Patient Utilization of ODLs and Insights Related to ODLs in Chronology.MD

Kathleen Morrison, Chronology.MD Project Director, Healthy Communities Foundation

Our study population of 30 participants was essentially a convenience sample. Our University of California, San Francisco (UCSF) clinical team posted flyers in the clinical offices. They also approached patients whom they felt would be interested in and capable of using an app designed to identify personally relevant observations of daily living (ODLs) and graph ODL input over time. We conducted an online survey in April 2012 to gain insight on the patient-reported utilization of our two applications — the Chronology app for ODL collection and the Crohnograph app for data visualization.

Our patient population was evenly split male/female; 61% were between the ages of 25-34, 25% were between 35-44 years, and 14% were between 45-54 years. Because the clinical practice is part of UCSF, it came as no surprise that several of the patients were graduate students or those employed in fields related to the technology industry. This was an extra bonus for us, because not only were many of the patients already comfortable with digital technology, but also they were also able to offer us great input and advice regarding the design and architecture of the apps we developed.

When asked whether they used the system, 93% reported yes. Those who did not use the system were either very sick during the course of the study (i.e., too ill to enter data), or very healthy (i.e., nothing to report; wanted to take a holiday from their illness). Overall, the ODLs that the patients felt were the most personally relevant to track were (in order of most frequently cited): abdominal pain, weight, energy, journal, stress, daily activity, medications, sleep, lab tests, and trigger foods.  Our sample size is too small to make any statistically significant conclusions, but we did find some variation in the types of ODLs collected by age. Patients in the 25-34 years age group were more likely to report abdominal pain and weight as the two most relevant ODLs for them to share with their providers; patients in the 35-44 age group reported that the journal and abdominal pain were most relevant to share; and patients in the 45-54 age group unanimously reported stress and energy as the two most relevant ODLs to share with their providers. Perhaps more pertinent is that patients who had been diagnosed with Crohn’s for 10+ years reported abdominal pain, weight, energy, stress, daily activity, and sleep as the most relevant ODLs to share with their provider.

Several patient interviews revealed that patients found the connection between sleep, energy and stress to be extremely illuminating and helpful to monitor. In addition, many patients  reported that they had no idea that increased sleep and daily activity had such a big impact on both their energy levels (increase) and stress levels (decrease), but  also impacted their level of  abdominal pain (decrease). One of the biometric devices patients used in this study, the Fitbit Body Monitor, tracked both sleep and steps taken (daily activity), which facilitated the ease of tracking of both of these ODLs.

Prior to the study, about half of the patients ages 25-34 years and 35-44 years monitored their symptoms, while only 25% of the patients aged 45-54 did so. After the study, 100% of the patients ages 15-34 and 45-54 reported that they are more likely to monitor their symptoms on a regular basis. About 50% of the patients ages 35-44 years reported that they are more likely to monitor their symptoms on a regular basis after the study.

At the beginning of the study, the cohort was informed that we would be beta testing a new technology, which would have bugs and glitches. Although developing and testing a new system was challenging, the patients were positive, patient, and shared a great deal of insight with our team. This study set out to identify ODLs relevant to patients with Crohn’s disease and to discern whether the visual narrative of these ODLs would be helpful in promoting patient-provider communication and collaboration. Based on our evaluation, we have established that our patient participants felt that they need a technology like this to track their symptoms, identify connections, and be better informed and prepared when meeting with their providers.

Learn more about the Crohnology.MD project.
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Meaningful Use on the iPad and Beyond

Nikolai Kirienko, Chronology.MD Co-Project Director, UC, Berkeley

Tablet computing at the point of care is poised to touch virtually every corner of care delivery in medicine. Yet, the currently proposed criteria for Meaningful Use Stage 2 have yet to embrace the post-PC world of medicine that’s just over the horizon. Someday sooner than we think, those large, immobile boxes chained to a desk will seem as quaint a notion as the endless stacks of paper charts they replaced.

Thankfully, Project HealthDesign offers a practical glimpse of our rapidly emerging future in action today.

By equipping patients and providers with an array of cutting-edge consumer technologies-- from iPads to WiFi biometric devices-- and putting them through their paces in clinical practice, we are able to learn a vast amount about the promise and pitfalls we're likely to encounter at scale in just a few short years.

