Digital Therapeutics

The buzz term in our industry right now is digital therapeutics. This term means using technology to supplement traditional clinical therapy methods. There’s more than just buzz around this growing field, however—many digital therapeutics are helping to address disparities in the healthcare system by providing cheaper and faster ways of delivering treatments.

Key Highlights

Digital therapeutics could fundamentally change the way we approach certain disease states. We spoke with our PRA experts about the recent developments in the area and the future of digital therapeutics.

Nick Tate
Nick Tate

Digital therapeutics could fundamentally change the way we approach certain disease states. We spoke with our PRA experts about the recent developments in the area and the future of digital therapeutics.

  • Greg Licholai, MD – SVP and Chief Medical Information Officer, Therapeutic Expertise
  • Kevon Kothari - VP of Corporate Development, Care Innovations
  • Julie Cherry, RN, MSN - Chief Clinical Officer, Care Innovations

How do digital therapeutics differ in terms of their application to both mental health and physical health?

KK: A digital therapeutic is an evidence-based intervention delivered through a digital medium, that’s typically delivered one-on-one with the patient. Digital therapeutics can help patients manage conditions, schedule when to take medication, and offer alternative treatment strategies.

From the perspective of mental health, digital therapeutics can be a care protocol, a care plan, AI, chat bots, or through the real time interaction between a patient and clinician. Medical devices, apps, and modules are all considered components of digital therapeutics and are complementary tools for both physical and mental health.

How will digital therapeutics address caring for different age groups such as kids, teens, and adults?

GL: Digital therapeutics offer much more distributional benefits than other healthcare services. For example, if we look at the crisis in behavioral health and mental health, the sheer number of people affected and the lack of trained clinicians to support those people is tragic. Research shows that anywhere from to 10-30% of the US population has some behavioral health or substance issue, which equates to millions of people.

Unfortunately, the total number of psychiatrists in the United States is in the hundreds of thousands, and the total number of nurses and other mental health professionals is maybe twice that number. Essentially, the healthcare system is completely overwhelmed and unable to reach many people with a wide range of issues.

One of the significant advantages of digital therapeutics is the highly efficient and broad distribution that we get using these applications. Even if it doesn’t reach everyone, the requirements for obtaining much broader distribution and wider access are promising.

JC: Digital therapeutics are also much more scalable than the one-on-one traditional encounters in healthcare. For example, during the current pandemic, virtual visits from your home are another extremely important component. Patients can't afford to have gaps in care.

How might digital therapeutics affect patient-caregiver relationships?

JC: If there's already an established therapeutic relationship, then the use of video visits in this model won’t hurt the relationship at all. I think it reinforces the relationship and keeps the therapy going. Perhaps when a patient is in their home setting, they may even be more honest and more open because they're more comfortable.

If a therapeutic relationship hasn’t been established yet, then I think it's more of a challenge because that relationship has to be established virtually. I think we all could agree that there's nothing better than face-to-face interaction.

KK: I agree completely with Julie, but there's also an enhancement with digital tools. With an asynchronous relationship, you have the ability to note and comment on moods, feelings, and issues that you may forget in a face-to-face situation.

If you have an appointment once a week, once a month, or once a quarter; that’s a lot of time in between face-to-face visits. That creates an opportunity to forget what you want to communicate. Digital tools are part of your care journey. You can comment on specific issues, you can write notes, you can take a physical reading offline and log the interaction or problem so you can share it later. It's a richer, more informative experience. Digital therapeutics are both a primary and complementary tool for patient care.

Have you heard anything about how digital therapeutic strategies address access to care? Anyone may be able to use it in their own home, but what about underserved populations? Is it affordable for them?

GL: That's an important point. We all know that access to health care in the United States is flawed to say the least. One of the promises of digital therapeutics’ scalability is to improve access. Barriers get dramatically lowered and everyone gains the ability to communicate in ways that make them most comfortable.

We mentioned the stigma about mental health. We know behavioral health and addiction are real issues, especially in underserved populations. Addressing those issues appropriately is certainly one of the promises and expectations of digital therapeutics. I think the initial research reports says that in small populations it’s succeeding. But admittedly, that reporting is still in early days, and still needs to be proven.

