What is a Carepartner?

The words we use matter. The word caregiver is often confusing for patients and their families, especially in the context of limited English proficiency and language barriers, as the word “caregiver” in health care is used interchangeably to refer to the doctor as well as to non-clinical individuals who are caring and supporting a patient.

Patients living with chronic illness, disability, rare disease,  life-altering, and life-limiting diagnoses often describe feeling a sense of a loss of autonomy and independence. They may feel guilt for needing the support of loved ones and not being able to fully care for one’s self or fulfill household obligations due to their health conditions. Many patients say they dislike needing a caregiver and despise the word. Needing a caregiver is a constant reminder of their illness and loss of dignity. The word “carepartner” is more positively received. A carepartner is a spouse, life partner, sibling, parent, family member, friend, or colleague who is there to support a person living with their diagnosis(es). A carepartner can be thought of as a team mate and support who is there, in sickness or in health; their actions defined by love and empathy, not sickness.

The New Roaring 20's

As the 2020 New Year celebrations come to an end, our real work begins. These Roaring 20's will be the era of the patient & carepartner, with our unmet needs, barriers, and challenges being brought front & center.

We are a force to be reckoned with. Our lived experiences and expertise are a secret weapon & a solid business strategy for those looking to authentically transform health care to invest in.

Navigating the chaos that is our health care system while living with a life-altering diagnosis or multiple co-morbidities can literally break a person over and over.

Remember, we are:
✨Bigger
✨Bolder
✨Louder
✨Fiercer
✨Brighter
✨Faster
✨Kinder
✨Smarter
✨Stronger
✨Unstoppable

TOGETHER

Pharma's 50 Shades of Gray: Including Patients in the Clinical Trial Life Cycle

“Is there a form I could fill out to provide my feedback?”

The silence in the room was deafening.

I exhaled with a furrowed brow, feeling extremely disappointed, wanting to stand up and apologize on behalf of the entire room that was seated so quietly. Apologize for the practices, procedures, and ideologies that had failed this woman panelist on stage, and so many others. Apologize on behalf of an industry that is advancing on so many levels, yet dropping the ball in too many priceless ways.

“Is there a form I could fill out to provide my feedback?”.

This simple question came from a vibrant young woman who just delivered a powerful narrative that brought a quiet room to a roar with the applause of a standing ovation.  This young woman detailed her harrowing patient experience of dying of advanced cancer to a tremendous success story reveling in the miraculous power of personalized medicine. She is years post the clinical trial that saved her life.

“Is there a form I could fill out to provide my feedback?”.

If she hadn’t stood at the podium and told us her story, no one would’ve known the horrors she witnessed, felt, experienced, or thought. If she hadn’t stood on the stage and articulated her story, no one would have known about her difficulties of finding the trial that saved her life. Without her story, no one would’ve heard her suggestions for improvement. If she just sat in her seat like every other member of the audience, no one would’ve known how scary, how exhausting, and how painful her journey was. Thank goodness she was invited to share her story! Otherwise, she’d just be another anonymous clinical trial endpoint successfully met.

It’s gravely concerning that after participating in a successful trial, no one invited her to help improve the process. If an educated, well-spoken, personable individual with a miraculous response to a cutting-edge therapy isn’t included in the enhancement, refinement, and co-design of clinical trials, who will be?

It’s common to hear from patients that they are not asked for their insights during or after participation in clinical trials. There is an aura of reverence surrounding people who have participated in trials. These individuals have made a profound sacrifice and leap of faith. Trial participants have agreed to introduce a foreign substance, a hypothesis, into their body, realizing that this unknown may save their life, end it, or run the gamut of all of the possibilities in between.

Imagine being diagnosed with terminal cancer, being sent home to die. Shattered. In physical, mental, and spiritual pain. Would you risk trusting an unknown therapy and introducing it into your frail, already dying body? Could you picture yourself taking an experimental agent and hoping for the best? How many of us are truly brave enough to put our trust and fate into the hands of science? Wouldn’t you agree that these experiences are profound, rare, and worth their weight in gold to thoroughly comprehend?

