Another Study Shows Disease Management Works

Here's more evidence that disease management really works.

The study, Online Disease Management of Diabetes: Engaging and Motivating Patients Online With Enhanced Resources-Diabetes (EMPOWER-D), was a prospective randomized clinical trial that is posted online over at JAMIA.

The Disease Management Care Blog summary:

Researchers at the Palo Alto Medical Foundation used the electronic health record (EHR) to look for active (seen once in the last 12 months) patients over 18 years of age with  Type 2 diabetes and an A1c greater than 7.5%.  If the primary physician approved, patients were then asked to complete a questionnaire and keep an appointment with a research assistant for additional review and discussion. Once patients agreed, they were entered into the study.

6,907 potential study subjects were identified, 1,594 agreed to complete the questionnaire and see the research assistant, 768 met additional research criteria. 415 agreed to be enrolled in the study, and 379 completed most of the 12 months of follow-up.

Patients were randomly allocated into one of two treatment tracks and followed for 6 and 12 months. The usual care (UC) track provided reminders about preventive care in addition to their usual visits with their physicians.  The intervention (INT) track had the usual physician visits, plus:

1. access to a "nurse care manager" (NCM) who provided advice and protocol-based medication changes,
2. Wireless uploads of glucometer readings into the EHR,
3. an EHR-based patient-specific summary "dashboard," that included risk scores, preventive care updates and a care plan,
4. web-based insulin, exercise & nutrition logs,
5. secure EHR-based messaging with the physician and NCMs and
6. patient-specific text and video offerings targeted by the NCMs.

The principal outcome measure was the A1c test, which is an indicator of overall blood glucose control. A level of 7 or lower is considered to be satisfactory control. At 6 months, INT patients statistically significantly decreased their A1c by 1.3 vs. 0.7 in the UC group.

At 12 months, there was still a difference favoring the INT group, but it did not achieve statistical significance: 1.1 vs. 0.7. 

Once the study was completed, the authors went back and looked at the proportion of patients that had decreased their A1c by at least 0.5.  At 6 months, it was 70% vs. 53% for  at 6 months, and 70% vs. 55% at 12 months for the INT and UC groups, respectively.  Both differences were statistically significant. 

Patients in the INT group were also more likely to lower their cholesterol, go through a medication adjustment, experience lower "treatment distress," have greater knowledge of their diabetes and be more satisfied with their care.  There was no difference in blood pressure control or the number of physician visits.  Overall health care costs or insurance claims expense were not measured.

Disease Management Care Blog take-aways:

You Want Evidence? Thanks to this high quality randomized controlled clinical trial conducted in a real world setting, the evidence base supporting the use of remotely placed nurse care managers continues to build.   Kudos to Palo Alto for simultaneously taking good care of their patients and conducting impressive research.

Patients At Risk: The combination of a) a steady percent of INT patients keeping their A1c 0.5 at 6 and 12 months plus b) a simultaneous overall average decline in the A1c makes the DMCB think that there was a subcohort of patients that "back-slid" and affected the group mean.  Commercial population health management service providers are working hard at prospectively identifying these higher-risk individuals for additional interventions.

Doing something is better than nothing: While the modest A1c decrease in the UC patients could have been due to regression to the mean, the DMCB wonders if they also benefited from being identified and monitored. 

Can Finally Point to Something Good About the EHR: While the EHR continues to disappoint in terms of consistently improving quality or reducing costs, this study demonstrates an important upside: it can be used to efficiently recruit potential research subjects.  That's important because thousands of candidate patients are needed to find hundreds of study participants
 
Physician Utilization Did Not Decline: Unfortunately, this study did not address multiple measures of utilization, so the DMCB doesn't know what to make of any decrease in potential costs versus the cost of the the program.

ACOs Take Note: While the Palo Alto System is not representative of most health care settings in the U.S., it does hold important lessons for Accountable Care Organizations. Given their contractual responsibility to improve diabetes quality as well as managed insurance risk, this study says they ignore the potential of remotely-based and technology-backed nurse care managers at their peril

Does Diet and Exercise Prevent Diabetes or Help Persons with Diabetes Live Longer?

It's such a no-brainer, right?  If persons at risk for diabetes would only eat right and exercise more, they'd avoid the disease.  And for those who develop diabetes, diet and exercise will reduce death rates and complications.

Yes and no, say Elizabeth Sumamo Schellenberg and colleagues at the University of Alberta.  Their review of the mixed published scientific evidence on the topic appears in the October 15 issue of the Annals of Internal Medicine.  The purpose of their study was to ascertain the impact of diet and exercise on the prevention of "Type 2 diabetes," as well as lowering complications among persons with who had established Type 2 diabetes. 

To be included, studies had to be prospective and compare the outcomes from an intervention versus a randomly selected control group. The study could only be included if it examined the impact of exercise plus diet and "one other component," such as "counseling, smoking cessation and behavior modification."  The outcomes had to include the development of Type 2 diabetes (in the prevention trials) or complications (in the treatment trials).

1289 candidate studies were found but only 20 made the grade. Nine were prevention trials and 11 were treatment trials.

For the prevention trials:

The interventions lasted from 6 to 72 months, with follow-up going for 3 to 20 years for between 39 to 3234 participants.  The counseling varied and included group and/or individual with or without tobacco cessation, telephony, goal setting, cooking classes or pills involving a range of physician and non-physician professionals.

Results?

Seven of the nine studies showed that diabetes can be delayed. When the results were pooled, compared to the control patients, the risk of developing diabetes over 10 years was only a third and the difference was statistically significant.

But, there was no detectable impact on cardiovascular disease events or on eye, kidney or nerve damage. That may have been due to not all the studies including these outcomes as well as the time it takes for these complications to occur once diabetes develops.  With more patients or more time, a difference could have become apparent.
 
For the treatment trials:

The interventions lasted from 6 to 48 months with follow-up for 6 to 93 months. The counseling was as varied as the prevention trials but included glucose and blood pressure monitoring as well as stress management and, in one instance, a three day residential retreat. There was likewise the range of professionals who provided the interventions.

