What Will Estrellita Be When She Grows Up?

Karen Cheng, Estrellita Co-Principal Investigator, University of California, Irvine

As our team’s data collection winds down, it is inevitable that we begin thinking about the next steps for the project. The feedback from parents has been overwhelmingly positive. They have found the data entry to not be too burdensome and have found it useful to have the data so readily accessible. They report feeling cared for and feeling a sense of security that they have an easy way to communicate with the Early Developmental Assessment Center (EDAC) nurse case manager.

Through this work, we have evidence that parents are willing and able to record observations of daily living (ODLs) about their infants, even in the first few months the infant is home. When we first started the project, our team had a lot of concerns about overburdening the parents and we strived to keep low the number of ODLs they had to monitor. But our fears were not borne out. This may have a lot to do with how usable the Estrellita app is — many thanks go to Karen Tang for her excellent work in designing the mobile app!

One next step for our team is to work on refining the ODLs and possibly add more. We would like to work with more clinicians, such as pediatricians, nurses, and specialists, to dig deeper and learn more about the kinds of data that could help them remotely monitor infants and that could help parents prepare for a conversation with a clinician.

It may be that the Estrellita app needs to support a large range of ODLs, and then allow the clinician and the parents to decide together which ones the parents should track. (Kudos to the Chronology.MD team for their “ODL Prescription” idea.) A major challenge for us at the start of this project was identifying a common set of ODLs that were of interest to a variety of clinicians and parents. Perhaps a better strategy is to allow clinicians and parents to tailor their ODL-tracking to the particular needs of the infants.

Our team remains optimistic about the potential of ODL-tracking to improve the health of preterm infants. We hope to continue our work and even to expand it to other regions of the world. A newly released March of Dimes/WHO report called “Born Too Soon” describes the problem of preterm births worldwide; worldwide, more than 10% of births are preterm. The rate in low-income countries is even higher. There is much work to be done to save these babies’ lives and to improve their health outcomes.

If you are interested in partnering with us to improve the health of preterm infants, we’d love to talk with you. You can contact Gillian at gillianrh at ics.uci.edu or Karen Cheng at kgcheng at uci.edu.

Learn more about the Estrellita project.
Read more posts from the Estrellita team.

RWJF Comments on Meaningful Use Stage 2 NPRM

Libby Dowdall, Communications Coordinator, Project HealthDesign National Program Office

Today, Robert Wood Johnson Foundation (RWJF) formally commented on the Electronic Health Record (EHR) Incentive Program’s Stage 2 proposed rule, issued by the Centers for Medicare & Medicaid Services (CMS). As a national program of RWJF’s Pioneer Portfolio, we, too, recognize health IT’s role as an important tool for improving health and health care in the U.S., and we applaud this effort toward the truly meaningful use of EHRs.

We encourage you to read a selection from RWJF’s general comments on patient engagement:

We are encouraged by efforts in the proposed rule regarding patient and consumer engagement, especially regarding secure messaging; direct, downloadable access to patient data; patient reminders; inclusion of family health history; and provision of patient education. Nevertheless, we would like to see the required percentages higher than proposed in some cases. In addition, as our Project HealthDesign makes clear, patients now expect to engage with their personal health data in apps and on mobile devices of their choosing. We expect this trend to increase significantly. Further, patients will almost certainly expect that the flow of information be in two directions. In other words, patients will reasonably expect they will have both access to personal health data but also the ability to provide personal data to their health professionals. Work by both Project HealthDesign and by RWJF’s OpenNotes project shows that health data is becoming essentially a platform for conversation between patient and health professional. Project HealthDesign uses patient-generated data to spark conversations about the course of treatment. OpenNotes enables patients to see their data and have a discussion with their health professional about that information. A recent study about OpenNotes (Ann Intern Med, 2011;155:811-819) indicates that patients feel very strongly about gaining access to actual information in their medical record. The patients in this study did not share concerns noted by physicians in the study that patients would not understand or would worry about aspects of this information.

Native apps on smartphones and tablets may currently provide the most engaging experiences with health data for the public. Unfortunately importing data about care, such as lab test results, remains a significant barrier to adoption and use for both patients and app developers alike. Ideally, efforts to liberate this data for things like these apps, other personal health information tools as well as a platform for conversations between patients and their health professionals will become a policy reality in future versions of this rule.

