Finally: Your Tax Dollars At Work for Something Worthwhile in Health Information Technology: The VA and Its CCR Registry

Suppose the Disease Management Care Blog asked you for a summary about the number and types of documents and emails excluding PDFs that are on your computer’s hard drive containing the words ‘diabetes’ or ‘hypertension’ that were created or modified on or after January 2, 2008 with a font size of 10 or greater? The DMCB guesses finding out would be a struggle for most of us. Yet, if you use that same computer open any individual file meeting any of the attributes described above, you’d be able to marshall state of the art information technology to manage all of the features of that file and more.

Welcome to the contrast between an electronic health record (EHR) and a registry. The EHR is configured to help the user manage the patient’s dedicated file. In a registry, the user is interested in managing all the patients meeting predefined criteria. The former is all about individuals while the latter is all about populations. Just because your PC’s operating system enables you to handle that single item open your desk top doesn’t necessarily mean you’ll be able to get a detailed snapshot of a piece of your hard drive containing all the files of interest.

Which is, until you think about it, very counterintuitive, especially to us clinicians. You’d think that in this era of terabytes, servers, and Googling, it shouldn’t be so hard to find out how many patients with chronic hepatitis C infection who live in Illinois and have Blue Cross Blue Shield insurance and received peginterferon between the ages of 45 and 55 years had a relapse of their disease within one year. You'd think that using that informaion to assess the quality of care among physicians and hospitals should be a few clicks away. Alas, just like your PC's operating system, it ain’t so easy.

But it is not impossible. Which is why anyone interested in learning more about the topic should check out the article by Lisa Buckus et al in an August 28 Journal of the American Medical Informatics Association (JAMIA) ‘PrePrint’ titled ‘Clinical Case Registries: Simultaneous Local and National Disease Registries for Population Quality Management.’ It describes the implementation of theVeteran Administration’s (VA) Clinical Case Registries (CCR) that was developed to stand alongside its much admired VistA EHR.

Interesting takeaways:

This is not easy. The software took five years and it’s still being expanded, not only because new data bases are being added but because VistA is also evolving. A change in VistA means a change in CCR.

The description of CCR involved a jargony informaticisms, but to the DMCB it seems that the CCR “crawls’ the VistA system much like Google web crawler bots.

CCR is updated nationally every 24 hours. There are tens of thousands of patient records.

Big emphasis on privacy.

While CCR reports and makes research possible on a national basis, it also enables local users to extract local registry information. ‘Canned’ reports are available but users have the ability to customize. They’re being exploited: over 2000 local reports are generated each month.

National level summary reports – good or bad – will be available on the internet.

While the identification of candidate patients for placement in the various registries by automated programming has high sensitivity and specificity, a live and specially trained person at 128 VA facilities is necessary to manually review and confirm some patients’ information prior to inclusion in any registry.

Positive or negative labs that determine the presence or absence of a disease state is read off a free text field, not via any direct data interfaces. The DMCB has heard that this is not usual: clinical laboratories are not formatting their data in ways that can be used at a population-based level. It suspects the same is true for imaging studies, like echocardiography, cardiac catheterizations and CAT/MRI scans.

A telling anecdote: a new drug-drug interaction was announced by the FDA and the VA was able to use CCR to quickly identify the patients at risk.

The DMCB rates this as a must read. So much of what we as a nation want to do in assessment of quality, cost effectiveness, comparative effectiveness research, leveraging information technology will be dependent on the creation of useful registries. The lessons from the VA in this article are important for physicians, policy makers and anyone interested in population-based health improvement.

Follow-Up on Vermedx

The Disease Management Care Blog is happy to report that it received clarification about the Vermedx study mentioned in a prior post:

• Many of the patients reported in the American Journal of Managed Care article were not involved in the original randomized clinical trial (RCT) in New York and Vermont. It turns out that the physician hospital organization - Vermont Managed Care - indirectly learned of the RCT and installed Vermedx independently. Not all VMC patients had access to Vermedx, which was based on geography, not primary care assignment.

• Yes, it's possible that Vermedx did not, or only partially, accounted for the observed difference in claims expense - an effect described a 'treatment assignment bias.' The authors argue that is less likely because the claims trend prior to the Vermedx install was similar at baseline and then diverged once the intervention was launched.

• The low number of patients was based on the selection of persons with two years of continuous enrollment. Many of the PHO's patients were only newly enrolled and didn't have two years of claims data to draw on.

• Generalizability is being tackled by seeking funding for a repeat study in an environment different from Vermont: inner city with a greater proportion of non-white individuals.

