Health Technology Is Not Sufficient When It Comes to Disease Management

The Disease Management Care Blog has always been suspicious of the health information technology (HIT) community's claims that their stand-alone and dehumanized robo-calls, passive monitoring systems, web-based learning offerings and computer-generated patient "messagings" are a population-based quality and cost panacea. While the DMCB may be old fashioned, it's always thought that HIT can add value and can be necessary but will never be completely sufficient. This HIT hubris contrasts with disease management programs, which package an array of high tech and high touch interventions into a mutually supporting whole that is greater than the sum of its parts.

Case in point is this study that was just published in the New England Journal of Medicine. Authored by Sarwat Chaudhry et al, the "Telemonitoring to Improve Heart Failure Outcomes Trial" (Tele-HF) randomly assigned recently discharged heart failure patients to one of two treatment arms: 1) an intervention group, that was asked to make daily call into a computer controlled system that generated an automated series of questions about health status, such as the presence of shortness of breath or fluid gain; if there was a decline, the patient's physician's office was alerted, or 2) usual care without any patient calls.

826 patients were in the telemonitoring arm and 827 were in the usual care arm. Over the 180 days following entry into the study, the number of readmissions, days in the hospital and death rates were compared. Since not all patients used the system as prescribed (14% didn't use the phone even once and toward the end of the study, about 55% were calling in at least three times a week), the analysis was correctly performed on an "intention to treat" basis.

There was no difference in outcomes. About 49% and 47% of the patients in the intervention and treatment arms, respectively, ended up being admitted. 27% of both arms were admitted for treatment of their heart failure. 11% of the patients in both arms died.

The DMCB is not surprised at the shortcoming of heart failure telemonitoring. Years ago, it agreed to implement a similar stand-alone program and came away very unimpressed. The DMCB thought that much more was needed, sch as nurse-based patient coaching, promulgation of evidence-based guidelines, identification and triage of patients with different levels of risk and facilitated access to an array of specialist and community-based programs.

In fact, the authors of the study would seem to agree with the DMCB. In the Discussion section of the paper, the DMCB found this very telling quote that couldn't have said it better:

In a previous, small, single-site trial of remote monitoring of patients, our group found a 44-percentage-point reduction in the rate of readmission, which was associated with significant cost savings. However, we were concerned that, in that trial, reliance on a single, highly skilled and motivated nurse case-manager who deployed an intervention developed by the investigative team limited the generalizability and scalability of the findings (bolding DMCB).

The DMCB says that's the point. Interventions like telemonitoring only add value when they are mixed with other population-based interventions, such as motivated nurse care coaches and coordinators.

However, the authors - as is generally typical of the mainstream academic community - also got it wrong. There is a sector of the health care industry that has figured out how to overcome the limited "generalizable and scalability" that is mentioned above.

It's called disease management. The DMCB thinks the failure to recognize that by not including that principle in the study design took an otherwise very promising intervention and made it look unnecessarily bad.

Patients with heart failure deserve better.

The Aldosterone Antagonist Eplerenone in Populations with Heart Failure: Another Task for Disease Management Programs

After the Disease Management Care Blog read this New England Journal of Medicine report back in 1999, it began to prescribe the aldosterone antagonist "spironolactone" for its patients with low ejection fraction chronic heart failure. Aldosterone is one of many normal human hormones that increase in response to a struggling heart. High levels of aldosterone contribute to a downward spiral of additional heart damage and impaired blood flow.

Unhappily, some of the DMCB patients developed dangerously high blood potassium levels. At the same time, reports of that side effect began to appear, for example here and also discussed here. Convinced that this was another example of the gulf between notions of academic efficacy and real world clinic effectiveness, the DMCB decided to return to the basic principle of "first, do no harm." It dropped spironolactone from its heart failure tool box.

With time, however, other reports like this began to appear, suggesting that if physicians were careful, spironolactone was still a good option. What's more, recommendations in favor of spironolactone appeared in the American Heart Association guidelines for the treatment of heart failure:

Recommendations Concerning Aldosterone Antagonists. The addition of low-dose aldosterone antagonists is recommended in carefully selected patients...based on the strong data demonstrating reduced death and rehospitalization in 2 clinical trial populations... For both of these major trials, patients were excluded for a serum creatinine level in excess of 2.5 mg per dL, but few patients were actually enrolled with serum creatinine levels over 1.5 mg per dL.... The average serum creatinine of enrolled patients was 1.1 mg per dL, above which there was no demonstrable benefit for survival. To minimize the risk of life-threatening hyperkalemia... patients should have initial serum creatinine less than 2.0 to 2.5 mg per dL without recent worsening and serum potassium less than 5.0 (page 1987).