Read RWJF’s full comment.

The comment period for the proposed rule closes tonight at 11:59 p.m. EST. Submit a comment at regulations.gov.

Snapshots from the Project HealthDesign Workshop

Libby Dowdall, Communications Coordinator, Project HealthDesign National Program Office

Last week, we convened in Nashville, Tennessee for our final Project HealthDesign workshop. Since the program’s inception in 2006, facilitators at the Vanderbilt Center for Better Health have helped us hone our ideas and collaborate across teams. These workshops have also served as critical opportunities for building a program that’s more than the sum of the individual projects.

Our workshops typically include participants from each grantee team, our National Advisory Committee, Robert Wood Johnson Foundation, the National Program Office, and several consulting groups. During this workshop, however, we were also delighted to welcome several special guests who are thought leaders from AHRQ, NSF, ONC, Kaiser Permanente, Open mHealth and Vanderbilt University Department of Biomedical Informatics.

Each of our five current Project HealthDesign grantee teams has conducted a demonstration project in which patients with chronic diseases have actively and/or passively tracked observations of daily living (ODLs). The resulting data has provided feedback to patients as they self-manage their health outside of clinical visits and has informed clinicians as they engage in clinical decision-making processes. Each team has implemented a unique system and approach toward these ends. Most teams are in the process of wrapping up their interventions, but many have not completed their evaluations.

For a comprehensive scan of tweets from the workshop (collected via the #phdworkshop hashtag), be sure to visit the “Preliminary Report Out from Project HealthDesign Grants” Storify curated by RWJF’s Steve Downs. For a recap from one of our special guests, read Ted Eytan’s “A visit to Project HealthDesign and the patient voice, spoken through their observations of daily living.”

Read on for snapshots from the workshop:

iN Touch participants more interested in yesterday or today's data than reports that show trends over time. #phdworkshop

— Project HealthDesign (@PrjHealthDesign) April 25, 2012

#phdworkshop We KNEW workflow mattered in effective use of #ODL s but we didn't realize that there are TWO workflows - pts AND providers!

— Patti Brennan (@pattifbrennan) April 25, 2012

@PrjHealthDesign grantees enrolled lots of hard-to-engage patients with very modest incentives. Hmm. Learnings here. #phdworkshop

— Patrick McCabe (@PMcCabe_GYMR) April 25, 2012

#phdworkshop what an asthma dashboard might look like, pt dropping into the danger zone. twitter.com/tedeytan/statu…

— Ted Eytan, MD (@tedeytan) April 25, 2012

In the future how will IT change your physical and emotional health? The line between utopia and dystopia can b fuzzy #phdworkshop

— Lygeia Ricciardi (@Lygeia) April 26, 2012

#phdworkshop Health is what happens when you pay attention to your life

— Deven McGraw (@HealthPrivacy) April 26, 2012

Great examples of mobile and sensor data #odl improving health care at the #phdworkshop. Thx @stephenjdowns @pattifbrennan

— Matthew Lee (@mattllee) April 27, 2012

Do we need a Technology Activation Measure in addition to a Patient Activation Measure? (A question from #phdworkshop)

— SusannahFox (@SusannahFox) April 27, 2012

Implications for Patient Engagement if the Health Reform Law Falls

Robert Belfort, Project HealthDesign Regulatory and Assurance Advisory Group, Manatt, Phelps & Phillips, LLP

It is hard to escape the news coverage about the constitutional challenge to the Affordable Care Act (ACA), and the attention being paid to the case is understandable. The ACA is arguably the most far-reaching piece of domestic legislation that Congress has passed since it enacted Medicare in the 1960s. Although the focus of the legal challenge to the ACA is on the individual mandate, which requires that almost all Americans without health insurance buy individual health insurance policies or pay fines, there could be implications for patient engagement initiatives if the Supreme Court strikes down the law.

The Supreme Court heard oral arguments relating to the constitutionality of the ACA on March 26, 27 and 28. The Court’s decision is not expected until late June. The first issue confronting the Court is whether the individual mandate should be struck down because it represents an unconstitutional exercise of Congress’ power. If the Court does decide the mandate is unconstitutional, it will then consider what should happen to the ACA’s hundreds of other provisions. The answer depends on whether some or all of these provisions are deemed “severable,” meaning that they operate independently enough of the mandate to stand on their own even if the mandate falls.

