5
Health Professional Education and Adoption
HIGHLIGHTS
- A major factor in the adoption of new technologies is the “activation energy,” that is, the additional effort required to learn and put the technology in practice over and above the day-to-day work of a clinic. If the activation energy is too high, adoption is unlikely. (Hammer)
- Adoption of a new medical technology also requires community physicians to be aware of it and its benefits and be willing to recommend and to refer their patients to the appropriate specialists. (Hammer, Miravite, Okun, Pathak)
- Access is one barrier to new medical technologies, which can be limited by insurance companies and by the lack of qualified providers. (Miravite, Okun)
- Big data provided by medical devices could be useful in identifying which patients could benefit from new medical technologies. (Morrell)
- Educating patients and getting them involved in their own care could help push the adoption of new medical technologies. (Pathak)
NOTE: This list is the rapporteurs’ summary of points made by the individual speakers identified, and the statements have not been endorsed or verified by the National Academies of Sciences, Engineering, and Medicine. They are not intended to reflect a consensus among workshop participants.
Moving from practical barriers involving patients to those involving clinicians and other practitioners, the workshop addressed barriers associated with health professional education and adoption. David McMullen, the director of the Office of Neurological and Physical Medicine Devices at the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health, asked participants to discuss the current barriers to increasing training and engagement among health professionals on implantable brain stimulation and the barriers of current practices and, second, to explore what relationships might need to be developed across different specialties and clinical practices to facilitate referrals and the continuance of care. McMullen commented that he hoped the panelists would not just highlight and discuss the various barriers but would also think through some potential solutions. “What can we do as a community to come together and blaze a new path forward?” said McMullen. Clinicians will certainly be critical to greater adoption of the technologies, he added, with their roles including both patient education and patient selection.
FACTORS INFLUENCING CLINICIAN ADOPTION OF TECHNOLOGIES
Lauren Hammer, a movement disorders and neuromodulation research fellow at the University of California, San Francisco, discussed some of the factors influencing whether clinicians adopt new technologies.
“Even if regulators approve and payers cover [the procedure],” Hammer said, “adoption requires patients and the caregivers to buy in. That requires that the clinical benefit outweighs the perceived burden on the patients.” A second factor is the so-called activation energy of learning this new technology (see Figure 5-1). How much additional burden is required to integrate the technology into the clinic? Even if the clinical process ultimately becomes easier once the new technology has integrated, it still may require a tremendous amount of effort to reach that point, learning the new technology and modifying various established processes to adapt to it. One must ask whether that activation energy is too great to overcome. “I have a strong interest in seeing these technologies succeed,” Hammer said, “and I still found it hard to integrate some of the most recent advances like image-guided1 or physiology-guided programming.2 Physicians are busy, stretched for time. Sometimes it is easier to do what we know works fairly well instead of trying something new.”
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1 Image-guided programming is the collection of images during implantable brain stimulation surgery that allow the physician to see the exact location for the device leads and stimulation. For more information, see https://www.bostonscientific.com/en-US/medical-specialties/neurological-surgery/deep-brain-stimulation-system/image-guided-programming.html (accessed February 27, 2024).
2 Physiological-guided programming is the collection of brain signals (e.g., local field potentials) while delivering the stimulation treatment. Physicians can correlate the brain signals with the stimulation and the patient’s symptoms to optimize care. For more information, see https://www.medtronic.com/us-en/healthcare-professionals/products/neurological/deep-brain-stimulation-systems/brainsense.html (accessed March 1, 2024).
SOURCE: Presented by Lauren Hammer on October 31, 2023.
A second factor in the adoption of new technologies is the role of doctors and other providers beyond the highly subspecialized clinicians who are most comfortable with such technologies. A recent paper reported that only about 10 percent of Medicare patients with Parkinson’s disease had seen a movement disorder specialist within the previous year, with more than 50 percent of them being managed and seen by a general neurologist (Pearson et al., 2023). “These are the partners who are going to be identifying who is appropriate for referral,” Hammer said. “And these are the partners who are going to be comanaging patients while stimulation is being optimized and, ideally, if we can make things simpler, even taking over stable management of these patients.” So it is vital, she said, that the subspecialists find ways to educate these community providers and bring them into care teams. “This is going to be important if we want to expand these technologies to more people,” she said.