With respect to Meaningful Use, and through Project HealthDesign, Robert Wood Johnson Foundation is characteristically ahead of the game, pioneering a scenario that, at first glance, may look ridiculous to folks steeped in the world as it is today. iPads? SMS messaging? WiFi? I can't even get my patients to show up! (Note the Estrellita team's most popular app feature: appointment tracking.)

As a member of ONC’s newly minted Consumer/Patient Engagement Power Team, it's been a privilege to work with ONC's senior adviser for Consumer E-Health, Lygeia Riccardi and MaryJo Deering, acting director of the Office of Communications, to examine the long view in the context of Meaningful Use.

They recently asked fellow patient advocates Hugo Campos, Heidi Sitcov and me to work alongside industry leaders as co-chairs of a remarkable group assembled to combine a rare blend of on-the-ground experience implementing health IT. Our task: to bring the patient voice, via direct item by item comments, before the Policy and Standards Committees overseeing the development of the Meaningful Use Stage 2 criteria.

Thanks to Project HealthDesign, I have no shortage of vivid patient experiences involving the challenges of working with electronic health data, which I hope to more explicitly detail along with our specific comments in an upcoming post.

In short, Project HealthDesign makes abundantly clear that patients today-- and in rapidly growing numbers into the future-- will expect to easily engage with their personal health data in apps and on mobile devices of their choosing. Native apps on smartphones and tablets may provide the most engaging experiences available, but importing data, such as lab test results, remains a significant barrier to adoption-- for patients and developers alike.

The SMART Platform within ONC’s Strategic Health IT Advanced Research Projects (SHARP) is working hard to reduce many of these barriers.In conjunction with existing standards, it will facilitate the role outlined early on by the Project HealthDesign Common Platform and through complementary third party services like Microsoft HealthVault.

My highest hope is that data liberation for apps, as advanced in these and similar projects, will become a policy and standards reality in Meaningful Use Stage 3 and beyond.

It will be a beautiful day when sharing components of my longitudinal health record, such as medication adherence or lab test results, with an iPad app is as simple and easy as installing an app on Facebook.

Chronology.MD, in conjunction with other interactive health history timelines such as SMART app challenge winner MyNote, or @KatieMcCurdy's inspiring medical life history will require this data for greater accuracy and to spare patients from hand transcription.

The details of my experience directing and using our app have made me a vocal advocate for the robust inclusion of patient engagement as more than just a theme in a spreadsheet. To make a transformational difference, truly liberated data will need to be hard coded into the policies and standards driving value in our rapidly evolving electronic health care economy.

Granting static electronic views of data will be a welcome improvement, as written in the current Meaningful Use criteria. But if patients can't engage with their data in order to create meaningful change in their daily lives-- via apps they might actually enjoy-- then it’s but one more health information silo that used to be on paper.  When it’s all said and done, Meaningful Use must be meaningful for patients for it to be truly meaningful at all. Thankfully, this is only the beginning.

How would you enhance Meaningful Use to aid dynamic patient engagement? Sound off in the comments so I can share your input with the Power Team.

 

The Challenges of Liberating and Aggregating Data for Optimal Patient-Provider Collaboration and Outcomes

Dan Bernstein, M.Arch., Chronology.MD Technical Partner, Medic8 Manager

Before a team of clinicians can develop and deploy a good treatment plan, they need the best available information in order to correctly and quickly diagnose a patient’s condition and status. 

In the past, many people saw the same doctor for most of their lives.  At the time, paper records were the best option we had; that’s not the case anymore.  Now, patients move and travel, see multitudes of health care professionals throughout their lives, and use several pharmacies and labs. Today, although electronic health records can make patient health data portable, information liquidity is not happening.

Almost every use case in health care should have the patient at its center. But most of the diagrams I’ve seen that illustrate how information flows in health care show patients as a byproduct, as an afterthought, or don’t even document their existence.

Today’s EHRs are not leveraging the power of intelligent data management. In fact, they are used in much the same way as paper records have been used traditionally.