The severability issue is a critical one. A number of the ACA’s payment and delivery reform provisions encourage patient engagement and care coordination, and, at least indirectly, could go a long way toward promoting the integration of patient-generated health information into care management and other health care delivery models.  These include provisions:

• establishing a Medicare hospital value-based purchasing program that pays hospitals based on performance against quality measures;
• requiring the development of similar value-based purchasing programs for other types of providers;
• gradually reducing Medicare payments that would otherwise be made to hospitals to account for preventable hospital readmissions; and
• establishing rules governing the formation and operation of Accountable Care Organizations (ACOs).

Each of these provisions attempts to reform the current health care payment system by rewarding health care providers for coordinating care and delivering better patient health outcomes – as opposed to rewarding them for the volume of services they provide. The ACO program, for example, creates financial incentives for providers to work together to treat patients across multiple care settings, including physician offices, hospitals, and in the home. An ACO consists of a group of providers that have agreed to collaborate to coordinate care for patients enrolled in Medicare Parts A and B. ACOs are intended to be patient-centered organizations, driven by the goal of delivering integrated, efficient and cost-effective care. ACOs that achieve quality targets and succeed in providing care at a cost less than what would otherwise be expected will share in savings with the Medicare program. To succeed, ACOs will likely have to find ways to better engage patients in their own health and health care. Incorporation of patient-generated health information, like observations of daily living (ODLs), could be one way of achieving this goal.

It is currently unclear whether the ACO program and other ACA payment reforms will continue to exist if the Supreme Court strikes down the entire ACA. Some have suggested that without the ACA’s payment reform provisions, health care providers will have less incentive to engage in innovative care coordination strategies, including those involving patient-generated health information. We will continue to follow the legal challenge to the ACA with great interest, and with an eye toward how it may affect the goals that Project HealthDesign supports. Please don’t hesitate to post any questions or comments about these issues below.

Read more posts about legal and policy issues.

Greetings from the Project HealthDesign Workshop

Libby Dowdall, Communications Coordinator, Project HealthDesign National Program Office

Be sure to follow along today and tomorrow as we gather in Nashville for our final Project HealthDesign workshop. Facilitated by the Vanderbilt Center for Better Health, these workshops have been vital to helping our grantee teams collaborate successfully, as well as for helping us identify themes and ideas at a program level. However, this is a unique workshop — even for us — in that we’ve invited the inspiring members of our National Advisory Committee, as well as a small group of special guests, to help us carry Project HealthDesign's vision forward. We’re gearing up to dream together about how our vision and work might impact health and health care in the future.

The great news is that you can follow along during the workshop by plugging into the #phdworkshop hashtag on Twitter. Please join us!

The Second Time Around

Refining iN Touch for a Second Cohort

Holly Logan, M.A., iN Touch Project Coordinator, San Francisco State University

During the first cohort, we came across many challenges; some we had anticipated and others surprised us. These learnings allowed us to refine our design and conduct a second cohort. For the second cohort, each participant started out with health coaching only for two months, then received an iPod Touch, and coaching plus TheCarrot’s customized iN Touch application for two months. The refinements addressed the three major challenges faced by the first cohort: 1) Access to Wi-Fi, 2) Coaching protocol, and 3) Staying in contact with the participants.

Many participants told us that the number one reason they had problems with recording their ODLs was because they did not have Wi-Fi at home and did not know where to access it. Although we had installed a Free Wi-Fi Finder app on their iPods, it still seemed that the participants faced a major obstacle when it came to finding Wi-Fi to record their ODLs. To address this issue, we asked Mission High School for permission to give the participants the Wi-Fi password at school. They agreed, so during the iPod provisioning, we entered the password into each device and informed the participants that they could record their ODLs during lunch and after school. This has been working well for the new cohort.

The second challenge was the initial health coach protocol we had created, which detailed how the health coach should direct participants about what to record, when to record, etc. For the first cohort, we sent reminders to ask participants to record, but we didn’t have a set schedule of what we wanted them to do on a weekly basis. For the second cohort, we developed a Health Coach Guide that the health coach was to follow each week when meeting with the participants. This included setting goals, asking participants to record, checking in through text messages and updating the health coaching logs as well as measurements at each visit. This has helped keep the coach and participants better engaged through each step.