And now the results from this huge international multi-site study have just been released. Over 2700 patients with heart failure who were already on aggressive state-of-the-art treatment for their heart failure were randomly assigned to another aldosterone antagonist called "eplerenone" or placebo. After 21 months, there was an absolute 7 % risk reduction for the combined end points along with statistically significant drops in deaths and hospitalizations. According to the accompanying editorial, the number-needed-to-treat (NNT) is an impressive 19. As expected, there were an increased number of patients who developed potentially dangerous increases in potassium levels in the treatment (11.8%) group vs. the placebo group 7.2%), but compared to the survival benefit, it seemed worth it.

This is noteworthy publication for the science of population health/disease management community. This report gives reason to advocate for the use of "aldosterone antagonists" in populations defined by the presence of dilated cardiomyopathy/low ejection fraction heart failure. Patients should be alerted about this treatment option, helped to understand it's risks, benefits and alternatives and coached to ask their docs about this. Since changes in kidney function can lead to high potassium levels, physicians in the real world may be understandably reluctant to start this therapy. Disease management can help by providing an important extra margin of safety by helping to make sure that patients have as well as keep any and all scheduled laboratory testing appointments. If the disease management program can get the lab test results, it can work with the physician to contact the patient to stop the medicine if there are any problems.

Heart Failure: JAMA Helps Us Understand Counting Measures and Measuring What Counts. Implications for CMS and Disease Management

Most population-based care afficionados will recognize these: measuring left sided heart function if there is a diagnosis of heart failure, using angiotensin converting enzyme inhibitors (ACEi) drugs among patients with low left-sided heart function, providing complete diagnosis-specific patient discharge instructions and giving tobacco cessation counseling when needed. That's right, these are the four state-of-the-art performance measures used by Medicare and the Joint Commission (thanks to recommendations from the National Quality Forum or NQF) to assess the quality of care for recently discharged patients with chronic heart failure.

JAMA has published (Aug 19, 2007;302(7):792) an important article on lingering quality-improvement disconnect between what is measured and what matters. Titled 'Heart failure performance measures and outcomes. Real or illusory gains' Drs. Gregg Fonarow and Eric Peterson of UCLA and Duke, respectively, point to the persistent gap between the gains in all four of the areas mentioned above versus the stubborn and persistently flat U.S. heart failure 30-day rehospitalization (about 20%) and one year mortality rates (close to 40%) over the last five years.

What is going on? The authors point out that the patients themselves may have changed: better care may have led to a relatively higher percent of sicker patients being left among those who make up the statistics in the latter part of the measure periods. Alternatively, the hospitals that are reporting these statistics may simply be doing a better job of documenting care that was really being given all along. Finally, the processes themselves may have limited impact. After all, only ACEi's have been definitively shown to slow the progression of heart failure.

It turns out that CMS is already looking at measures that matter, like readmission and mortality rates. Drs. Fonarow and Peterson point out that's a step in the right direction, but also suggest that future quality metrics should be linked to 'outcomes of interest' like tobacco cessation rates (not counseling), better statistical risk adjustment, developing registries that go beyond simple administrative claims and working with independent physicians and hospitals to create better buy-in.

This has implications for CMS' recent self-congratulations over the updated results from the MCMP and PGP demonstrations. The DMCB notes the demos included additional measures that could have accounted for the improvements, such as flu shots and use of beta blockers. On the other hand, much of what CMS is up to is still heavily laden with process instead of outcome measures. What's more, how well CMS can translate their promising successes among voluntary organized systems into the mainstream of its FFS payment environment remains to be seen.

Finally, there are important implications for other stakeholders in population-based management. The physicians from UCLA and Duke should know better and think about the track record of disease management in managing heart failure, including its endorsement by the American College of Cardiology/American Heart Association (check out p. e448) and its wide use by the participants in the very demos named above. Furthermore, they need to consider the emerging role of the medical home in better coordinating care once patients get discharged. These two (and soon to be one says the DMCB) systems of care may be just the ticket that pulls together all the resources it takes to reduce re-hospitalizations and decrease mortality rates. They can credibly apply their information technology, EHRs, registries and richer data bases to measure the progress really matters.

The DMCB thinks the population-based care approaches have a much better chance of success than a bureaucracy like CMS, no matter how much they read JAMA or try to follow the author's well-intentioned recommendations.

Should Patients with Heart Failure Receive Exercise Therapy? Implications for Disease Management Organizations with Heart Failure Programs

O’Conner and colleagues asked that question in an April 8 JAMA article titled “Efficacy and safety of exercise training in patients with chronic heart failure.’ You’d think exercise is good, because it increases stamina, promotes well being and should decrease the likelihood of the heart getting worse.

