DEVICE TRAINING - Maximizing Patient Adherence by Minimizing the Forgetting Curve

INTRODUCTION

Imagine this scenario: you just bought a new home and your mother teaches you how to maintain the chlorine levels in the pool, a fairly complicated task she says you should perform once a month. You watch as she goes through each step, and when she leaves that night, you think you feel prepared. Thirty days later, though, is a different story —you walk outside, stare blankly at the pool for a few minutes, then walk inside and call your mother.

We’ve all been in situations like this where someone teaches you to do something that’s not a regular task. A day later, you’re able to recall that information pretty easily. A week on, it’s a little fuzzier. As time passes, the information fades more and more. This is called the forgetting curve. Research dating back to the late 1800s shows that as time passes, less and less information is retained.¹

Forgetting is probably OK when it comes to pool maintenance, but now imagine you have just been diagnosed with a chronic condition such as diabetes and the complicated task you need to perform is self-administering a dose of injectable medicine in your home, miles away from a medical professional.

In this situation, there is little room for error. There are other factors at play in addition to the forgetting curve, including the fact that the patient is not just tasked with the physical aspect of learning how to operate a new drug delivery system, but also the psychological reality that their lives are likely forever changed based on their recent diagnosis.

For these reasons, combined with a trend toward patients demanding treatment solutions they can self-administer outside of clinical environments, it is important that pharmaceutical companies and their drug delivery system partners proactively address the forgetting curve by rethinking how patients learn to use self-administration systems.

PUTTING PATIENTS FIRST

Being diagnosed with a chronic condition is not easy. With diseases such as diabetes, hemophilia, rheumatoid arthritis, and multiple sclerosis and other chronic conditions, a patient is often beginning a life-long journey of care. After the initial shock of diagnosis has worn off, patients may experience a sense of relief that the cause of their health issues has been found. But many will respond with deep-seated emotions, such as anger or depression. The need to adhere to a regimen of treatment may be met with denial, fear, or anxiety.

While adjusting to their new normal, patients around the world with chronic diseases are also seeking freedom from frequent doctors’ visits, sometimes opting instead to self-administer their critical medications at home, when offered. This trend is emerging alongside another: an increase in new biologic and biosimilar medicines for the treatment of many autoimmune diseases.

With a steady pipeline of biologics and biosimilars poised to come onto the market as self-injectable treatments for many chronic conditions – often in auto-injectors or wearable injector systems – the pharmaceutical industry is experiencing the very beginning of the potential that exists for a new wave of drug delivery. Patients who must regularly self-administer medication have eagerly awaited this shift to more user-friendly drug delivery systems that better align with how they live their everyday lives.

However, as the use of biologic therapies is on the rise, it can be challenging for patients tasked with injecting these therapies to do so consistently and effectively, as many are delivered as large doses of highly viscous medicines. This is compounded by the fact that biologics are often dosed less frequently, meaning that just as a patient is adjusting to a new diagnosis and how to use a self-administered therapy and new drug delivery system, the time between doses gets longer and potential loss of device familiarity looms larger. Knowing what we know about the forgetting curve, that poses a real problem for patients.

DEVELOPING FOR USABILITY

Before patients ever have a drug delivery system in their hands, manufacturers of that system need to understand the fundamentals of patient-centric design so they can create self-injection systems that patients can and will use. One of the most successful elements in fulfilling the need for patient-centric design is human factors analysis, which benefits the patient by making injection systems more comfortable and user-friendly. Human factors analysis accomplishes this through environmental research: observation and interviews provide the critical context needed to make a qualitative assessment of a patient’s abilities and challenges. Observing patients as they go about their day — and considering all of the surrounding environmental factors such as temperature, ambient noise, and lighting — can help researchers better understand how the patient will use a self-administration system. In-person surveys, questionnaires, user-based performance testing, and heuristic analysis also add to the base of human factors knowledge.

