Patient Uncertainty as a Motivator for Study Participation

Kathleen Morrison, M.P.H., Crohnology.MD Project Co-Director, Health Communities Foundation

Medical sociologists and public health experts have recognized the important role that patient uncertainty plays in the lives of patients with chronic diseases for decades.¹ Fifty years ago, the standard paradigm in the health care system was one of profound information asymmetry, whereby patients depended on physicians to inform them of all aspects of disease diagnosis and treatment. As the disease burden in the U.S. shifted from primarily acute disease to primarily chronic disease, the roles of patients and providers have barely changed. Because chronic disease has no cure, requires patient engagement for effective treatment, is best addressed if the patient is knowledgeable about consequences of the disease and its therapies, and is most effectively treated if the patient and provider collaborate, it requires a different level of patient engagement than acute disease.² These concepts of patient-centered care and patient management of their own information are at the heart of the Project HealthDesign mission, and promise to forever alter the role patients play in the treatment of their diseases.

Crohn’s disease disproportionately impacts young adults. The average age of onset is 15-30 years, a time when many people make the most important and long-lasting decisions of their lives. When we interviewed a small sample of our Crohnology.MD patient cohort, before we deployed the technology for the study, we asked them what the most difficult aspect of living with Crohn’s disease was. It is noteworthy that 100% of the patients interviewed cited uncertainty about their future disease symptoms as the most difficult aspect of living with Crohn’s and as the primary motive for wanting to participate in this study. Patients who were healthy at the time of the interview were worried about when they would get sick again, and how sick they might become. Patients who were suffering from active disease symptoms worried about the unknown: How bad would their symptoms get,? When would their symptoms end? A couple of patients noted that, in some ways, it was easier when there was a disease flare, because then there was no uncertainty – it was clear that the only option was to stay in bed. As the interviewer, my heart went out to our patients; as a researcher, I felt that they were spot-on in deciding to enter this study. Our patients have chosen the observations of daily living (ODLs) that they feel are relevant to their life and health, and they are now able to view the ODL data they’ve recorded and look for ODL interactions and trends in the mobile app we developed for this study.

Going forward, we hope that the patients who use our technology will be able to identify ODLs (either individually or in groups) that directly impact both wellness and disease severity. We would also hope to see improved patient/provider collaboration, and perhaps even time and cost savings associated with more efficient (or reduced) clinical appointments. In the short run, however, if we can help patients reduce the stress associated with their uncertainty about their disease, by engaging them in monitoring and reviewing their data and providing an avenue to make associations between ODLs, medications, and well-being, then perhaps we will be addressing the patients’ #1 concern. Not too shabby.

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¹ Davis F. Uncertainty in Medical Prognosis, Clinical and Functional. Am J of Soc 1960.

² Holman H , Lorig K. Patient Self-Management: A Key to Effectiveness and Efficiency in Care of Chronic Disease. Pub Hlth Rep 2004;119:239-243.

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Learn more about the Crohnology.MD project.
Read more posts from the Crohnology.MD team.

The Cohort Selection Process for Crohnology.MD

Elena Rodriguez Fisher, R.N., FNP-C, Crohnology.MD Clinical Partner

Would you like an iPad?

Offering an iPad in exchange for participating in a study that aims to improve patient-provider communication instantly gets people’s attention. But even without the iPads, recruiting 30 study participants with moderate to severe Crohn’s Disease is far from difficult.

Patients with Crohn’s may require immunosuppressive medications to help control their disease and many have had complications that have necessitated surgery. As a result, Crohn’s patients tend to be highly motivated and are often up for trying anything that may limit the symptoms of the disease or improve their quality of life. The harmful effects of assorted medications, therapies, surgeries, and impositions on personal and professional pursuits tend to foster this openness toward new approaches if there is a chance their health may be improved.

The selection criteria for our study require that participants must:

1. Currently be under the care of a health care provider at the University of California, San Francisco Center for Colitis and Crohn’s Disease;
   
   
2. Possess the means and be willing to communicate with their provider electronically;
   
   
3. Be willing to attend clinical follow-up visit(s) with their provider during the study period;
   
   
4. Be open to participating in focus groups, completing surveys and using technology to collect and integrate observations of daily living (ODLs);
   
   
5. Be able to read, write and speak English; and
   
   
6. Be eighteen years old or older at the time the study begins.  

Potential participants received informational handouts at scheduled office visits or after contacting their providers via email. These handouts instructed them to contact the nurse practitioner at the Center for Colitis and Crohn’s Disease via email if they were interested in enrolling in the study. Most candidates quickly responded to express interest. When discussing the study, many potential participants even disclosed that they already tracked their symptoms using paper or electronic diaries, spread sheets, or timelines.

