Disease Management for COPD.... Kills?

Can disease management for chronic obstructive pulmonary disease (COPD) kill?

Until now, that question, thanks to this classic 2006 Canadian study that was published in Chest, would have never crossed the Disease Management Care Blog's mind. In that study, 191 recently hospitalized COPD patients were randomly assigned to either usual care or a self-management program with ongoing care management that included home visits and telephonic counseling. Using the perspective of a "health care payer," the economic analysis showed a per patient savings of $3,338 vs. an expense of $3,774. However, that was based on a caseload of 14 patients per nurse per year. The authors calculated that if that number was increased to a more real-world standard of 50-70 patients per year, the savings would exceed $2000 per patient. The DMCB likes to reference this Chest study in its publications and quote it in its lectures because it was randomized, statistically rigorous (all costs were detailed) and targeted (resources were focused on high risk and recently discharged patients).

And the DMCB was feeling even more confident about the benefits of COPD disease management thanks to this recently published American Journal of Respiratory and Critical Care Medicine study. This one was conducted at five U.S. VA hospitals involving 743 patients with a history of COPD-related hospitalization or an emergency room visit, on chronic oxygen or using systemic corticosteroids. The control group patients received usual care while the intervention group got a single education session, an "Action Plan" for self-treatment of exacerbations and monthly follow-up calls from a case manager. After 1 year, COPD-related hospitalizations and emergency visits was 0.82 per patient in usual care group versus 0.48 per patient in the disease management group. The difference was statistically significant.

While common ingredients include tobacco cessation, flu shots, giving patients basic information about COPD and teaching breathing, coughing techniques, lifestyle modifications as well as energy conservation for day-to-day activities, the DMCB thinks the secret sauce of COPD disease management is the "Action Plan." It's mentioned as an option in the Global Initiative for Chronic Obstructive Lung Disease or "GOLD" guidelines (113 pages can be downloaded here, you'll find it mentioned as "B" evidence on page 71). An Action Plan typically consists of a ready-to-go and "shoot-first-and-ask-questions-later" patient initiated package of antibiotics and glucocorticosteroids that are started if there is a sudden cold, infection, cough, shortness of breath or other disease exacerbation.  Both of the studies mentioned above included this in the intervention group.

Disease management: check.

Action plan: check.

Which is why this news is so counterintuitive (hat tip to KevinMD). According to this article, the VA's Bronchitis and Emphysema Advice and Training to Reduce Hospitalization "BREATH" COPD disease management trial, which was started in 2006, was halted early in 2009 because of higher all cause mortality rates in the intervention group.

The DMCB went to the clinicaltrials.gov website to find out more. BREATH was a two phase study. The first part was a twelve month "feasibility" study performed at six VA sites that targeted a recruitment of 180 patients, followed by a second phase expansion at 8 other sites targeting the recruitment of an additional 780 patients. In reading the protocol, the DMCB thinks the intervention group received the standard mix of disease management services, including the education, telephonic follow-up and an Action Plan.

The trial was stopped in 2009. According to news reports, a manuscript in the works and should be published in the coming months. Until the paper gets published, the DMCB can only speculate about the cause of the increased death rate in the disease management intervention arm of BREATH. If it had to guess, however, it would wonder if the Action Plan play some sort of role - perhaps the antibiotics led to microbial resistance or the steroids hampered immunity.

Stay tuned.

(late post - Google formating wouldn't work)