There are over 21,000 clinical trials listed in clinicaltrials.gov as recruiting in the US.  Were these trials designed to be tailored to the lives of the people living with a diagnosis and inclusive of all lives with a diagnosis? It depends on whether the expertise of patients and carepartners were included throughout the continuum of the clinical trial life cycle.

Over the last year, it’s been my personal curiosity to ask members of pharma if their company includes patients in the clinical trial life cycle. When I broach the subject, there is a broad spectrum of reactions, the majority of which are accompanied by clear discomfort, agitation, defensiveness, dismay, and confusion. These responses all fall into an ambiguous gray area. Here are 50 answers I have received in response to the question: Does your company include patients’ expertise and insights in the clinical trial life cycle, from study design planning, during trial implementation, after trial closeout, and post-launch of product?

1.     There are compliance issues.

2.     There are regulatory hurdles.

3.     What business incentive is there to do that?

4.     Patients don’t know anything about clinical trial design, management, or operations.

5.     We don’t have a budget for that!

6.     The FDA doesn’t require patient feedback or insights in the clinical trial process for drug approval.

7.     (Look of confusion)

8.     Our company is patient-centered. We don’t need patient insights.

9.     We don’t have the staffing to do that.

10. Pharma doesn’t traditionally speak with patients.

11. Our stringent timelines cannot accommodate this.

12. Where would we find patients to participate?

13. (eyes narrowing) Are you one of those patient activists?

14. Patients aren’t well spoken.

15. Patients aren’t professional enough to participate in these conversations

16. Our legal team would go into cardiac arrest.

17. We do not have the technology in place to do this.

18. It sounds like a great idea but upper management would never approve.

19. Our marketing team is working on a campaign.

20. We only work with non-profits.

21. It’s on the backburner for this fiscal year.

22. This is a conflict of interest.

23. We’re one of the top biopharmaceutical companies in the industry. We know what we are doing.

24. Do you know how much it costs to execute a clinical trial?

25. (eye roll)

26. Our clinical operations team runs like a well-oiled machine.

27. Do you have any references or data to support the benefit of including patients in clinical trial design?

28. Patients are unreliable and volatile.

29. That’s a waste of time.

30. Working with patients is a pain in the @ss.

31. How could pharma work with patients? They don’t trust us!

32. Sounds great in an ideal world, but we have pressing deadlines to meet.

33. Patients have their own agenda and won’t collaborate.

34. We can’t base our clinical trials on patient complaints.

35. Our company runs successful trials and gets approvals without patients involved in the process.

36. That’s another trend that will phase out soon.

37. Whose responsibility would that even fall under at our company?

38. We are watching to see how other companies are doing it.

39. Those tactics are for companies that can afford the “bells and whistles”.

40. We tried. It didn’t work.

41. We are too small of a company to implement this.

42. We don’t need more paperwork.

43. What is the return on investment?

44. We’ll talk to patients but we can’t pay them.

45. We are too big of a company, with locations all over the world. How could we coordinate this?

46. We are so overwhelmed, we can’t take on another initiative.

47. Is there a standard operating procedure for implementing this?

48. What happens if they all start talking about the adverse events of their treatments?

49. How can we trust patients?

50. Our investors don’t care about patient-centered practices and co-design. They want drugs going to market.

Pharma’s 50 shades of gray does not run industry wide. There are pioneers who are committed to changing the status quo, actively working with patients and including them on many fronts. It is evident that these trailblazers are excited by their partnerships with patients. They speak loudly and proudly about their patient-centered initiatives, with an enthusiasm that is invigorating and resounding. They acknowledge that this isn’t a just a nice gesture or outreach program. Partnering with patients is solid business sense.  Collaborating with patients bridges silos, brings meaning to daily work, and creates unique opportunities for experiential learning.

It is important to note that those within pharma who collaborate with patients are more open to leveraging technology and machine learning, discussing mobile health, digital platforms, and telehealth, exploring benefits of utilizing blockchain, as well as recognizing the importance of patient-reported outcomes. Coincidental? Absolutely not.  There is unprecedented value and power in including patients in optimizing the drug lifecycle. Augmenting trials to patients’ values, preferences, and needs is a solid win on all fronts. Do not mistake this as another passing trend!

