The Center for Information Therapy has been working with the U.S. Department of Health & Human Services (HHS) for two years to develop a Healthy People 2020 Ix objective, as part of the HHS’s efforts to update and improve its health communication & HIT objectives for the next decade. We are pleased to report that the following objective has been released for public comment, the last stage of the process.

HC/HIT HP 2020–8: Increase the proportion of patients whose doctor recommends personalized health information resources to help them manage their health.

In addition, other Ix-related objectives are included in this section, including:

HC/HIT HP2020–6: Increase the proportion of persons who report that their health care providers always involved them in decisions about their health care as much as they wanted.

HC/HIT HP2020–7: Increase the proportion of persons who use electronic personal health management tools.

The public comment period is now open, and it is a great opportunity to voice your opinion about what should be the country’s public health objectives for the next decade.

The U.S. Agency for Healthcare Research & Quality (AHRQ) has just released a thorough literature review of the “Impact of Consumer Health Informatics Applications.” The report, prepared by the Johns Hopkins Evidence-based Practice Center and led by Chris Gibbons, is part of AHRQ’s evidence report/technology assessment series.

Gibbons et al concluded that “available literature suggests that select CHI applications may effectively engage consumers, enhance traditional clinical interventions, and improve both intermediate and clinical health outcomes.”

The abstract is below and can be accessed here and has a link to the full 500+-page report.

Objective: The objective of the report is to review the evidence on the impact of consumer health informatics (CHI) applications on health outcomes, to identify the knowledge gaps and to make recommendations for future research.

Data Sources: We searched MEDLINE®, EMBASE®, The Cochrane Library, Scopus™, and CINAHL® databases, references in eligible articles and the table of contents of selected journals; and query of experts.

Methods: Paired reviewers reviewed citations to identify randomized controlled trials (RCTs) of the impact of CHI applications, and all studies that addressed barriers to use of CHI applications. All studies were independently assessed for quality. All data was abstracted, graded, and reviewed by 2 different reviewers.

Results: One hundred forty-six eligible articles were identified including 121 RCTs. Studies were very heterogeous and of variable quality.

Four of five asthma care studies found significant positive impact of a CHI application on at least one healthcare process measure.

In terms of the impact of CHI on intermediate health outcomes, significant positive impact was demonstrated in at least one intermediate health outcome of; all three identified breast cancer studies, 89 percent of 32 diet, exercise, physical activity, not obesity studies, all 7 alcohol abuse studies, 58 percent of 19 smoking cessation studies, 40 percent of 12 obesity studies, all 7 diabetes studies, 88 percent of 8 mental health studies, 25 percent of 4 asthma/COPD studies, and one of two menopause/HRT utilization studies. Thirteen additional single studies were identified and each found evidence of significant impact of a CHI application on one or more intermediate outcomes.

Eight studies evaluated the effect of CHI on the doctor patient relationship. Five of these studies demonstrated significant positive impact of CHI on at least one aspect of the doctor patient relationship.

In terms of the impact of CHI on clinical outcomes, significant positive impact was demonstrated in at least one clinical outcome of; one of three breast cancer studies, four of five diet, exercise, or physical activity studies, all seven mental health studies, all three identified diabetes studies. No studies included in this review found any evidence of consumer harm attributable to a CHI application.

Evidence was insufficient to determine the economic impact of CHI applications.

Conclusions: Despite study heterogeneity, quality variability, and some data paucity, available literature suggests that select CHI applications may effectively engage consumers, enhance traditional clinical interventions, and improve both intermediate and clinical health outcomes.

Kaiser Permanente released two new ads as part of its ongoing “Thrive” campaign. Although both are quite entertaining, the one that struck me most is titled, “Connected.” Much has been made of Kaiser’s multi-billion dollar investment in health information technology (HIT), but perhaps what has received too little attention is how they structured it.

What the “Connected” ad does masterfully is to visually, technologically, and audibly demonstrate that all its technological investment has its member at the center and is focused on facilitating connections for that member. Connections to data, information, clinicians, and ultimately to everything that a member might need to manage their health and “thrive.”