Maybe, maybe not.

The Disease Management Care Blog is going to share its four conclusions first. Readers who find them interesting may want to read the rest of this lengthy post. Even if you don’t want to read all of this, the conclusions alone should enable you to confidently quote from JAMA on an important issue in disease management - to the amazement of your colleagues and boss. That's because you regularly read the DMCB:

1. Among this ambulatory population with chronic heart failure, the overall event rate was striking: over the 30 months, there was a 15% mortality rate and about 2/3 ended up dying or being hospitalized. Chronic heart failure is a bad disease.

2. If a population of patients with a mean age of 59 years and on maximal medical therapy is assigned exercise, a simple assessment of utilization (hospitalizations, ER visits and the like) won’t show any impact. Your fees will be at risk.

3. This paper suggests baseline exercise tolerance, the level of heart function, mood, history of atrial rhythm problems and the cause of heart failure can have an impact on outcomes. Predictive modeling keying on these factors may be necessary to identify patients with a clinical profile that suggests exercise therapy is helpful. Good luck trying to convince your customers after the fact that these clinical factors helped or hindered your results. Adjusting for co-variates after the fact is a luxury for the academics, not you.

4. Even if the disease management organization does everything right in the promotion of exercise for persons with heart failure, the impact won’t be seen for about 2 years. A single year reconciliation may miss the impact of exercise in this population.

Recall ‘chronic heart failure’ typically describes a condition in which the heart muscle is weak and the heart chambers dilate. Interestingly, ‘forward’ (or downstream) flow (into the arteries of the body) is preserved. It’s ‘behind’ (or upstream) where the blood flow dams up. This leads to fluid retention (swollen legs) and shortness of breath (from fluid buildup in the lungs). Think of that sump pump downstairs: as that begins to fail, the hose leading outside still has lots of flow. It’s the basement that’s filling up with water.

This 82 site study randomized 2331 patients with weakened hearts to either 1) usual care with advice to exercise or 2) three supervised 15-35 minute group sessions of walking, treadmill or stationary cycling per week for a total of 36 sessions (over 3 months) aimed at getting to 70% of maximum heart rate. The duration was increased over the next 4-6 months and then slightly decreased with an ultimate target of continuing to exercise for a total of 120 minutes per week. The average age was 59 years, 40% were non-white and the median ejection fraction (a test of just how flabby the heart is) was 25% (compared to the normal measure of more than 50%, that’s low).

Key results?

All cause mortality 17% (usual care or EC) vs. 16% (exercise group or EG). Not statistically significantly different (NS).

All cause mortality or being hospitalized 68% (UC) vs. 65% (EG), not significant (NS).

All cause mortality or being hospitalized or having an emergency room visit or urgent clinic visit for heart failure problems 77% (UC) vs. 76% (EG), not significant (NS).

Cardiovascular mortality of hospitalization: 58% (UC) vs. 55% (EG), not significant (NS)

The Disease Management Care Blog was ready to conclude that heart failure exercise was destined for the comparative effectiveness research dumpster. Then it ran into this statement:

“Four baseline characteristics (duration of the… [baseline] exercise test, ventricular ejection fraction, Beck Depression… score and history of atrial fibrillation or flutter) were identified as highly prognostic. After adjusting for these covariates and heart failure etiology, exercise training was found to reduce the incidence of all-cause mortality or hospitalization by 11%.”

This 11% effect (by looking at the figures) was not readily apparent for about two years.

Huh? The DMCB recalls that this study involved randomization. That’s supposed to assure that all the conditions that might favor one group over the other are evenly distributed. If the baseline prevalence of exercise tolerance, heart function, mood, atrial rhythm disturbances and heart failure cause were the same in both groups (and it looks like they were), why would the authors make this statement?

The answer is because adjusting for covariates in randomized trials is not unusual . The ‘adjustment’ is a statistical approach that helps neutralize the persistent impact of these factors once the trial is concluded. As their impact was dampened, the difference in all cause mortality and hospitalization became more apparent.

Read the Disease Management Blog and Keep Up with the Peer-Reviewed Literature on Diabetes and Chronic Heart Failure

Holmes AM, Ackermann RD, Zillich AJ, Katz BP, Downs SM, Inui TS: The net fiscal impact of a chronic disease management program: Indiana Medicaid. Health Affairs 2008;27(3):855-64

The Disease Management Care Blog would expect nothing less than a prospective randomized trial on disease management from one of the Gods of General Internal Medicine. Thomas S Inui is among the authors of such a study recently published in Health Affairs. His prodigious biosketch can be found here. Note that he is a former President of the very academic Society of General Internal Medicine (SGIM), which has been curiously mute on the exciting and controversial developments in real world population-based health care. More on this in a future blog.

