Maintaining the Patient Perspective in Patient-Centered Outcomes

Sara Koliner, Policy Analysis Project Assistant, Project HealthDesign National Program Office

Last week, the Patient-Centered Outcomes Research Institute (PCORI) approved 51 awards as part of its second cycle of funding in support of the development of a National Patient-Centered Clinical Research Network, part of the “Accelerating Patient-Centered and Methodological Research” Priority for Research.

Studies in Comparative Effectiveness Research (CER) rely on dense and nuanced information in order to accurately assess the quality of one treatment over another. The studies approved by PCORI, especially those concerning the assessment of prevention, diagnosis, and treatment options, cannot rely on coarse measurements such as mortality rates or a running list of potential side effects to inform medical providers and policymakers about the quality of life lived by treated patients. Instead, studies such as this could benefit from the real-time collection of the patient’s observations during treatment — information that Observations of Daily Living (ODLs) readily provide.

For example, a PCORI-funded University of Pennsylvania study has proposed to investigate the comparative effectiveness between two treatments for inflammatory bowel diseases, including Crohn’s disease. In order to quantify patient preferences for relevant treatment outcomes, a discrete choice experiment will be implemented using known attributes (e.g. the risk of serious infection, treatment failure requiring surgery, etc.). While these attributes of a treatment are important to informed decision making, they do not capture the entirety of patient-preference, especially with regard to unpredicted effects experienced during treatment.

The Project HealthDesign team, Chronology.MD, also focused on individuals with Crohn’s disease, but with the focus on their experiences during the study, rather than just the clinical outcomes. By giving patients a way to self-monitor through the collection of ODLs, the team made an enlightening observation (discussed in a blog post last year):

“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. […]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.”

We already know that patient-defined, patient-generated ODLs provide incomparable insight into a person’s health experiences on the individual scale—but that’s only half the story. The translation of these personal cues into values that can be compiled, cross-listed, and categorized brings patient-level data to the scale of a population. Through the amalgamation of individual-level data, the Chronology.MD team could see that a 30-year-old patient with Crohn’s Disease may prioritize weight over stress as an indication of health, while a 50-year-old may more likely do the opposite. When attempting to assess the effect of a treatment—especially in terms of quality of life—researchers must take these (in this case, age-related) preferences into account. Patient-centered outcomes rely on the perspectives, vocabularies, and concerns of real patients, not just the outcomes that clinicians are concerned about.

As we wrap up our eight year project and look to the future, it is important to also stress how much value remains to be produced by ODLs in the research agenda of patient-centered outcomes. Mobile technology and application software have never been more ready to be utilized by those working outside the confines of the traditional clinical research lab, and we are excited to see how patient-defined, patient-generated data illuminates the Comparative Effectiveness Research field.

ChronologyMD sees great results from “participatory design” process

Over the next six months as Project HealthDesign draws to a close, our grantee teams will be posting final reflections on their completed research.  Read here about the innovative work of our Chronology.MD team.

ChronologyMD: Reflections on the Project and Next Steps

By Linda Neuhauser, Chronology.MD Co-Principal Investigator, University of California, Berkeley; Kathleen Morrison, Chronology.MD Project Director, Healthy Communities Foundation, University of California, Berkeley; Deryk Van Brunt, Chronology.MD Co-Principal Investigator, Healthy Communities Foundation; Jonathan Terdiman,Co-Principal Investigator, University of California at San Francisco; Marcos Athanasoulis, Chronology.MD Chief Technology Officer, Healthy Communities Foundation; Nikolai Kirienko, Chronology.MD Co-Project Director, University of California, Berkeley; Elena Rodriguez Fisher, Clinical Partner, UCSF Inflammatory Bowel Disease Center; and Daniel Bernstein, Founder, Medic8 Manager LLC, Product Manager, iMedic8

Background: The goal of the ChronologyMD project was to use participatory processes with patients with Crohn’s disease and their healthcare providers to develop eHealth applications that would improve both patients’ management of their disease and also shared decision-making with their clinicians. Our project was guided by a “design science” theoretical framework, which advocates intensive, iterative, user-centered design, coupled with continuous evaluation. We engaged 30 patients with Crohn’s disease, their providers, and our project team to co-design an application to enable patients to input information about their “observations of daily living” (ODLs) into an iPad, iPhone or other device. The selected ODLs included information about health symptoms, medication adherence, activity, sleep, energy, laboratory data, and journaling related to their health and wellbeing. An electronic scale and an activity and sleep monitor allowed patients to upload that information automatically to their device. The project also developed a second application that provided a visual display of the data to help patients and providers understand ODL changes and interactions over time.  The ChronologyMD applications were developed on the iMedic8 software platform and deployment was managed by Medic8 Manager LLC.