Results? 

Compared to the control patients, there was no statistically significant difference in all-cause mortality.  Some individual studies had beneficial outcomes involving cardiovascular events or diabetes complications, but they included the aggressive use of medications.  There were no sustained impacts on weight or dietary intake.  And if pills were not included, there was also no real improvement in measures of blood glucose control.

The Disease Management Care Blog's take?

The good news is that there is good evidence that exercise and diet can prevent diabetes.  The bad news is that it takes years for that "return on investment" to declare itself and typically involves interventions that fall outside the traditional health care delivery system.  It's unlikely, thinks the DMCB, that current iterations of payment reform (value based purchasing, bundled payments or upside risk) can be marshaled to make this a reality.  That being said, population health management (PHM) companies like Omada Health are making their evidence-based services available to, for example, employers who have a longer term commitment to the well being of their "human capital" outside of the traditional insurance market.

The bad news is that once diabetes declares itself, diet and exercise don't result in life extension, and control of complications as well as overall blood sugar levels is more a function of pills than lifestyle. Accordingly, expectations need to be realisitically shared with patients and PHM should emphasize taking the pills as prescribed.

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.

Small Local Program, Big Results: Who Cares If D.C. Is Tied Up in Knots?

While the national mainstream media focuses on Obamacare's dimming prospects, internecine Republican conflicts over the merits of a government shutdown, pugnacious Democratic debates over government price controls and who should take credit for the drop in health care cost inflation, check out this local city paper article on the One Simple Idea (that) Could Revolutionize Health Care. As the reporter pointed out, there was no press release, no touting and no awards.  Simply results.

The DMCB agrees.

Barbara Schneider and her team work with Philadelphia health insurer Keystone First's community outreach and care coordination programs to intervene on the "sickest of the sickest" diabetics.  These are 35 patients who are admitted on average more than twice a month.  Patients who are on a first-name basis with all the local emergency rooms nurses on all the shifts. Patients who live in run-down boarding houses on a good day.  Patients who are lucky if their blood sugar is only 600 mg%.  We're talking hundreds of thousands of dollars in health care costs.

Dr. Schneider's lay community health workers (more info on the science here) are seeing these individuals in parking lots, McDonald's, row homes and halfway houses  to cajole, coach, text, call, shuttle and haggle with patients, families, social workers, pharmacists and insurers to dismantle barriers one patient at a time.  If a patient isn't ready to stop abusing drugs, that doesn't mean he can't be taught to use a glucose meter.  While living circumstances may be chaotic, that doesn't mean she can't use a cell phone instead of just going to the emergency room.

As Dr. Gawande noted in his The New Yorker article about the super-utilizers, those kinds of interventions can add-up significant savings.

While Keystone has yet to release an analysis on the impact on claims expense for these patients, a cursory review of the data shows emergency room visits have been cut by a third, while inpatient stays declined by more than half.  Even with the DMCB's limited background in analytics, it suspects that when the return on investment is finalized, Keystone will conclude that the program was an unqualified success.

To the DMCB, this is what it's all about.  Washington DC can continue its partisan scorched earth battles while, in the meantime, small regional community minded health insurers like Keystone First are figuring out how to do right by patients using novel programs like this. 

Image from Wikipedia

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

The Important Look AHEAD (Action for Health in Diabetes) Study: No Benefit from Exercise and Weight Loss in Diabetes?

Diabetes? Exercise and then die just as soon.

It makes sense, doesn't it? If persons are overweight and have diabetes, diet and exercise-based "prevention" should translate into fewer heart attacks, strokes and deaths, right?

Wrong.

It turns out that a just-published and high quality research study shows it's not so simple.  What's more, the Disease Management Care Blog brazenly suggests that the disease management/population health vendors discovered this years ago.

The just-published study is here in the prestigious New England Journal of Medicine. The DMCB suspects that, thanks to the mainstream media's fixation on Snowden, SCOTUS, and Shakira possibly hawking Obamacare, this important research may not get the front-page attention it deserves.  Considering that it was ten-year, prospective, randomized multi-center academic study involving over 5000 patients, that'd be a shame.

Here's the DMCB's summary:

Eligibility: Participants had to be between 45 and 75 years of age with adequately controlled (A1c less than 11) "type 2" diabetes, an "overweight" body mass index (BMI) of 25 or more, blood pressure less than 160/100, an ability to exercise and access to a primary care provider. 

Recruitment: This went from August of 2001 through April of 2004. It was also tailored to keep insulin-using participants to less than 30% of the study group.

Interventions That Were Compared: Participants were randomly assigned to an "intensive lifestyle intervention" study arm or a "support and education" study arm.  The intensive group received weekly group and individual counseling for six months that subsequently tapered over the subsequent duration of the study. The counseling included a 1200-1800 calorie diet plus 175 minutes of moderate physical activity per week that was aimed at achieving a weight loss of at least 7% of body weight.  The support group got only three group sessions per year. Medicines and their doses were generally left to the primary care provider.

Outcomes Studied: Participants' waist circumference, weight, blood pressure, medications and exercise tolerance were assessed once a year. Hospital and other medical records were reviewed to assess the number of deaths and cardiovascular events, such has heart attack or stroke.

The Study Population: 5,124 persons were enrolled; 2570 were randomly assigned to the intensive group while 2575 were assigned to the support group. The average age was 59 years, 60% were women, the median duration of the diabetes diagnosis was 5 years and the average body mass index was a hefty 36. Only 4% were lost to follow-up.

Outcomes:  After a median of 9.6 years of follow-up......

• patients assigned to the intensive group lost approximately three cm. from their waist and six kg. in weight vs. zero cm. and four kg., respectively, in the support group. This translated to a weight loss of 6% of body weight (vs. the target of 7%) in the intensive group vs. about 3.5% in the support group.

• the A1c, which is a test of overall blood sugar control, was about two tenths of a point (7.4% vs. 7.2%) lower (i.e. better) in the intensive group. LDL cholesterol was also lower. Better control of the diabetes meant that the persons in the intensive group were taking fewer medicines at lower doses.

