Disease Management for Hypertension: A Call to Action

While the population health management service industry has a successful track record when it comes to chronic heart failure, diabetes and asthma, the Disease Management Care Blog thinks, after a quick scan of the literature, that there are fewer studies of its impact on hypertension.

 A recent Morbidity and Mortality Weekly Report (MMWR) reminds us that that's a problem.

The National Health and Nutrition Examination Survey(NHANES) performs interviews and physical examinations of a representative sample of U.S. households.  This particular report on the prevalence and treatment of high blood pressure was based on a sample of 20,811 individuals from four 2-year survey cycles that were performed from 2003 to 2010.

Extrapolating from the sample, 66.9 million persons or 30.4% of the U.S. populationn have high blood pressure. Of this population, just over half (54% or 35.8 million) have uncontrolled hypertension.  Of these persons, 31 million (or 88%) had been seen by a health care provider in the preceding year. The prevalence of uncontrolled hypertension among those hypertensives with Medicare was 52%. Not having health insurance or having seen a health care provider in the past year increased the risk of untreated and uncontrolled high blood pressure.

What's more, the DMCB discovered control of hypertension doesn't appear to be getting better over time.

The good news is that the treatment of high blood pressure is not all that complicated and that team-based non-physicians can play an important role.  Patients should be engaged on weight control, a DASH diet, restricting salt, exercise and moderating alcohol intake. Medication therapy can be individualized and tailored to meet mutually agreed-upon goals and to minimize any barriers.  Check out this MMWR table and you'll see references to "lifestyle counseling," "self monitoring," "self-management education."

Given the looming shortage of primary care care settings and the coming influx of newly insured persons, the DMCB believes population health management will need to be part of the solution.  In addition to the established science, the industry 1) understands the importance of risk stratification, 2) can be bolted onto accountable care arrangements and 3) understands that optimal outcomes are somewhere between 46% and 100% control.

Hopefully, given the relative dearth of high quality studies, this opportunity will be accompanied by ongoing studies of outcomes.

Another Large Scale Research Study Confirms the Value of the Approach of Population Health Management

And here's another study, this time published in JAMA about Kaiser in Northern California that found that the following five components resulted in an increase of population-based blood pressure control: 

1. "Registry" (which the Disease Management Care Blog says is really a stand-alone database that is outside of the electronic health record);

2. "Control Rates" (which the DMCB figures is really an updated "dashboard" that displays key metrics to administrators and docs that provides feedback and helps keep everyone on the same page);

3. "Guideline" (in reality, it was a campaign to gain provider buy-in consisting of emails, publications, pocket cards, conferences, lectures and decision support);

4. "Medical assistant" follow-up operating under protocol to adjust medications (a.k.a population-based care management)

5. "Single" pill treatment (in other words, keep it simple by using pharmaceuticals that are combined in a single once a day prescription pill).

DMCB readers will not be surprised to know that the registry showed a progressive improvement in BP control (defined as less than 140/90 with the usual HEDIS® caveats) from 43.6% in 2001 to 80.4% in 2009.  Because everyone with hypertension at Kaiser was in the registry, there is no internal comparison group.  However, national and northern California HEDIS® rates for blood pressure control ranged from 55.4% to 69.4%.

While the results are 1) not necessarily generalizable outside of integrated systems like Kaiser (so we don't know for sure that this would work in a network of primary care clinics in Idaho), and 2) may have been influenced by an influx of patients with mild and easy-to-treat hypertension during the campaign), the DMCB is impressed. 

An 80% control rate for hypertension is damn good. 

The DMCB also figures that each of the interventions above are mutually supportive and even synergistic.  The whole is much greater than the sum of its parts.

How to translate this kind of success to networks of independent practices?  The answer, says the DMCB, is population health management: sponsored programs that can be owned by an insurer or a provider network that synergistically identify a population, maintain a data base, create a virtuous cycle of measurement and adjustment, get the doctors on board, deploy care managers and are smart about the pharmacy benefit.

If your a PHM service provider, vendor, consultant or stakeholder, the DMCB suggests this is one of those research papers you should bookmark, quote and aspire to.

Image from Wikipedia

Should Patients in Population Health Management Programs Have Access to Lay Care Coaches?