By taking a systematic, data-driven human factors approach to addressing usability earlier in development of injectable drug delivery systems, it’s possible to troubleshoot and eliminate or minimize the risk of potential user errors and help build successful outcomes for the end-user patient. Incorporating patient feedback earlier into the design process also assists in creating delivery systems that address factors such as reducing fear and discomfort during the injection process.

What does patient-centered design mean in practical terms? It includes listening to patients to address their personal priorities. Often, this involves talking to users three to five times before even prototyping a self-injection system to characterize their needs and how to best meet them. It also means understanding how patients feel about their diagnoses and conceptualizing how to make a drug delivery system that will improve their outlook, as well as finding out what features and design factors will improve medication adherence. It is also important to continually validate and improve designs to ensure that data-driven research is optimizing the approach to designing patient-friendly injectors. Armed with this knowledge, it’s possible to create delivery systems that patients are more likely to use correctly the first time and every time.

SHIFTING THE FOCUS TO PATIENT TRAINING

No matter how well designed a delivery system is, however, a patient will still likely need some amount of training to become acclimated with proper use, instilling confidence and lowering anxiety. As the market for wearable drug delivery continues to expand, doses of biologic drugs are likely to get larger and trend toward less-frequent dosing will continue. As research on the forgetting curve shows, retention decreases the further out from a learning experience one gets, pharmaceutical companies and their drug delivery system manufacturing partners will need to equip patients with valuable training information that is more readily retained.

So, how do you make something stick in a patient’s mind? The first answer is to make the training you provide to patients multisensory, meaning that more than one sense is activated during the process. Research shows that activating multiple senses during a training helps people internalize that training and reduces the effect of the forgetting curve.² For example, if you hear someone reading the Instructions for Use (IFU) of a medicine while you’re reading the IFU, that training is both audible and visual. If you’re touching a device while you hear someone read the IFU, and the device itself speaks instructions to you, now the training is tactile, visual, and audible.

To begin to implement this style of training into West’s self-injection systems, in 2016, West partnered with Noble^®, a leader in patient-centric onboarding and training, to provide a multisensory-based educational training program. Studies report that 40% to 60% of patients could not correctly report what their physicians expected of them 10 to 80 minutes after they were provided with the information. In addition, more than 60% of patients interviewed immediately after visiting their doctors misunderstood the directions regarding prescribed medications.³ By offering pharmaceutical companies multisensory education programs and technologies for wearable self-injectors, informed by human factors analysis into the development of patient training technologies and education materials, West and Noble aim to help improve the patient experience, reduce errors and anxiety, and help increase adherence to prescribed injectable therapies.

TAKING TRAINING TO THE NEXT LEVEL

Everybody involved in manufacturing, packaging, and delivering a medication to patients wants to achieve optimal patient outcomes. But, a key factor in this is ensuring patients comply with their treatment regimens, which can sometimes be difficult to achieve. Medication non-adherence is a leading cause of poor clinical outcomes and increased healthcare costs. Industry analysts estimate poor medication adherence costs the US healthcare system more than $290 billion in otherwise avoidable medical spending.⁴ According to a study performed by Capgemini, the pharmaceutical industry’s global revenue loss due to non-adherence to medication for chronic conditions is estimated to be $564 billion.⁵ Part of improving adherence comes through designing a user-friendly product based on human factors research and analysis, as previously mentioned. But training plays a critical role as well because it sets a foundation for ease of use of the product.

In the near future, training will meet people where they are spending more and more time: on their smart phones. An app may present visual confirmation of the steps, provide error correction, and offer multiple training events (instead of only one at the onset) that a patient can watch and re-watch as needed. Creating multiple touchpoints over the course of the 30 or 60 days patients are waiting between doses that activate different senses can help make patients feel more confident in self-administering their medication. One touchpoint may be a text message. Another, a conversation with a chat bot. Yet another, on-demand videos or picture glossaries stored in a digital library full of assets available at the touch of a screen.