• But it was all for naught.  During the course of the study, there were 403 cardiovascular deaths, non-fatal heart attacks or heart-related ("angina") hospitalizations in the intensive group, vs. 418 in the support group. The calculated rates of 1.8 vs. 1.9 events per 100 person years was too small to be statistically significant and was more likely the result of chance or randomness.

The Disease Management Care Blog's take?

The early painful lesson of the "disease management" industry was that a broad life-style intervention applied to a large group of diabetics was not going to meaningfully improve outcomes. Critics believed that while the interventions were conceptually sound (diet, exercise, weight loss), the delivery was flawed. 

This just published NEJM study would suggest the intervention itself is futile. If so, that is bad news.

"Not so fast!" says the DMCB.

In addition to renaming itself (now "population health"), the industry responded to the science and the critics by retooling.  It learned to channel tailored interventions at population sub-segments who are most likely to experience a specific benefit. Instead of an "intensive" weight loss intervention for all overweight diabetics, population health can use baseline survey, insurance or clinical data to spot (risk stratify) those diabetics who are most likely to achieve a specific benefit that could range from (for example) a sustained 7% weight loss to reduced readmissions.

This NEJM study tried to benefit all diabetics.  A better approach is to find which diabetics will benefit.

As an aside there were some other issues with the study to bring up when debating the study with colleagues and foes:

The BMI of 36 suggests this was a very obese study population that lost only 6% of their body weight during the course of the study.  Since weight was still a health risk at the end of the study, the DMCB wonders if the intervention would have shown more benefit with a less heavy population.

The support group also lost weight and lowered their A1c, which could have obscured the clinically significant benefit in the intervention group. 

This accompanying editorial points out that lower statin and ACE drug use in the intervention group could have paradoxically increased their risk, since these drugs are known to lower the incidence of stroke and heart attack.

The editorial also points out that spin-off studies have already shown that the intervention group benefitted from higher quality of life.

Patient Perceptions of Risk, Media Innumeracy and The Enduring Futility of the Annual Check Up

Today the DMCB caught up on some reading of the medical literature. 

The first article is an example of how researchers' risk thresholds don't match patient perceptions.

The second article is an example of media innumeracy. 

The third article is likely to be ignored by everyone.

1. Should Cardiac Telemetry Not Be Used for Patients with Only a Three Percent Chance of a Problem?

Suppose, asks the Disease Management Care Blog, your elder family member mysteriously passed out and was seriously injured?  You would wonder if a cardiac problem could be the cause. While the likelihood of that is typically low, even the small chance of something being "wrong with the heart" is enough to make patients and their families worry.

But suppose the chance of a heart problem was only.... 10%?  Or 5%? Or 1%?    

Once a decision is made to admit a patient with loss of consciousness to a hospital, doctors typically arrange for "cardiac telemetry." That broadcasts the electrocardiogram on an ongoing basis to a monitoring unit.  Unfortunately, however, the demand for a hospital telemetry "slots" is high and the monitoring requires additional personnel.

As a result, clinical guidelines like these have been developed.  They define high risk patients who warrant telemetry and low risk patients who don't.  For example, patients who have had a recent heart attack are vulnerable to unstable heart rhythms, while patients with stable atrial fibrillation can probably be safely managed off telemetry. Patients who have passed out and are stable on telemetry after 3 days are considered low risk.

Enter Evan Benjamin and colleagues who applied the guidelines to a retrospective audit of how telemetry was used for 501 consecutive patients at four Massachusetts medical centers.  Since patients could transition from high to low risk as the days passed, the unit of measure was "patient-days" (if two patients were each on telemetry for 4 days, that yielded eight "patient-days"). 

38% of the total 1559 patient-days were low risk. Among the high risk patients, a heart problem was detected in 21 out of 100 patient-days.  In the low risk patients, a problem was detected in 3 out of 100 patient days. 

The authors argue that these data show that better enforcement of guidelines that restrict access to telemetry would result in more cost-effective care.  The DMCB isn't so sure, because it intuitively thinks most patients and doctors would consider a 3% (3 out of 100 patient-days) a low enough threshold to warrant monitoring.

Good luck, says the DMCB, enforcing that. 

2. Just How Bad is the Link Between Red Meat and Diabetes?

"Yikes!" said the DMCB after listening to this NPR broadcast and reading this WSJ article.  It appears that increasing red meat consumption increased the risk of diabetes among previously healthy people "by 50%!"  While its first impulse was to throw away those frozen strip steaks, the DMCB took a deep breath and did something the reporters neglected to do: read the article.  It turns out that the approximate risks went from approximately 0.2% to 0.3%.  More than 99% of the carnivores did fine.  Once again, the reporters failed to discern that while the relative risk was high, while the absolute risk was vanishingly low.

3. A Reminder that the Annual Check Up is a Waste of Time and Money

After reviewing 16 studies involving over 180,000 participants, the authors in this JAMA study concluded:

.... general health checks were not associated with lower rates of mortality or morbidity.  However, general health check may increase the number of diagnoses and the use of medications.

The irony is that The White House and CMS profess to being evidence-based while remaining simultaneously committed to "wellness checks."

Image from Wikipedia

Aggressive Insulin Treatment vs. Pills for Diabetes with Athersclerotic Disease: No Difference in Outcomes

When doctors and their patients review the treatment options for diabetes mellitus, a common question is "Why mess around?" If the blood glucose, thanks to a relative lack of the hormone "insulin," is "high," shouldn't the more "natural," tighter and physiologic answer be... insulin? While there are pills that can lower blood glucose levels and patients detest shots, it's unclear if the long term clinical, economic and quality-of-life outcomes favor one approach (oral medications) over another (insulin).

The Disease Management Care Blog thinks that these are the issues that were explored by the important, international and huge multi-center "ORIGIN" Study.  The results have just been published by the New England Journal.

Over 12,000 persons over age 50 years with

1) impaired glucose control or "pre" diabetes (more on this topic here), or

2) just-diagnosed diabetes or,

3) well-controlled diabetes (A1c less than 8 to 9%) on no or just one oral medication

and

4) established heart or atherosclerotic vascular disease

were randomly assigned to insulin glargine (with dosing that aimed for a normal blood glucose of 95 mg.%) or usual care (that relied on physician judgement and local guidelines). 