Based on prior posts like this, the Disease Management Care Blog thinks the answer is yes. 

That being said, this hot-off-the-presses research paper shows just much we need to learn about this emerging approach to the care of persons with chronic conditions like diabetes, high blood pressure and chronic heart failure.

Lay Persons Educating Persons With Chronic Conditions in Primary Care Clinics

The paper was just published in the Annals of Internal Medicine. It was a one year randomized study involving the patients at six Allina Health primary care clinics. 

Twelve lay "care guides" had at least 2 years of college education and "strong interpersonal skills." They received two weeks of education that included setting goals, identifying and overcoming care barriers, behavior change techniques, the limits of scope of practice and how to use the electronic records to message physicians.  It was up to the care guides and the patients to decide on how often they needed to meet in face or by telephone. The guides were supervised by two RNs.

Active (i.e. seen in the clinics within 6 months) patients who agreed to be in the study with high blood pressure, diabetes or heart failure were allocated in a 2:1 ratio to either a "care guide" or usual care. Goals were proscribed and were the usual HEDIS-style outcomes, such as achieving blood pressure control, reaching an A1c level, getting an echocardiogram, being on beta-blocker medications or getting a pneumovax immunization.
 
The study was not "blinded," in that they and their providers were aware of the assignment. Recruitment began in July of 2010 and the study was completed in April of 2015. 6168 patients were screened, 2135 patients agreed to participate and 1423 and 702 completed the study from the care guide and usual care study arms.

Results?

One year later, 82.6% of the care guide patients achieved their selected care goals vs. 79.1% of the usual care patients. That 3.5% increase was statistically significant.

Most of that improvement was accounted by a higher rates of tobacco cessation, pneumovax immunization, getting persons with diabetes to get an eye exam as well as urine protein testing, and getting persons with heart failure to go through an echocardiogram.  There were no statistically significant impacts on blood pressure control, diabetes control, cholesterol control or medication prescribing.

The care guides interacted with their patients on average 7 times (2 face-to-face and 5 by telephone).  They messaged physicians an average of 4 times.  There was no difference between the two groups in primary care office visits. Estimated cost was $286 per patient per year.

The Disease Management Care Blog's take:

There is increasing interest in incorporating lay-persons in the outpatient care of persons with chronic conditions.  That makes sense, because much of the educational "payload" may be deliverable using far cheaper and more engaging "peer" members of the community who - literally - speak the patients' language.  This is a nicely done randomized clinical trial done in a real world setting that adds to our understanding of this care option. The bottom line is that this study showed that the care guides had a real impact.

When the DMCB looks at the actual numbers, it is also clear that the study had an uphill climb.  Many of the baseline measures of blood pressure, diabetes and heart failure quality relatively high to begin with. The impact of the care guides may have been much greater in a population with a lower baseline (such as in this study) with more "room" to move.

Problems to think about for the next study.....

Not all outcomes are created equally: Unfortunately, this study was something of a disappointment because the improvements were spotty, relatively small and limited to lightweight "testing" outcomes vs. more -hard-to-achieve disease control outcomes.  It may one thing for a peer patient to talk a patient into a urine test or a heart scan, it's another getting a patient to take more pills.  That may take a professional educator, a pharmacist or nurse.

What do the patients want: In addition, the goals were based on a one-size-fits-all HEDIS approach.  They were not adaptable, negotiable or subject to shared decision-making.  If that had been in the mix, patient engagement may have been an additional ingredient that could have pushed other outcome measures toward statistical significance.

What do the docs think: The DMCB notes that provider office visits did not go down among the care guide patients compared to the usual care patients. This makes the DMCB wonder if there wasn't enough physician buy-in: if there had been higher trust in the care guides' ability to manage these patients, it would have been reflected in less need to see the patients for a separate appointment.

Predictive modeling to the rescue: Finally, there is the problem of treating all chronic illness patients the same. Not all patients with high blood pressure, diabetes or heart failure are as susceptible to behavior change, and not all patients who engage in behavior change achieve better outcomes.  The trick is to use risk stratification to find the patients with the greatest chance at benefit.  This study may have benefited from a more focused approach.

