often stressed-out visitors. And the typical healthcare campus or system has grown, encompassing multiple buildings and sites.
Wayfinding platforms, which can be accessed on a visitor's smartphone or tablet, can be an invaluable resource, and a strong statement toward improving the patient experience. They not only help put visitors at ease but help ensure that patients make scheduled appointments, ensuring care management plans are met, and physician workflows aren't interrupted.
At Nicklaus Children's, Seo sees the platform as the foundation for a much more intricate patient portal, one that can serve as the patient's front door to healthcare.
"This can be more than just a platform for wayfinding," he says. "There's a lot that we can connect to this to improve the patient experience. We are in the midst of a massive consumerization of healthcare … and this is what people have come to expect from us. We want their experience to be as smooth and frictionless as possible."
Nicklaus Children's isn't unique in this strategy. Many health systems across the country are using a tiered approach to developing a patient portal, so that they don't overwhelm either their patients or their staff with new technology and services. The idea is to roll out one service, such as wayfinding, allow some time for everyone to get used to the platform, then gradually add other services to that platform.
"This is our initial foray into the digital experience for patients," Seo says. "We want to make sure we get this right before we move on."
That means making it as convenient for the staff as for the patients. Seo says a wayfinding platform had always been a priority for hospital staff, not just for their own use but as a tool for improved patient engagement. Care providers have a vested interest in making sure patients get to where they need to be in the healthcare system, to reduce the stress and annoyance of missed appointments and to make sure patients are on the best care management path.
Success will be measured in use. Seo says the health system will be keeping close tabs on who uses the platform, how often, and whether it gets people to where they need to be (measured, of course, in the number of no shows and late arrivals for appointments.) They'll also make sure the platform is accurate, in that it's giving detailed and accurate directions and not sending anyone astray. That means making sure every location in the health system is accurately mapped, the cafeteria is open, the ATM or the bathroom is actually right around the next corner, and the doctor's office is where it should be.
"It's not as simple as it seems," says Seo. "It's complicated, and it needs to be intuitive. We need to make sure the overall platform is very contextually aware of [how the health system delivers healthcare services.] It's important that this be a part of how we conduct business, not just be an add-on."
Once both visitors and staff get used to using the app to find their way around the health system, Seo says they'll look to add other services, such as registration, health records access, insurance verification, communications and scheduling tools, even virtual visits. He wants this to be a portal, through which patients and their families access information, talk to care teams, and schedule their visit to the health system before it takes place.
"This is what we're moving toward in healthcare," he says. "This is what people are beginning to expect, and we want to give them that intuitive, seamless experience."
Researchers at the University of Michigan, analyzing Medicare data through 2021, are reporting that the traditional Medicare population used telehealth during the pandemic to access care, but they haven't been overusing the platform.
A popular criticism of telehealth is that people will be using it more than they should, leading to unnecessary healthcare appointments and expenses. But researchers at the University of Michigan say that's not true in the Medicare market.
An analysis of Medicare data through 2021 finds that while virtual visits have increased considerably as a result of the pandemic, with roughly one-third of traditional Medicare members taking part in at least one telehealth visit last year, those numbers aren't excessive. This means that the Medicare population, comprised primarily of older Americans, is using the platform to replace in-person care, rather than just because they can.
“As telehealth use hits its stride in the Medicare fee-for-service population, the fears that flexible telehealth rules might lead to an increase in the total volume of outpatient visits has not panned out,” Chad Ellimoottil, MD, MS, director of the Telehealth Research Incubator at UM's Institute for Healthcare Policy and Innovation and lead author of the study, said in a press release. “With all the evidence we have to date, it appears that telehealth has been used as a substitute for in-person care rather than an expansion of care.”
The distinction is important, especially as the nation moves away from the pandemic and the healthcare industry looks to adopt a long-term telehealth strategy when the public health emergency ends. Advocates say telehealth should be a standard practice of care, comparable to in-person care and regulated along the same lines. Opponents argue the platforms is ripe for misuse and abuse, and that it should be governed more strictly to prevent waste and abuse.
Ellimootil and his colleagues found that about 9% of all outpatient appointments made by people with traditional Medicare coverage were virtual in the latter half od 2021. That represents a decline in virtual visits compared to the time period between mid-2020 and mid-2021, but a large increase compared to prior to the pandemic in 2019.
