White Paper: Critical Characteristics in Identifying a Rare Disease CRO Partner
Patient-Consumer Participation and Patient-Consumer Customer Service
Video Killed the Radio and Internet Killed the Mall
Remember the good old days of old school retail? The first thing was knowing the always-changing hours of stores, and keeping them all straight. You had to get there early or just get lucky that the elusive “truck just came in” or you would walk out empty-handed. Or worse, you would have to settle for the wrong color. Or even worse, for a similar (but not the exact) product. You could probably find a good deal back then, at least as far as you knew. Of course, there were coupons if you remembered your circular, which was sometimes a challenge.
There were other logistical obstacles as well, such as finding parking spots, fighting the crowds, yelling at your kids (or sometimes the inverse), and carrying around all of those bags. And much of this happened in a huge square mile of asphalt, brick, and mortar called “the mall,” the same place that probably still exists but in a much more lonely and unkempt condition now. It has its once-a-year revival on Black Friday but generally stores are closing and the traditional retail paradigm is gone. Is the same thing happening in healthcare?
Introduction: The Patient-Consumer
Consumers today are better informed at least partly due to the evolution of communication and technology–especially in the context of the societal change towards interconnectivity. Search engines provide ways of finding pertinent information in a timely manner, and social media apps serve as avenues for interaction and commentary. The expectations that go along with this growing public knowledge base are twofold: consumers expect to meaningfully participate in their purchase experience more than ever, and they also expect a modern customer service experience. Customer engagement–with providers of goods and services, not to mention other consumers–has probably never been as pronounced as it is today.
Patients have been on a similar engagement trajectory, seizing greater control of their healthcare. In fact, broadly applying the traditional retail model to healthcare would allow the opportunity to view patients as consumers of medical data, advisement, goods, and services. Patients are then seen as independent purchasers, partners with others in their medical journeys, and co-authors of their destinies. The implications of “the patient-consumer” are vast, ranging from gathering medical information to expressing desired needs to participating in the clinical trial design process.
Correspondingly, better-informed patient-consumers are developing and realizing their own engagement expectations on par with the other decisions and transactions in their lives: fuller individual participation in outcomes, and richer customer service experiences.
Part I: Patient-Consumer Participation
Learning and Sharing
Consumers in the marketplace can find the items and services they are seeking through online searches, execute purchases, and then inform others about their experiences via apps and social media. With these technologies, users are armed with both their own information and vicarious experience. The end result is consumer empowerment, both as a large group and as an individual buyer.
When purchasing a vehicle, for example, truecar.com provides real-time data about how much particular models have sold for in a given area. This is clearly a valuable negotiation tool. Consumers can read reviews not only about the vehicles themselves, but about the purchase experience. In addition, other apps and articles are used by buyers to discover the best time to buy, as well as how to secure the optimal deal. The same set of opportunities are increasingly available for patient-consumers, using services like searches to learn more about disease states and other sites for treatment options. Most people have a go-to medical site (such as webmd.com) used to find out basic and perhaps even complex information. There are apps and online portals that offer even more individualized services.
Shoppers are accustomed to using their phones to scan barcodes to get pricing; they also bring coupon barcodes to stores to get scanned in order to receive discounts. For the patient, Pfizer has developed an app that allows patients quick access to information to their product and the patient’s medical condition by scanning the product’s barcode (Pfizer, 2016). This allows for greater control, access, and learning on the patient’s end.
There are numerous examples of apps to change appointments, order refills, and take other various patient actions. The use of available technology for patients mirrors the use of consumers purchasing and using everyday goods and services. Consider the advantages in terms of security, convenience, and value of banking and financial apps and the vast possibilities of healthcare apps.