• In the meantime, the larger RCT has been submitted for publication and is underoing review.

The DMCB thanks the folks in Vermont for the feedback and salutes them for their transparency as well as willingness to subject their system to the travails of peer review. The DMCB also thinks the Editors over at AJMC could have done a better job of getting more of the facts into the original manuscript prior to publication.

Based on this additional input, the DMCB would have to say its opinion of Vermedx kicked up a notch. It's possible that the difference in claims expense was due to factors associated with geography and this involved a newly enrolled PHO population. There is still a lot we don't know about the participants in the trial or about the PHO's practice setting. It's also a stretch to believe anything involving a relatively small patient population when it comes to trending. However, this is a good start and the DMCB is looking forward to reading more about Vermedx in the years to come.

Last but not least, the authors are to be commended to simultaneously a) initiating a care system and b) studying the impact with an appreciable amount of scientific rigor. This is what is necessary if we're going to understand how initiatives like this work in the real world and is an important lesson for the disease management/population care community.

Does This Diabetes Registry Reduce Health Care Costs?

Sometimes the Disease Management Care Blog thinks healthcare is one big ‘journal club,’ where we get huddle over interesting policy and scientific reports from the medical literature. It’s not sure if this Vermedx article would pass muster as particularly worthy of a lot attention, but given colleagues’ emails about the media attention this has received (here and here for example), the DMCB decided to take a closer look at this paper and the technology it represents.

Here’s the facts: Vermedx is an privately owned information system that receives lab results on a daily basis, stores the data in a registry and produces physician reports that include flow sheets and recommendations along with letters to patients. Overdue labs generate patient and physician reminders.

Vermedx was subjected to a ‘randomized clinical trial’ involving over 55 primary care practice sites caring for 7,000 patients across New York and Vermont. Primary care sites, not patients, were randomized to either use of Vermedx or to usual care. While the results were never published, it was observed that there was no impact on ‘glycemic control, cholesterol level, blood pressure and self-care behaviors’ for the patients in the Vermedx sites. Yet, patients’ self reports seemed to indicate that health care utilization had declined. If true, this would suggest Vermedx ‘saved money.’

That brings us to this paper, which was published in the American Journal of Managed Care. The authors sought to confirm that there were savings by looking at the claims experience of a subgroup of patients in “Vermont Managed Care,” a physician hospital organization (PHO) that apparently participated in the randomized trial described above. This PHO has just over 31,000 covered lives. 153 patients from the primary care sites that used Vermedx were compared to 870 persons with diabetes that were cared for by the PHO physicians without Vermedx. A comparison of ‘trend’ (the rate of increase in health care costs) after Vermedx was implemented favored the Vermedx primary care site patients: trend was observed to go down in the Vermedx patients so that at the end of one year, the per member per year difference in claims expense was just over $500 and at four years it was just over $3500. The study was financed ‘in part’ by an external grants (making the DMCB wonders if the rest was financed by Vermedx).

The DMCB thinks this is instructive because it helps us remember to ask certain fundamental questions when reading studies like this:

Was it the intervention (in this case Vermedx) or could something else have accounted for the observed improvement (in this case, claims expense)? Since these sites had to voluntarily agree to use the system ahead of time, the DMCB wonders if they may have already been inclined to take good care of their patients with diabetes. Readers may ask ‘who cares?’ so long as it worked, but the DMCB thinks it’s important to know if it was Vermedx or if it was Vermedx combined with especially motivated physicians.

Is the (870 person) comparison control population adequate? In this case, the patients that served as the comparator were drawn from clinics staffed by other physicians in the PHO. There is no description of the other physicians, many of who may not have been primary care physicians or had patients interested in a primary care-centered relationship. In other words, it may not have been the absence of Vermedx in this control group that drove up costs, but the kinds of patients and their physicians - which would be unaffected by Vermedx. Why didn’t the authors report claims from a group of patients from the PHO clinics that agreed to participate in the original randomized clinical trial but were not assigned Vermedx?

Are the results generalizable? In other words, readers need to know if the results are likely to be replicated in their clinical settings. Note that in this Vermont PHO, there are about 31,000 PHO enrollees, yet only about a thousand persons with diabetes were included in this study. Given the overall prevalence of diabetes, the DMCB thinks that may be low. The DMCB wonders how a ‘diabetic’ was defined in this study (in fact, the percent of Type 1 and Type 2 are not disclosed) and if this represents the definition of a person with diabetes in say, Omaha. This is especially true because the savings were based on a relatively small number of persons. The average health plan has tens of thousands of persons with diabetes. In addition, there is no information in this report about the source of the savings: inpatient vs. emergency room vs. other types of healthcare utilization were not reported.