Is your company somewhere in the 50 shades of gray? What is holding you back? Is your company a pioneer in being authentically patients first and collaborating with patients? How can early adopters share best practices to eliminate every single one of these 50 gray areas so as to collectively move the industry forward to being truly patients first?

The Need for Healthcare Experience Literacy

As an advocate and carepartner for over 20 years, I have seen things I can not unsee. I have experienced things I can not forget. I have heard things I can not unhear. I have come to understand all of my experiential learnings as reflection of a single, major omission in US healthcare. We don't teach anyone how to be a proactive member of the US healthcare system. I'm not just talking about patients or their carepartners. What about healthcare policy decision makers? How about those within pharma designing new medications? What about innovators creating new solutions to advance healthcare?  Shouldn't we all have the same foundation of knowledge to be members of our healthcare system? How are we preparing the next generation for healthcare?

Our pre-K through grade 12 public education is lacking severely in healthcare experience literacy. Literacy alone is not enough. Health literacy not enough. This is a call-to-action for healthcare experience literacy. Imagine the possibilities of ingraining the essentials of the healthcare system incrementally from early childhood through young adulthood! See my latest publication for more details: 

https://medium.com/savvy-cooperative/conquering-the-next-frontier-healthcare-experience-literacy-97eb5f0ffd8d

Book Review: In Shock by Rana Awdish, MD

This May at the Cleveland Clinic Patient Experience Summit , I had the opportunity to hear a mind-blowing talk by a physician named Dr Rana Awdish. Her story was a personal account of how she literally died at her own hospital, losing her entire blood volume into her abdomen due to a ruptured liver tumor. Pregnant at the time, she lost the baby. She continued with her journey of pain, suffering, recovery, and healing while the audience sat pin drop silent, tears and sobbing audible. Her experiences as a patient transformed her understanding of medicine and how it should in actuality be practiced; with compassion, with empathy, and through making space for suffering and vulnerability. Needless to say, I couldn't wait to dive in to the pages of her book. Here's my review. 

Dr. Awdish tears down the walls housing her personal experiences as a doctor turned patient. She masterfully guides the reader through multiple vantage points: as a doctor expecting a child, to the loss of a child and her own “death”, to miraculous survival, painful determined recovery, multiple set backs, surgeries, and medical emergencies, with victories and profound revelations throughout.  You will need to put the book down to dry the tears that fall out of pure sympathy. The reader will experience complete disbelief that a single person could possibly endure such devastation, pain, and grief.  The story captivates with a raw authenticity, transporting the reader through a broad spectrum of emotions the reader couldn’t possibly be prepared to experience: disbelief, grief, devastation, sadness, victory, joy, and true hope.  Dr. Awdish’s deep inner reflections are juxtaposed with her seemingly endless battle for life, providing a thought-provoking framework for redefining the terms patient experience, patient engagement, doctor satisfaction, and the meaning of true healthcare. There is no doubt that medical education must be refreshed after experiencing this harrowing account.

Readers will undoubtedly leave this book permanently changed and rocked to the core. In Shock professes a convincing perspective on the need for compassion and human connection in medicine.  Dr. Awdish makes a clear case for the need for more empathy for doctors, patients, and their carepartners. She is a visionary enlightened by her profound experiences as a patient. This should be required reading by every medical and nursing student, every hospital administrator, technician, and staff member. There isn’t a single person who wouldn’t benefit from reading In Shock and experiencing the consequent opening of the soul first-hand. 

My (REJECTED) Letter to the Editor

          As a researcher, I can fully appreciate the review process and recognize that there is simply only so much space allotted in any given journal. My recent submission was a Letter to the Editor of the New England Journal of Medicine (NEJM) regarding a perspective “Saying Goodbye to Lectures in Medical School- Paradigm Shift or Passing Fad?” by Schwartzstein et al, on alternatives to traditional teaching formats in medical school.  Given the elite status of the NEJM, I wasn’t entirely surprised to receive a rejection. Perhaps my simple little opinion wasn’t written in cream-of-the-crop style. The more concerning alternative is that the submission was rejected because it was not representative of the masses of submissions received or the popular vote. Perhaps no one else feels strongly about incorporating patients and care partners in the design and delivery of medical education. I find this gravely alarming.