Finally, communicating with the patients and scheduling them to come down during school hours was an issue with the first cohort. We had been using a texting application called Text4Plus, but a lot of the participants were not getting our texts. We had no way to know if they had received our messages or not. For the second cohort, we updated all of the iPods by installing iMessage, and sent and received messages through that application. iMessage allowed us to verify whether a message had been delivered.  If it did not say ‘delivered,’ we knew to send it again until it was delivered. This has helped us stay in better contact with the second cohort, and we have been able to easily let them know when we have sent a pass for them to come see us during school hours.

We are now in the third month of the new cohort, and we may still face challenges in the next two months. However, we’ve had a lot of success with giving the participants the Wi-Fi password, following a detailed protocol and keeping in contact with them through iMessage.

Learn more about iN Touch.
Read posts from the iN Touch 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.

 

Our Participants’ Favorite Feature in the Mobile App: Appointments!

Karen G. Cheng, Estrellita Co-Principal Investigator, University of California, Irvine

When our team was first identifying the observations of daily living (ODLs) we were going to support in our app, we had a lot of discussions about whether to include appointments. They did not seem to fit into cleanly into the definition of ODLs. Yet, clinicians told us repeatedly that they needed to know if and when infants had attended appointments with other doctors. Missed appointments are a huge problem in this population, negatively impacting the care of the infant and adding extra cost to an already strained health care system.

We decided to go ahead and include this feature in the Estrellita app. All along the way, we questioned our decision, as it took much longer to build the appointments feature than we had anticipated. We also questioned how many times parents would actually track appointments, because we did not know for certain how many appointments the infants had.  

However, we have since found that tracking appointments is a very useful feature for the parents in our study – and one they often report as their favorite! In Estrellita, parents can pull a doctor’s contact information from the phone’s Contacts list (or manually enter it). They can choose the doctor’s specialty, record the time and date of the appointment, record any questions to ask the doctor, and easily enter a follow-up appointment. When an appointment is coming up, parents receive reminders starting two days before the appointment. After the appointment time has passed, an automated Estrellita message asks parents whether they attended the appointment; if they did not attend the appointment, the app encourages them to reschedule the appointment. A Past Appointments tab allows parents to quickly glance at a list of previous appointments

Through the clinician web interface, the EDAC case manager can see monthly calendars for each baby. Icons are used to indicate when appointments are scheduled and whether the parent and infant attended or missed the appointment. Because of these data, there have been several cases in which the case manager was able to follow up with parents to ensure that the missed appointment was rescheduled.

When I look at the monthly calendars, I am just stunned at the number of appointments these infants have. Many of the infants in our study have four or five appointments per month. Some have as many as three per week!  Rarely are the specialists in the same office.  And so, these sleep-deprived parents have to manage not only the dates and times of the appointments, but also the locations – amidst other family obligations, work commitments, etc. It’s no surprise that parents miss appointments! 

Our hope, then, is that Estrellita has been able to help parents reduce the number of missed appointments – either by reminding them of the time and location of appointments or by encouraging them to reschedule. Preliminary analysis of interview data supports this goal, and we hope to see more evidence of it as the study continues.

Learn more about the Estrellita project.
Read more posts from the Estrellita 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.

Reaching Out to Physicians

Matthew Lee, dwellSense Lead Researcher, Ph.D. Student in Human-Computer Interaction, Carnegie Mellon University

As mentioned in our previous blog post, each of our study participants has a different set of clinicians who provide care for them. At our request, our participants took out their address books to look up their doctor's information and shared it with us. Now we had the daunting task of trying to convince time-strapped physicians to spend 30-60 minutes with us to review the patient-generated data from the dwellSense system.

Our recruitment approach began with sending a letter to the physicians' offices that described the study, said it involved one of their patients, and emphasized how valuable their contributions would be to our study. We didn't hesitate to use whatever persuasive strategies we could think of, including name-dropping and some gentle groveling. We made sure to mention that the research was funded by the Robert Wood Johnson Foundation, a name that undoubtedly carried a lot of weight with clinicians. We also used the fact that I’m a student who’s working on completing my Ph.D. dissertation. The letter asked not only for the clinician to agree to an interview session to support the cause of the study, but also to support my Ph.D. dissertation. People often are willing to help students with their work in ways that they might not help a corporation or something a little less faceless. Fortunately, I didn't mind casting myself in the role of a struggling graduate student for the sake of science. 