This should not come as a surprise. When Kaiser launched their Epic implementation several years back, they decided to call it “HealthConnect.” Now, their vision is playing out among the more than 3 million Kaiser members taking advantage of that connectivity.

The connection theme deserves more attention in the national debate on reforming the health care delivery system. Connections among people and information can be incredibly powerful in enhancing clinician-patient relationships, creating truly patient-centered medical homes, and facilitating participatory medicine.

It’s important to note, however, that connection is about far more than simply creating electronic links between people and data. In order to maximize the connection potential, the data need to be translated into understandable, meaningful, useful information for each user. That information needs to be accessible in a convenient way for each person, and it must be proactively delivered to them in a just-in-time fashion in a way that engages them to initiate effective actions.

When we put all that together, those connections can create effective, efficient health care delivery.

At the second meeting of HHS’s HIT Policy Committee today, the committee’s Meaningful Use (MU) Workgroup offered a proposal that represents some important strides forward. From an overarching perspective, we can see progress in the fact that engaging patients and families is now one of the primary four or five goals for how “meaningful use” of HIT can transform health care.

The HHS Office of the National Coordinator (ONC) for HIT distributed a matrix along with the presentation by MU workgroup co-chairs Paul Tang and Farzad Mostashari. One of the five health outcomes policy priorities is “Engage patients and families,” and the associated care goal is “Provide patients and faimiles with access to data, knowledge, and tools to make informed decisions and to manage their health.”

Interestingly, when Mostashari presented the “achievable vision for 2015,” the slide advocated for “All patients have access to their own health information.” But Mostashari said, “All patients have access to the information they need to have.” I think the latter describes a broader set of information needs and would do more to meet the health outcomes policy priority.

For the 2011 objectives, Tang stated that the MU Workgroup’s “goal is to capture in coded format and to report health information and to use that information to track key clinical conditions.” By 2013, the goal becomes “guide and support care processes and care coordination,” leaving “achieve and improve perofrmance ans support care proceses and on key health system outcomes” by 2015.

The 2011 objectives under engage patients and families:

• Provide patients with electronic copy of — or access to — clinical information (including lab results, problem list, medication lists, allergies) per patient preference (e.g., through PHR) for outpatient (OP) and inpatient (IP) care
• Provide access to patient-specific educational resources (OP/IP)
• Provide clinical summaries for patients for each encounter (OP/IP)

For 2013:

• Offer secure patient-provider messaging capability (OP)
• Provide access to patient-specific educational resources in common primary languages (OP/IP)
• Record patient preferences (e.g., preferred communication media, advance directive, health care proxies, treatment options) (OP/IP)
• Documentation of family medical history (OP/IP)
• Upload data from home monitoring devoices (OP)

For 2015:

• Access for all patients to PHR populated in real time with data from EHR (OP/IP)
• Patients have access to self-management tools (OP)
• Electronic reporting on experience of care (OP/IP)

Many of these elements derive from the document that the Consumer Partnership for eHealth developed (a process in which the IxCenter was involved), though there are some areas where some improvements in the ONC document would go a long way toward driving better care. Some of these points were made during the meeting by HIT Policy Committee member Christine Bechtel, which I voiced support for during the public comment period, and I also added some of my own (or expanded on themes raised by Christine) there and here.

• Certainly, some of the elements should be moved up — earlier in the timeline (e.g., secure messaging, patient access to self-management tools & decision support, and electronic reporting on experience of care).
• The access to electronic information needs to be “timely” (a word that should be added); timely applies both to the speed at which it is made available and the ability to get information targeted to the consumer’s particular moment in care.
• Incorporation of data generated by the consumers themselves beyond just what can be uploaded from electronic monitoring devices (per the 2013 criterion).
• There should be more attention to consumer information tools (beyond just narrowly definted personal health records) and more clarity around the kinds of tools that consumers need — not just self-management tools but also decision support tools and tools that facilitate effective & efficient communication to improve the infrastructure for participatory medicine.