But let’s turn our attention to the study at hand. It was about the economic impact on disease management (DM) in an Indiana Medicaid population. Indiana has been looking at the role of DM for quite awhile. As patients were randomly enrolled in the program, they were followed over time and compared to patients who had not yet been enrolled, otherwise known as a staggered implementation. Over 800 persons with either diabetes or chronic heart failure were studied with an average of 21 months’ worth of data. Cost of the program (excluding start up) ranged from about $20 per member per month (PMPM) for telephonic care up to about $57 PMPM for nurse care management. High risk persons were assigned to the nurse care management, while low risk patients were assigned to telephonic care.

AmeriChoice ran the call center. The Indiana Primary Health Care Association provided the nurse care management

For CHF:

High risk PMPM savings vs. controls: $150 – not statistically significant

Low risk PMPM savings: $247 – statistically significant

For Diabetes:

High risk PMPM savings: - $144 (more expensive in the intervention group) – not statistically significant

Low risk PMPM savings: $3.80 – not statistically significant

The authors concluded that disease management was cost saving for the low risk heart failure group. They were unable to show savings in the high risk heart failure group or in either group with diabetes.

What does the DMCB think?

Once again, it’s possible to do credible research outside of research settings.

What’s true in Medicaid doesn’t necessarily apply to populations with other types of insurance. For example, a similar study in a commercial population showed diabetes disease management was associated with savings, while in an integrated delivery system, low risk heart failure disease management seemed to not result in savings. Go figure.

In their discussion, the authors expressed surprise that there were savings for low risk persons with CHF. For the DMCB, that’s still not that counterintuitive. Moderate amounts of disease may be more amenable to intervention. Persons with mild disease will do well no matter what you do, while those with advanced disease will have problems despite the best of care.

The authors also noted that the baseline characteristics of the control and intervention patients were imperfectly matched, which could have skewed the results. It’s also possible that higher numbers of participants may have achieved statistical significance. The DMCB also wonders if the protocols used to identify the 'high risk' versus 'low risk' patients could have been responsible or if the nurse protocols to manage the high risk heart failure patients or the diabetes patients weren’t up to snuff.

Healthways and CMS Shakes Hands. Is a Phase II Next?

Healthways and CMS have signed an "Amendment" which 'changes the financial performance target for both its Initial Cohort and Refresh Cohort to budget neutrality from 5.0% net savings and 2.5% net savings, respectively.' The Disease Management Care Blog checked the CMS web site for more info. Finding none, it listened in on a recording of the May 6 Healthways Investor Relations web cast.

As the DMCB understands it, a new analysis of a 'refresh cohort' consisting of approximately 4000 enrollees with just chronic heart failure shows the company is within reach of achieving budget neutrality. They feel it is possible that in the remaining months, they can demonstrate an additional $3-$4 hundred thousand in savings and get from 93% of fees to 100%. If they reach it, they note that the original legislation requires the Secretary of HHS to launch Phase II because (and this was read out loud during the call):

"With respect to chronic care improvement programs conducted under subsection (b), if the Secretary finds that the results of the independent evaluation conducted under subsection (b)(6) indicate that the conditions specified in paragraph (2) have been met by a program (or components of such program), the Secretary shall enter into agreements consistent with subsection (f) to expand the implementation of the program (or components) to additional geographic areas not covered under the program as conducted under subsection (b), which may include the implementation of the program on a national basis.

special emphasis on 'a program' not all programs.

Because of the budget neutrality agreement, Healthways has been able to recognize $5.2 million of revenue that was otherwise tied up in its Medicare Health Support pilot. Guess what they are doing with this money? Instead of letting it flow into the company's bottom line, they are using it to disperse bonuses to the 'colleague' employees who are working in the MHS Program.

Does anyone have any doubt that the colleagues are going to work hard in the coming months to achieve the neutrality? Einstein has been quoted as saying the two most powerful forces in the Universe are gravity and compounding interest. From previous experience, the DMCB knows a 3rd force is nurses. It also knows of all the chronic illnesses, heart failure is probably the most amenable to efforts to decrease inpatient utilization.