After we sent these letters to the clinicians’ offices, we waited. Fortunately, because many of the physicians were also part of the University of Pittsburgh Medical Center, we were able to find their email addresses on the University of Pittsburgh website and send the letter to them via email. To our surprise, we received responses from four of the primary care physicians we targeted within a week of sending the letter and/or email.

For those we didn't hear back from, we followed up with a phone call. Some offices received the letter, but other offices reported that the letters were lost in the sea of paperwork that flows in and out of the office. Many asked to have the letter sent again by fax, a 1980s-era technology apparently still widely used in doctors’ offices. After faxing the letters, we followed up with the offices to make sure they received them and got on the radar of the physician. We found that the front office staffs are usually quite accommodating of our requests to make sure the letters (and presumably other paperwork) get into the hands of the physicians. 

Thus far, we have been able to interview five physicians, and we still have approximately seven physicians to follow up with to see if they would like to participate. Overall, we were delighted with the responses we have received so far. As we reflect on the reason for our success, we have come to find that certain physicians were really interested in the idea of patient-generated data, in particular, medication taking, and how it could provide a window in the everyday functioning of one their patients (with multiple chronic conditions). We also think that leveraging the fact that it is part of a Ph.D. dissertation and giving busy physicians a chance to help a student was another reason they were willing to make time for us.  Stay tuned for a follow up post about some of the interesting findings from our interviews with physicians. 

Learn more about the dwellSense project.
Read more posts from the dwellSense team.

White House Releases Report on Consumer Privacy, Calls for Legislation

Deven McGraw, Proje­ct HealthDesign Regulatory and Assurance Advisory Group, Center for Democracy & Technology

Project HealthDesign grantee teams have long recognized that the robust use by patients of technologies such as personal health records (PHRs) and mobile health applications to improve health and well-being depends on trust. Individuals need assurance that the personal data they collect and share using these technologies will be handled responsibly and with respect for its sensitivity. But health data collected by and shared through consumer-facing technologies is typically not covered by HIPAA or state health privacy laws.

At a roundtable on privacy and security protections for PHRs hosted by the Department of Health and Human Services (HHS) in 2010, Project HealthDesign grantees submitted testimony noting some of the privacy and security issues raised by their projects and the challenge of addressing these issues in an uncertain legal environment.  Failure by policy-makers to address this uncertainty chills innovation and places obstacles to widespread consumer adoption of promising health information technologies.

Securing enactment of comprehensive privacy policy is never easy, but the future is looking a bit brighter. Just last month, the White House released a report expressly acknowledging that “[p]rivacy protections are critical to maintaining consumer trust in networked technologies” and calling for stronger privacy rules to protect personal information, including health information, shared by consumers with private sector companies.

Specifically, the White House sets forth the following “Consumer Privacy Bill of Rights”:   

• Individual Control:  Consumers have a right to exercise some control over what companies collect from them and how they use it.

• Transparency:  Consumers have a right to easily understandable and accessible information about privacy and security practices.

• Respect for Context:  Companies should limit their collection, use and disclosure of personal data to those purposes consistent with the context in which consumers provided the data.

• Security:  Companies should maintain reasonable safeguards to control risks such as loss, unauthorized access, and improper disclosure.

• Access and Accuracy:  Companies should provide consumers with reasonable access to personal data collected about them and appropriate means to correct inaccuracies.

• Focused Collection:  Companies should collect only as much personal data as they need to accomplish the purposes that are consistent with the “Respect for context” principle.

• Accountability:  Companies should be accountable to enforcement authorities and consumers for adhering to these principles.

The White House also calls on Congress to enact legislation adopting the Consumer Privacy Bill of Rights as law and providing enforcement authority to both the Federal Trade Commission (FTC) and State Attorneys General. The White House also directs the U.S. Department of Commerce to convene multi-stakeholder groups to negotiate codes of conduct that would implement the Consumer Privacy Bill of Rights in ways tailored to the privacy issues raised by specific industry sectors.