A NURSE PRACTITIONER’S PERSPECTIVE
Joan Miravite, a nurse practitioner, assistant professor of neurology at the Icahn School of Medicine, and director of interdisciplinary clinical care for movement disorders at Mount Sinai, described herself as having several roles: a deep brain stimulation (DBS) programmer; an educator of patients, clinicians, and advanced practice providers; and an advocate both for patients and for the use of advanced practice providers in neurology to address the current shortage of neurologists, decrease wait times, and increase access to care.
She spoke briefly about barriers to care, mentioning both a lack of relevant training for clinicians and various knowledge gaps related to the procedure. A major barrier, said Miravite, is limited access to the procedure, particularly because of its treatment by insurance companies. “Some insurance companies deem DBS still experimental,” she said, “and I’ve had some insurance companies deny me from programming patients because
I’m a nurse practitioner and not a physician.” In New York, nurse practitioners are not able to bill Medicaid for any procedures they perform in Article 28 facilities,3 Miravite said. So, despite her expertise, “I’m not able to use it to help all of my patients.”
She listed several approaches to improving the current situation, including creating scalable models of care; building a consensus on DBS management; collaborating with foundations, organizations, payers, and industry to educate and streamline therapy; and using advanced practice providers in specialized care. The ultimate goals, Miravite added, are to foster health equity, increase the quality of care and patient access, and improve patient outcomes.
USING BIG DATA TO IMPROVE TREATMENT
Martha Morrell, the chief medical officer of NeuroPace, Inc., and a clinical professor of neurology at Stanford University, began by expressing her excitement about the progress that has been made in the field and her incredible optimism about its future. Just as clinicians need to manage the expectations of their patients, she said, they need to manage their own. “Do we think we are going to develop a therapy and it is going to come out fully formed?” she asked. “Of course it’s not. It is not perfect yet.” But there has been amazing progress in a variety of devices, and that progress should only continue.
Morrell then explored the utility of applying big data from medical devices to improve the treatment of brain disorders. She began by talking about some of the requirements that these data must fulfill in order to help improve such treatment. First, the data should be accessible and comprehensible to users, and in particular, the information derived from the large, complex datasets must be interpretable by the physician and the patient. Second, the data should be disease-relevant. “We shouldn’t show all the data,” Morrell said, “but only the data we have identified as important.” This should include things like biomarkers to track how somebody is doing and help predict outcomes. Third, the data should enhance the efficiency of clinical care. “We have to make everybody’s life easier,” she said. And fourth, the data should contribute to treatment decisions that improve clinical outcomes. “Otherwise,” she said, “none of this data is worth anything.”
BARRIERS TO THE ADOPTION OF DEEP BRAIN STIMULATION TECHNOLOGIES
Michael Okun, the executive director of the Norman Fixel Institute for Neurological Diseases at the University of Florida and the medical advisor
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3 For more information on what is denoted as an Article 28 facility in New York, see https://www.health.ny.gov/facilities/hospital/regulations (accessed February 28, 2024).
of the Parkinson’s Foundation, offered a few comments about the state of the DBS field.
First, he said, the word “adoption” implies a voluntary aspect, which is equally true for the adoption of a technology. But that means it is necessary to get buy-in from the community of users, and that has not proved to be easy in this case. “We can blame health care systems, regulatory agencies, health care payers, we can blame ourselves,” he said, but there has not yet been the necessary buy-in.
“Second,” he continued, “you have to actually want it to adopt it.” A recent discussion at the most recent Deep Brain Stimulation Think Tank4 concerned whether the technology has been branded correctly: “There was a discussion about should we be calling this brain pacemaker, which is something . . . people can understand . . . better.”
Third, even if people want the technology, it will be necessary that we are able to provide it to those people. “So we have a lot of people in society across the world that want therapies we may not be able to deliver,” Okun said. “We have to remember that it’s bidirectional. The arrows go both ways.”
Yet another potential barrier is the need for experts to operate the devices, he said, but he suggested that this issue may prove not to be a major barrier. In the case of Parkinson’s disease, for instance, clinicians and nurses are sufficient. Although the initial trials may require experts, he said, it should be possible to eventually develop easier-to-use technologies. “Once you know the biology, there should be a simpler, more elegant path to the answer,” he said. “So let’s not get overwhelmed with that.”
AN INDUSTRY PERSPECTIVE
Yagna Pathak, medical science manager at Abbott Neuromodulation, provided an industry perspective to the discussion.