The authors deserve credit for being open to the possibility of unmeasured differences between the two groups. This was brought up in their discussion of the results.

Conclusion? There isn’t enough here for the DMCB to believe the press reports. If these results can be repeated and more transparently replicated as well as more completely described in other settings, there may be merit to this information system. As noted before, the DMCB believes the solution to chronic illness care management ultimately resides in an interlocking system that includes electronic records, the medical home, disease management, smarter physician reimbursement, better insurance benefit designs, consumerism and registries. Vermedx and the approach it represents may - or may not - be a step in that direction.

Note: The DMCB emailed 'infoATvermedx' as well the principal author of the published study asking for more information about the possible limitations described above. After one day, there was no reply.

Diabetes and the Government Sponsored Disease Registry of New York City

Registries. Everybody loves ‘em. These data bases promise sorting, insight, planning, action and improvement, right? Government should not only support them, but maybe even sponsor them, right? Use them to create documents with maps, hm?

Not so fast. The April 28 edition of the Archives of Internal Medicine (not online at the time of this posting) has a well written pro vs. con debate on the topic. Specifically, New York City (that's a map displaying the burden of disease in the 5 boroughs) is requiring that all its laboratories forward A1c results and demographic data on all persons with a diagnosis of diabetes mellitus to the NYC Department of Health and Mental Hygiene. Once patients are in the data base, they will be given the ability to ‘opt-out’ of being contacted. If there is no opt-out, patients with an A1c greater than 8% will be alerted by letter and sent education materials. The ordering physicians will also receive alerts along with treatment recommendations.

This is a slight twist on a familiar subject for readers of the Disease Management Care Blog. This debate centers around government sponsored registries. There are still some important lessons.

The ‘pro’ article by Drs. Littenberg and MacLean of the University of Vermont has the all the usual arguments and then some. Registries have been used to conquer other scourges of mankind. They track incidence and prevalence. They enable program budgeting, planning and refinement. They provide insight about the quality of care by geography. They’re part of the Chronic Care Model, and that’s good, right? They also enable the follow-up of individuals. The reason why other registries have a single digit opt-out dropout rate is because patients are good citizens. Registries are expensive and government funding guarantees success.

Dr. Trief and Mr. Ellison rise in opposition to the motion. They note that public health registries were created to help combat communicable infectious disease, not chronic illness. They looked for studies that examined the link between A1c self-awareness and diabetes control and could only find one - and it apparently demonstrated no link existed. Another study is quoted that failed to find an association between the use of a registry and health care utilization among persons with diabetes. What’s more, other studies that gave alerts (for example, fax) to physicians for other conditions failed to show much improvement. They also feel the downside risks also cannot be discounted. The appearance of government intrusion could prompt patients to stay away from their physicians, the New York City registry could be ‘hacked’ and patients may be justified in worrying about how their data could be used against them in the future. While not so clearly stated, they indicate a registry is helpful when it is integrated with other quality enhancing initiatives – which are lacking here.

The DMCB is inclined to agree with the ‘con’ perspective, especially the patient dimensions – and not just because the 'pro' authors are from the People’s Democratic Swedish Republic of Vermont. Being a blog, however, it can’t help adding some other 'con' POVs by opining that while this is a well-meaning initiative, physicians are becoming saturated with prompts, nudges, reminders, alerts, warnings, cautions and alarms from well meaning good-doers using faxes, screen prompts, emails, calls and letters containing guidelines, lists, recommendations, contact information, disclaimers, bar graphs and HIPAA boilerplate. New York City’s foray may provoke registry-fatigue or even blow-back from the docs and what’s worse, give the government sponsored population-care a bad name – not only because stand-alone registries don’t work very well, but because they also annoy docs with false positives.

The DMCB can't tell if the NYC Department of Health understands notions of private-public partnerships, which would allow it to use this otherwise good idea to enable a number of other population-based care options. Does anyone have any insights to share?

In the meantime, the Archives invites readers to submit their own 250 word, clearly labeled “pro” or “con” abstract to their journal. If selected, you’ll be invited to author a full manuscript on the topic for peer review consideration.

Addendum to my post on quotes from the WHCC: My physician colleagues from internal medicine will enjoy a learned description from a surgeon who, during a presentation on the topic of medical devices, shared his insight about a key feature of nanotechnology: ‘it’s really really small.’ Yup.