Under the legislative approach advocated by the White House, these codes of conduct – when reviewed and approved by the FTC — would become safe harbors that insulate companies that follow these codes from liability. But even if Congress does not act, these codes of conduct — when companies voluntarily follow them — can be enforced by the FTC, which already has authority to force companies to comply with privacy commitments made to consumers. The Department of Commerce is expected to soon begin convening multi-stakeholder groups to develop the codes of conduct called for in the White House report.

Entities covered by existing federal data privacy laws like HIPAA would be exempt from the new legislation. However, the White House does call for review of whether existing laws could be “simplified” to benefit both consumers and companies.

To what extent would national, consensus-based policy protecting health data collected, used and shared by commercial companies reduce barriers to more widespread adoption of consumer-facing health technologies like PHRs and mobile apps?  Share your thoughts in the comments.

Read more posts about legal and policy issues.

Patient Attitudes About Sharing Patient-generated Data with Health Care Providers

Matthew Lee, dwellSense Lead Researcher, Ph.D. Student in Human-Computer Interaction, Carnegie Mellon University

In our evaluation of dwellSense, each study participant had a different primary care provider. We wanted to engage with each one of these physicians to identify how they would use the patient-generated data about medication taking, phone use, and coffee making. Unlike many of the other current Project HealthDesign teams that had one or two clinicians on their team who provided direct care for the participants, we had to reach out to the clinicians who were in our participants’ existing care networks.

The first step was convincing participants to allow us to speak to their health care providers (PCPs, specialists, nurses, therapists, etc.). Because they felt the data we were collecting about their observations of daily living were valuable for their doctors to have, it wasn't a stretch for them to give us permission. Our patients generally had very trusting and positive relationships with their health care providers. From this experience, we expect that a technological solution or service that shares data about ODLs or activities of daily living (ADLs) with clinicians would not normally be met with much opposition.

However, participants were a little tentative when we asked them to sign a release form authorizing their health care providers to speak to us, the research team members, about their medical conditions when we evaluated how care providers utilized the data about ODLs in their workflow. At this point, we reassured them that the point of the study wasn't to dig up all the details of their medical history from their care providers, but rather to give permission to the care providers to bring up any details that were relevant for evaluating the usefulness of patient-generated data in their workflow. All participants trusted us to keep matters confidential, as we were bound by university IRB confidentiality rules. Furthermore, all participants were open in sharing the details of their medical history and conditions with us as part of the study, so it was unlikely we would discover any secrets when speaking with their care providers.

Extrapolating from our experiences and applying it to how a third-party technology or service might share patient-generated data and collect medical details from the health care provider, we envision that these systems should limit the additional information they collect from health care providers, or at least allow the patient to control what information their health care providers can disclose to the system. Integrating patient-generated data about ODLs and ADLs directly into EHRs may work around this issue, but the patient-generated data, visualizations, and analytics may still reside with a third-party. Any information about how the patient-generated data are used or accessed by the care provider may reveal sensitive patient information. Thus, we are learning that the information flows among patients, care providers, and third-party services should be an important part of designing a useable system for sharing and using patient-generated data about ODLs and ADLs.

Learn more about the dwellSense project.
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Engaging Patients Through Trust

Barbara Massoudi, BreathEasy Principal Investigator, RTI International
Rita Sembajwe, BreathEasy Project Manager, RTI International

Editor's note: This post is fifth in a series on patient engagement.

When describing the BreathEasy project patient population to colleagues, we’re often met with skepticism about the wisdom of working with an economically disadvantaged population. Some people ask whether it wouldn’t have been easier to work with a middle income population or with people who already own smartphones. The assumptions underlying these questions are that this population can’t be trusted with expensive equipment, or won’t be reliable recorders of their observations of daily living (ODLs). Our colleagues are expecting that the choice of population will somehow negatively impact our ability to conduct the research, and therefore, should be avoided.

We tell them the members of the BreathEasy patient population were selected specifically because they stand to benefit the most from using the application as they inherently have fewer resources at their disposal! Patients enrolled in the study were selected because of socioeconomic status based on their residential zip code, and that method worked well for us. The median income for BreathEasy patient participants is between $10,000-15,000 annually; participants have a high school diploma or less education; and most are unemployed.