What are some of the benefits of using technology for mental health? Do you see PRA taking a bigger role in this kind of technology as it advances?

GL: At PRA, we’re interested in enabling efficiencies in healthcare, specifically improving access to healthcare from a research and healthcare delivery standpoint. We do this daily through the use of data collection and analysis, connected devices, and mobile platforms.

These three areas are necessary in effectively delivering digital therapeutics. I know PRA is already stepping up to play a bigger role in this space. We already have extensive work in clinical research and clinical trials, and these enabling areas overlap strongly with digital therapeutics, so there is natural synergy.

KK: I would absolutely agree. Our Care Innovations tools are created based on a behavior change model. They are built and developed with aspects of behavioral health, mental health, and cognitive behavioral therapy (CBT) as a core competency and a core tool used to help drive patients towards a better general education and health care outcome. We have mental health tools, capabilities, and care plans, but ultimately everything that we do has an underlying CBT approach.

JC: Many programs in this industry are disease-focused. Our clinical behavior change model focuses not only on components of a disease, but a comprehensive picture of the patients. We focus on psychological, socio-economical, and medical factors.

Important components of our program include engaging patients in behavior change and addressing the psychosocial issues that come with any challenge in wellness. These components are based on a theoretical model that we developed from ten years of ethnographic research. We’ve sophisticated our ability to address those issues and to successfully engage patients, as well as deliver programs for schizophrenia, PTSD, severe depression, anxiety, sleep disorders, and bipolar disorder, to name a few.

Care Innovations’ Health Harmony platform has been available for the last 15 years to address all kinds of health conditions, including mental health. We’ve already weaved that mental health component into our COVID programs.

The COVID-19 programs we’ve recently built also have mental health components. We all know about the anxiety, stress, and fear surrounding the pandemic, so we built a psychosocial component into the platform. We built instructional and supportive content that helps acknowledge and address the kind of mental health issues that come with what's going on in the world.

The quarantine program leans more into the mental health aspect, because aside from staying safe and maintaining good clean health practices, the number one issue for people in quarantine is around their mental health.

Startups like Brightline and Neuroflow are addressing measurement-based approaches to mental health. What do you think inspired the growth of these startups? Will we see more startups like these, or will companies like PRA take over this space?

GL: There's a number of reasons why behavioral health is an area that can be optimized for digital therapeutics and digital interventions. Evidence behind behavioral health in digital therapeutics, which includes affective and cognitive disorders and addiction and substance abuse disorders, is extremely strong. Also, there is ample evidence around behavioral changes in healthcare management—modifying diseases that can influenced by lifestyle changes, such as diabetes and obesity.

We should consider what makes these areas so amenable to digital health. It’s probably due to cognitive reinforcement around positive and healthy messages. This is something that works well in a digital therapeutic realm. A number of companies are using digital platforms for therapeutics. Additionally, there are companies that go into more specific type of cognitive interventions, such as training and mental exercises that are demonstrating positive results.

KK: With mental health specifically, there’s a particular social stigma that still surrounds it. Access to these types of digital tools allows you to provide care solutions that might not be readily accessible or socially acceptable. Digital tools are helping to alleviate that possibility of social stigma. Mental health services also commonly suffer from poor accessibility. These digital tools allow a patient greater access to options and opportunities in order to procure care.

Patients are human beings who go about things differently. Digital therapeutics possess unique feedback mechanisms that provide real-world evidence in real time, which can help us understand how patients use a given therapeutic and what’s most effective for them.

By addressing these nuances, we can work to provide more widespread, personalized healthcare—especially for areas like mental health. PRA is currently involved in the development of a digital therapeutic for mental health, which is just one of many studies that are utilizing this new clinical frontier to bring treatments to those who need it most.

Today’s patients are evolving. So, why are we still demanding they conform to the traditional way of participating in clinical trials? By leveraging our data, expertise, and technologies, we can meet patients where they already are. From wearables and eConsent to virtual visits and videotelephony, we’re helping bring medicines and treatment to patients faster and more cost-effectively than ever before.

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