Now is your Chance to Weigh In Early on Meaningful Use Stage 3

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

Just before Thanksgiving, the Office of the National Coordinator for Health IT (ONC) released a formal Request for Comment (RFC) on potential objectives for Stage 3 of the meaningful use program. Although Stage 2 of the program has not yet begun, the RFC provides a very early opportunity for members of the public to weigh in on the next set of objectives and measures providers and hospitals will need to meet in order to qualify for the final phase of HITECH EHR incentive payments. 

The RFC proposes potential Stage 3 objectives and asks more open-ended questions in the following areas:

• Improving Quality, Safety, and Reducing Health Disparities;
• Engaging Patients and Families;
• Improving Care Coordination;
• Improving Population and Public Health;
• Information Exchange; and
• Assuring Privacy and Security of Health Information.

The potential objectives and questions in the RFC were developed by the Health IT Policy Committee, and the response from the public will be used by the Committee to inform its final recommendations with respect to Stage 3. To date, CMS and ONC have relied significantly on the Policy Committee’s recommendations in developing the meaningful use objectives and certification criteria.  Consequently, this is an important opportunity for interested stakeholders to help shape the future of meaningful use.

The final rules for Stage 2 make significant strides in assuring that patients have prompt electronic access to health data generated in the course of an office visit or as part of a hospitalization, and that patients can securely e-mail their health care providers. Increasing the flow of health information to patients is critical to achieving better individual and population health and a more patient-centered health care system. 

But improving the flow of information from clinical care teams to patients will not by itself facilitate a more collaborative, patient-focused health care system. Electronic health records also should enable clinical care teams to receive relevant information from patients, and providers unaccustomed to receiving electronic data from patients may need incentives to adopt more three-dimensional models of patient engagement.  The RFC asks for public input on how the meaningful use and EHR certification programs can enable, or even provide incentives for, the collection and use by clinical care teams of “patient-generated data.” 

Specifically, the RFC proposes the following Stage 3 meaningful use menu item for providers and hospitals: 

Item SGRP 204B:  “Provide 10% of patients with the ability to submit patient-generated health information to improve performance on high priority health conditions, and/or to improve patient engagement in care (e.g., patient experience, pre-visit information, patient created health goals, shared decision making, advance directives, etc.).  This could be accomplished through semi-structured questionnaires, and EPs and EHs would choose information that is most relevant for their patients and/or related to high priority health conditions they elect to focus on.”

The RFC further asks for public input on the “readiness of standards to include medical device data from the home,” and on the following more open-ended questions:

• What information would providers consider most valuable to receive electronically from patients?
• What information do patients think is most important to share electronically with providers?
• How can the HITECH incentive program support allowing doctors ad patients to mutually agree on patient-generated data flows that meet their needs, and should the functionality to collect those data be part of EHR certification? 

The RFC further asks for “published evidence or organizational experience” to support responses to the above questions.

In addition to responding to the Stage 3 proposal and the corresponding questions, stakeholders should provide feedback on the Policy Committee’s decision to propose this objective as a “menu” item, which will make it only optional for providers and hospitals participating in the meaningful use program. The RFC notes that the Committee decided to propose this objective as a menu item based on concerns raised by the Health IT Standards Committee that most EHRs do not have the “essential functionality” to accept patient-generated data. 

The Policy Committee’s Meaningful Use Workgroup hosted a hearing on patient-generated data several months ago.  Patricia Flatley Brennan, Project HealthDesign National Program Director; Nikolai Kirienko, Chronology.MD co-project director; and I all presented testimony on the Project HealthDesign grantees’ experience with incorporating patient-generated data – specifically, observations of daily living - into clinical workflows. This testimony will help inform the Committee’s deliberations on Stage 3 criteria, but more input from the public is needed on the above questions as well as others that are focused on improving health and health care for patients.  Now is the time to weigh in; comments can be submitted electronically at http://www.regulations.gov/#!docketDetail;D=HHS-OS-2012-0007 and are due by 11:59 pm ET on Monday, January 14, 2013.  

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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.

A Partnership, not a Prescription – Observations from an Alternative Medicine Practitioner

Rebecca Dymzarov, Policy Analylst Project Assistant, Project HealthDesign National Program Office

In addition to being the policy analyst project assistant here at Project HealthDesign, I am also a licensed practitioner of Alternative Medicine and Acupuncture. Engaging patients to be active participants in improving their health, and identifying health problems through incorporating Observations of Daily Living as a diagnostic tool, is a tried and extremely useful method in the arena of holistic medicine. It is extremely exciting to see this concept enter the main stream through Project HealthDesign.

