Care Management Kills?

A randomized clinical trial of a comprehensive care management program is reported in the Annals of Internal Medicine.   (Annals Article)  The shocking fact about the trial is that it appeared to have excess mortality in the intervention arm, so much so that the trial was stopped early.  About two hundred patients were in each arm, with the intervention consisting of group and individual sessions, phone calls and an action plan to identify condition worsening. It sounds like a fairly nominal and innocuous intervention A lot of people with COPD die and here more died in the intervention arm, so halfway through, the trial was stopped.  It also was not meeting the endpoint of lower hospitalizations.  The design of the trial included a data monitoring committee, which was proven to likely be prudent.  The results diverge from results from other similar trials.

We are as skeptical as anyone about the benefits of care management, disease management, wellness, etc. until proven by solid credible research evidence.  Many things are hyped in health care, few come any where close to the promise.  But we are also very skeptical that the outcomes of this trial reflect anything related to the care management program, other than that like many others it may just not make much of a difference.  Anytime a trial is stopped early for a safety problem, it can be artificial, because if it had continued, the mortality might have reverted to the mean and equalized in the two arms.  Nothing in the deaths appears linked to actual features of the intervention.  And there can always be mysterious, unrealized selection and execution factors which may account for the difference.  So hopefully no one takes this trial as a reason not to continue seeing if there are care management programs which can make a quality and cost difference.