After one year, 50% of the insulin group hit their targeted blood glucose level and their median A1c (a measure of average blood glucose control over time) was 5.9%.  The usual care group achieved a median glucose level of 123 mg.% and after one year the A1c was 6.2%.  The difference in A1cs persisted over the remainder of the study (Table here)

The mean age of the participants was 63 years with an impressive median follow-up of 6 years that yielded outcome results on 99% of the participants.

Results?  No difference in heart attacks or kidney disease.

When cardiovascular death, nonfatal heart attack, non-fatal stroke were combined, the incidence was the same in both groups - about 3% per year.  There was no difference in kidney outcomes including deterioration in function or need for dialysis.  Hospitalization rates for any cause were the same in both groups.  There was an isolated difference involving angina that, in the DMCB's mind, may have been a statistical fluke.  You can look at the outcomes for yourself here.

There was one important difference.  Among the 1456 persons without formal diabetes (the "impaired" group - see above), persons given the insulin were less likely to progress to a formal diagnosis of diabetes (25% vs. 31%).  Unfortunately, they paid a price, because they had a higher rate of insulin-induced low blood sugar reactions (an incidence of 17 vs. 5 per 100 person-years).

Based on these results, the DMCB thinks:

1. Turning to insulin treatment early in the course of pre or diabetes treatment for persons with heart disease doesn't appear to offer any important difference in macrovascular (heart attack and stroke) disease or kidney disease outcomes. However, that's only true among patients who have achieved an A1c below 7%.  (The DMCB can't figure out what happened to the patients with a baseline A1c in the 8% to 9% range who didn't get to an A1c below 7 - did insulin help them?)

2. What's more, it's possible that driving an A1c lower - once it's below 7% - doesn't offer any additional outcomes advantage.

3.  While early insulin supplementation may prevent the "burn out" of the insulin-producing cells of the pancreas, the price for that is a higher incidence of low blood sugar reactions.  Even though this "cure" of diabetes may seem like a big deal, why bother if there's no difference in survivorship?

4. As the population health management service providers discuss care planning with their patients with diabetes and heart disease, the topic of early aggressive insulin may come up.  Here's an answer to that question.

5. If accountable or risk-assuming organizations believe that early aggressive insulin treatment will lower the direct costs attributable to heart disease among their patients and enrollees with diabetes, the answer is no.

That out-of-ate but compelling image is from a 2003 HHS website on why Prevention Makes Common Cents

Insulin for Persons Already on Metformin: A Population Health Perspective

As most population health providers know, diabetes guidelines tend to focus on shorter-term or "intermediate" outcomes, such as average blood sugar levels or A1c levels.  That's because these short-term measures are surrogates for "long term" outcomes, such as blindness and kidney disease.

Two inconvenient facts have complicated the focus on intermediate outcomes:  

1) Once a threshold has been achieved, lower short-term blood glucose control doesn't necessarily lead to better long term outcomes;

2) The side effects of drugs - that otherwise work quite well at achieving short-term blood glucose control - may outweigh any long-term advantages. 

And now a just-published research study from JAMA raises the possibility that insulin has additional long-term side-effects.

According to diabetes mellitus treatment guidelines from organizations like the American Diabetes Association, the first medication option for Type 2 diabetes should be metformin.  If that doesn't work, the ADA suggests that there are several options for a second drug, including one of several sulfonylureas (glyburide, glipizide or glimepiride) or insulin. 

Sulfonylureas are pills, but have a reputation for not leading to the same level of diabetes control as insulin.  Unfortunately, while it's a more potent means of blood glucose control, insulin has to be injected.

Further details on the methodology are below.* Basically, Veterans Affairs electronic records were "mined" to find thousands of persons with diabetes who were using metformin and then had to start either insulin or a sulfonylurea.  Propensity scoring was then used to create two otherwise similar cohorts of patients and neutralize the impact of the diabetes control and disease burden.

2436 patients on metformin and insulin were compared to 12,180 patients on metformin and a sulfonylurea. 

After a median of 50 months of observation, the risk of a heart atttack, stroke or death from all causes was 43 per 1000 person-years in the insulin group vs. 33 in the sulfonylurea group.  That difference was statistically significant.  When deaths alone were examined, there was likewise an increased number in the insulin group (34 per 1000 person years) vs. the sulfonylurea group (23 per 100 person years).

The Population Health Blog's take:

This study raises the possibility that, among persons with diabetes on metformin, insulin is associated with an increased absolute risk of about 1 per 100 person years (10 per thousand person years, or one person out of a hundred persons followed for one year) of heart attack, stroke or death vs. the sulfonylurea pill.  Yikes.

Before we ban insulin in this population, however, the PHB is reminded that this was an observational study.  As an accompanying editorial points out, propensity scoring is not perfect and other unmeasured and confounding factors in the population could be biasing the results.  Short of a randomized clinical trial, there are other databases that could be mined the same way.  That includes those of the population health vendors, who also have a stake in risk stratification and long-term follow-up.

In the course of coaching persons with diabetes on metformin who are considering insulin, the additional risk of heart attack, stroke or death should be raised.  While the study above isn't perfect, the possibility is something that health care consumers need to weigh.

++++++++++++++++++++++

*Methodology:

Veterans 18 years and older who.....

1) were followed for at least two years with provider visits every 6 months,

 2) who had been placed on metformin and regularly used it between 2001 and 2008,

3) had one year of records prior to the first prescription for metformin and

4) were not on dialysis or in hospice

Once a vet filled a prescription for either insulin (long acting, premixed or short/long acting) or a sulfonylurea (glyburide, glipizide or glimepiride) and continued it for 6 months, their records became eligible for the study.  Patient records were excluded if there was no follow-up for six months, if the meformin was stopped for 3 months or a third diabetic drug was prescribed.