            Revising the manner in which knowledge is delivered, i.e., virtually, in Q&A sessions, flipped classrooms, augmented reality, etc., addresses only part of the issue of sustained learning in medical trainees. It is important to incorporate the power and influence of storytelling to enhance the medical education experience. It is important for curated curricula to foster life-long learning not only in students, but also in the medical experts responsible for shaping young minds.  Current medical curricula offer learning as a 1 way street with information being disseminated from professors to students. Medical education is missing patient and care partner stories and experiences. More on that here: http://www.kevinmd.com/blog/2017/07/every-medical-student-needs-hear-patient-caregiver-stories.html

            Here’s my formal rejection from NEJM in response to my submission below. Does anyone else believe in the power of incorporating patient and care partner stories to enhance medical education?

Dear Dr. Cordovano,

I am sorry that we will not be able to publish your recent letter to the editor regarding the Schwartzstein article of 17-Aug-2017.  The space available for correspondence is very limited, and we must use our judgment to present a representative selection of the material received.  Many worthwhile communications must be declined for lack of space.

Thank you for your interest in the Journal.

Sincerely,
XXXXXXXX Editor

(Original Submission) To the Editor,

It was disappointing Schwartzstein et al. (Aug 17 issue)1 did not include patients and care partners in the design, development, and delivery of medical education. Students are only learning part of the story from cadavers and medical experts at respective institutions. We must foster the creation of curricula that are not only engaging, thought provoking, and evidence-based, but also unite patients and physicians, promote shared-decision making2, and delivery of compassionate care. Patients and care partners bring an authentic breathe of experience and perspective3 that textbooks and medical experts cannot impart or convey. It’s time to invest in participatory medicine and welcome patients and care partners to share their experiences living with disease significantly earlier into the careers of medical trainees. This model offers a unique opportunity to foster interactive, collaborative learning for all involved: medical trainees, seasoned medical experts, and patients and care partners. A change in the culture of medical education is more profound than revising curricula alone.

References:

1.     Schwartzstein R, Roberts D. Saying Goodbye to Lectures in Medical School- Paradigm Shift or Passing Fad? N Engl J Med 2017; 377: 605-607

2.     Barry M, Edgman-Levitan S. Shared Decision Making- The Pinnacle of Patient-Centered Care. N Engl J Med 2012; 366: 780-781

3.     Awdish R. A View from the Edge. N Eng J Med 2017; 376: 7-9

Robotics, Technology, and the Patient’s Clipboard

As a little girl, The Jetsons used to be one of my favorite shows to watch. An animated sitcom produced by Hanna-Barbera, The Jetsons featured a quaint family of 4 living in a space-age, futuristic era where daily life was rendered simpler by the glories of robotics, whimsical advancements, and high-tech innovations. I can still close my eyes and picture myself as a 6 year old, daydreaming about what the future would be like. 

Fast forward to August 2017. I’m watching a client struggle to wrestle their insurance card out of their wallet while juggling a clipboard with patient intake papers, her phone, and a water bottle.  Peripheral neuropathy stemming from many cancer treatments has made grasping things difficult and excruciatingly painful.  “But nothing has changed since last week, do you still need another copy of my insurance card?” asks the exasperated patient, still trying to free the pesky card from the tiny pocket in her wallet. “Office policy”, replies the receptionist curtly without looking up, “And fill out the forms because we are updating the records in our system”. There are 3 pages of forms. The patient has been coming here for over 2 years. All of the information is EXACTLY the same. She slowly fills out everything as diligently and neatly as she can, refusing my offer to help do it for her.