Care Management Service Providers and the Potential of Accountable Prescribing

In previous posts, the Disease Management Care Blog has repeatedly questioned the wisdom of a one-size-fits-all, top-down, blunt force and Ver 1.0 approach to measuring health care quality.  That's why it's glad to see that the New England Journal of Medicine agrees with the DMCB in this Perspective by Nancy Morden and colleagues on the topic of Accountable Prescribing.

The authors point out that while blood pressure should be less than 140/90, LDL cholesterol less than 100 in persons with a history of heart attack and A1c should be less than 7% in persons with diabetes, it's clear that the cure can be more costly than the disease.

For many individuals with mild elevations in blood pressure, diet and exercise can be enough and, if that doesn't work, cheap water pills often work great.  Among persons with elevated cholesterol levels, inexpensive statin prescriptions can save lives. Metformin for diabetes has been around for decades and it a first line agent no matter what the A1c is.

As a result, they call for measuring and rewarding quality based on accountable prescribing that not only measures the numbers (blood pressure, blood cholesterol or diabetes control), but the percent of individuals receiving conservative or first line treatments.  While this approach would require an even more detailed databases/registries, it's within reach of most commercial insurers and advanced electronic record systems.  We owe it to our patients to provide a tailored, bottom-up, nuanced and Ver. 2. approach to measuring health care quality.

It's also a concept that the population health and care management service providers could, with the right kind of clinical partners, lead.  This calls for a pilot program and, in the DMCB's humble opinion, the sooner, the better.

For a better idea of how this might work, check out this table.

Image from Wikipedia

Another Randomized Controlled Clinical Trial Proves Outsourced Population Health Care Management Works: Hypertension

Here's another high quality randomized controlled clinical that confirms the benefits of outsourced care management.

Margolis and colleagues accessed Minnesota's HealthPartners' electronic records to identify all patients who had had two sequential primary care clinic blood pressure readings that were more than 140 systolic or 90 diastolic.  These patients with hypertension were asked by letter and then phone calls to participate in the research trial.  Those who agreed were rechecked by research assistants who re-measured the blood pressures to confirm the hypertension.

16 clinics participated. 8 were assigned to the intervention group. 8 served as comparison (control) "usual care" clinics that relied on usual physician care.

In the intervention clinics, a pharmacist interviewed each patient and sought agreement to lower the blood pressure by 5 points. The patients received a home BP monitor that transmitted data to AMCHealth six times a week. The pharmacist and patient met by telephone every 2 weeks. Based on the BP monitoring and the telephone interviews, the pharmacist used a standardized medication algorithm to adjust medications until control was achieved for 6 weeks.  Telephone calls were then reduced in frequency to monthly.

The research assistants reassessed the participants' blood pressures at 6, 12 and 18 months.

Over 14,000 patients were identified and 2020 agreed to be screened. 450 met criteria for persistently elevated blood pressures. 228 were cared for in the intervention clinic and 220 were cared for in the usual care. The mean age was 61 years, 45% were women, 82% were white and 48% had a college degree. The average blood pressure was 148/85.

Both groups had a similar frequency of follow-up visits. 380 patients had completed both 6 and 12 month follow-up visits with the research assistants. 

The proportion of patients with controlled BPs at both visits in the intervention clinics was 57.2% vs. 30% in the control clinics. If those patients lost to follow-up were counted as blood pressure "failures," the success rate was 48.5% vs. 25.1%. Both sets of measures were statistically significant.  The relative proportions held up at 18 months.

Unsurprisingly, intervention patients were taking more medications over the duration of the study and at 6 months were statistically more significantly more likely to report that they were taking them. 

Six patients in the intervention group vs one in the control group had "events" related to low blood pressure, dizziness and loss of consciousness.

The cost, based on pharmacist time, was $1350 per patient.

The Disease Management Care Blog's take:

This adds to a growing body of evidence that non-physicians working under clinical protocol side-by side with busy primary care physicians can achieve control of a chronic condition - in this instance, hypertension.  This is a core attribute of population health.

Another piece of good news is the emergence of the electronic health record as a means to identify patients who are program candidates.  Now that's "meaningful."

The bad news:

The cost was $1350.  It is unlikely that those direct costs were mitigated by hypertension-related "savings" within the same fiscal year.  On the other hands, thinks the DMCB, the use of other types of non-physicians with or without IT-based decision support and higher throughput could lessen that cost.  The DMCB is sure that the population health service providers are already on it.