52% (approximately 92,000) of the 178,000 vets on metformin did not use another medicine.  Most were men (95%) and white (70%).  2948 were started on insulin and 39,990 started a sulfonylurea. The persons placed on insulin had, on average, worse diabetes control (A1c 8.5% vs. 7.5%) and a higher disease burden.

A Thursday Three-fer: Diabetes Predictive Modeling, The Threat of Ambulatory Care Write Offs and It's the National Debt, Stupid!

At Risk?

Diabetes Predictive Modeling: Evidence Based, Peer Reviewed and Open Domain:

As Accountable Care Organizations, Patient Centered Medical Homes, care management vendors and managed care organizations continue to grapple with health care costs, they want to know who is at greatest risk in the coming months.  When it comes to diabetes mellitus, John McAna and colleagues (one of whom is the Disease Management Care Blog) is riding to the rescue with their American Journal of Managed Care paper "A Predictive Model of Hospitalization Risk Among Disabled Medicaid Enrollees." 

While the data were based on two states' Medicaid claims data sets, the research may be generalizable to other populations.  Factors that most strongly predicted a future hospitalization were increasing age (especially more than 65 years), a prior pattern of repeated hospitalizations (especially 3 or more) and the Charlson Comorbidity Index. The good news is that all the independent variables and their odds ratios are not-only evidence based, they're available for use by your actuaries and statisticians as quick as you can download the paper (after signing in) at the bottom of page 4.

Rumored Ambulatory Care Write-Offs: An Achilles Heel of Integrated Delivery Systems and ACOs?

In its recent travels, the DMCB was informed by two credible and astute physician-leaders that hospitals that have recently acquired outpatient physician practices are typically "writing off" ambulatory care bills because a) contesting small fee disputes are relatively costly and b) the threat of Medicare "overcharge" or RAC audits is existential.  That's significant because those small charges add up into millions and can mean the difference between a profitable outpatient clinic system and a loss leader.

It's Not the Economy, It's Not the GDP, It's the National Debt, Stupid:

The DMCB also recalls repeatedly hearing that it was President Nixon who first called attention to the growing fraction of the nation's gross domestic product going toward health care. The problem was that no one knew what was the "right" percent of GDP.  Mr. Nixon thought 7% was too high. If 7% isn't, in retrospect, bad, why is the current level of about 18% so bad?  What's so different?

The answer: it really is different this time.  What's bad is that health care is responsible for the lion's share of the separate problem of the growing national debt, which has been directly linked to national security.  Yikes.

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?

Obesity Surgery in Diabetes Mellitus: A Three Year Trial Shows High "Cure Rates." The Implications for Population Health

In case there is any doubt about the long-term efficacy of obesity surgery for diabetes, check out this three year study that was just published by the New England Journal of Medicine. 150 persons between the ages of 20 and 60 years with an A1c greater than the recommended target of 7% and a BMI greater than 27 were randomly assigned to either gastric bypass, sleeve gastrectomy or intensive medical therapy. 8 persons dropped out after being assigned to medical therapy and one patient had their surgery cancelled. Over the next 3 years, 4 persons were lost to follow up.

Of the remaining participants, two thirds were women and three quarters were white. The mean age was 48 years, the average BMI was a prodigious 36 and the mean A1c was a poor 9.3%, with an average duration of diabetes of just over 8 years. 

Of the 40 medical patients, 5% ended up with an A1c of 6%, versus 38% of the 48 bypass and 24% of the 49 sleeve patients.  The average weight loss was 4.3 kg in the medical patients vs. 26 and 21 kg in the bypass and sleeve patients. While only 2% of medically treated patients were able to stop their diabetes medications, 69% and 43% of the bypass and sleeve patients were able to do so. Only four patients in the surgery groups required additional surgery for the treatment of complications.  None died.

The Population Health Blog finds the results compelling enough to believe that the surgical option for obesity-related diabetes mellitus may be turning out to be a first line option.  The complication rate is acceptably low and the "cure" rate of up to 70% (if defined as not having to take medications) is likely to be welcomed by patients facing a lifetime of otherwise chronic illness.

Criticisms?

Critics may worry that any long-term economic benefits at a population-based level may be cancelled by the cost of surgery.  The PHB understands that, but doesn't believe that obesity surgery should be viewed through a "return-on-investment" lens.  Rather, the value assessment of "outcome" (in terms of diabetes and obesity cure) per unit of cost (dollars spent) is a as good as an investment compared to, say, coronary artery bypass grafting or a knee replacement.

Critics may also worry that obesity surgery is more of a symptom of an overfed society and that our national treasure would be better spent on understanding our dietary dysfunctions.  The Population Health Blog cannot disagree, but doubts that our national health spending can be wired so that every dollar spent on the promotion of nutritional wisdom will reduce the near-term health care cost crisis from diabetes.  We need to be prepared to invest in both.

Implications for Population Health

It appears to the PHB that this was a single site "efficacy" study involving an academic medical center.  We don't know if the low complication rate observed here is typical of other hospitals that offer obesity surgery.  In addition, this study did not examine the impact of the more popular approach of banding surgery.  That being said, this three year trial suggests that bariatric surgery should be offered in the suite of options for persons meeting the criteria above.

The good news is that shared decision making has already been evaluated in this setting.  While the majority of participants are more likely to chose conservative treatment, the point is that a 40-70% chance of cure over three years should be raised in the course of patient-centric coaching.  Population health vendors in the diabetes-obesity "space" should be prepared to engage patients on this treatment option and help them decide if surgery is the right choice for them.

Image from Wikipedia

Bariatric Surgery to Cure Diabetes: Two Compelling Studies But There Are Still Four Reasons for Healthy Skepticism

A cure for diabetes?

Mrs. Jones (name changed) was obese. Her weight remained persistently high despite education and entreaties about diet and exercise. She hated taking all those medications. She dreaded bathing suits.

And then.... she had bariatric surgery. She shed pounds faster than Supreme Court justices spanking a health insurance mandate. Instead of having a corpulent and unhealthy patient, the Disease Management Care Blog had a svelte and healthy patient.

Based on witnessing first hand patient transformations like this, the DMCB knows that bariatric surgery for obesity works.