The surge in telehealth use during the pandemic was helped by a series of federal and state waivers aimed at increasing access to and coverage of telehealth, so that health systems could protect their staff and isolate those infected by the COVID-19 virus from others. Those waivers will end with the end of the PHE, and telehealth supporters want new or revised regulations in place to continue the momentum and allow health systems to continue their programs.
The Center for the Undiagnosed Patient at Cedars-Sinai takes on healthcare's most perplexing cases, and has helped several patients get their lives back.
Healthcare is complex, and not without its mysteries. Sometimes healthcare providers have to be detectives to figure out a diagnosis and treatment.
At Cedars-Sinai, a team of clinicians from a wide range of specialties gathers every week to tackle one particular mystery. They're part of the Center for the Undiagnosed Patient, a specialty clinic launched in 2017 to help patients whose conditions defy identification.
HeralthLeaders recently sat down (virtually) with Leon Fine, MD, a professor of medicine and biomedical sciences at Cedars-Sinai and medical director of the center, to talk about the center's mission. This interview has been edited for length and clarity.
Q. How was the Center for the Undiagnosed Patient launched?
Leon Fine: There was a sense that existing medical diagnostic systems, even in academic medicine, were failing to address a segment of the patient population that was left undiagnosed, frustrated [and] uncertain. There was a substantial level of underlying anxiety [with patients] about their condition due to its chronicity and the inability of the medical community to solve the problem.
So we set up something, and were careful about naming it. We called it the Center for the Undiagnosed Patient, singular, rather than Center for Undiagnosed Patients, plural. There was something quite specific in deciding that, in the sense that each prospective patient would have to have a good sense that we were really interested in them personally, and that we were about to address their problem.
Dr. Leon Fine, medical director of the Center for the Undiagnosed Patient at Cedars-Sinai. Photo courtesy Cedars-Sinai.
Who are these patients? Many have what would be broadly called rare diseases, very infrequent diseases that most doctors haven't encountered. Another group of patients has more traditional diseases: heart failure, lupus, atherosclerotic heart disease, etc., but present in atypical ways. There are also patients with multiple diseases involving multiple organs, called comorbidities. They may have had a presenting symptom that is a single thing, such as chest pain or shortness of breath, but behind that there is a series of diseases which actually could have contributed and have to be taken into consideration.
These are all long-term patients. Many have seen multiple specialists; it's not unusual for patients to have seen more than a dozen doctors, sometimes many more, each one bringing to the table their specific area of knowledge [but not] seeing the whole patient.
The question was, if we were to set up a new entity called the Center for the Undiagnosed Patient, why would any patient want to come and see us? Because we would just be the 12th doctor. Why would they have any more confidence in coming to see us, because they'd already seen so many doctors. That to me was a very central question to be answered.
The answer came with a notion that the only way we could do it was to bring a so-called team approach to the patient. Number one, the patient would access our center, and it was absolutely essential in this age of online medicine that the patient be seen personally. Number two, the leadership team at the center was constituted of generalists and not specialists.
Every patient who was presented would first be considered by a team of at least a half a dozen doctors [who ask] 'Can we possibly help this patient and could the weight of opinion of six talented and capable people have more impact on the patient's belief than just seeing yet another doctor?'
Q.How are the patients screened?
Fine: A patient can access the center online or by picking up the phone and talking to someone. We require that the patient's background information be made available to us. Nowadays that's much easier, because a lot of this information is in the electronic medical record, but in many cases it's not. And in many, many cases, the narrative of what happened to the patient and the timeline was missing. You get soundbites, as it were, of information, and getting the story becomes that much more difficult.
We require a referral from a doctor, because it's much more convincing if the doctor is the person who's providing the information, but we do open the door to patients accessing us directly. The reason is we are not a treating center. We are a diagnostic center. So if we are able to come up with some useful answers, we want to feed them back to someone who can then take that patient by the hand and lead the patient through a whole series of therapeutic options and therapeutic trials.
We have a very talented nurse practitioner (Jennifer Elad, DNP, ACNP) who spends hours, literally, going through the patient's records. There are often hundreds of pages of records that have to be screened. We've even had a patient with a thousand pages of records. It requires many hours to sift through these records, and it's even more difficult to put them into some sort of context, like a three- or four-page summary, which can then be presented to our leadership team.