Even with state of the art population health, the rate of hypertension control was ultimately 50%.

A small excess of participants experienced an excess of treatment side effects.  While this may be the inevitable consequence of more aggressive treatment, it could expose the program to liability.

This was Minnesota: we don't know if this would work in, say, Los Angeles.  This needs to be tested elsewhere.

Image from Wikipedia

Retail Clinics for Chronic Conditions Like Asthma, Hypertension, Lipids and Diabetes Mellitus: A Look At the Value Proposition

Is there a business model in there?

To the delight of skeptics, pundits and bloggers everywhere, U.S. health reform continues to follow its predicted trajectory: fiscal shortfalls are now biting the nominally "wealthy," the Feds aren't about to admit that they're in over their head on implementing their health insurance exchanges, opportunities for cronyism are increasing and the DMCB spouse is wondering why her supposedly expert-husband can't find health insurance for less than a thousand a month.

In the meantime, there's no sign that Washington DC will ease up on the "accomodative" money-printing presses that are feeding "QE Infinity."  That's no problem, though, because Europe is reminding us that once the paper currency is undermined, selling gold is a handy way to quell grumpy voters and prop up the welfare state.

Yet, Clayton Christensen tells us a fix is at hand: much of health care's quality and costs travails, he says, can be solved by embracing the disruptive innovation of non-physician treatment of acute and chronic conditions.  His supporters are undoubtedly cheering Walgreens' recent decision to to have its 330 Take Care Clinics add hypertension, diabetes, high cholesterol and asthma care to its portfolio of nurse practitioner services.

After reading the usual retail clinic policy tomes both for ("access to care") and against ("health care balkanization" plus "missed diagnoses"), the Disease Management Care Blog isn't convinced that Walgreens' decision is such a slam dunk.

That's because these clinics' business proposition is less about innovation and more about being a loss leader that increases retail pharmacy foot-traffic. In fact, offering free retail clinic services has been tried. The premise is that the retail customer-patients will stop by the pharmacy window for new drugs and, while they're at it, renew those other high margin prescriptions.  If they pick up some diapers and nail polish while making their way to the front of the store, all the better.

While that certainly sounds good, retail clinics are not a build-it-and-they-will-come cash machine.  Recall that CVS had to pull the plug on its retail clinics several years ago.  Foot traffic didn't materialize and the supposed loss leader turned into a money pit. 

The good news for Walgreens is that they have Jeffrey Kang in their corner.  Prior to this, he led health insurer CIGNA's disease management initiatives. He undoubtedly understands retail, population-based outcomes and care coordination. If anyone can pull this off, he can.

The DMCB's conclusions?

It won't be easy. While Walgreens' we-accept-all-insurance plans-VISA-Mastercard-and-American Express foray into primary care might work, it could also fail. Large health care systems use their primary care providers to feed their high margin and still-profitable specialty care services.  On the other side, small physician-owned practices are learning that hustling, high service standards, attention to overhead, accurate billing, patient mix and ancillaries can be profitable. Walgreens has neither. It remains to be seen whether this publicly owned company's bottom line will be aided by salaried NPs chasing pharmaceuticals' narrowing margins.

Speaking of margins, the DMCB wonders if Walgreens will use its clinics to steer patients toward favored formularies or aid rebate and market share agreements. Could they also use and eventually monetize the Big Data like Target to further the company's business interests? If any one knows, please contact the DMCB.

Commoditization?  The DMCB thinks so and it's not alone. Over time, the professionals staffing these clinics may find primary care is more complex and that they and their patients deserve better.

Ease of Exit? For who? Given that this is ultimately a business, it would be corporate malfeasance if Walgreens didn't have an exit strategy. Unfortunately, one company's exit could be another patient's abandonment. That's a real risk for the patients who come to count on Walgreens for their longitudinal care.

Patient Centered Medical Home Threat... or Friend?  The DMCB doesn't think so. If the medical home offers the value that its advocates say, savvy health care consumers will be able to vote with their feet. If the PCMH falters, it won't be because of Walgreens; in fact, the threat of competition may force help medical homes be more efficient.  In the meantime, medical homes should treat retail clinics like a community resource and refer (or outsource) appropriate patients for routine health care. Why not?