This reminds me of my time as an architect. Even though most firms had begun using what were then considered state-of-the-art CAD systems, I soon realized that moving to digitized systems hadn’t magically allowed them to work smarter (e.g., they hadn’t created symbol libraries of common building elements or building systems broken out into individual files for re-use and global updates). That was 20 years ago. Ad while architecture firms and CAD systems have evolved, health care and EHR systems seem to have been dragging their feet.

Organizations need to jump feet first into the patient-centered digital realm. Today, supporting both paper and digital systems is inefficient. 

It’s a travesty that in a modern society patient health records are stashed away and only made available to the patient or a physician at another hospital through a process that hasn’t changed since the early part of the last century.  Here is what I experienced in my recent interaction with University of Chicago Hospital when trying to get my own health records:

• The hospital mails me blank forms to document my approval to release my records. These forms are not available to be faxed or emailed or on their website for download.
• There are charges for me to get a copy of my records.
• Even though the University of Chicago Hospital uses an Epic EHR system, I can’t access my own information via an online patient portal.
• I have records at three different hospitals that all use Epic EHR systems, but it's not easy to share my health information between the systems.

It’s a backward system that requires a patient to jump through hoops to request information from his providers, hospitals, labs and pharmacies. Any organization that impedes the appropriate transfer or sharing of patient health information should be penalized.

If the best available information is to become available to both patients and providers at the point and time of care, then it’s going to require lots of changes and all of our support.

Learn more about the Crohnology.MD project.
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Technology Challenges and Successes: A View from Chronology.MD

Marcos Athanasoulis, Dr.P.H., M.P.H., Chronology.MD Technical Director, Healthy Communities Institute
Kathleen Morrison, M.P.H., Chronology.MD Co-Project Director, Healthy Communities Foundation

Our technology team has included a diverse group: a health informatics researcher/CTO, an architect, a health services researcher, and a UCB undergraduate/patient/usability specialist. Because our project experienced administrative delays and personnel setbacks during the first year of funding, the beginning of 2011 required an expedited execution of our app technology. With four people and four very different levels of expertise in the various disciplines required to develop a mobile health app, the effort has been fun, challenging and occasionally frustrating, but ultimately rewarding and educational.

We developed two apps for this study: the Chronology.MD app that allows patient participants to enter data on an iPhone/iPad/iPod, or via SMS text message on other types of phones; and the Crohnograph app, which provides visualizations of the patient data in trend line form on the iPad.

Some challenges we addressed include:

• Multiple technology partners
  In addition to Apple devices, each patient also received a Withings Body Mass Scale and a Fitbit activity monitor that are used to collect ODL data (e.g., weight, steps taken, sleep) . We brought in technology partners, including iMedic8 (the medication adherence app upon which we built our platform), so that we didn’t have to reinvent the wheel. Working with iMedic8, Withings and Fitbit brought us great capabilities but meant coding our apps to conform to all of these existing platforms.

• Multiple authentication methods
  Similarly, the authentication processes for Withings and Fitbit were different. One supports direct back-end authentication while the other requires the user to navigate to their site on the device to authenticate. To make this happen, our developer needed to adapt around the existing workflow of these two technology partners.
  
  
• OS upgrades
  We confronted the realities of dealing with Apple OS upgrades. Because an upgrade occurred mid-project, our app needed to work with Apple OS4 as well as the newer OS5.
  
  
• Hardware variations
  We had to work with multiple types of hardware, and we had to find ways for the app to work with multiple configurations such as the iPad and SMS text messaging.
  
  
• Patient data integration
  Our plan for patient data integration was thwarted when Google Health (our planned data repository) was discontinued. Changes happen. Even large, stable companies cancel products, and we have had to adapt to this reality.
  
  
• Performance issues
  Although our design team had outstanding ideas about data visualization (e.g., screen pinch and zoom timelines for data), some of those ideas were beyond the reality of processor/computing capacity at this time.
  
  
• Vendor issues
  Apple hardware is elegant, but we did have challenges working with Apple, including a very limited discount for nonprofits and research projects, as well as having to go through their application review process with a limit of only 100 provisions for testing.