Commentary on Heart Failure & the Medical Home, plus News about Healthways and the Merits of Carve-In-Out-Outs

"Ruh roh," thought the Disease Management Blog, "another negative disease management program report." Grimly steeling himself, he traced down the reference. Its Jaarsma et al: Effect of moderate or intensive disease management program on outcome [sic] in patients with heart failure. Arch Intern Med 2008;168(3):316-324. The entire article is available for viewing (thanks, Archives!)

Over a thousand persons discharged from a hospital with chronic heart failure (HF) were randomly assigned to one of three groups: usual care, basic support (additional outpatient visits with a specialist nurse) or intensive support (visits plus weekly telephone calls, home visits, support from other non-physicians). About 50% were NYHA II and the other 50% were III or IV. During the 18 months of prospective follow-up, there was no statistically significant difference in death rates or hospitalizations across the three groups.

What should readers be aware of?

In the 3rd paragraph of their own published "Comment" about their data, the authors point out that there are two explanations for their negative study: either the intervention didn't work, or the comparison control group did much better than expected. The authors explicitly noted that the surprisingly good control group data "in particular may have an important role." Note that the all of the study subjects received intense coordination from cardiologists in Heart Failure Clinics. Adding a "disease management" program to that mix did little.

The Disease Management Blog also notes this study was conducted in The Netherlands. Issues of culture, access to care and the scope of the insurance benefit make generalizing these results to the U.S. doubtful. Just because it doesn't work across the pond doesn't mean it won't work here.

But, there are two other thoughts I'd like to offer, one methodological and the other about the true nature of the study.

There seemed to be lots of patients with NYHA Class IV disease in this study. Class IV is a sick group and many physicians will tell you that individuals with this burden of disease are extremely fragile and very prone not only to exacerbations of their heart failure but are highly vulnerable thanks to other co-morbidities. They are destined to be high cost no matter what is done. Accordingly, I doubt if usual disease management interventions directed at this segment of a heart failure population are able to garner much of a "return on investment" in mortality rates, hospitalizations, quality of life or claims expense. The same may be true at the other end of the spectrum of disease, where it is not unusual for patients with very mild heart failure to do well for years at a time. The types of interventions described in this article will only "bend the trend" in the mid-spectrum of disease. That's the point of my crudely constructed image.

While I wish I could take credit for this insight about the spectrum of disease, it belongs to Ed Wagner, thanks to his 2004 Annals article.

From a methodological standpoint, the authors were destined to have trouble demonstrating any impact from basic or intensive support because the patient population wasn't ideal: it included patients who were destined to do very well and patients who were destined to do very poorly in all three treatment arms.

Last but not least, who says this was "disease management?" While it meets the commonly held view of a "typical" disease management program, this was really a physician-owned program in a network of hospital-based specialist clinics using an approach much more akin to the Medical Home. Too bad the authors didn't substitute those two words in the title in lieu of "disease management." Now THAT would have been interesting and probably generated a lot more media attention.

And speaking of disease management, some additional bad news for Healthways. The disease management blog recalls the happier times described in this article in Managed Care Magazine. Nothing like an activist State Attorney General to rain on the parade of a state-of-the-art program, even if Minnesota Blue Cross Blue Shield had compelling data showing a beneficial impact on claims expense that was in excess of the high fees. No matter: the AG was on a search and destroy mission thanks to BCBS' other questionable uses of their enrollees' hard earned premium dollars.

Note that this health plan is considering bringing its disease management programs "in-house," not abandon them. They seem to still believe in the concept, and so do the health care analysts quoted in the bad news article linked above. As for going in-house, the disease management blog wishes them good luck. I believe that while there are some good reasons to do that, cost isn't one of them. The ultimate cost of well run "carve in" programs are not that different from the "carve outs." Instead, you get (or rather, the enrollees get) what you pay for.

Instead, I believe the real opportunities for savings in population care will turn out to be blended approaches that use the best of both "carve in and out." The well run disease management organizations are so good at what they do and are unmatched in their delivery of high value, industrial strength, telephonic-based patient engagement. For many patients with some conditions at some stages of disease, that may a perfect intervention.

On the other hand, health insurers may be better able to marshal the kind of local resources necessary for high touch care coordination and case management. For other patients (especially those outside of the Netherlands and without NYHA Class IV heart failure), that may be the perfect intervention. Even better, Health Plans could stand aside and carve this function out ("carve out and out") to the real "on-the-ground"experts in a network of Medical Homes.

The disease management blog suspects the "vendors" understand the potential of "carve out and outs" and are keenly interested in figuring out how meaningfully integrate their telephonic-based programs with the physician community's Medical Home approach. For more on pros and cons of that interesting vision, check out 1) what Vince Kuraitis has to say about the complimentary potential of Medical Homes and disease management and 2) what the DMAA has to say about it.