A final improvement to the training space is making it part of a connected health experience. With an eye toward patient-centricity, West collaborated with HealthPrize^® Technologies, LLC, to integrate their Software-as-a-Service medication adherence and patient-engagement platform with West’s injectable drug delivery systems (Figure 1). The combined offering provides electronically connected drug delivery systems that track when patients take their medication, educate and engage patients to help increase adherence and medical literacy, and reward them for compliance with their prescribed regimen (Figure 2). In short, they offer connected health.

Expanding that offering and applying it to training activities can be powerful. The software platform can serve as the backbone for the aforementioned digital library of training materials. Patients can receive points redeemable for real merchandise by chatting with someone or watching an on-demand video. If effective training on a drug delivery system takes 20 minutes, incentivizing patients to invest that 20 minutes can offer one more step toward the goal of maximum adherence. Going forward, biotech and pharmaceutical companies will likely look toward their drug delivery system partners for insights on training.

CHALLENGES WITH TRAINING

While the benefits to effective training have huge potential, there are a number of challenges presented as well. First and foremost, as with many things, is cost. Including multisensory training that is available in a digital library will come with increased expenses, which, in a world of shrinking reimbursements, could impact the bottom line for pharmaceutical manufacturers. As time passes and the market continues to become more patient-centric, this may change and the investment may be clearer.

Another challenge is a lack of data connecting increased adherence with improved outcomes. There is plenty of data showing that connected health solutions as well as direct education to doctors in areas with low medication adherence can help improve adherence levels. For example, patients enrolled in HealthPrize programs demonstrate persistently high engagement rates and materially higher adherence rates, nearly 50% higher than baseline, on average. In order to connect that higher adherence with improved outcomes, patient utilization needs to be monitored in the short-, middle-, and long-term and compared against ongoing patient health. That is something that is in its infancy. But things are changing. Just recently, biotech company Amgen and health and well-being company Humana partnered to identify opportunities to improve health outcomes by following patients who have five major diseases – cardiovascular disease, osteoporosis, neurologic disorders, inflammatory diseases, and cancer. The partnership will probe into specific therapeutic areas, one of which will be the impact of wearable technologies on medication adherence for these diseases.

SUMMARY

The markets for wearable drug delivery systems and biologics are expected to continue growing for many years. These trends, combined with a patient population that is looking for increased convenience and autonomy, place a mandate on pharmaceutical companies and their drug delivery system partners to improve training practices for patients beginning to learn to use self-injections systems. As the forgetting curve shows, retention drops as time passes. Therefore, employing research-backed methods such as using multisensory training materials will be important to consider. To that end, pharmaceutical companies should work with their drug delivery system manufacturers to make human factors-based, multisensory training a core part of their integrated drug solution. After all, it’s the patients who will benefit, and that achieves a goal shared by all involved.

REFERENCES

1. Replication and Analysis of Ebbinghaus’ Forgetting Curve. 2015.
2. Frontiers in Psychology. Influences of Multisensory Experience on Subsequent Unisensory Processing. 2011.
3. Oman Medical Journal. Patient Medication Adherence: Measures in Daily Practice. 2011.
4. The Network For Excellence In Health Innovation. Thinking Outside the Pillbox: A System-wide Approach to Improving Patient Medication Adherence for Chronic Disease. August 2009.
5. Capgemini Consulting. Estimated Annual Pharmaceutical Revenue Loss Due to Medication Non-Adherence. November 2012.

Chris Evans is Vice President, Global Innovation, at West Pharmaceutical Services, Inc. He has been in product development for over 20 years, primarily in healthcare packaging and device development. He graduated from the University of Maryland with a degree in Biology/Chemistry, and his first decade of work concentrated on the manufacturing, engineering, and commercialization of new products working for various OEMs and design firms. Since then, he has worked mostly on the “frontend” of innovation, managing teams in discovery/user research, human-factors, mechanical innovation, concept creation, and intellectual property development. He is the holder of 19 US patents with several more pending. With West for 9 years, Mr. Evans is now responsible for transformational new product and technology development, focusing on device usability and enhancing the patient experience. He also manages West’s Connected Health Initiative and the resulting partnerships and alliances brought together to assemble a “patient-engagement ecosystem.”