Advocacy and Me
The internet also allows for advocacy groups to increase their participation levels by setting up websites that can be found by patients. Societal stigmas about illness have eroded over time, leaving patients more apt to discuss their individual situations online. Michael J. Fox, in revealing his Parkinson’s Disease decades ago, was a leader in building and publicizing advocacy in the cable news world. It is much more common now for celebrities to discuss their illnesses, especially using social media. Lady Gaga revealed her illness on Twitter in 2017 by stating: “In our documentary the #chronicillness #chronicpain I deal w/ is #Fibromyalgia. I wish to help raise awareness & connect people who have it.” This generation has the online tools and the yearning to share individual struggles and successes.
There are forums, groups, and social networks all over the internet, both organized and informal, covering a wide array of interests and activities. There is a similar trend for patient-consumers. Patientslikeme.com is a social network that allows individuals to connect with others and find new treatments, trials, and data. Overall, the end results of patient-consumer participation are empowerment and confidence, and perhaps the spark to create an organization that might not have existed before to serve a need or fill a gap. Patient advocacy groups for rare diseases are created in such a way all of the time.
Online users refer to youtube.com for videos about how to tackle a variety of different tasks– made by stakeholders that collate, edit and disseminate pertinent information. Think about a minor car repair or following along with a recipe. Similarly for patient-consumers, Global Genes toolkits are interactive stakeholder-driven data modules that assist and educate rare disease patients in various areas, such as fundraising, health insurance, and social media. (https://globalgenes.org/toolkits/).
Design Creep Vs. Patient-Consumer Feedback
The patient-consumer has also increasingly weighed in on design features. This is clearly true outside of medicine. Harley-Davidson Motor Company, traditionally secretive about their motorcycle plans and models, realized and admitted they were not listening to the consumer. Heather Malenshek, Vice President of Marketing at Harley-Davidson said in Bloomberg Businessweek: “If we just show up with those products and don’t prepare to meet the new customer on their terms, we won’t be successful.” (Suddath, 2018, p. 39) Recently, they released a public plan for the next several years about what they are building and why.
This idea of “design creep” is present in clinical research as well, as manufacturers release new versions having not interacted with the patients who will be using their products. The evolving patient-consumer will increasingly allow for impact on the research design model. Stated plainly: “The incremental development of technology or even healthcare can easily become a case of advancing the industry for the sake of it. This can lead to a solution that is looking for a problem, without taking into consideration the patient/consumer point of view.” (French et al., 2018, p. 1). This is “progress” without a basis.
Instead of releases for the sake of releases, patient-consumer interactions with developers will allow for participation in the evolutionary process. Patient engagement benefits drug discovery by sharing insights on preventing disease, how the disease impacts their daily lives, and their thoughts on current compliance and delivery of medications. (Allarakhia, 2015). The Patient-Centered Outcomes Research Institute (PCORI) sponsors an Ambassador program to help train patients on clinical trial design and health technology (Anderson & McCleary, 2016). This clearly demonstrates a move towards enhanced participation.
Just as consumers often participate in the next iteration of products, patients are also exerting influence in the healthcare realm. Patients have been involved in developing the protocol, recruitment procedures, and selected outcomes for a study involving asthmatic children (Domecq, 2014). For five years concluding in 2017, the FDA had 24 meetings developed for patients and caregivers–all for different diseases–to ascertain how the illness affects lives and how treatments address needs (Anderson & McCleary, 2016). This could have long-reaching impacts on drug development.
Consumers routinely make their opinions known regarding various products and their safety to government agencies. Recently, The EPA and DOT announced three public hearings about new vehicle standards. According to the site, “The SAFE Vehicles Rule would update and correct the current national automobile fuel economy and greenhouse gas emissions standards to give the American people greater access to safer, more affordable vehicles that are cleaner for the environment.” (EPA, 2018). The capacity to contribute in government meetings is increasingly possible in healthcare. Patients will be more involved in pharmacovigilance activities such as risk assessment, risk management planning and evaluation along with the sponsors and regulatory agencies (Smith & Benattia, 2016).