In thinking about practical barriers to further use of DBS that are related to professional education and adoption, she said she sees the issue from three perspectives. The first is awareness of the current state of technology. To illustrate the problems related to that awareness, she told a story about an experience she had at the Consumer Electronics Show (CES) in January 2023. “The people that go to CES are probably the most in-the-know of cutting-edge technology,” said Pathak. “They came to our booth. We were talking about deep brain stimulation, and they just looked at us like we were talking about something that was still being innovated on.” They asked when the technology would become available for humans. “I just looked at them, and I said, ‘This has been around for over 30 years.’
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4 For more information on the 2023 DBS Think Tank, see https://fixel.ufhealth.org/research/deep-brain-stimulation-think-tank (accessed November 26, 2023).
And it was the first time that it struck me that it is not nearly as ubiquitous to everyone as it is to us.” The problem, then, is that many of the people who are shaping decisions about whether to adopt the technology are not familiar with it and may not even know it exists. By contrast, she said, everyone knows about cardiac pacemakers. “How do we make our technology as ubiquitous as pacemakers are?”
The second barrier relates to the referral pathway, she said. A patient goes to a doctor, gets referred to another doctor, and another, and eventually gets to a specialist who can recommend DBS. “By the time the patient even knows to go to a specialist, it may be too late,” Pathak said. “At least for deep brain stimulation used for movement disorders, there is a very optimal window,” which means that it is important to educate doctors along the referral pathway so that patients can get referred as soon as possible to appropriate providers.
Finally, Pathak emphasized the importance of educating patients and getting them involved. “Patients listen to patients,” she said. “Their stories resonate with other patients. So I think we all need to spend a lot more time understanding our patients, listening to our patients, and making sure they have enough knowledge and education to spread it around in their communities so [other] patients are more empowered to ask their doctors for the therapies that they think they require.”
DISCUSSION
To begin the discussion, McMullen asked Pathak whether the right people were at the workshop to address the DBS issue effectively. “I do think we have the right people,” she said. “I think this is a multidimensional problem which requires multidimensional solutions.” One sector that may be missing, she observed, are patient advocacy organizations (e.g., Parkinson’s Foundation or Dystonia Medical Research Foundation) that can provide a patient-oriented lens on what progress is needed.
Okun disagreed and said that it would have been valuable to get a more international perspective from organizations like the World Health Organization. “If you could [solely] blame the problem on the FDA or the National Institutes of Health or whomever, then why are all these other countries having the same problem?” he said. “I think we have to stop blaming and start thinking that maybe this is a global issue.”
Barriers to Referrals
McMullen asked Okun about issues with referrals, specifically what barriers he saw that make it less likely that doctors will refer patients who might be helped by DBS to specialists familiar with the technology. It is
more a system problem than anything, Okun said. He explained, “We get upset at internal medicine doctors and geriatric doctors for mishandling Parkinson’s disease, though they are tasked in 30 minutes with dealing with cholesterol calculator, cardiac risk, an examination of the lungs and counseling on, preventive measures . . . by the tail end of the visit they may notice, or the person may mention a shaking tremor. Those folks with Parkinson’s disease may be the lucky ones as one in five [Parkinson’s patients] don’t have a tremor.” Then a patient is referred to a neurology specialist who then may refer the patient to a sub-specialist. Generally speaking, Okun said, the health care system is not set up to incentivize the best care for a patient: “Everybody is playing their role within limited systems, limited amounts of time, limited amounts of resources. We have to figure out how to put those pieces together and incentivize them correctly so that the person gets the best possible treatment. And we don’t do that.”
McMullen then turned to Morrell and asked how her company, NeuroPace, had succeeded in convincing clinicians to adopt its technology. “We are all learning,” she said. “The way you start out is figure out what you are doing well and what could be done better and just pick it off piece by piece.” One thing that the company found success with was sponsoring programs available to fellows and trainees that allowed them to “come and in a nonpromotional way learn about the technology and apply it.” Those programs were met with great enthusiasm, she said, adding that the younger generation seems to be more open to learning about and using new technologies and new treatments.
Educating Physicians About Deep Brain Stimulation
McMullen asked Hammer about the exposures to neurotechnology that neurologists get in their residency programs. Hammer said that neurological residents get relatively little exposure to technologies such as DBS, which is a problem. She suggested that ways should be found—such as 2-week programs—to help residents become more familiarized with these technologies. “It doesn’t have to be long,” said Hammer. “It just has to be enough that neurology trainees know [the technologies] exist so they can then potentially seek out further education themselves.”
