Chronic Obstructive Pulmonary Disease (COPD) significantly impacts patients’ lives, and enhancing their ability to manage symptoms is crucial for improved outcomes. This study aimed to assess the effectiveness of a comprehensive care management program (CCMP) in reducing COPD-related hospitalizations.
This randomized, controlled trial, registered at ClinicalTrials.gov as NCT00395083, compared a CCMP to standard guideline-based care across 20 Veterans Affairs outpatient clinics. Participants were patients with a history of COPD hospitalization within the past year. The CCMP intervention included four individual COPD education sessions, one group session, a personalized action plan for exacerbation management, and proactive case management via scheduled telephone calls. Both the intervention and usual care groups received a COPD informational booklet, and primary care providers were given COPD guidelines for patient management. Patients were randomly assigned, stratified by site.
The primary outcome measured was the time until the first COPD hospitalization. Study staff, blinded to group assignment, conducted telephone assessments of COPD exacerbations and hospitalizations. All hospitalizations were independently reviewed. Secondary outcomes included healthcare utilization for non-COPD issues, all-cause mortality, health-related quality of life, patient satisfaction, disease knowledge, and self-efficacy.
The study enrolled 426 patients (209 in the CCMP group and 217 in usual care) before it was prematurely terminated by the data monitoring committee due to serious safety concerns. The average follow-up period was 250 days. At the study’s cessation, the 1-year COPD-related hospitalization rate was 27% in the CCMP group and 24% in the usual care group. The hazard ratio was 1.13 (95% CI, 0.70 to 1.80; P= 0.62), indicating no significant reduction in hospitalizations with the CCMP. Alarmingly, there were 28 deaths in the intervention group compared to 10 in the usual care group, with a hazard ratio of 3.00 (CI, 1.46 to 6.17; P= 0.003). Among deaths with assignable causes (71%), COPD-related deaths were notably higher in the intervention group (10 vs. 3), with a hazard ratio of 3.60 (CI, 0.99 to 13.08; P= 0.053).
The study’s limitations include the inability to fully explain the increased mortality in the CCMP group and limited assessment of the educational session quality. In conclusion, this comprehensive care management program for patients with severe COPD did not reduce COPD-related hospitalizations and was unexpectedly linked to increased mortality, contrasting with findings from previous studies. The results underscore the importance of data monitoring committees in clinical trials, especially those involving behavioral interventions, to ensure patient safety.