In the end, patient-consumers can and should be driving outcomes, even when the end result is death. ”Patients and carer perspectives are vital for developing healthcare strategies that are equitable, accessible, effective and patient-centred.” (Purtell et al., 2017, p. 1) This article about end-stage kidney disease points out that even when the outcome is dying, the patients can participate in highlighting what they want at the end of their lives. The eye-opening part is that even without survival the respondents had an overwhelmingly positive treatment experience (Gawande, 2014; Purtell et al., 2017).
Patient-Consumer Participation Implications
Patient-consumers can use the available tools to be increasingly smarter and more aggressive about the things they want and need. “By participating in the (healthcare) decision processes, patients can exercise their fundamental rights; while from the consumer perspective, they may demand quality services.” (Souliotis, 2016, p. 175). This describes the evolving healthcare marketplace and the individual’s vital role in it.
Stated in an alternative way: “Four dimensions prevail when a patient participates in their healthcare (1) information, (2) communication and education (3) coordination and integration of care; (4) expression of patients’ values, preferences, and expressed needs” (Souliotis, 2016, p. 175). It is interesting to note the emphasis placed on individual value systems here, as the wave moving forward will undoubtedly move toward personalized medicine–and not only in terms of treatment options but also with regard to the big picture and whole person.
Key Takeaway: Smarter patients with better tools and larger forums are expressing needs and wants
You, Your Computer, and Everyone Else
Ever win an eBay auction against someone from some faraway place? It feels good to emerge victorious, but in truth people don’t always work against each other. In fact, sometimes it is good to have other humans around–to write reviews and join you in unified campaigns. In the age of 24-hour shopping cycles (which clearly means no “closed” signs), you absolutely will find what you are seeking, and you will get the best deal that is possible at that moment. And you have the opportunity through social media and other outlets to share your satisfaction level with thousands of people. If you are not happy with how things went, it might be time for the universe (the seller) to face a reckoning with the dreaded bad review. In most cases, the process is really rather easy. You find things you want, compare them, buy them, and complete transactions–all online. You follow their progress via tracking, they appear on your doorstep quickly, and you can return them as easily as they arrive. And remember, don’t forget to tell everyone everything, including how you made up your mind, how much you paid, how you were treated, and how things turned out. Are similar things happening in healthcare?
Part II: Patient-Consumer Customer Service
Customer Service Relationship-Building
Consumers expect their business to be earned and then re-earned over time. This is achieved by providing good products, positive interactions, honest communication, and opportunities for feedback. Patient-consumers should also expect enhanced customer service. This will manifest in fuller interactions and relationship-building, as well as the use of surveys and ensuing actionable items. These actions and others could greatly benefit patient attraction, education, and retention over time.
It goes without saying that part of retail business is interacting (either face-to-face or online) with customers. The patient-consumer has a similar experience. 90% of Center for Devices and Radiological Health (CDRH) employees will interact with patients as part of their job duties (Anderson & McCleary, 2016). This statistic shows the importance of interaction between the FDA and patients, specifically, the vital work of using communication to determine how devices affect the lives of sick people and their families.
Patient-consumer customer service will have implications in clinical research as well. Sponsors and advocacy groups have engaged patients in clinical research in several ways that include stronger relationships between the investigator and the patient, protocol study design, training, risk tolerances and finally drug discovery. The Practice-Based Clinical Research Network provides a strong relationship between the doctor and patient and in turn provides better data than recruiting anonymous patients (Robbins, Curro, & Fox, 2013). Physicians who know their patients will know how to direct them into appropriate trials that are the correct fit.
Gathering (The Right Deep) Data
A key part of customer service is gathering customer feedback and data. “Psychographics is the study of what marketers call a consumer’s AIOs — activities, interests and opinions. This extends beyond the classic demographic data that all marketers collect, focusing instead on cognitive attributes” (Bendes, 2018). The trend is towards data collection that is more complex, and hopefully more useful. The same could be said for the patient-consumer. The Patient-Centered Outcomes Research Institute (PCORI) has developed a comprehensive evaluation to look at the extent of engagement in clinical research as well as its effects — “which includes visual models, sets of questions, metrics, methods, and sources of data” (Anderson & McCleary, 2016). This is a deep dive into several sources of input that go beyond clinical data that supports safety and efficacy of potential products.