Okun agreed that such educational approaches could be important, particularly in helping newer physicians become familiar with DBS and other neurotechnologies. Another approach to addressing the issues with referrals, he said, would be to expand the use of navigators, who could help patients in health care systems to access the best possible care and get them more options quickly and connected with doctors and clinicians who can best address their needs. “I very much like this model and would advocate strongly for that,” Okun said.
Expanding Access to and Use of Deep Brain Stimulation
A workshop participant asked what the panelists thought would work well to increase access to advanced care in community clinics, given the educational gap between academic centers and community clinics. Morrell offered an initial answer by saying that it is important to help community physicians better understand the needs of their patients and where those needs can best be met. One way would be to develop a system that takes all the information acquired by devices used in a patient’s care, interprets it, and comes up with a solution. “Obviously,” she said, “the holy grail would be to have a truly closed-loop device where the device is constantly collecting information and then acting upon it in a dynamic way. . . . If we had something that was truly closed-loop, then it would be pretty easy for that to be implemented at a level that did not require the ultimate specialist.” Such a device does not yet exist, she said, but many people believe that it will sometime in the future.
Okun agreed and emphasized the importance of statistics and keeping in mind how individual patients are doing relative to everyone else. For many of the devices now being used, he said, about 80–90 percent of patients are doing well. Thus, if a patient falls at the 80th percentile, the physician should be told that this person is doing well; just keep an eye on it. Conversely, it is important to identify the 10–20 percent who are not doing well. “We need to work together to identify those people,” he said, and send them to the appropriate clinicians, whether specialists or sub-sub specialists. In that way, community physicians will be able to obtain the assistance they need in determining which of their patients are doing okay and which need to see a more specialized provider.
Pathak suggested getting professional societies involved in educating their members on the benefits of implantable technologies and which patients can benefit from them. Awareness is a major problem right now, she said, but even when physicians are aware that these technologies exist, they often still prefer drugs and noninvasive therapies, even though studies have shown that as many as 70 percent of patients will benefit from DBS without complications. “I think that needs to be stressed a little more,” she said. “This does need to not be the last resort, but it can come earlier.”
Litt added that the responsibility for identifying patients who can benefit from implantable brain stimulation does not need to be placed entirely on physicians. “There are enough biomarkers you can extract from the electronic medical record (EMR) which could easily come up and say, this patient meets these measures and these criteria and should be considered for brain stimulation.” The University of Pennsylvania system performs such monitoring for hypertension, postnatal care, and the initiation of diabetes care. “We did an experiment through EMR where we looked through medi-
cally refractory epilepsy patients at our own hospital seen by neurologists within our own system meeting criteria for presurgical evaluation,” said Litt. “We found it was 15 per month. So, if that is what is happening in our system, what is happening out in the community?”
The Relationship Between Physicians and Future Technologies
McMullen asked Hammer about what can be expected with future technologies, including artificial intelligence (AI). Who will be delivering this care in the future? Will it be neurologists? Clinical engineers? Other members of the clinical teams? Some new type of specialists altogether?
Hammer answered that it will depend in part on how well AI is integrated into the new technologies. “If you have AI or machine learning take all the data and make a suggestion to the clinician that makes sense and has some sort of biologic or medical interpretation, then the need for human data scientists to make a patient-specific model or do specific data mining is a lot less important.” A lot of clinicians, she said, would prefer some system that processes the data and makes reasonable recommendations. “So if there is no additional effort [for the clinician] to learn and interpret, those automated systems would be very powerful.” Still, she added, there is a great deal of work that must be done to get to that point, and in the meantime, it will be necessary to have data scientists or other specialists bridge the gap. Community providers may find it challenging to independently handle the new technologies in their current form, thus “having support from other trained professionals, like technicians focused on the neural data, would be useful.”
Okun pointed out that if community physicians and others are going to rely on systems that interpret big data and make suggestions, they will have to be comfortable with the “black box” nature of those suggestions because there will be no indication of why the suggestion was made. The FDA could be helpful here by reviewing and approving algorithms, signaling to doctors that they can trust the recommendations.
Hammer commented that while the sorts of people who were attending the workshop would probably want to understand what the black box was doing, community physicians and many others may not necessarily be interested in all those details as long as the FDA signaled confidence in the recommendations.
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