Background: Enhancing a patient’s self-management skills for chronic obstructive pulmonary disease (COPD) symptoms is crucial for improved health outcomes. A comprehensive care management program (CCMP) is designed to provide structured support and education.
Objective: This study aimed to evaluate the effectiveness of a comprehensive care management program (CCMP) in reducing the risk of hospitalization for patients with COPD, a significant chronic condition.
Design: A randomized, controlled trial was conducted to compare a CCMP with standard guideline-based care. The study, registered at ClinicalTrials.gov as NCT00395083, took place across 20 Veterans Affairs hospital outpatient clinics.
Participants: The study included patients who had been hospitalized for COPD within the previous year, representing a population with significant chronic disease burden.
Intervention: The comprehensive care management program (CCMP) consisted of COPD-specific education delivered through four individual sessions and one group session. It also incorporated an action plan to help patients recognize and manage exacerbations, along with proactive telephone calls for ongoing case management. Both the CCMP group and the usual care group received a COPD information booklet, and primary care providers were given COPD guidelines to inform patient management. Patient assignment was randomized and stratified by site.
Measurements: The primary measurement was the time until the first COPD-related hospitalization. Secondary measurements included general healthcare utilization outside of COPD, mortality from all causes, health-related quality of life, patient satisfaction, disease-specific knowledge, and self-efficacy in managing their condition. Assessments of COPD exacerbations and hospitalizations were conducted via blinded telephone assessments, and all hospitalizations were reviewed by blinded adjudicators.
Results: A total of 426 patients out of a planned 960 were enrolled when the study was prematurely halted by the data monitoring committee due to serious safety concerns. 209 patients were in the intervention group and 217 in the usual care group. The average follow-up period was 250 days. At the point the study was stopped, the cumulative 1-year incidence of COPD hospitalization was 27% in the CCMP group and 24% in the usual care group (hazard ratio, 1.13 [95% CI, 0.70 to 1.80]; P= 0.62). Unexpectedly, there were 28 deaths from all causes in the intervention group compared to 10 in the usual care group, a significant difference (hazard ratio, 3.00 [CI, 1.46 to 6.17]; P= 0.003). Among deaths with assignable cause (71%), COPD-related deaths were notably higher in the intervention group: 10 versus 3 in usual care (hazard ratio, 3.60 [CI, 0.99 to 13.08]; P= 0.053).
Limitations: The reasons for the increased mortality in the CCMP group could not be fully determined from the available data. Additionally, the assessment of the quality of education provided within the comprehensive care management program was limited.
Conclusion: This randomized controlled trial found that a comprehensive care management program (CCMP) for patients with severe COPD did not reduce COPD-related hospitalizations and was associated with an unexpected increase in mortality. These outcomes diverge significantly from prior studies on similar interventions. The findings suggest careful consideration of data monitoring committees in clinical trials, especially those involving behavioral interventions, and highlight the complexity of implementing comprehensive care management programs for chronic conditions like COPD.