Finally, although clinical summaries are mentioned in this section, there are more ways in which improving care coordination (one of the other key five goals identified by the committee along with: engaging patients and families; improve quality, safety, efficiency, and reduce health disparities; improve population & public health; and ensure adequate privacy & security protections for personal health information). Specifically, the stated care goal for “improve care coordination” is “exchange meaningful clinical information among professional health care team.” Given that, for many of the measures proposed in the care coordination section, there is substantial research to support exchanging clinical information with patients and families improves care, reduces readmissions, etc., there should be an explicit inclusion of patients & families in that exchange.

If you also would like to share your comments with ONC, instructions for doing so are here.

For the past several months, the Center for Information Therapy (IxCenter) has been working alongside other consumer advocates to guide the HHS definition of “meaningful use” of EHRs to include consumer access to meaningful information. Part of that collaboration has been with the Consumer Partnership for eHealth (CPeH), which has brought together many organizations dedicated to advancing a patient-centered care delivery system. We also believe it’s important to build a meaningful use definition off of robust definitions of patient-centered care, such as that proposed recently by Don Berwick.

With the decisions on meaningful use now being hammered out by the Office of the National Coordinator (ONC) for HIT with input from the HIT Policy Committee (with detailed guidance from a meaningful use workgroup), CPeH has developed a consumer pathway to meaningful use to help inform the discussions.

Here’s an overview of our recommendations:

• To ensure care is comprehensive, coordinated, personalized and planned:
  • By 2011:
    • Care summary is generated and shared with the patient and other authorized providers and family caregivers after every visit or
      discharge.
    • Reminders about preventive services, medications, necessary/routine tests, and follow-up care are sent to patients via their preferred medium
  • By 2013:
    • Prompts and key information (patient preferences, health goals, functional status, preferred language, advance directives and social situation) are used to individualize and customize care
    • Patient generated data is incorporated into the clinical context for individualized care
    • Connections are made to community resources
• To ensure patients and their caregivers are partners, making informed, shared decisions:
  • By 2011:
    • Patients have electronic access to the lab results, medication lists and problem lists
    • Care summary (see above)
    • Patients are connected to resources that help them understand their medical information in the context of their specific health needs
    • Providers make available shared decision making tools to promote partnership in care and treatment decisions
  • By 2013:
    • Patients have real-time electronic access to their medical record along with linkages to tools that make the information meaningful and useful to them
    • Patients have access to evidence-based decision support tools that enable informed choices tailored to their preferences
• To ensure transitions between settings of care are smooth, safe, effective and efficient:
  • By 2011:
    • Care summary (see above)
  • By 2013:
    • Referrals are made to online patient coaching and/or other self-care management tools
• To ensure patients can get care when, where, and how they need it:
  • By 2011:
    • Patients are able to use secure messaging or email for more timely and beneficial communication with their providers
    • Personal health records (PHRs) or other consumer tools are populated by providers and are easily portable
  • By 2013:
    • Patients are able to use online scheduling for more convenient access to their care providers
    • Providers use remote monitoring to manage patients with chronic illnesses in the least restrictive way
    • Electronic tools provided by the health care team are accessible to people with visual, hearing, mobility, cognitive, and other impairments (and in multiple languages)
• To ensure patients and their caregivers are participants in continuous quality improvement:
  • By 2011:
    • Information about patients’ experience of care is collected electronically and used to improve
    • Quality data are electronically generated, aggregated and publicly reported in ways that are meaningful for consumer use
    • Information about race, ethnicity, primary language, and gender is collected and used in ongoing efforts to reduce disparities
  • By 2013:
    • Data regarding cost and the clinical quality of care are electronically collected and publicly reported for consumer use
    • Outcomes measures are reported stratified by race, ethnicity, primary language, and gender to spur disparities reduction

We firmly believe that effective, meaningful use of HIT can help create a platform for a better, more efficient health care delivery system, but only if we design it to meet consumers’ needs and preferences at the right time, in the right setting, and in the right way. The elements above will take us a long way in getting there.