Despite clinical anecdotes, however, obesity surgery skeptics have pointed out that the evidence has been marred by the lack of any prospective randomized clinical trials. Looking backwards at outcomes data can't rule out the possibility that something else was going on to account for the surgery's apparent success. Most of all, this includes self-selection bias where patients, who are destined to independently do well, select surgery. By leaving assignment to chance, docs and patients are out of the decision-making. This randomization helps researchers be more confident that the surgery, and nothing else, accounts for any observed outcomes.

Enter the New England Journal of Medicine, which published the results from two landmark prospective and randomized trials that compared obesity surgery to conservative medical management:

1. Geltrude Mingrone and colleagues screened 72 and then randomly assigned 60 diabetic persons with a BMI of 35 to either a) conventional medical therapy (targeting an A1c of 7% using a multidisciplinary team with visits every 3 months for a year and then one additional visit at two years) or b) gastric bypass or c) biliopancreatic diversion.  The study occurred at Rome's Catholic University. Follow-up lasted two years. At the end of the study, 56 patients' data were available for analysis. 15 of the 20 patients who had gastric bypass, 19 of the 20 patients who had the diversion and zero of the medically treated patients were off diabetes medications and had normal blood glucoses. As expected, surgery resulted in a whopping decrease in the BMI down to approximately 29.  In contrast the mean BMI was 43 in the medically treated group. Two patients had the surgical complications of hernia and obstruction

2. Philip Schauer and colleagues screened 218 patients and randomly assigned 150 diabetic obese persons with BMIs ranging from 27 to 43 to either a) medical therapy (life style counseling, weight management home glucose monitoring and medications with diabetes specialist clinic visits every three months that targeted an A1c of 6%) or b) "Roux en Y" bypass or c) sleeve gastrectomy. The study occurred at Cleveland Clinic. Follow-up lasted one year and 140 patients' data were available for analysis. 5 of 41 patients in the medical therapy group vs. 21 in the 50 assigned to gastric bypass and 18 of 49 who had the sleeve achieved the A1c of 6%. What's more, most of the surgery patients who achieved the targeted A1c were off all diabetes medications.  As expected, the surgery groups decreased their BMI down to the 26-27 range, while the medically treated patients' BMI remained essentially unchanged.  In contrast to Rome, there was a wider range of complications that included 4 reoperations and 1 patient that developed a gastrointestinal leak with peritonitis.

Based on these data plus less pristine studies, its clinical experience and common sense, the DMCB is convinced that bariatric surgery works. These two studies are an important step forward in building the case for the use of this approach in persons with obesity and diabetes.

That being said, there is still room for some skepticism. That lingering doubt could be enough for a commercial insurer to limit coverage. It may be enough to prompt a PCP to recommend that an obese patient with diabetes should still hold off on surgery a bit longer. It may be enough for patients and families to wait another year until there are more confirmatory studies.

Here's why:

1. The studies were not "blinded." The purpose of "blinding" is to keep patients and doctors from being swayed by a "placebo effect." While that's intuitively silly, there is a possibility that having abdominal surgery made those patients believe they were going to lose weight and be cured of diabetes. After all, sham surgery has been known to help angina chest pains.

2. The studies are not necessarily "generalizable." Both studies were conducted by teams of surgeons from single institutions. While we can take Rome and Cleveland's word for it, we don't know if obesity surgery done at Bumkinville's Our Mother of Holy Deficit Hospital will have the same success and low rates of complications.

3. Speaking of complications, both studies were not adequately "powered" to fully assess mishap rates. While there were small single digit differences in the rates of complications, the small numbers may not tell the whole story. Having more patients enrolled in these studies would have increased the ability to meaningfully quantify all the possible bad outcomes.  That was one of the lessons of the Vioxx catastrophe.

4. Last but not least, the success of the surgery may have been inflated by the relatively poor performance of the non-surgical comparison groups. We know very little about the "intensity" of the medical treatment, other than they had the benefit of accessing a multidisciplinary clinic every three months. Population health management experts know that lifestyle change requires an intense program that includes engagement in a personalized and multidimensional care plan that includes far more frequent in-person and telephonic coaching. We don't know if the medical therapy group achieved this level of excellence.

Despite these limitations, however, the DMCB is more convinced that, for patients in whom nothing else works, bariatric surgery can reverse diabetes.

Does the Medical Home Really Result in Better Diabetes Care?

Is the pursuit of evidence-based medicine evidence based?  That was the head-cramping question the  Disease Management Care Blog grappled with when it read this just published Health Affairs article, Tool Used To Assess How Well Community Health Centers Function As Medical Homes May Be Flawed.

Readers will recall that the National Committee for Quality Assurance (NCQA) is a Washington DC-based not-for-profit that champions the use of performance measures to assess the quality of health care.  Provider organizations go through an assessment process based on the measures and, if they pass muster, are "recognized" by the NCQA.  The performance measures are based on peer-reviewed medical evidence, vetted by expert panels and then opened for public comment before they are finalized and used.

The DMCB knows this because it has served on two of the NCQA panels.

 While its most visible activity has been the ranking of health insurers, the NCQA has been offering a soup of recognition, accreditation and certification programs for other types of provider organizations including the disease management vendors (for example) and, more recently, medical homes.  More on that group of providers later.

Once you earn it, the NCQA quality badge is more than just a festively colored addition to your letterhead and collaterals. Given the past evidence that purchasers also pay some attention to it, the DMCB recalled being unsurprised when the number of disease management vendors sporting the newly established NCQA accreditation logo multiplied faster than the number of vixens at a Kennedy White House pool party.  They reasonably believed that it would help them gain credibility and give them a leg-up against their competition.

But even if the NCQA performance measures are based on the scientific quality as well as consensus and drive competition based on quality, the question remains: if an organization achieves NCQA recognition, does that really mean that patients are better off for it?

Enter Robin Clarke and colleagues who wanted to know if that was true for medical homes and their patients with diabetes. They adapted the 2008 version of the NCQA's medical home evaluation survey tool to 40 Los Angeles community primary care health centers. The medical director or executive team at each center had to complete the tool which was scored in the usual manner.  The score - and the corresponding level of recognition - was then compared to the centers' clinical diabetes care measures based on the National Quality Foundation's (NQF) quality measures. These measures were collected on samples of patients based on reviews of the medical records.