Technology successes we can identify at this point include:

• We predicted that participants would want to use their own phones for the project, which turned out to be the right call. Not everyone wants to give up their plain old cell phone for a smartphone. In order to accommodate these users, we incorporated SMS text messaging into the app, and all patient participants received iPads that can be used for both ODL data collection and data visualization.
• The popularity of the iPad and the other devices we offered to the cohort have resulted in great user compliance and lots of enthusiasm for the project.
• We have been able to integrate data via the effective APIs available from Withings and Fitbit.
• The device makers realized that multiple people in a household will use the Withings scale, and the log in allows additional names and tracking capabilities. Similarly, iMedic8 can handle additional users.

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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Towards a High Performance Personal Health Record

Marcos Athanasoulis, M.P.H., Dr.P.H., Crohnology.MD Technical Director, Healthy Communities Institute

A common hope among non-developers in the e-health and mobile space is that the personal health record (PHR) is the nirvana for keeping all data in one place and enabling a whole host of PHR applications. Although the PHR can do a pretty good job of keeping data in one place, what is often misunderstood is that for developers to do anything useful with a PHR, they inevitably need to have a local copy of that data. And, as soon as an application has its own data, it is a slippery slope to having its own data definitions, data that isn’t shared, and data that gets out of sync with the primary PHR. Until some major barriers are addressed, mobile application developers are faced with real challenges to actually building applications that run directly off of PHR repositories.”

Let’s take a look at the top four barriers to using PHRs as a true backbone for applications:

1: Performance

If you are querying a significant amount of data at once, rather than getting one measurement for one period, it is often not practical to rely on a remote query to database – especially if you want results in anything less than the time it takes to get a cup of coffee down the hall.

2: Network Availability

Most mobile applications cannot count on having a connection to the Internet. If the developer relies on a remote PHR to get their data, and there is no Internet connection, then the developer will not able to provide the user with the data they need. If the developer keeps a local copy, then they can access it with or without a network connection. 

3: Tools Availability

Most application development environments are optimized for a standard database backend. Most developers know how to write SQL to fetch data from a database, and they have the tools to readily use that data in an application. Adding a layer of an API call for every piece of data adds a considerable layer of complexity to the development process.

4: Lack of Standards

Even if there were a high performance, distributed PHR that let you write SQL directly against it, which one would you pick? You might have chosen Google Health. But because Google is discontinuing the product, Google Health is no longer a good choice. You could choose Microsoft HealthVault, but you are tying your fortunes to Microsoft. There is not yet a true distributed, open PHR that developers can count on for the next five years – or even the next year.

None of these barriers is insignificant. The Project HealthDesign teams have struck a balance by maintaining local copies of data, but, when possible, pushing data to and pulling data from PHRs like Google Health and Microsoft HealthVault. But until an open architecture for high performance exchange of PHR data is invented and adopted, mobile health applications developers will continue to maintain data locally and use the tools that allow them to build mobile health applications that really help people.

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Thinking about Science, Evaluation and e-Health Design

Linda Neuhauser, Dr.P.H., Crohnology.MD Co-Principal Investigator, School of Public Health, University of California, Berkeley

One of the big challenges we have faced in the Crohnology.MD project is developing an evaluation plan. We are all familiar with the trade-offs between using qualitative and quantitative methods. If we choose a primarily quantitative approach, we may have statistical results, but may not really understand the phenomena being tested. If we select a qualitative approach, it’s hard to know whether the results would be similar if tested on a larger cohort. This is the typical tension in evaluation design. My view is that traditional evaluation methods are not well suited to novel e-health experiments, like the Project HealthDesign projects. I’ll start with a personal story:

Last March, I participated in a conference on Artificial Intelligence and Health Communication at Stanford University. There were many fascinating state-of-the-art projects. I was especially intrigued by a project using avatars as health coaches. The developers described how they gathered some preliminary (formative) information at the project outset, implemented the project, and then quantitatively evaluated the outcomes. The developers and the funder considered this an acceptable design, as would many evaluators. However, the results uncovered an important problem—the users did not find the avatars adequately believable and that interfered with their engagement with the virtual coaching. Similar surprises cropped up in other projects that were presented, even though the developers of the projects were highly talented, had given careful thought to the evaluation, and had used both qualitative and quantitative methods. As a result, a number of these projects will now need to be re-funded, redesigned and re-evaluated. I left the conference with the strong impression that some of these problems could have been avoided if the developers had used different evaluation methods. Certainly, e-health evaluation is an area that needs a lot more attention.

