Health for life

He was 58. He had diabetes and coronary artery disease (CAD). But his CAD was under control with medications and he had no symptoms. He exercised and performed well on stress tests.

Yet on a Friday afternoon, while preparing for his Sunday broadcast of Meet The Press, Tim Russerts heart stopped beating. All efforts to resuscitate him failed. Less than an hour after he collapsed, on June 13, 2008, Tim Russert was pronounced dead. The cause? A blood clot resulting from a ruptured cholesterol plaque.

What could have been done to save him?

According to Russerts doctor, Michael Newman:

"He had done everything he was supposed to do to manage the disease [CAD], although his weight was a problem." ... He "struggled with it."

Dr. Newman added that the incident made us "appreciate the uncertainty of our lives."

Perhaps, as Dr. Newman said, attacks such as Mr. Russerts cant be anticipated. But once they present themselves, how a heart attack victim acts, or how those around him act, could save a life. Dr. Newman claims that a defibrillator could make a difference.

However, being sensitive to how you feel, and responding to it, can also make a difference.

The following story appeared in Tuesdays New York Times:

Not a Moment Too Soon, I Thought of Tim Russert

Its author, Michael Bicks, related a profile eerily similar to Mr. Russerts:

"Though I am a 50-year-old guy with a stressful job and a little too much around the middle, I had a clean bill of health. I had good cholesterol numbers and a great doctor, and recently I had passed a cardiac stress test."

During an early morning bike ride, Mr. Bicks began to feel nauseous and developed a cough. He had only mild chest discomfort, but expressed "an overwhelming feeling that something was not right." He stopped riding, took a rest, and decided to check himself into the hospital.

"A doctor attached some wires to my body and conducted a quick EKG. “Mr. Bicks,” he said minutes later, “you are suffering a heart attack.” "

Mr. Bicks may not have been able to anticipate his heart attack, but paying attention to the signals his body was giving, and acting on them, saved his life.
________

I love comedies. Satires, in particular. Some of the greatest of life lessons were buried deep within satirical works of literature, theater, and film. We laugh through them, but seldom do we stop to consider the valuable nuggets weve been just given.

In respect to filmography, what are probably two of my most favorite scenes are: Chers observations to her friend Tai, about Monet paintings, in the movie "Clueless"; and Camerons enthrallment with the little girl in Georges Seurats "A Sunday Afternoon on the Island of La Grande Jatte," in the movie "Ferris Buellers Day Off."

These two scenes loosely mold a certain view I hold about life: Upon close examination, our lives are one, big, muddy mess; only from a distance, can we truly appreciate the elaborate works of art they have become --  black splotches and all. Just because we cant see the big picture now, does not mean there isnt one.

This week has been no different, for me.

The fact is, the diabetic online community painted a pretty big canvas, this week. Some used dark, somber, depressing hues. Some used vibrant, optimistic shades. In the end, we formed something. A message, quite loud, and clear. Emotions, and watercolors were mixed, and something out there... was soon formed... that when I step back, its quite the masterpiece.

Diabetics are TIRED... 