Only 30 of the centers completed the tool. They were made up of 88 LA clinics that were taking care of more than 600,000 mostly low income patients. The vast majority of the patient population was Medicaid.

The NCQA survey tool is based on a combination of "must pass" criteria combined with a 100 point scale.  The average score among the centers in this study was a respectable 67. Eight would have received the highest Level 3 Recognition (more than 75 points), three would have been Level 2 (between 50 and 75) and the remainder were Level 1. The percent of patients who had a measure of HbA1c, LDL, or blood pressure in the past twelve months was 84%, 70%, and 90%, respectively. Approximately 60% of patients had kidney disease screening and 35% had a diabetes eye examination.

However, when the authors used multiple methods to look for a statistical association between higher scores or Levels and higher quality percentages on the NQF measures, none was found.

To their credit, the authors point out that 1) theirs was a faux and unaudited NCQA process, 2) that a Level 1 accreditation, while no better than a 2 or a 3,  may be better than a "zero," 3) that persons with conditions other than diabetes may still benefit from this kind of process and 4) that they didn't use the 2011 edition of the tool.  The DMCB adds that this was in a community health setting involving mostly patients with Medicaid insurance. It's possible that patients in other settings, socioeconomic classes or with other types of insurance could benefit.

Despite the limitations, the DMCB thinks this is an important study that puts the NCQA into perspective and tells us what it may and what it may not be doing. Hopefully this kind of study will be done in other settings involving other provider types, including the disease management community.  In the meantime, the NCQA would be well served to continue to examine the links between its prsitine interpretations of the science and the real-world benefits for patients. 

In other words, it's time for us to better understand the link between pursuing outcomes and actually achieving them.

Rockin' to Some Outcomes Numbers

There's been surge in peer review literature and twitter commentary on the merits of statin for prevention. The Population Health Blog says show clever videos like this to patients with high blood pressure, high lipids or diabetes and let them decide.



An email to Dr. McCormack said "well done, sir, well done."

Diabetes Control and Lower Weight Is Associated With Statistically Significant Savings

A complication of diabetes

The study is reported here in the American Journal of Managed Care.

Researchers at the western Massachusetts Reliant Medical Group were interested in knowing whether there was any association between control of blood sugar among persons with diabetes and their health insurance claims expense. Using combined data from their electronic health record (EHR) plus insurance claims, they identified all (continuously enrolled) adults with at least one physician encounter between January 2007 through December 2011 for a diagnosis of diabetes, who also were being treated with metformin and a sulfonylurea drug.  This yielded a population of 2044 patients.

This study had some useful benchmark data for other providers with caring for a similar diabetic population. 27% had an A1C goal of less than 7%, 64% had an A1C goal of less than 8%, 33% had a blood pressure less than 140/90 mm Hg, 68 % had a LDL of less than 100 mg/d, and 34% had a body mass index (BMI) less than 30.

After controlling for age, gender, enrollment date, race, payer type and comorbidities, the researchers found that having a target A1c less than 7% (indicating good diabetes control) was associated with $992 per member per year (PMPY) in savings. There were $1445 PMPY in savings for an A1c less than 8%, and $1218 for a BMI less than 30 - all versus persons who did not achieve those goals.  Just controlling blood pressure, or cholesterol levels did not result in statistically significant savings  

Combining a low A1c, blood pressure control less than 140/90, low LDL cholesterol and BMI in various combinations seemed to result in savings in excess of $2000 per member PMPY.  Most of the savings related to diabetes control appeared in the outpatient category, while most of the savings related to BMI appeared in the inpatient category.

The DMCB's take:

1. Not all persons with diabetes may have a "diabetes" diagnosis in the EHR or a bill submitted to an insurance company that uses that particular code. The DMCB likes this study because it's more likely that a person with diabetes will eventually show up in a 5 year period. Plus, the use of metformin and a sulfonylurea medication makes it easier to accurately capture persons with diabetes.

2. This is another in a series of observational studies that infers that persons with target control of blood glucose or who are not overweight experience lower claims expense compared to persons with poor control or who are overweight.

3. What this study does not prove is that blood glucose control or weight control causes low insurance claims expense.  Association does not equal causality any more than "white hair" causes heart attacks.  In order to prove causality, persons with diabetes and similar baseline claims would need to be randomly allocated to good vs. bad control of their blood glucoses (or good vs. bad weight) with prospective and simultaneous comparison of the future expenses over time.  That's called a randomized controlled trial.

4. Remember the ACCORD study?  Persons were randomly allocated to tight vs. very tight control of their blood glucoses and the death rate unexpectedly causally went up for persons with very tight control. The DMCB brings that up because, in the AJMC study described above, less tight control of diabetes (A1c less than 8% vs. the target of 7%) was associated with even greater reductions in claims expense.  Is this further evidence that tight control of diabetes leads to problems?

5.  Unexpectedly, blood pressure or LDL control was not independently associated with lower claims expense.  That's important because Accountable Care Organizations that assume blood pressure and cholesterol lowering pill compliance will result in shared savings may need to reconsider.

Ultimately, while this study doesn't prove that successful population health management for diabetes would save money, it's one more piece of evidence pointing in that direction.  Let the studies continue.

Prospect Theory In Patient Empowerment for Medical Decision Making

Is that a decision tree an Iva stick figure?

Iva Pairabigglutees was just informed she has diabetes and needs to start taking medicines.  Since she is leery about taking pills, she quietly wonders why she can't cure herself with a diet. Little does her doc know that she doesn't intend to follow her medication instructions. She also doesn't know that Iva's poor diabetes control is destined to undermine the clinic's pay-for-performance bonus payment.

What went wrong?

The answer, according to this JAMA article, is that the doctor didn't deploy a behavioral economics framework to support Iva's decision-making.  One such framework is the "prospect theory" model that boils patient decision-making into a "three step heuristic."
 