Our experience working with these patients has proven to be very different from what our colleagues anticipated. As we approach the conclusion of the six-month evaluation period, we’re still seeing very consistent reporting of ODLs by the patients. In fact, whenever patients have anticipated a time when they won’t be tracking consistently, such as a planned surgery or childbirth, we’ve received text messages stating that they’ll be off the application for some time, but back on soon. We’ve also received phone calls and text messages when patients have had unexpected events, such as hospitalizations, that have caused them not to report. The patients have been very apologetic about not recording for a few days.

What we find striking about this is that the level of patient engagement we’re seeing exceeds that of middle class populations. Perhaps the BreathEasy population is more grateful for the mobile application and the opportunity to participate in the study. We’ve heard patients express that such an app “…will help me and my doctor track my asthma a lot easier,” which tells us that they do feel like the app serves a purpose. We have also heard patients express the view that “the app is designed by us, for us, and for our benefit.” These are certainly encouraging words for researchers taking a user-centered design approach. We also think there’s an important element of trust and fulfillment of expectations here. As Barbara’s mother used to say, “If you expect people to do great things and let them know it, they usually won’t let you down.” We’d say there’s more than a bit of that happening here. Stay tuned for a future post on the outcomes of our evaluation period.

Learn more about BreathEasy.
Read more posts from the BreathEasy team.

Participatory Medicine 2.0

Michael Christopher Gibbons, M.D., M.P.H., Project HealthDesign National Advisory Committee, Johns Hopkins Urban Health Institute

Editor's note: This post is fourth in a series about patient engagement.

In “Participatory Medicine: Must You Be Rich to Participate?” in the Journal of Participatory Medicine, Graedon and Graedon pose a question: “Is the participatory movement leaving [the non-affluent] behind?” Their article suggests that only the affluent members of our society can afford care that is participatory. Their premise appears to be built on two assumptions that should be regarded as faulty.

Redefining patient engagement

The first is that the only engagement relevant to the participatory community is the engagement between a patient and a clinical provider. The primary causes of morbidity and mortality in contemporary society are chronic diseases.  By definition, individuals have these ailments for up to 30 or 40 years. Antecedents of atherosclerosis (fatty streaks) have been documented in 10-year-old children (5), yet most individuals only become aware of the existence of a problem after the age of 50. As such, the actions, behaviors and exposures that impact health begin early in life and are often the result of engagement with a vast array of individuals (relatively few of which are medical providers). In addition, most patients are actually in clinical settings for a relatively short period of time over the course of their lives. In other words, most of the interactions, or participation, that govern the important behaviors that impact health occur outside of the clinical setting and between patients and non-clinicians.

This reality is in no way an attempt to downplay the importance of either clinical encounters or clinical providers, but rather an attempt to illustrate the fact that when we fail to understand the full context of participatory medicine, we may similarly fail to understand the true barriers, drivers and opportunities for participatory medicine to make a difference.  More importantly, we may also be unable to fully understand why patients have such difficulty achieving clinical goals or why well-intentioned and elegantly designed interventions yield only marginal results. In fact, emerging data suggest that patients are participating in their health care in a big way, just not as much with their health care providers.

Patients turn to the Internet for health information and support

For the first time ever, more Americans are turning to the Internet for health and medical information than are turning to health care providers.(1) In addition, emerging evidence suggests that the Internet has considerably more influence over consumer health decisions and actions than traditional channels like print, TV and radio.(3) The numbers of online health seekers have swelled to more than 175 million people to date.(6) Increasingly, they report having become informed and empowered. They have generally been able to find what they are looking for and report that the Internet is increasingly helping them to connect to emotional support and practical help for dealing with their health issues.(2) In fact, racial and ethnic minorities and the poor appear to be using some forms of technology more than their non-minority counterparts.(4)

We can argue and speculate as to why these things are happening or the long-term impact of these shifts, but the reality is that these shifts are, in fact, happening. These changes may represent an important opportunity to reach and engage many patients, including those who historically have been left behind. The most important questions then become:

1. Do our evolving notions of what health care and participatory medicine need to become include the realities in which patients live?
2. Will current and future health care providers embrace these realities and lead the inevitable change?

