A Comprehensive Care Management Program to Prevent Chronic Obstructive Pulmonary Disease Hospitalizations Full Text
Annals of Internal Medicine,
Fan VS et al. - A comprehensive care management program (CCMP) in patients with severe COPD had not decreased Chronic Obstructive Pulmonary Disease (COPD)-related hospitalizations when the trial was stopped prematurely. The CCMP was associated with unanticipated excess mortality, results that differ markedly from similar previous trials. A data monitoring committee should be considered in the design of clinical trials involving behavioral interventions.
Methods- A randomized, controlled trial comparing CCMP with guideline-based usual care.
- 20 Veterans Affairs hospital-based outpatient clinics.
- Patients hospitalized for COPD in the past year.
- The CCMP included COPD education during 4 individual sessions and 1 group session, an action plan for identification and treatment of exacerbations, and scheduled proactive telephone calls for case management.
- Patients in both the intervention and usual care groups received a COPD informational booklet; their primary care providers received a copy of COPD guidelines and were advised to manage their patients according to these guidelines.
- Patients were randomly assigned, stratifying by site based on random, permuted blocks of variable size.
- The primary outcome was time to first COPD hospitalization.
- Staff blinded to study group performed telephone-based assessment of COPD exacerbations and hospitalizations, and all hospitalizations were blindly adjudicated.
- Secondary outcomes included non-COPD health care use, all-cause mortality, health-related quality of life, patient satisfaction, disease knowledge, and self-efficacy.
- Of the eligible patients, 209 were randomly assigned to the intervention group and 217 to the usual care group.
- Citing serious safety concerns, the data monitoring committee terminated the intervention before the trial's planned completion after 426 (44%) of the planned total of 960 patients were enrolled.
- Mean follow-up was 250 days.
- When the study was stopped, the 1-year cumulative incidence of COPD-related hospitalization was 27% in the intervention group and 24% in the usual care group (hazard ratio, 1.13 [95% CI, 0.70 to 1.80]; P = 0.62).
- There were 28 deaths from all causes in the intervention group versus 10 in the usual care group (hazard ratio, 3.00 [CI, 1.46 to 6.17]; P = 0.003).
- Cause could be assigned in 27 (71%) deaths. Deaths due to COPD accounted for the largest difference: 10 in the intervention group versus 3 in the usual care group (hazard ratio, 3.60 [CI, 0.99 to 13.08]; P = 0.053).
