|"I need to call someone..."|
Talk to some of the Ayatollahs dominating the academic medical-industrial complex about telephonic disease management and they'll 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 paper's 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. That's 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. That's 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 don't 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 isn't this spashed on the company's 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 prefer. What's 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. What's 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. They're 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.