If not, we may be destined to well-intentioned but largely unrealistic notions that ultimately leave the health care system far behind where many patients are already going.

References

1. Cybercitizen Health v8.0.  2008. New York, NY, Manhattan Research. Ref Type: Report
2. E-Health Solutions for Healthcare Disparities.  New York: Springer Pubs; 2008
3. Cybercitizen Health v9.0.  2010. New York, NY, Manhattan Research. Ref Type: Report
4. Korzenny F, Vann L. Tapping into thier connections: The multicultural world of social media marketing.  2009. Talahassee, FL, Florida State University Center for Hispanic Marketing Communication. Ref Type: Report
5. Tanganelli P, Bianciardi G, Simoes C, et al. Distribution of lipid and raised lesions in aortas of young people of different geographic origins (WHO-ISFC PBDAY Study). World Health Organization-International Society and Federation of Cardiology. Pathobiological Determinants of Atherosclerosis in Youth. Arterioscler Thromb 1993; 13(11): 1700-10
6. Taylor H. Cyberchondriacs on the rise? [electronic article]. 2010.

Read more posts from the Project HealthDesign National Advisory Committee.

Patient Engagement is the Hallmark of Patient-Centered Care

Project HealthDesign Comments on PCORI Draft National Priorities for Research and Research Agenda

Patricia Flatley Brennan, Ph.D., R.N., Project HealthDesign National Program Director

Editor’s note: This post is third in a series on patient engagement. Many of our health policy comments, including the one below, deal with patient engagement and patient-centered approaches to health and health care.

I appreciate the opportunity to provide comments on PCORI’s “Draft National Priorities for Research and Research Agenda” (Draft National Priorities), published January 23, 2012. I serve as director of Project HealthDesign, a national program of Robert Wood Johnson Foundation’s Pioneer Portfolio. Through Project HealthDesign, I have come to realize that being “patient-centered” means engaging patients in all parts of the care process, from designing and selecting treatment approaches, to determining relevant indicators of success, to evaluation of the desirability and achievement of the outcomes obtained. Although many groups understand “patient-centered” to mean that patients are the targets or recipients of health care, Project HealthDesign promotes a vision in which “patient-centered” means that patients are involved in the design, implementation and evaluation of care.

The Draft National Priorities addresses patient needs and preferences, and also focuses on engaging patients in identifying areas for further research. However, we believe patients have a lot more to offer than simply providing input into research priorities. Early and frequent engagement of patients and their caregivers – from characterizing a problem all the way through the process of addressing and solving it – is the hallmark of patient-centered care. Patient-centered care requires more than a one-time engagement of patients; it requires systematic, deliberate and ongoing engagement of patients in dialogue about priorities, clinical investments and therapeutic strategies.

We challenge PCORI to create effective research models that engage patients, garner patient participation across the care continuum, and provide meaningful indicators of the patient-centeredness of the care provided. PCORI must take the lead in determining the extent to which patient-centered care improves the lives and well-being of individuals and/or results in a more efficient and effective health care delivery system.

Specifically in regard to priority 3, part D (page 19), I present Project HealthDesign as an effective case study for what an “innovative approach” might look like. Following a design-demonstrate-evaluate process, Project HealthDesign’s five current initiatives are working with more than 135 patients with various chronic diseases. Because we engaged teams who share a common focus on patient-centeredness but are addressing different clinical care problems, each team has been able to leverage findings from the other teams.

Through these linked grants, the teams have equipped their patient participants to track, review and share with their care providers “observations of daily living,” or ODLs. Five teams are engaged in evaluating the impact of sharing ODLs on patients’ care and care outcomes. These ODLs are patient-generated, can range from information about an individual’s pain or energy levels to truly unique observations about a patient mood state, and may serve as another class of patient-centered outcomes. Reports resulting from this data help patients and their caregivers take action to improve the patient’s day-to-day health outside of the clinical setting. These reports also help to improve the quality of clinical visits and provide clinicians a clearer view of the patient’s daily life and health. For more information about our work, please contact me directly or visit projecthealthdesign.org.

This comment was submitted to PCORI in response to its “Draft National Priorities for Research and Research Agenda.” To learn more about PCORI, please visit pcori.org.

Read more health policy comments from Project HealthDesign.