(RxWiki News) When patients receive education and self-management tools for their disease, they usually have better outcomes. But what if those tools seem to hurt rather than help?
People with chronic obstructive pulmonary disease (COPD) had a higher risk of death after participating in an education and self-care program. The authors of the study do not know why added education and self-care increased the risk of death.
"Talk to your doctor if you're having trouble breathing."
Some studies in the past have shown that educating patients and giving them the tools to self-manage their COPD can lower the number of hospitalizations. Vincent S. Fan, M.D., M.P.H., of the Veterans Affairs Puget Sound Health Care System, and colleagues thought their study would have similar results.
Instead, their study showed some unexpected findings.
Before the study was cut short because of safety reasons, 38 patients died. Twenty-eight of these patients were enrolled in an education and self-management program, while only 10 had received usual care.
According to the authors, their data could not explain why the death rate was so much higher among patients in the program. They write that they had a limited ability to gauge the quality of educational sessions.
The education and self-management program included four individual education sessions and one group session. It also included an action plan for spotting and treating exacerbations, or fits, of COPD. Patients in the program had scheduled telephone calls to keep them on track with their self-management goals.
For patients in the program, there was a 27 percent risk of being hospitalized from COPD-related complications. In comparison, the risk for patients receiving usual care was 24 percent.
Deaths caused by COPD were the biggest difference between the two groups. Only three usual care patients died due to COPD, compared to 10 in the intervention group.
The authors write that their findings "differ markedly from similar previous trials."
They go on to recommend that a "data monitoring committee should be considered in the design of clinical trials involving behavioral interventions."
Because these findings are so different from other similar studies, it is possible that the program itself is not to blame. Other factors - such as the demographic of the participants - could have played a role.
The study, which included 426 people with COPD, is published in the Annals of Internal Medicine.
Funding for the study came from the Veterans Affairs Cooperative Study Program.