As a private patient advocate, I often accompany patients and their care partners to a broad spectrum of appointments, spanning follow-ups with their primary care physicians to specialists such as oncologists, cardiologists, or rheumatologists, to imaging centers for MRI’s, CAT scans, PET scans, and mammograms, to hospitals for pre-admission testing, surgical consultations, or procedures, or to phlebotomy labs for routine blood draws. I’ve observed hundreds, if not thousands, of patient encounters with front desk receptionists. No matter what the setting, there’s a common denominator routine that unites most of these experiences:

(front desk receptionist):  “Please fill out this paperwork (handing a clipboard to the patient) and I’ll need a copy of your insurance card.”

The moments that follow can be filed under “Complete Waste of Time”.

• Patients can’t get their insurance card(s) out of their wallet.
• Patients can’t find their insurance card in their wallet because the last time they were asked for it they were so flustered juggling the clipboard they shoved in a random spot.
• Patients begin filling out the intake forms they’ve filled out many times before.
• Patients realize they didn’t bring their glasses so they can’t actually read the form that’s also  often poorly photocopied.
• The pen starts running out of ink a third of the way through.
• Patients start looking for a new pen.
• Some patients continue writing, pressing harder on the paper in hopes of reactivating the pen. Many curse, press harder, and rip the form.
• Patients wait for the receptionist to return their insurance card so they may proceed to fill out the insurance information on the intake form.
• Patients try to write their insurance information (ID number, group number, address, member phone number, etc.) on the miniscule lines on the form.
• Patients can’t find the group number on the insurance card. (Insurance companies, take note!)

We are in a fascinating era of robotics, artificial intelligence, virtual/augmented reality, and digital technologies that fulfill people’s wildest imaginations.  The cancer surgical landscape is being transformed by advancements such as the da Vinci System (Intuitive Surgical), a robotically assisted surgical device bringing surgeons enhanced precision, dimension, and control while extending the possibility of minimally invasive surgery to patients https://www.intuitivesurgical.com/products/davinci_surgical_system/.  Robear (Riken), a bear-like nursing robot, can perform care-giving tasks such as lifting patients from their bed, transferring them to a wheelchair, and helping patients stand from a sitting position http://www.riken.jp/en/pr/press/2015/20150223_2/.  Hospital acquired infections may have met their match with Xenex, the germ-zapping robot, which uses high intensity pulsed ultraviolet light from xenon lamps to significantly decrease microbial loads in hospital patient rooms https://xenex.com/video-demos.  And who can resist the cuteness of the PARO seal (AIST), a therapeutic robot that fulfills unmet needs within the animal-assisted therapeutic space http://www.parorobots.com.  This is just a sampling of the wonders out there. There are even wide spread reports anticipating a robotic takeover and fears of automation replacing humans in a variety of sectors. With all of this pure genious rocket science and technology, can someone please explain to me how the hell patients are dealing with clipboards, insurance cards, fax machines, and paper chart folders with 3-hole punched paper records? Dear technology, you’ve missed the mark. You need to go back to the basics and fill in the (MAJOR) gaps before aspiring to have robots take over the world.

Many aspects of healthcare are not the futuristic Jetsons-like encounter I daydreamed of as a little girl. Dear Apple, for the love of all that is holy, please tell me there is an solution in the making that will allow patients to wave their phone Apple Pay-style to confirm basic demographic patient and insurance information so we can simplify the patient in-take process at every healthcare facility touch point. And while you are at it, lets have the capability to pay any co-pays with a second wave of the phone.  I mean enough with this cash, checks, or digging for a credit card nonsense.

Alternatively, at this juncture, it may be easier to perhaps bring in Pepper (SoftBank Robotics), the humanoid robot, into waiting rooms across the nation as an acting patient assistant to fill out the damn paperwork and get the insurance cards out for patients https://www.ald.softbankrobotics.com/en/robots/pepper. I’ll bet you a dollar it may easier than solving the current shortcomings and interoperability issues surrounding electronic health records (EHR) and patient portals.  It may also be more pleasant of an experience than many of the interactions I’ve witnessed with some front desk receptionists. Dear tech companies, looking forward to what you come up with. In the meantime, excuse me while I go find a pen that works for my client.