Most candidates were selected because they have a history of emailing their health care provider two or more times a year or because they expressed an interest in doing so. Most of the candidates who declined to participate in the study cited the time commitment or their current life demands as the primary reasons for refusing to participate. The selection process occurred over a 2 1/2 month  period, and the study enrollment goal was reached prior to study initiation.

Study participants are genuinely excited to be involved; though, as one might expect, they do frequently ask, “When do we get our iPads?”

Learn more about the Chronology.MD project.
Read more posts from the Chronology.MD team.

Selecting Observations of Daily Living (ODLs) – Patient and Provider Priorities

Kathleen Morrison, M.P.H., Crohnology.MD Project Co-Director, Health Communities Foundation

Crohn’s disease is a painful and often burdensome disease. Although debate is ongoing as to the exact cause of the disease, we do know that there is a genetic component, as well as an environmental component to the disease. We know that the disease is nearly nonexistent in Southeast Asia, but that when Southeast Asians move to the U.S., we start to see Crohn’s disease in that population. Jonathan Terdiman, M.D., our clinical principal investigator, describes the disease as “… a war going on between different types bacteria in the intestines of an individual.” The standard of treatment varies, depending on the severity and extent of the disease in the patient. For this reason, Crohn’s disease provides a perfect opportunity for patients and providers to explore the usefulness of observations of daily living (ODLs) in promoting increased collaboration and communication in the understanding and treatment of the disease.

We knew that in order to capture the ODLs that would be most useful for our project, we had to get input from both patients and providers. Prior to our focus groups with both of these groups, we reviewed the literature, taking into account the most often used of quality of life indices for Crohn’s disease – the Crohn’s Disease Activity Index and the Harvey-Bradshaw index. In addition, we reviewed the quality of life markers identified in the Inflammatory Bowel Disease Questionnaire (IBDQ). We selected a baseline set of ODLs based on the markers that had been identified as most useful and presented them (separately) to our patient and provider focus groups. We then asked them to rank the ODLs.

Although ODLs are patient-directed observations, we wanted to make sure that the providers felt that the ODL information being collected would help inform their treatment decisions. Our goal is to create an ODL collection system that is both personally relevant to patients and clinically useful for providers. Our budget allows us to identify and collect data on 6-10 standardized ODLs—including a few biometric measures such as weight and test results—and we were very curious about how much overlap there would be between the patient and provider focus groups.

Provider Priorities

Not surprisingly, there were both similarities and clear differences between the priorities of the representative focus groups. Both groups agreed upon the importance of pain, activity level, bowel movements (BM), medications, weight and test results. Yet the providers acknowledged that the level of ODL importance really does vary by patient. For example, although BM is an important indicator of Crohn’s severity, many different aspects of the disease can impact BM, including where the disease is impacting the colon, how far the disease has progressed and food intake. Because of the entirely subjective nature of this marker, the providers broadly felt that it would not be one of the most useful indicators to follow in this study. Similarly, they felt that energy level and mood were subjective measures that would vary by patient and that these ODLs would not necessarily assist the providers in their treatment decisions.

Patient Priorities

The patients preferred that the ODLs be very individualized. The women in the group wanted to track their menstrual cycles in order to see the correlation with pain and other indicators. This topic never came up in our discussion with providers. Several patients mentioned that missed workdays could be used as a proxy for pain, missed sleep or BM complications. The patients felt that energy level and mood were directly correlated with how sick they were and how motivated they were to exercise and work; they felt strongly that these indicators were related to their pain and disease symptoms. This group of patients was interested in investigating the interactions between two or more ODLs and the biometric measures, including medications taken. The patients had strong ideas about which ODLs they would track and why. In fact, some of them had already been tracking their symptoms for some time. Interestingly, the patients all commented that they would be more likely to collect ODL information when they were not feeling well. “When I feel good, I want to forget that I have Crohn’s disease, and I want to stay as far away as possible from it,” said one patient.

A Collaboration Between Patients and Providers

It took several weeks for our team to identify our final list of ODLs to be tracked.  We took into consideration factors identified in the literature; by the providers; and by the patients. Given the wide range of patient preferences about which ODLs to track, as well as Dr. Terdiman’s recommendation that the patients and providers should work together to identify the most relevant ODLs to track, it seems that a collaborative process is already in the works. In order to accommodate the ODLs that patients wish to track, but that are not on our official ODL list, our developers have introduced journaling functionality, whereby patients will be able to add and tag other ODL data that they deem important and relevant to follow. We hope that both patients and providers find the process of ODL identification and collection to be illuminating and rewarding.