In terms of feedback, all sellers rely on customer surveys (from ebay.com to local brick and mortar stores). It is important to note that the goods and services are not solely evaluated; the service and experience themselves are probed. For the patient-consumer, the shift is also towards patient centricity. One example is The Consumer Quality Index Inpatient Hospital Care is a survey intended to measure the patients’ experience in the hospital and to gain knowledge about their patient-centered care (Smirnova, Lombarts, Arah, & van der Vleuten, 2017). Patient centricity is only possible with customer service that seeks to understand and then adjust to their clientele.
A Customer Service Study Champion
Most people rely on a professional partner to help them navigate through the intricate transactions and situations in life. Consider the roles played by financial advisors, tax preparers, mortgage brokers, or even life coaches and therapists. When the stakes are perceived to be highest, consumers and their families simply do not want to brave challenges alone.
The patient-consumer would also not want to figure out treatment options and clinical trials on their own. One innovative rare disease Contract Research Organization (CRO) is currently outlining its plans to utilize what it is calling a “Study Champion.” This role will add another layer of continuity to clinical trials, shifting patient responsibility from the study site to the Study Champion. Traditionally, patient care was exclusively looked after by the sites; the new model will allow a more personal approach for patients, specifically more help getting through the trial.
In terms of patient-customer service, this role will provide an unprecedented level of patient support, and build a bridge of continuity for sites and home health care nurses. The Study Champion will be an expert in the systems and tasks for study participants, a one-stop-shop for patient support. This could include working closely with advocacy, community and physician outreach to aid in patient recruitment efforts, providing travel and lodging concierge services, assisting in navigating the complex study information including logistics, dosing, and technologies, providing valuable patient feedback allowing both sites and sponsors to take corrective action sooner. This change will ensure that the study participants have a dedicated team member to support them during their time in the study, thereby, decreasing the number of people a participant must go through in order to obtain the support that is needed. This strategy will ultimately lead to greater compliance, satisfaction, and retention.
Patient-Consumer Customer Service Implications
The identification of patients as the true consumers (and not pharmaceutical companies, hospitals, or doctors) leads to relationship-building. There will be a growing need for charismatic and organized individuals with experience working with patients to ask patients questions and lead them through treatments and trials. Customer-focused and customer-facing, they will receive the first call if people have questions or feedback.
Ultimately, “[t]hey (patients) want safe, effective, timely clinical care from skilled clinicians who are able to make them feel personally cared for, included in decision making and comfortable” (Torpie, 2014, p. 6). By increasing data collection in various forms of surveys, patients can communicate not only about their bodies and symptoms but about their wishes and values. “The only true experts about what matters most to patients are patients themselves” (Torpie, 2014, p. 8). The only way to find out what is important is to ask the patient-consumers.
Key Takeaway: Relationship-Building In Healthcare Leads to Greater Comfort, Knowledge, Compliance, and Potentially Outcomes
The Rise of the Machines (And Satellite Clinics)
It is not a stretch to picture hospitals suffering the same fate as malls. Still present, but a lot less important. You can see it already: Walmarts are offering small neighborhood versions of themselves, just as healthcare clinics are popping up all over the suburbs. Don’t worry, you are getting big-box hospital brands, just a half-mile from your home. The care is literally coming to you, both nearer to your house and to your house. Medical goods and services (and not just pills and orthotics) but tests and check-ups are on their way to your door.
Time will tell if real-time tracking of doctors driving to you will be available. What we do know now is that cable and satellite installation windows have been reduced first from four hours (really all day) to two and now just one, so we should be hopeful about healthcare delivery. While you are waiting, and more importantly, while you are out and about, you will accomplish a lot of things with your healthcare.