Outcomes and Lessons Learned: The intensive participatory design and continuous evaluation methods were critical to developing effective applications. During the year of designing the applications, we used focus groups, personal interviews, usability testing, training observations, and other methods to create and refine the applications. Ongoing input from patients allowed us to adjust and modify our data collection and visualization technologies, and provided us with insight and information that will be useful in the future. For example, we learned that some patients wanted very granular information about their health that they could input multiple times a day, and wanted the ability to create new ODLs. Patients were very enthusiastic about the ChronologyMD applications and inputted over 28,000 ODLs over an eight-month period. The percentage of patients who tracked their ODL-type symptoms and behaviors increased from 40% before using the system to 92% after eight months of using it.

Patients were highly enthusiastic about the system and reported many positive effects, including improved understanding and tracking of important symptoms, medication adherence, and health behaviors. One of the most important findings was that this system enabled patients to see important associations among health factors, and make changes accordingly. For example, patients reported that they noticed that when they got more sleep and exercise, and took their medications, they felt better, could reduce pain medications, and manage their disease and life better. We concluded that people often require very personalized information to motivate them to make specific healthy changes. Clinicians in the study also concluded that the system greatly improved the quality of patient-provider health care visits. We learned that the opportunity for our Crohn’s patients to provide a more thorough and comprehensive patient narrative at the time of the clinical appointment proved to be useful and, in some cases, essential in helping patients and providers make better decisions regarding patient care.

Next Steps: Going forward, we see a lot of opportunity for innovation and expansion of this technology. The vast majority of patients in the study would like to continue using the system in the future and other patients with Crohn’s have asked how they could have access to the system. Through the participatory design process, they proposed changes to create an enhanced system in the future. We gained a more complete understanding of the challenges of developing a mobile health platform, and realized the importance of having a system revision that could collect data in a format that would also facilitate data analysis.  Clearly, the ability for patients to collect and view ODL data has applications for just about any chronic disease and we have had conversations with potential developers interested in adapting this approach for chronic pain, Alzheimer’s, cancer and other health issues. Our challenge is to find funding to refine the system and do a randomized controlled study of a larger number of patients, including incorporating patient data into the electronic health record to demonstrate “meaningful use” for long-term sustainability.

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

Terrific attendance at Project HealthDesign webinar

Wendy Swanberg, Communications Coordinator, Project HealthDesign National Program Office

More than 200 people signed up for last week’s webinar, "From the iPhone to the EMR: Can patients' personal health data help improve their clinical care?” to learn about the latest work by Project HealthDesign’s grantee teams.  Co-hosted by Stephen Downs of the Robert Wood Johnson Foundation (RWJF) and Patricia Flatley Brennan of the National Program Office, the webinar set a wider lens on the growing interest in weaving patient-generated data into the matrix of clinical health care.   

Steve Downs explained that as part of RWJF’s Pioneer Portfolio, Project HealthDesign was created to stimulate innovation in the area of personal health records.  “We laid out a vision where your medical record would serve as a platform” he explained, “and then lots of third-party apps could be tailored to your specific needs.”  The project’s five research teams took that vision and created applications tailored for patients with chronic conditions, from asthma to obesity to Alzheimer’s disease.

Project director Patti Brennan described what might be the most significant finding to arise from the project, the discovery that information from patients’ daily lives -- data about things like diet, mood and stress level – can play an important role in managing health care.  These “Observations of Daily Living,” or ODLs, became central to the grantees’ research projects and represent a significant, new category of patient-generated data.  Brennan also introduced a short video where members of each project team illustrated their projects’ findings and challenges.

Project investigator Katherine Kim described how her team’s iN Touch application helped young people struggling with obesity to become more engaged in managing their health and lifestyle.   Dr. Stephen Rothemich outlined findings of his team’s BreathEasy project, showing how ODLs can provide clinically useful information and in some cases can lead to changes in diagnosis or therapy. 

Finally, National Advisory Council member Dr. Michael Christopher Gibbons spoke eloquently of the critical role personal health records can play in a rapidly evolving society, where new approaches are needed to tend to the needs of a growing population of seniors, minorities, immigrants and the underserved.  

If you registered for the webinar but weren’t able to view it, follow this link and log in with the email address used at registration.

Chronology.MD: Lessons Learned and Next Steps

Kathleen Morrison, Chronology.MD Project Director, Healthy Communities Foundation; Linda Neuhauser, Chronology.MD Co-Principal Investigator, University of California, Berkeley; Deryk Van Brunt, Chronology.MD Co-Principal Investigator, Healthy Communities Foundation; Marcos Athanasoulis, Chronology.MD Chief Technology Officer, Healthy Communities Foundation

Crohn’s disease presents major treatment challenges for patients and clinicians to manage. The Chronology.MD project has developed an interactive mobile system in which patients with Crohn’s disease can input important observations of daily living (ODLs) such as symptoms, medication adherence, sleep, and activity, and share these data with clinicians during visits to enhance treatment decisions. In our last post, we reviewed preliminary data from patient responses to our online survey. We found that the vast majority of our patient participants liked our system and used it. We learned that patients had diverse views of the value of specific ODLs, and that age and sex may influence their views of what is personally relevant. For example, patients ages 40-50 were slightly more likely to track stress, while patients ages 20-30 were slightly more likely to track pain. Women reported that menstrual cycle information would have been an important ODL. Because our small cohort comprised only 30 patients, this information is not statistically significant, but it does help inform future research and practice.

