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.

Seeking Public Comment on Proposed Governance of the Nationwide Health Information Network

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

On May 15, the Office of the National Coordinator for Health IT (ONC) released a formal Request for Information from the public (RFI) on governance of the Nationwide Health Information Network (NwHIN). ONC defines NwHIN as a "set of standards, services, and policies that enable secure health information exchange over the Internet." In the early years of federal health IT initiatives, the NwHIN was described as a “network of networks,” reflecting a strategy of achieving nationwide health information exchange by establishing state or regional health information exchanges and linking them together. The new definition reflects the belief that exchange does not require the building of new networks but also can be achieved through the use of common, interoperable standards in an environment of trust.

In the RFI, ONC observes that electronic exchange to date “has been governed by a patchwork of contractual relationships, procurement requirements, State and Federal laws, and industry self-regulation,” and this this patchwork has led to “asymmetries in the policies and technical standards.” In developing governance conditions, ONC hopes to establish “a consistent, baseline set of ‘rules of the road’ for electronic exchange.”

The RFI proposes "conditions for trusted exchange" (CTEs) in three areas:  safeguards (which focus on the protection of individually identifiable health information), interoperability (which focus on the technical standards needed for interoperable exchange), and business practices (sound operational and financial practices). These CTEs would impose some requirements that go above and beyond what current law requires. For example, one of the safeguard CTEs would require entities to implement security safeguards like encryption that currently are not mandatory for health care providers. ONC anticipates that the CTEs will be reviewed annually and evolve over time (some will be retired, others will be added), as exchange needs become more robust and standards are improved. The 16 proposed CTEs, and the specific questions ONC has asked the public to weigh in on, can be found in the RFI.

The entities ONC intends to govern are not individual providers but instead the intermediaries that facilitate exchange among providers and patients. Examples include state or regional health information organizations (RHIOs), health information exchanges (HIEs), and private networks established by vendors. The RFI proposes that intermediary entities be validated with respect to their compliance with the governance CTEs. Those intermediary entities that are validated are then called NwHIN Validated Entities or NVEs. The RFI also proposes oversight over the validators; ONC will remain responsible for overseeing NwHIN governance but also intends to seek and select a private-sector entity to have oversight over the validators.

NwHIN governance is proposed to be voluntary, although ONC anticipates that they could become mandatory conditions for participation in certain federal programs. The idea is to create a set of conditions for trusted exchange that intermediary entities will seek to follow – and those intermediaries will agree to exchange data with other intermediaries who have committed to following the same conditions.

Comments on the RFI are due on June 14, and can be filed electronically. The Health IT Policy Committee also will be considering comments to the RFI at its June 6 meeting. ONC expects the public comments to help shape a forthcoming proposed regulation on NwHIN governance.

Read more posts about legal and policy issues.

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