Learn more about the Chronology.MD project.
Read more posts from the Chronology.MD team.

Participatory Medicine @ UCSF: Off the Whiteboard and onto the Smartphone

By Nikolai Kirienko, UC Berkeley

As a patient at UCSF, I’ve witnessed bedside technology evolve at a rapid pace over the years. From nurses capturing vitals on tablet computers, to patients escaping through 50-inch HDTVs, high tech surfaces are helping us connect and accomplish our age-old goals in very modern ways.

Yet, during a recent admission, the interactive surface that most captured my attention was an upgrade to a decidedly low power device: the patient whiteboard. 

As strange as it may sound, this was the most engaging piece of technology in my hospital room: it was a collaborative medium for asking questions, coordinating specialist teams, mapping out treatment options and otherwise sequencing the series of events leading up to the most important day of my hospitalization: my planned date of discharge.

Dr. Niraj Sehgal, a product champion for the newly revamped whiteboards recently wrote in the Journal of Hospital Medicine, “Patient whiteboards can serve as a communication tool between hospital providers and as a mechanism to engage patients in their care, but little is known about their current use or best practices.” 

In my experience, I witnessed the whiteboards performing the function of ‘random access memory’ within our group collaboration process; a kind of short-term, shared memory vital to executing a task. It made sure that everyone was looking at the same information at the same time, much as we hope to accomplish with the design of Crohnology.MD.

So, perhaps the wisdom the whiteboards can offer us as designers of personal health care applications is an illustration of participatory medicine as best defined by patient engagement, which does not always require the latest in technology to be effective. For example, in preliminary user tests we've found that SMS can engage as well as or even better than a native app for capturing certain ODLs.

Ultimately, the whiteboards at UCSF, and the culture of patient participation they represent, are steadily paving the way for all the advanced bedside collaboration technologies destined to take their place. And even if people and their processes evolve slowly, when it comes to putting the patient in the driver’s seat, sometimes the right technology is just a surface to write on. In the meantime, I'll be snapping pictures on my smartphone- until we finish a smarter dashboard. 

Reformation or Revolution? ODLs in the medical record: from patient narrative to patient safety

By Nikolai Kirienko, University of California, Berkeley, Crohnology.MD Project Director

Read all Crohonology.MD blog posts

“History is a guide to navigation in perilous times.  History is who we are, and why we are the way we are.”

David C. McCullough vividly brought this to life in his chronicles of the American Revolution. I’m moved by the significance of these words in the context of yet another great American saga.  It’s one whose story is still being written, and upon which the future health and prosperity of our country now depends -- our definition of the meaningful use of health care IT.

As we unleash an unprecedented national effort to reform our ailing health care system, like a patient navigating in perilous times, we should look to our medical history for guidance on who we are, and why we are the way we are.  In this history of health care reform, just a few of us can be providers, but everyone is a patient.  And patients have stories to tell, too.

Yet, if history really is written by the victors, perhaps now is a good time to stop and ask: in our current system of keeping medical records, one upon which the nation has embarked on a $27 billion quest to modernize over the next five years, who will write the history?

Over the last 10 years, despite logging well over a year in the hospital, I have only read my chart a handful of times.  In each of these instances, it was only because the chart was literally placed in my lap while I sat in a wheelchair, waiting for a CT Scan.  And each and every time, I have been surprised, and occasionally shocked by what I read. 

In short, my journey as a patient has too often been shaped not by my own methodical input, but by a game of telephone, through which a group of relative strangers author a narrative about my life. As the patient, I am neither the author nor the reader by design.

I’ve met and lost young friends in the hospital due to preventable error, and all of these tragic experiences have hardened me into an unapologetic advocate for patient safety, a movement perpetually defined by its challenges to the status quo.  As such, I have no doubt that ODL's in an open medical record would have prevented many of the scars I bear today. 

In our definitions of meaningful use for technology fueled health care reform, it would be a mistake to merely build a more efficient electronic billing machine that only makes our system faster at its flaws. 

Rather, we should embrace this as the once in a lifetime opportunity it is to re-imagine, re-engineer, and re-create a unified, patient-centered digital work flow. One built around collaborative clinical documents with structured, patient defined, and clinically useful input flowing in and out of the medical record. In other words, hospitals need to open the door to well researched ODL’s, as a matter of patient safety.

But first, we need to open the medical history. We need to make it accessible to the individual patient. In this reform, 'We, the people', are all patients.  And the goal of these reforms should be to give us all a hand with which to help write our own medical history. That would be a revolution.