For those interested in the detailed recommendations from CPeH, please contact me directly or leave a note in the comments section.

Nancy Shute has a nice piece in yesterday’s Charlotte Observer that summarizes “6 ways electronic medical records might make diagnosis easier and more convenient, and care safer.” An excellent writer, Nancy has done a good job of boiling down all the grandiose discussions on EHR functionality into tangible, “what have you done for me lately?” functions. This consumer orientation to EHR functionality is badly needed as we define “meaningful use.”

With every one of them, however, by attaching information therapy (Ix) to the technological function, we could substantially expand the utility of that application. So, I’d like to propose amendments to Nancy’s six high-impact apps.

1. “Skip trips to the doctor.” Yes, secure e-mail with your clinicians is a huge convenience factor, and attaching an information prescription about what to do next (or when it really would be time to come into the office) would provide additional value to the patient.
2. “Track Mom’s medical chart even if you’re in Albuquerque or Altoona.” As long as you can actually interpret what’s in the online record, that’s fine. But what if the medical jargon raises more questions than it answers. If the chart via the portal contains links to content that contextualizes the data points, you’ll feel a lot more comfortable staying in Albuquerque or Altoona.
3. “Get lab test results without having to play phone tag with the doctor’s office.” By hyper-linking the lab test results to brief explanations of what each acronym means, what the “normal” ranges are, and what it means if your values are “abnormal,” the lab values will have much more meaning.
4. “Never again drag X-rays to a specialist.” Very few lay people can interpret radiology images, so attaching the radiology report (translated into plain language) to the digital files will empower consumers.
5. “Find out if your prescriptions could have dangerous interactions, before you start taking them.” But then what? Provide some guidance to the consumer about alternatives or what questions to ask your doctor, pharmacist or other health care professional.
6. “Use your cell phone to tap into your health records.” Put everything together from above, and the more ubiquitous cell phone really will ring!

As we move forward in defining what we want out of “meaningfully used” EHRs, let’s take a page from Nancy’s book and boil these functions down into what they actually mean for the day-to-day lives of consumers. But let’s also go the extra step of making the most of the electronic opportunities that present themselves by connecting data points to content that helps all consumers use these tools most effectively.

There’s a lot of buzz out there in the blogosphere about the next steps on health information technology (HIT) standards. Certainly, the recommendations of HHS’s new HIT Standards Committee to its new HIT Policy Committee clearly will inform how HHS implements the HIT provisions of the American Recovery & Reinvestment Act (ARRA).

Many of the decisions will need to be made quickly, which is part of why John Halamka (Vice-Chair of the Standards Committee) put some of his thoughts on the Web this morning, as did Mark Leavitt, Chair of the Certification Commission for HIT (CCHIT).  Leavitt was specifically defending CCHIT’s structure in the face of a recent Washington Post article and other comments made on The Health Care Blog, among other places.

I certainly wouldn’t pretend to have all the technical answers for the HIT Standards Committee. The Center for Information Therapy firmly believes that we need to advance the discussion productively, as I believe virtually all of those engaging in online dialog are trying to do.

Among the most critical issues that has not been adequately addressed is the relationship of standards-setting to the ultimate impact on consumers’ access to meaningful, useful electronic information to help them manage their health. An Issue Brief I wrote a few years ago for the California HealthCare Foundation is just as relevant today (maybe more so given the stakes involved in 2009!), so I’d highly recommend it to those interested in improving health care delivery.

The basic premise of the CHCF Issue Brief, “Lost in Translation: Consumer Health Information in an Interoperable World,” is:

“…Availability of information does not necessarily translate into understanding or taking appropriate actions. While momentum builds for a National Health Information Network infrastructure, it remains unclear what role patients will play in the interconnected world of providers.