• Of fear mongering, population targeting, and misinformation in the media: Yes, non-communicable health conditions are dangerous, and they need a certain level of awareness; NO, they dont benefit from overly inflated, statistical research, aimed at scaring to death, targeting, humiliating, and laying blame on certain populations. This kind of environment only engenders animosity, a lack of empathy, and persecution, as well as breeding depression in those affected.
• Of the same, stereotypical, awareness figures: Yes, diabetes can affect an aging, overweight population... But it can affect everyone else, as well! So many of us are NOT old, or overweight. Many of us are young, active, healthy, athletes even. (Yes, even many Type 2s!) Why not showcase people who have worked WONDERS in spite of diabetes? People who can garner our pride, and our motivation? People who are not clueless, but veterans at this game.
• Of the same, stereotypical, awareness messages: Diabetics dont need to follow a 60% carbohydrate diet, in order to do well. Diabetics can be low carbers, vegans, moderate eaters, athletes who consume even more carbohydrates than this. We come in all shapes, and sizes, and we dont live by a chart... We live by what our glucose meters tell us! The sheer mention of a new diabetes cookbook out there really enrages most diligent diabetics... because we KNOW its a lot of bunk. Theres no such thing as a diabetic diet, and there are so many stupid notions out there to even recap in this little post (like that everything needs to be low fat), that I wont even go there.
• Of the insincere profiting from our disease: Of cheesy product marketing, cook books, miracle cures, and scam artists. Of medications and treatments that cost an arm and a leg, accessories that cost an arm and a leg, and tools that are kept from folks who need them because only those who are privileged to good health insurance, or a good income, can access. 
• Of the FDA: Famous for slowing down progress in what many deem as necessary advances, and tools in our community, yet the fast trackers of so many dangerous drugs, at the same time. Oh, why, FDA, must you not advance progress on something like a more accurate blood glucose meter... but you are eager to fast track yet another drug before we are fully ascertained of all its risks in a certain population? (You know, this didnt use to be like this... I guess back in the 80s we complained the slowness of medication approval killed people... I can see it in certain diseases, etc, but Im not so sure the dangers outweigh the risks, in diabetes. If Victoza sucks... its no ones fault but Novo Nordisks, and the FDAs.)
• Of the constant social equation behind having Diabetes: 
• Diabetes needs psycho-social support. Its one of those conditions that just incredibly grips at the heart of where we are the most connected to one another -- the social connections and moments that, though sometimes centered around food, nourish our souls and our relationships.
• Of just the entire need to JUSTIFY ourselves, and who we are, and what we are to outsiders. The road to self acceptance, and the personal acceptance of others as diabetics (and whatever their stories) is a MARATHON... often with thorny roses, along the way. 
• Of the lack of progress on these issues, and the lack of change: This same old tired song and dance is being played upon our diabetic lives, over, and over... and over again.  

"I need to call someone..."

The Disease Management Care Blog apologizes in advance for a long post about an important study comparing two state-of-the-art weight loss interventions.  Get some caffeine and hang in there.  If you are interested in the science of disease management and its role in obesity, you will not be disappointed.

Talk to some of the Ayatollahs dominating the academic medical-industrial complex about telephonic disease management and theyll give you the same look that they give to something unsightly that they just discovered on the end of their finger after rubbing their nose.  The idea that some remote (ugh!), telephone-based (bleh!) for-profit (yuck!) company could contribute anything to their vision of the health delivery is health policy apostasy.

But what how does this ideology stack up against the evidence?  

Until recently, we haven’t really known because there were few head-to-head comparisons of traditional “disease management” vs. traditional patient counseling.  But now we have the just-published POWER (“Practice-based Opportunities for Weight Reduction” study that was funded by the NHLBI and (whoa!) Healthways.  The authors were from Johns Hopkins University, which has a long-term consulting agreement with Healthways. They had final say on the research methodology and the papers contents.

POWER was a prospective clinical trial that randomly assigned patients to one of three weight loss intervention strategies.  One consisted of “remote” telephonic treatment counseling, the second provided in-person counseling and the third was a control group.  The in-person sessions were provided by Johns Hopkins employees while the remote telephone counseling was provided by Healthways.

Study patients with obesity and at least one risk factor (hypertension, hyperlipidemia or diabetes) were recruited from six Baltimore primary care practices from 2008 through 2009.

All the interventions used basic nutritional and exercise guidelines that were delivered with state-of-the art “social cognitive theory,” "behavioral self-management,” “positive reinforcement” and “motivational interviewing.” Both of the intervention groups had access to a web site with learning modules plus feedback. If there was no log-on to the web site every 7 days, patients were sent a reminder email. 

Persons in the disease management-style remote support arm of the study got 12 weekly calls lasting 20 minutes for three months, which was followed by 3 monthly calls.   Persons assigned to the traditional in-person coaching arm got nine group sessions and three individual sessions over the 3 months followed by one group and two individual monthly sessions over three months. 

Participants’ weight loss was assessed at 6 and 24 months.

The patients primary care physicians received summary reports and encouraged their patients’ participation.

Readers should note that this was an “effectiveness” trial.  Unlike “efficacy” trials, the protocol dispensed with the usual run-in period or making sure patients were adherent to the protocol before or during the study.

1370 persons were screened and 415 were randomized.  64% were women, the mean age was 54 years, 41% were black, 97% had commercial insurance and the mean BMI was a hefty 36.6.