Along with that summary, [Elad] has also spoken to the patient. A presentation is then made to the group, which consists now of three lead internists, a lead pediatrician, myself, and the associate director, another generalist who has a specialty in pulmonary medicine.
The first question to be asked is, do we think we can be helpful by taking on this patient? If the sense is not really, we don't waste the time of the patient or our own time in pretending or hoping that we can do something. There's a small number of applicants who we tell, "We are terribly sorry, but we do not think we can be help with you."
I should point out that in order to cover the cost of the hour spent going through the record, we do require that the patient pays $500. That hardly covers, but certainly contributes to the patient's commitment to us as it were.
If we decide that this is a patient that we want to take on, we then [ask] how are we going to approach this case? Which of our lead internists will take the case?. We also have approximately 25 specialist consultants. And we have a psychiatrist on our team. [Similar] centers that have sprung up around the country have chosen to deflect the psychiatric case from their interest, because they don't feel that this is part of what they're all about. We have recognized that there's no patient we have seen that doesn't have a psychological overlay to the problem. We can then refer the patient to a psychiatrist if we feel that was a dominant component of the problem.
We assign the case to one of our lead internists or pediatrician, who then sees the patient face-to-face. With COVID, we had a number of patients that we couldn't do the face-to-face, but we were not prepared to compromise on that. We must see the patient, because medicine is about taking a very comprehensive history. Looking at a patient and talking to a patient gives you an immense amount of information that you simply could not get online.
We try not to duplicate some of the specialists the patient has already seen. If someone has an issue relating to rheumatology, they've already seen three rheumatologists, each with a different twist. We're very careful about that, because this is not going to really enhance anything.
Once the patient has been seen by a selected group of specialists, it goes back to the original generalist to summarize the case, which then is represented to the group, and that closes the loop.
We've been going now for a few years. The number of cases we see, because of the time commitment, is not large enough to do any statistical analysis. But off the top of my head, I can roughly say that we make a new diagnosis with a name in about a third of our cases.
Another third of patients gain substantially from the encounter because we're able to confidently tell them that they don't have all the awful diseases they thought they had. You do not have cancer. You do not have a heart that is failing. You do not have blood vessels that are not working. Most patients believe us, but of course some still don't believe us, and we know when they leave us, they'll go to the 13th doctor. Nothing we can do there.
The other third of patients, we simply don't know. We've gone the whole route, and we honestly say, 'We simply cannot solve your problem.' We do say to them, 'We'd be very happy to see you again, let's say in six months' time, to see if something has evolved, and we'll be able to see whether we can add anything.'
Q. How long does it take for you to come to a conclusion on a patient, whether it's a diagnosis or you can't diagnose?
Fine: In most cases, we make an opening for this person within two weeks. The initial evaluation takes maybe a week or two. It takes us another week or two to get an appointment for the person to see the generalists, and we try and make sure that the consultants are available around that time.
I'd say that it probably takes a couple of months, but there are some patients who take much longer. Patients who come from afar, from out of state. It does not happen in our center the way it does in some institutions where the patient comes in, and two days later they get a printout. We cannot do it that way, and we don't pretend to do it that way. We are being very thorough.
Q. What about the patients that you can't do anything for? What's the next step for a patient like that?
Fine: That's one of the most frustrating and disappointing parts of diagnostic medicine. We can see they are flailing around looking for a doctor who can help them, so the referring physician is a very important element in the whole cycle.
If the patient says, 'Well, can you make a suggestion?,' we try not to make suggestions about doctors in our own institution, because that could be self-serving. Our function is to help with the diagnosis We can confidently say that we don't think the patient has this, that, or the other. It's just possible that something will emerge later, where we can be of help.
Q. You mentioned about a third of the patients you are able to find a diagnosis for. How does it feel to be able to help someone who's been looking for help for so long?
Fine: That's the reason we do it. There was a woman in her 70s who suddenly started getting frequent episodes of abdominal pain. Every time it occurred it was slightly different, in a different point in the abdomen, for a different [length] of time, and it started getting worse and worse. She goes on pain killers. Some work sometimes, some don't. This went on for a number of years.