“…As clinical information becomes more directly available to consumers through the Internet or through other electronic communications from providers, a mechanism for meaningful, consistent translation to engage consumers is lagging…”

I urge all those working hard to drive forward meaningful use of HIT to consider the issues raised in this CHCF Issue Brief and ensure that HIT implementation leads to more effective and efficient care for everyone.

I participated in a personal health record (PHR) workshop yesterday hosted by the Center for Democracy & Technology (CDT). CDT’s goal was to gain input from a wide array of stakeholders (an impressive collection of about 40 health care leaders with different types of expertise in PHRs) to help inform CDT’s recommendations to federal agencies — HHS and the Federal Trade Commission (FTC) — and try to build some degree of consensus among key stakeholders.

[NOTE: All comments at the meeting were not for attribution, but I confirmed with the organizers that there was no problem in sharing my own impressions following up from the meeting.]

There’s no doubt that current federal statutes and regulation (and there are potentially many that apply to PHRs) create considerable uncertainty regarding how to balance promotion of consumer engagement with concerns over privacy and security. Existing regulations from HIPAA, the Electronic Communications Privacy Act, and others coupled with the new provision from the American Recovery & Reinvesment Act (ARRA) — not to mention the complexity of layering state laws on top of that — provide a lot of work for privacy attorneys. But with all the different (potentially) applicable federal and state laws/regulation, there is very little practical guidance on what has to go into privacy policies. PHR implementers can find some guidance from FTC consent decrees, which can represent an expansion of the law.

That lack of clear legal guidance clearly has not helped get consumers engaged in using PHRs to manage their health. Estimates on nationwide PHR usage typically fall in the single digits (in terms of percentage of the US population).

Controversy over the estimates prompted me to share the fact that I’m likely registered to use multiple PHRs (I don’t even know, but probably 4 or 5), but I’m not actually using any of them because my experience has not proven any of them to provide any value to me in managing my health. The only PHR I use is for Molly Seidman — my golden retriever — because my vet (Friendship Hospital for Animals) offers a simple pet portal free of charge that includes messaging with the clinic, health reminders, medication management tools. In fact, during the meeting yesterday (literally less than an hour after I made this comment), some helpful information therapy (Ix) arrived in my email inbox that linked relevant educational information about Molly to the pet portal.

[Why, oh why, does the $2.5 trillion US health care system not offer the humans in my family as good care as my golden retriever gets? Not that she’s not deserving, but…]

What’s clear to me, however, is that — despite the challenges created by the patchwork of laws and regulations — consumer engagement in PHRs suffers when we focus too much attention on the legal issues surrounding privacy and security.

There’s no doubt that we need to deal with privacy and security concerns up front, but as long as the conversation focuses on data, it’s all about people’s fears. It’s not about value. Consumers don’t intrinsically care about data.

In contrast, consumers do care about tools that make it easier for them to accomplish specific health tasks for themselves and the people they love. If PHR certification, for example, continues to focus exclusively on privacy, security and interoperability rather than including attention to functionality, consumers have no reason to get into the PHR game.

Members of Kaiser Permanente or Group Health Cooperative and patients at Palo Alto Medical Foundation are using PHRs at rates probably 10 times the level of the general population. There are a lot of reasons for that, but one of the big ones is that those people have been provided with an opportunity to manage their health effectively through portals that connect them not only to their personal health data, but to Ix and related tools that help them manage their families’ health.

There was a song from the 1960s musical “Hair,” that begins “LBJ took the IRT…” Some days in DC, it feels like the wonks’ version of that. In other words, an abundance of acronyms but a lot more debate about HIT and “meaningful use” and a lot less long, flowing hair and “youth of America on LSD.”

There was an excellent briefing on Capitol Hill yesterday, organized by AARP and sponsored by the Alliance for Better Health Care (ABHC). It was officially “off the record,” so I won’t quote anybody, but it’s safe to say that there was strong consensus among the diverse panel on several important issues.