This is a task of monumental proportions.  Thankfully, I see a bright future; one in which the pioneering ideas behind Project OpenNotes and Project HealthDesign can combine into a single, patient-centered record, obscuring the distinctions we once made between an EMR and a PHR.  This is the beginning of a history I can’t wait to experience. 

What do you want from meaningful use: revolution or reform?  Add your thoughts to the record, in the comments below!  

ODLs: Thinking Meta, Part 2

By Nikolai Kirienko, University of California, Berkeley, Crohnology.MD Project Director

For an unvarnished peak behind the curtain, the following is an account of how my approach to ODLs has dramatically evolved over the last three weeks in the midst of an unfolding health crisis. 

Ability barriers to clinical collaboration via ODLs:
On days where I could have benefited from the feedback of ODLs the most, I was the least likely to be recording them. Why? On the worst days, I was literally too nauseated to answer my phone when it rang, let alone futz with one of the three Crohn's symptom tracking apps on my iPhone - none of which even acknowledged my nausea and related gems as symptoms. Secondly, I didn't want to dwell on this negative experience for even a second longer than I had to.

The situation becomes isolating quickly; the acute aspects of the experience are unpleasant, embarrassing, socially burdensome and I hardly wanted to acknowledge them to myself or anyone else. I just wanted to hideout until it all blew over. Because it does pass, eventually. But, the cost in the meantime is often far too steep. So how can we address this difficult situation with ODL's?

Promising practice:
We need to rethink our ODLs reporting methods. The obvious solution: include the ability for caregivers/very special friends to report ODLs. However, I live alone for weeks at a time. The less obvious solution: make it impossible not to report. As in, no status is in fact, a status.

A reporting approach vaguely similar to 'Plerts' comes to mind: notifying a caregiver or provider when the last reported ODLs were trending into negative territory for consecutive days and/or weeks, only to disappear altogether. Skip out on your ODLs, and expect a call. Or better yet, a knock at the door. Yet, this implies a social contract-like, community based approach to reporting ODLs; which means actually taking ODLs seriously as a team sport, and deliberately assigning roles. No more hiding.

Motivation barriers to clinical collaboration via ODLs:
Never underestimate the power of denial, especially in a complex condition.

Promising practice:
Whenever possible, subjective ODLs need an objective counterweight. For example, when treating anemia, display hemoglobin alongside subjective reports of fatigue. When treating depression, display exercise (step count from a pedometer) along side subjective reports of mood. When sampling pain, (at least in Crohn's) it makes sense to view it along side weight (say, from a bluetooth weight scale) because when eating is painful, the easiest response is to simply eat less, or nothing at all. Balancing subjective ODLs with 'device enabled' objective ODLs is likely to provide a more clinically relevant picture than either sampling method alone.

Contextual barriers to clinical collaboration via ODLs:
These solutions are most relevant to the 5% of a given patient population that have multiple co-occurring conditions and tend to account for over 50% of the cost of annual care. (see Medicare and complex conditions)

Promising practice:
We have to design for the 95% without sacrificing the 5%'ers for whom this technology has the potential to be truly life saving. This is where I think a multi-tiered approach to ODLs makes sense: maintain a lightweight interaction limited to the bare minimum of ODLs with the least effort to record, while revealing more granular reporting of an expanded ODLs set as needed for those who can use them. 

This is a raw look at my 'n' of one experience with ODLs, but I hope it's honesty and candor is valuable to others designing for chronic illness. At the core, ODLs are about getting at the truth, especially when it hurts- while reminding those who are suffering that they are not alone. In the not too distant future, help may be an ODL away.

ODLs: Thinking Meta

By Nikolai Kirienko, University of California, Berkeley, Crohnology.MD Project Director

In my view, the process of designing ODLs is an exercise in what brain researcher, author and Wired contributing editor Jonah Lehrer calls 'thinking meta,' or thinking about thinking.

As a patient engaging in medical research, I have an especially great opportunity to transform my experience of a complex medical condition by changing the way I think about it.I happened to learn how valuable it can be to manipulate this aspect of focus through years of practice coping with intractable chronic pain in the hospital. Some call it a frame, a nudge, or the placebo effect, while patient narrative, rhetoric or guided imagery come to mind; the simple fact is that telling a story invokes persuasion by playing on our brains expectation of what comes next.

Why I don't record ODLs: Fear and denial
For example, as a patient, (and busy student) it's been pretty easy to stress out as I've witnessed my daily routine slowly grind to a halt over the last three months. With every passing week, the clues have been stacking up: the monthly IV Crohn's therapy that once worked so well has been slowly failing to shield me from active disease. And I know far too well what's likely to come next, in my case; hospitalization, and the very real possibility of surgery. 

