COPD self-management trial "stopped early because of excess deaths"

"Unanticipated excess mortality" ends a non-traditional care study for COPD patients.

This randomized, controlled trial, reported in the latest Annals of Internal Medicine, compared standard care with a "comprehensive care management program" (CCMP) to prevent rehospitalization for COPD.

The trial was conducted via 20 Veterans Affairs hospital-based outpatient clinics, and recruited 426 COPD patients.

The intervention they were studying, reports MedPage Today, "consisted of 4 weeks of 90-minute education sessions, which included an action plan to identify and treat COPD exacerbations and  scheduled telephone calls from a case manager.  Patients also got "a COPD information  booklet."

The trial was abandoned in 2011 prematurely for two reasons: First, they only got about 44% of the participants they wanted.

Second, though rehospitalization was not much higher for the intervention arm than for the control arm, "there were 28 deaths from all causes in the intervention group versus 10 in the usual care group," the researchers report. "Deaths due to COPD accounted for the largest difference: 10 in the intervention group versus 3 in the usual care group..."

"Available data could not fully explain the excess mortality in the intervention group," they add.