We took the history, and we presented to the group all the CT scans that had been done with the abdomen that were negative. There was nothing there that we could see. Then one of our group said, 'Has the patient ever had a CT scan of the abdomen during an episode of pain?' We looked through the record, and the answer was no. And he told the patient, 'When you next have an episode, we would like to see you and do a CT scan on you while that happens.' The patient had an episode that lasted a day or two, came to see us, we did the CT scan on the abdomen, and guess what? We found that she had a partial bowel obstruction in the abdomen.
Our surgeon went in, found that the piece of bowel was adherent to this little opening, freed it under laparoscopy, and closed the little opening through which the bowel was protruding. The patient has never had pain since then.
That was remarkable. And all that we did was to ask a single question. Had we not done that we wouldn't have seen the distension of the bowel due to obstruction, we couldn't have made the diagnosis. That was just an interesting case. I'm not suggesting that all of our cases are like that, but that it certainly illustrates how a single insight can be a key insight in some cases.
Q Are diagnoses confusing or complex, or are they unusual?
Fine: They tend to not be unusual. They tend to be diseases which present in a complex way and which we simplify because of our breadth of expertise. We say, 'Let's not focus on that particular symptom that would seem to be peripheral.' If you see a problem list for patients, there are at least a dozen things on that problem list, and each one has value. We try to prioritize what we think the most important or the second most important is.
These are [usually] relatively common diseases. But there are also a number of new ones. Every time you open the New England Journal of Medicine, there's a new genetic disease that has been described. So we do genotyping on our patients. We analyze the genome when we think there may be a genetic explanation. We get the report, and anything that looks like it may be a mutation or an unusual polymorphism of the gene, we look in. Data analysts look at the record to see whether there are any other cases which are linked to that particular abnormality.
We have had cases where we discovered something which didn't make any sense, and we went out into the international community and said, 'Has anybody else seen a patient like this' Sure enough, some have, and eventually there is a whole network of doctors who've seen one case.
You could say, if there's nothing you could do for the patient, what good is it for the patient? The answer is, patients do feel comforted that a name can be applied to their condition, that other people have it, and maybe someone now will start looking for a solution to the problem. That's where publishing in an academic setting comes in. The group publishes together, the disease gets a name and an understanding, and that often opens the door to someone saying let's try this. It works for them.
Q: the resources you have at your disposal, you pretty much can go anywhere for help on these types of cases.
Fine: We do have a broad range of consultants. Cedars-Sinai is one the leading academic medical centers in the country. We're proud of that. And I must say that the reputational value of the Center for the Undiagnosed Patient is appreciated by its leadership.
Think about this: The practice of medicine today is very much dependent on income generation. What doctor can spend a few hours with a patient and legitimately bill that patient for the time they spent? Are we generating large amounts of money for the institution? Absolutely not. Is the institution proud of this entity and does it believe that it is something that enhances their reputation in a very positive way? Absolutely yes.
There are two dimensions to this. One is the training of younger doctors, which we haven't yet done but we want to do. We would like to bring in medical residents in training, to listen in and participate and see how we analyze things.
We are also now starting to build a strong research arm at the center. We're very lucky to have some very talented people who study the biochemical components of diseases. So we will get a patient in and we will take some blood samples and urine samples and various things, send them to these biochemists, and they analyze the genome, they analyze the patient's lipids, they analyze the patient's metabolic products. They see a pattern for the patient which can be looked at side by side with the patient's physical and clinical presentation.
Now, you can't make much of one or two cases, but when you have 20 or 30 cases of someone presenting, let's say, with an irritable bladder, you might see patterns of expression of various genes and various proteins that are different amongst that group of patients. Some present this way, some present that way. And then you say, maybe our description of this as cystitis is oversimplistic. These patients seem to have three different diseases, all presenting in the same way, but if that's the case biochemically, then clearly the diagnostic and treatment should go along with that.
Q: What does it feel like to finally solve a riddle, to be able to give a patient the answer to a question that may have evaded everybody else, and they finally got an answer that they've been so long waiting for?
Fine: We do have a sense of triumph. My God, look at it, something so simple, and we solved it. We are known as a group that tries to tackle medical mysteries. I don't think that sense of triumph happens as often as you think it might. Sometimes the contribution is only partial, not complete. And I can remember where we actually made the specific diagnosis and it was clear that it was a rare diagnosis and we were very happy that we made it, but the patient's symptoms didn't get better as a result. We said, 'Who knows, maybe we haven't solved it yet.' So we're very cautious and I hope modest about not overplaying what we've achieved.