As these symptoms progress, I confess there are many days when it's far too easy to roll over in bed, take a pain pill and desperately try to ignore them. And/or go snowboarding. (never underestimate the power of denial, and helicopters) 

Why I do record ODLs: Hope and growth
Yet, the budding investigator (and zen meta master) within finds inspiration in a rare opportunity to observe a host of new ways in which ODLs can make my life, and hopefully the lives of others with complex medical conditions, easier. After all, that's what ODLs are all about: sharing measurements of health status for the purpose of getting well.

So, with ODLs emerging as the vocabulary of a new approach to patient narrative, they have the potential to powerfully shape the way patients focus on, process and communicate their experience of chronic illness on a daily basis.

My advice to fellow ODLs designers: make sure your ODLs have a good bedside manner. Like a great physician, great ODLs should frame clinical information for patients in a way that realistically accounts for medical reality, while simultaneously engaging and inspiring a patient's hopes and beliefs in their ability take action and get well.

In my next post, I'll pull back the curtain even further and illustrate the specific strengths and limitations I've experienced as a patient/designer working with ODLs in the midst of a health crisis.

Crohnology.MD - Visualizing Patient Narratives via ODLs in Crohn's Disease

This post is the fifth and final in a series that introduced you to our five new grantee teams.

By Nikolai Kirienko, University of California, Berkeley, Crohnology.MD Project Director.

How do you communicate the impact of a chronic illness when you look much healthier than you feel?  This question has dominated my life from the time I was 12.

It started before the summer of 7th grade, when I came down with the flu along with most of my class.  But when school began the next fall, I was still sick.  In fact, I remained ill during the fall semesters of 8th through 11th grade.  And no one, including my doctors or myself knew exactly why.

Managing Crohn's Disease
Then on December 28, 1998, during my senior year of high school, I was airlifted out of Bear Valley, CA with a full bowel obstruction. Six years of chronic inflammation from an undiagnosed case of Crohn’s disease had finally scarred my small intestine almost entirely shut. Yet, it was all very quick and unexpected as the helicopter lifted me off the mountain, leaving my family and my new snowboard behind in the middle of what had been a great powder day.
 
What my family, my doctors and I all missed were the subtle, progressive signs of steadily worsening Crohn's disease.  The destructive patterns of this illness can unfold slowly over years, often without surfacing in a single definitive blood test or the most advanced medical diagnostic image.

For 600,000 American's with Crohn's disease, many of whom are young and leading active lives, accurate communication around these subtle, every day patterns can be a vital first step towards accessing appropriate care in a timely way.

Crohnology.MD
Over the last 10 years, I've had five more surgeries, spent over 300 days in the hospital and learned to keep a detailed electronic record of my symptoms.  However, with 5,000 pages of text spanning four solid years of daily observation, I encountered an entirely new problem.  How do I make sense of all this data?  Especially when I have just 15 minutes to summarize weeks, months and years of experience with my provider in clinic!
 
Evolving from those early efforts, Crohnology.MD has emerged with the goal of making it easier for every patient with Crohn's disease to accurately select, record and share the most important health patterns from their everyday lives. By deploying connected technologies that can blend into a daily routine, such as smart phones and wireless weight scales, we hope to give patients and those who care for them more timely and actionable insight into the relationships between weight fluctuations, chronic pain, fatigue, sleepless nights, stress and of course, all those fun gastrointestinal symptoms.  
 
The Crohnology.MD Team
Crohnology.MD is a collaborative research effort between the University of California, Berkeley, the Healthy Communities Foundation and the University of California, San Francisco. At the UC Berkeley School of Public Health, Principle Investigators Deryk Van Brunt Dr.P.H. and Linda Neuhauser Dr.PH. are guiding our team with decades of experience and research in the collaborative development and evaluation of online consumer health interventions.  At UCSF, Principle Investigator Jonathan Terdiman, M.D., Director of the Crohn's and Colitis Center, and Elena Rodriguez, R.N. M.S. C-NP are working to ensure that Crohnology.MD fits well into a clinical workflow, while also improving the patient-provider relationship. Leading Crohnology.MD’s implementation and development is pioneering Continua Alliance member and systems integrator Praduman Jain and his staff at Vignet, with Paul Hamera providing design, and Marcos Athanasoulis, Dr.P.H. providing technical direction on behalf of The Healthy Communities Foundation.

We hope you'll visit our webpage for Crohnology.MD updates and follow our progress through the blog!