We learned from patient interviews that each patient has a unique story of their illness, as well as unique priorities. Tracking ODLs often helped patient participants identify important factors (e.g., activity, sleep, stress, medications) that influence their symptoms and pain. Our use of contextual inquiry (focus groups, surveys, and interviews) allowed us a more comprehensive understanding of important ODLs and the factors that influence a patient’s use of a mobile device for ODL collection.

Clinician participants primarily saw the Chronology.MD system as an important patient app – a data collection and visualization system that helps patients focus and prepare for office visits. If patients are more focused, then the visit is more efficient and both patients and providers will be more satisfied with the encounter. Our clinician participants suggested that we incorporate the ODL data visualization graphs into the University of California San Francisco clinic’s Epic EHR system in real time. That way, the provider wouldn’t be overwhelmed by too much data in their EHR interface outside of the appointment. This way, providers would pull up the data at the time of the appointment, and the patients could discuss the ODLs that were most important since the last visit.

Because we developed our technology during the study and used iterative participatory design processes, we had a lot to do in a relatively short amount of time. Going forward, we know that our patients would like a single app for data collection and visualization, along with the ability to enter ODL data via SMS text message. We also learned that system bugs and crashes are a deterrent to utilization, and that a more comprehensive list of ODLs should be included. Our patients are committed to finding a way to continue using and improving the system, and many have reported that the use of the system is what keeps them healthier, more pain-free, and able to reduce the use of narcotic pain-killers.

Going forward, our clinicians would like to see this app add even more utility to the clinical visit. For example, incorporating data that address validated indices such as the CDAI (Crohn’s Disease Activity Index) and/or the Harvey-Bradshaw index (a simpler Crohn’s disease index), would permit providers to review these index scores with patients in real time and would allow patients to monitor their scores on a daily or weekly basis. Clinicians said that incorporating one or both of these indices would greatly enhance their ability to collaborate with patients.

In addition, our clinicians felt that this app could be used to equip patients with important information about Crohn’s disease – including where the disease occurs, the course of the disease, how to determine remission, the importance of medication adherence, the benefits of biologic vs. steroid drugs, and the importance of paying attention to general health maintenance (e.g., up-to-date vaccinations, pap-smears, and skin cancer screening). Ultimately, if this app could help better educate, inform, and prepare patients for office visits (including visits to other specialty providers not well-versed in Crohn’s disease) and if it could include more detailed information about medications, lab tests, scans (e.g., last colonoscopy, GI involvement), and symptoms to discuss, then providers would see it not only as an important patient app, but also as a very useful provider app. Clinicians told us that this app could  change the standard of care for Crohn’s.

We have learned from this pilot study that both clinicians and patients are interested in finding the balance between collecting and tracking data that is important to each group. Neither group wants to collect extraneous data, nor do they want to collect data for extended periods of time. The balance point between clinician and patient, and the ODLs that are personally relevant to patients, as well as clinically significant for providers, we call the ODL Prescription (ODL Rx). We are exploring support for future studies that will build on pilot study findings to create a technology that helps identify the ODL Rx for individual patients and satisfies the goals of both patients and providers to help manage this complex disease.

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

Project HealthDesign Director Testifies at Meaningful Use Workgroup Hearing

Libby Dowdall, Communications Coordinator, Project HealthDesign National Program Office

Today, Patricia Flatley Brennan, R.N., Ph.D., Project HealthDesign national program director, and Nikolai Kirienko, co-project director for Project HealthDesign’s Chronology.MD team, will testify at a hearing on the incorporation of patient-generated information to manage health. This hearing is organized by the Meaningful Use Workgroup of the HIT Policy Committee.

Brennan has been invited to testify on the business and technology of patient-generated data and its use in clinical care. Her written testimony (pdf) draws upon the experiences of all fourteen Project HealthDesign teams throughout the program’s two rounds of funding, as well as the teams’ interactions with hundreds of patients. However, she will focus mainly on stories and findings from Project HealthDesign’s five current teams.

Brennan’s testimony will focus on three main points:

1. We need to expand the idea of patient-generated data to include patient-defined data.
2. Sharing patient-defined data with clinicians improves the business of health care.
3. Existing technologies are adequate but not optimal for the clinical integration of patient-defined and patient-generated data.

Kirienko will draw upon the experiences of Project HealthDesign’s Chronology.MD team; he will also speak as an advocate for patient engagement in health and health care. His testimony will focus on the need for patient access to open APIs in the EHR and the need for standards for dynamic patient engagement on mobile devices.

Paul Tang, M.D., Project HealthDesign National Advisory Committee chair, co-chairs the Meaningful Use Workgroup, and Deven McGraw, J.D., M.P.H., a member of Project HealthDesign’s regulatory and assurance advisory group, is also a member of the Workgroup.

Listen to the webcast.
Read more policy-related posts.

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

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.
Read more posts from the Crohnology.MD team.

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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