As the DMCB understands it, prospect theory makes the unspoken biases that we all have more explicit.  By identifying all the background assumptions and preferences that patients bring to the physician's office, decision-making can be crafted so that everyone (family, doc and patient) is on the same page.

Briefly, the three steps are:

1. Simplify choices by focusing on the key differences between the treatment options, such as survival rates, quality of life, costs or side effects.

Iva wants to lose weight, while the doctor wants the measure of blood sugar control, the A1c, to be below a target.  What Iva didn't know is that she might live longer (survival) to see her grandchildren (quality of life) by taking a once-a-day generic (cost) with minimal side effects. What the doc doesn't know is that Iva could care less about P4P.

2. Understanding that patients prefer greater certainty when it comes pursuing gains and are willing to accept uncertainty when trying to avoid a loss.

In contrast to a patient battling cancer with a "nothing to lose" attitude about the option of toxic chemotherapy, Iva isn't about to "lose" anything: she otherwise feels well.  No wonder why some, including the Disease Management Care Blog, thinks pay-for-performance should be extended to patients (dubbed "P4P4P").  Iva is far more likely to respond to the certainty of, say, a discount on her next purchase at Whole Foods.

3. Cognitive processes lead people to overestimate the value of their choices thanks to survivor bias, cognitive dissonance, appeals to authority and hindsight biases.

Iva's favorite TV show is The Biggest Loser, but what she doesn't know is that for every successful dieter there are dozens that never make it.

Naturally, the DMCB is taking a very complicated topic in a densely written article and simplifying things, but it hopes the point is made.

CODA: the current blunt-force approach to the measurement of health care quality falls fall short of recognizing the sophisticated approaches like prospect theory and assisted patient decision-making.  After Iva has had a chance to review the pros and cons of the various options for diabetes control, she still may choose to try a diet.  We should be measuring how often patients are given a choice about their A1c, not how many achieved A1c target levels.

Image from Wikipedia

Medicaid Disease Management: No Impact on Emergency Room Utilization or Inpatient Costs for Enrollees with Diabetes?

Regular readers of the Disease Management Care Blog know that Medicaid is coming. While many of the nation's Governors have declined President Obama's invitation to run Medicaid the Affordable Care Act way, others have agreed to use the ACA's generous funding to enroll millions of their indigent citizens into this vastly expanded public insurance program.

"No problem!" says the disease management vendors.  For years, they've been offering their services to state Medicaid programs and would be happy to expand their contracts.

Unfortunately, an article by Matthew Conti that was just published in the journal Health Services Research suggests that that may not be a good idea.  The article's title is Effect of Medicaid Disease Management Programs on Emergency Admissions and Inpatient Costs.  The only thing that's missing are the words "The Lack of Any" at the front of that sentence.
   
The article studied the impact of diabetes "opt-out" disease management on diabetic patients' emergency room utilization and admissions in three states' Medicaid programs: Washington (started in 2002), Texas (started in 2004), and Georgia (started in 2005).

These states with were compared to states without diabetes disease management.  These control states were selected on the basis of baseline Medicaid enrollment trends that were similar to the three study states. These control states were Hawaii, Kentucky, Massachusetts, Maryland, Maine, North Carolina, Nebraska, South Carolina and Tennessee.

To perform the comparison, Dr. Conti used the Agency for Health Care Research and Quality's (AHRQ) National InPatient Sample (NIS) from the Health Care Cost and Utilization Project ("HCUP"). These databases contain patient-level and longitudinal hospital information on inpatient stays, including cost, payer, admission type (e.g., emergency, urgent and elective), age, gender, primary payer, and total charges. The span of data that was used went from 2000 through 2008.

A complicated pre-post "difference in differences" model was used to compare baseline vs. follow-up:

1) total inpatient charges/Medicaid enrollment (which averaged $430 per diabetic enrollee, with a 95% confidence interval of $265 to $700) and

2) emergency admissions/inpatient admissions (a ratio of 0.37 per admission with a standard deviation of plus or minus 0.12)  All Medicaid enrollees with diabetes were included in the analysis, whether or not they had been enrolled or opted out.  The author used this approach figuring that if a statewide disease management program enrolled up to a third of eligible persons with diabetes (that was the case in Texas), there should have been an observable impact on the entire population. That's the approach favored by the Disease Management Purchasing Consortium.
 
The results?  No state with disease management had lower emergency room utilization or inpatient costs for their Medicaid enrollees with diabetes. The DMCB couldn't find a table with numbers, but the figures (which can't be reproduced without permission) show little impact over time.

What can readers conclude?  Assuming that, during the period of study, the three states' Medicaid programs suffered from the program's endemic issues of underpayment to providers with a relative lack of access to primary care:

1. "Blanket" call-everyone telephonic disease management cannot make up for fee-for-service Medicaid's shortfalls.  It remains to be seen if the ACA's revitalization of Medicaid will make up for this and increase the parallel impact of disease management. 

2) This also means that Medicaid's experience with disease management can't be generalized to other types of insurance with better provider payment rates and patient access to care.

That being said, the DMCB has two concerns:

1. If the DMCB is reading this right, it appears all persons of any age with diabetes were included in the study, including Type 1 diabetics.  If that's correct, that could have also blunted the impact of any disease management program, since children are over-represented in Medicaid and the impact of remote telephonic coaching in Type 1 is widely viewed (even among the disease management vendors) to be ineffective.  Insulin-requiring kids need lots of face-to-face hands-on care.

2. The DMCB is unfamiliar with the three study states' disease management programs, but if they were set up the "old fashioned way" to contact all persons with diabetes without the modern regard to future risk and "impactibility," then it's little wonder that the programs failed.  State-of-the-art population health management tailors its programs by focusing on subsets of persons with chronic conditions that are most likely to benefit.  Any impact on emergency room use or inpatient charges for these patients would be lost in the data "noise" of everyone else's utilization.

Should Medicaid programs that are facing huge jumps in enrollment abandon Medicaid as a result of this study?  Based on this study, the DMCB doesn't think so.  The findings are interesting, but more research is needed.