ABHC, a multi-stakeholder group that promotes comparative effectiveness research (CER) addressed several issues, including CER’s role in addressing disparities, integrating CER into clinician workflow and health plan activities, and the employer perspective on CER.

Several issues relating to consumers emerged from the discussion. First, CER is critically important to filling information gaps for clinicians and patients. Second, if we want to CER to truly help patients, they need to be at the table in CER design to identify priorities and ask research questions. Third, CER findings need to be broadly disseminated, including to consumers, which means that they need to be translated into a way that makes CER findings meaningful to consumers.

Finally, CER dissemination is not enough to ensure the consumer engagement in care that is so critical to better, more efficient health care. We need to come up with creative strategies — like information therapy (Ix) — to ensure that CER findings are well integrated into the care delivery process in a way that supports shared decision making (SDM) and participatory medicine.

I also attended a meeting the eHealth Initiative (eHI) Privacy Workgroup hosted yesterday with staff from the Government Accountability Office (GAO) that are studying privacy issues related to health information technology (HIT) implementation. GAO is examining privacy practices in health information exchange (HIE) organizations and other provider networks that exchange clinical patient data.

CareEntrust is unusual among HIEs in that it decided to develop the consumer application first, which it rolled out in May 2007. Consumers in Kansas City can now access through a secure portal a wide range of personal data on medications, lab results, visits, procedures, immunization, vital signs, demographics, and allergies. It turns that, thus far, about 18% of consumers now use these data — certainly better than the general population, but still a lot of room for improvement.

Also from the meeting, I heard that the operational HIEs with opt-out policies report very few (far less than 1%) of consumers are opting out of participation in the HIE. Interesting note, however, about what both Kansas City & Memphis HIEs say about the few that do opt out. I’m not sure exactly what it means, but it turns out that most of these opting-out consumers come from the IT industry. Is that funny or scary?

A final interesting point of discussion: Data related to discharge and care coordination have been defined as “operations” data (I gather through HIPAA). In many cases, however, there’s a strong argument to be made for it to be redefined as “treatment” data in order to facilitate greater continuity of care and what the Institute of Medicine recommends in terms of “continuous healing relationships.”

Several articles published in today’s New England Journal of Medicine are worthwhile reads (all of which, I believe, are free full text).

• News flash (not!): We have a long road ahead. A new study out of Harvard updates the dreary state of electronic health record (EHR) adoption by U.S. hospitals. Just 7.6% of surveyed hospitals have a basic system and a measly 1.5% have a comprehensive EHR system throughout the hospital.
• Incoming HHS National Coordinator for Health Information Technology David Blumenthal, MD, MPP, makes some important points about how the HIT provisions in the stimulus bill were designed to generate “improvements in health and health care” and not just increase EHR adoption. Aside from the financial incentives (and  down the road, penalties) for providers and the important infrastructure created, Blumenthal highlights the critical importance of the “federal government’s skill in defining two critical terms: ‘certified EHR’ and ‘meaningful use.’” He is right that tightening certification criteria and “motivating providers to take full advantage of EHRs” are prerequisites for HIT actually improving quality and efficiency. I’ve described this and the importance of stretching out “meaningful use” to meet the needs of consumers before.
• Paul Tang, MD (Palo Alto Medical Foundation), and Tom Lee, MD (Partners), have an excellent piece comparing the advantages of stand-alone personal health records (PHRs) with what they call “integrated PHRs.” The latter term describes electronic portals that allows patients to gain access to provider EHRs and, perhaps more importantly, communicate directly with their clinicians. One of the big question marks is how fast will the stand-alone version effectively integrate with clinician records to help support the kind of information-supported communication that facilitates participatory medicine.
• An interesting piece from Kenneth Mandl, MD, MPH, and Isaac S. Kohane, MD, PhD, from Children’s Hospital in Boston, makes the argument that HIT “components should be not only interoperable but also substitutable.” Thankfully, they describe in excellent detail the broad range of applications and examples that comprise those “components.” It’s an excellent list, though it could benefit from some more emphasis on content applications.