I believe the roots of the evaluation conundrum lie in the foundations of scientific inquiry. Before the mid-20^th century, the dominant “positivist” view was that truth is knowable and generalizable and the focus was on discovering the laws that govern the physical world. This perspective advanced the idea that quantitative methods (like randomized controlled trials) should be the gold standard of research and that their findings could be broadly extrapolated. In the past 50 years, the scientific paradigm has shifted. In the “post-positivist” world, the “critical realists” have emerged and posit that it is impossible for humans to adequately perceive the real world, and that claims about reality must be subjected to the widest possible examination.

There is now a greater understanding that it can be very difficult to define what we want to study, much less quantify the results. This is particularly true when we move from the natural sciences to human sciences—people don’t follow the more predictable laws of the physical world. In the health arena, we now have a host of social sciences to help us understand the connections between people and health. Changes in evaluation design have paralleled changes in views about scientific inquiry. Qualitative methods are considered increasingly important to achieve a deeper understanding of the complicated nature of human health and behavior. Likewise, there is a growing recognition that formative work needs to take place before investigators even know enough to finalize a research design that focuses on outcomes.

Scientists have identified a newer research challenge: one posed by what is now called “design (or artificial) sciences.” This field is concerned “not with how things are, but with how they might be.” (Simon, 1996).  Those who study design sciences say that they pose special challenges for research methods because understanding a problem and solving that problem often happen at the same time. Similarly, there is no “end” to the design and problem-solving process. Obviously, design science efforts are not well suited to traditional research approaches that test a priori hypotheses. For this reason, design sciences emphasize real-time, iterative investigative approaches, such as usability testing, over the more simplistic “before” and “after” methods of traditional evaluations. In other words, just as we are experimenting with observations of daily living (ODLs) to get finer, time-sensitive information about participant data, we need to do the same in our evaluations.

In my view, the Project HealthDesign projects, which create new technologies and measure complex daily interactions between people, their environments, and their health, lie at the intersection of human and design sciences. Effective evaluation designs for these projects will need to include a strong focus on usability and other iterative testing over time, artfully linked with formative and outcome measures. There is no definitive guidance for such evaluation designs. Fortunately, the Project HealthDesign teams have taken a pioneering experimental approach to finding a better path forward.

Have you successfully employed both quantitative and qualitative evaluation techniques on a project? What advice can you share with us?

Reference:
Simon, H. 1996. The Sciences of the Artificial, 3^rd Ed. MIT Press.

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Kirienko Provides Patient Perspective on Improving Patient Access to Health Information at Consumer Health IT Summit

Libby Dowdall, Communications Coordinator, Project HealthDesign National Program Office

A Sept. 11 article in USA Today featured Nikolai “Kolya” Kirienko, patient advocate and project director of Project HealthDesign’s Crohnology.MD study. The story, “HHS Aims to Improve Patients' Access to Electronic Records,” previewed new initiatives that support patients as they seek access to their own health information.

The following initiatives were then formally introduced at the U.S. Department of Health and Human Services (HHS) Consumer Health IT Summit on Sept. 12:

• Federal rules (pdf) that would strengthen patients’ rights to access their own laboratory test results.
• A straightforward model privacy notice for personal health record (PHR) vendors.
• BlueButtonData.org, which encourages organizations to register their commitment to offering Blue Button data download functionality to their patients and users.

Kirienko, who has Chron’s disease, also appeared at the Consumer Health IT Summit, along with patient advocates Donna Cryer and Denis Stasulis. "We desperately need collaborative medical records,” said Kirienko, whose story illustrates how patient access to health information and patient-clinician cooperation can help improve care for patients with chronic diseases.

As project director of Crohnology.MD, Kirienko has casted a vision for and helped to develop a mobile personal health application that allows patients with Crohn’s disease to self-track observations of daily living (ODLs) and symptoms between clinical visits. Because the application allows users to customize data views and share them with their clinicians, he and his team hope to see the application spark and support richer conversations between patients and providers during clinical visits.

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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?”

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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.

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