You will be in constant communication with caregivers via apps. And finding other patients like you. And expressing yourself and your beliefs (because they are relevant to your care). You will be building relationships to challenge and support your decisions, all for your betterment. Is the future occurring now in healthcare?
Conclusion: Patient-Consumers Moving Forward
The future of consumers will include more individualized shopping rather than competition for commoditized items.This will also be true for patient-consumers. Expect to see more technological prompting to take medications and enhanced remote measuring of their effects. Sick people could also see less time in clinics and more visits at home, complete with portable equipment. There could be less invasive techniques for delivery of care, and ultimately a pivot towards personal medicine.
These new drugs need to be envisioned and manufactured. The FDA has realized that the most important stakeholder feedback comes from the patient. In 2012, The FDA established a program called the Patient-Focused Drug Development (PFDD) to gather information regarding the patient’s perspective on specific diseases and their treatments (FDA, 2018). Through these meetings, drug developers will be able to see the realistic burden that diseases cause for patients and their families, as well as the limitations and benefits that treatments are currently providing, so they can identify unmet treatment needs and new outcome measures in clinical trials (Chalasani, Vaidya, & Mullin, 2018). These focal points of building relationships and sharing responsibilities with patients will potentially be hallmarks of the next generation of innovations in treatments.
- Allarakhia, M. (2015). Exploring open innovation with a patient focus in drug discovery: an evolving paradigm of patient engagement. Expert opinion on drug discovery, 10(6), 571-578.
- Anderson, M., & McCleary, K. K. (2016). On the path to a science of patient input. Science translational medicine, 8(336), 336ps11-336ps11.
- Bendes, K. (2018). How Retailers And Brands Can Use Consumer Data More Effectively. Retrieved September 15, 2018 from https://www.forbes.com/sites/forbescommunicationscouncil/2018/08/16/how-retailers-and-brands-can-use-consumer-data-more-effectively/#60b7104325e8.
- Chalasani, M., Vaidya, P., & Mullin, T. (2018). Enhancing the incorporation of the patient’s voice in drug development and evaluation. Research involvement and engagement, 4(1), 10.
- Domecq, J. P., Prutsky, G., Elraiyah, T., Wang, Z., Nabhan, M., Shippee, N., … & Erwin, P. (2014). Patient engagement in research: a systematic review.BMC health services research, 14(1), 1.
- EPA Press Office (2018). EPA and DOT Announce Three Public Hearings on the Proposed SAFE Vehicles Rule. Retrieved September 15, 2018 from https://www.epa.gov/newsreleases/epa-and-dot-announce-three-public-hearings-proposed-safe-vehicles-rule.
- Food and Drug Administration (2018). Patient-Focused Drug Development: Disease Area Meetings Held in Fiscal Years 2013-2017 [Website] Retrieved from https://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ucm347317.htm
- French, J., Lujan, J. L., Bardot, D., Graczyk, E. L., Hess-Dunning, A., Triolo, R. J., … & Zbrzeski, A. (2018). The Need for Understanding and Engaging the Patient as Consumer of Products Developed by Neural Engineering. Journal of neural engineering.
- Gawande, A. (2014). Being mortal: medicine and what matters in the end. Metropolitan Books.
- Pfizer, (2016). Retrieved September 15, 2018 from https://www.pfizer.com/files/investors/financial_reports/annual_reports/2014/world_safety.htm
- Purtell, L., Berquier, I., Douglas, C., Taylor, B., Heffernan, D., Hoy, W., … & Healy, H. (2017). What a patient wants: A consumer perspective of kidney supportive care
- Robbins, D. A., Curro, F. A., & Fox, C. H. (2013). Defining patient-centricity opportunities, challenges, and implications for clinical care and research. Therapeutic Innovation & Regulatory Science, 47(3), 349-355.