When a patient comes to me with a health concern, I interview them and obtain the necessary information to formulate a tentative diagnosis and to create a treatment plan. This interview process is an in-depth evaluation of just about every aspect of the patient’s health and lifestyle. The answers to these questions provide valuable input into the diagnostic process.  It is usually a voyage of discovery -- every symptom, and how those symptoms change through the treatment process, provide clues both to me and the patient on how to improve their health.

I am always surprised by how difficult it is for people to answer questions about themselves at the beginning of treatment. Questions like; “how often do you experience pain? have a headache? where do you feel the pain? how often do you feel sad? how often do you have a bowel movement? how often do you wake up during the night? do you have less energy after you eat certain foods? do you feel sick after you eat certain foods?” are often answered with “I don’t know.”  There are always exceptions, but most people aren’t that tuned in with what is happening with their bodies. No one has ever asked them to pay attention to these things. 

Just like everything else in life, to be good at something takes practice. So people who work with me practice making observations about their daily lives. I often ask my patients to keep a journal. These journals  capture the same type of information captured by some of Project HealthDesign’s mobile applications.  Through the interview process, we identify and prioritize what observations they will track by identifying those that are impacting the patient most negatively. In my experience, when the process of discovery and the treatment planning is a partnership instead of a prescription, my patients are more likely to follow through with keeping their journals and following other recommendations.

I have the advantage of seeing my patients regularly and for more than 15 minutes at a time.  During these regular visits, patients get really good at answering my questions and start to notice patterns about their health on their own.  It is easy to see in my patients that a sense of empowerment comes along with actively participating in the discovery of what a healthy lifestyle is for them.  Also, by closely following changes in their daily lives it is easier for them to identify those things that improve their health or make it worse. For many patients, having a record of how their progression through treatment, including lifestyle changes, has positively impacted their health provides continued motivation for them to be their own advocate, and to keep making positive changes.

In addition to being the policy analyst project assistant here at Project HealthDesign, I am also a licensed practitioner of Alternative Medicine and Acupuncture. Engaging patients to be active participants in improving their health, and identifying health problems through incorporating Observations of Daily Living as a diagnostic tool, is a tried and extremely useful method in the arena of holistic medicine. It is extremely exciting to see this concept enter the main stream through Project HealthDesign.

When a patient comes to me with a health concern, I interview them and obtain the necessary information to formulate a tentative diagnosis and to create a treatment plan. This interview process is an in-depth evaluation of just about every aspect of the patient’s health and lifestyle. The answers to these questions provide valuable input into the diagnostic process.  It is usually a voyage of discovery -- every symptom, and how those symptoms change through the treatment process, provide clues both to me and the patient on how to improve their health.

I am always surprised by how difficult it is for people to answer questions about themselves at the beginning of treatment. Questions like; “how often do you experience pain? have a headache? where do you feel the pain? how often do you feel sad? how often do you have a bowl movement? how often do you wake up during the night? do you have less energy after you eat certain foods? do you feel sick after you eat certain foods?” are often answered with “I don’t know.”  There are always exceptions, but most people aren’t that tuned in with what is happening with their bodies. No one has ever asked them to pay attention to these things. 

Just like everything else in life, to be good at something it takes practice. So people who work with me practice making observations about their daily lives. I often ask my patients to keep a journal. These journals  capture the same type of information captured by some of Project HealthDesign’s mobile applications.  Through the interview process, we identify and prioritize what observations they will track by identifying those that are impacting the patient most negatively. In my experience, when the process of discovery and the treatment plan itself is a partnership instead of a prescription, my patients are more likely to follow through with keeping their journals and following other recommendations.

I have the advantage of seeing my patients regularly and for more than 15 minutes at a time.  During these regular visits, patients get really good at answering my questions and start to notice patterns about their health on their own.  It is easy to see in my patients that a sense of empowerment comes along with actively participating in the discovery of what a healthy lifestyle is for them.  Also, by closely following changes in their daily lives it is easier for them to identify those things that improve their health or make it worse. For many patients, having a record of how their progression through treatment, including lifestyle changes, has positively impacted their health provides continued motivation for them to be their own advocate, and to keep making positive changes.