Researchers in a recent study hypothesized that a self-management program for chronic obstructive pulmonary disease (COPD) could benefit patients. But a trial of a care management program for COPD patients had to be cut short due to excess mortality rates.
An article in the May 15 issue of Annals of Internal Medicine described the study.
The authors enrolled 960 COPD patients in 20 Veterans Affairs hospital-based outpatient clinics in a randomized, controlled trial comparing a comprehensive care management program (CCMP) with guideline-based usual care. All patients had been hospitalized for COPD within the last year. The CCMP included individual and group education sessions, an action plan for identification and treatment of exacerbations, and scheduled telephone calls from a case manager.
Patients in both groups were provided with a COPD information booklet and their physicians were given a copy of COPD guidelines and instructions to follow them. Researchers were to follow both groups to record the time to first hospitalization. However, a safety monitoring board stopped the trial before enrollment could be completed. Of the 209 patients enrolled in the CCMP group, 28 deaths occurred from all causes versus 10 in the usual care group. There were no differences seen in the number of hospitalizations or the time to initiation of treatment for an acute exacerbation of COPD. Researchers could not determine the cause of increased mortality or the reason that CCMP patients did not initiate treatment sooner.
The author of an accompanying editorial in the same issue of Annals cited several examples of clinical trials that were terminated early due to negative events. He stressed the importance of engaging an experienced data-monitoring committee that can make wise, ethical judgments when evidence of harm arises in clinical trials.
The authors of the CCMP study for COPD concluded that self-management may not be appropriate for COPD.