After randomization, there was some drop out: 366 were weighed at 6 months, 355 at 12 months and 392 at 24 months. 

At 6 months: the control group lost 1.4 kilograms (kg) while there was 6.1 kg lost in the remote support, and 5.8 kg. lost in the in-person group.  Thats 3.1 lbs vs. 13.4 lbs vs. 12.8 lbs.

At 24 months, the weight loss .8 kg in the control, 4.6 Kg in remote support and 5.1 Kg for in-person.  Thats 1.8 lbs, 10.1 lbs and 11.2 lbs. That translates to body weight changes of 1.1%, 5.0% and 5.2%.  The percent of persons hitting at least 5% weight loss was 18.8% in the control group, 41.4% in the in-person support group and 38.2% in the group getting remote support. 7.8% of controls, 27.5% and 18.8% of controls, remote and in-person support patients, respectively, reached a BMI less than 30  

There was no statistically significant difference in weight loss outcomes between the two intervention groups.  In other words, the small changes between the disease management and in-person counseling could have been the result of chance.

What can readers conclude?

1.  This was a solidly performed study with important implications for a still-evolving national strategy in the battle against obesity.  If an intervention can lead approximately 40% of persons to lose 5% of their weight over two years, maybe the science of non-invasive weight reduction has gotten to the point where insurers should cover it.  While the DMCB remains suspicious about “mandates” and “the minimum benefit,” there are other policy levers that could be pushed to make this happen.  This is doubly true when you think about the costly alternatives of drugs and weight loss surgery.

2.  Seen through the lens of a disease management vs. in-person counseling competition, the industry’s “best” (Healthways) went toe to toe with the health system’s best (Johns Hopkins) and it was a tie.  When it comes to weight loss, it now comes down to who can do it cheaper and who can scale it.

3.  While this was a solid study, readers should be aware of its imperfections.  Since there were so few patients on Medicare or Medicaid, we dont know how this would work in patients with public insurance. This was not double blinded, so it’s possible that the outcomes were skewed because patients and their doctors were aware of their assigned treatment arm. The drops-outs weights went unmeasured and their data could have changed the results.  There was a high reliance on group sessions in the "in-person" arm of the study, which may not be as effective as one-on-one counseling. The in-person sessions were also “remote” from the PCPs’ offices and may have been a poor substitute for the one-on-one counseling envisioned for a robust PCMH.  Successful weight loss is usually defined at 10% of body weight at one year instead of 5% at 2 years.  It’s also difficult to discern the relative contribution of the web site vs. the physician support vs. the nurse counseling.  We don’t know what happened to the patients’ blood pressure, cholesterol levels or their blood glucose control.  Finally, Hopkins had a doubtful but potential conflict of interest in a study that showed non-superiority vs. one of their customers.

4 While the DMCB doesn’t want to quibble, close scrutiny of the p-values in a table comparing the percent of persons reaching a BMI less than 30 for the in-person vs. remote support cohorts shows that it came quite close to being statistically significant at p = .07.  In other words, Healthways (27.5%)  almost beat Johns Hopkins (18.8%).  Using the same criteria in this study widely hailed as proving that Group Health’s medical home saves money, Healthways did beat Johns Hopkins.

5  Healthways deserves kudos for submitting to and committing resources to a clinical trial.  To the DMCB, the search for scientific truth is a price of doing business.  Their shareholders may think that cash is better spent on pursuing customers or driving efficiencies, but this research is an investment that will yield returns over the long run.  Other for-profits "get it" and so does Healthways.  The only question is why isnt this spashed on the companys web site?

6  If both interventions are equivalent, the DMCB suggests that they are not necessarily exclusive.  A truly enlighted approach to this would be to let patients choose which form of counseling they per.  Whats more, if patients were allowed to choose, the amount of weight loss for both groups would probably be even greater.

7. Last but not least, this is further evidence that "disease management" has grown up.  This "DM Ver 2.0" is based on far more sophisticated principles of behavior change than those used in the Medicare Health Support debacle.  Whats more, this Johns Hopkins paper reminds us that physicians, in the course of routine patient encounters, are simply not an option when it comes to weight loss counseling.  Theyre too busy and their job is to provide a supporting role.

"POWER" - one more acronym and one more piece of evidence to use in defense of disease and population-based care management.