title: A comprehensive care management program to prevent chronic obstructive pulmonary disease hospitalizations: a randomized, controlled trial.
abstract: BACKGROUND
  Improving a patient's ability to self-monitor and manage changes in chronic obstructive pulmonary disease (COPD) symptoms may improve outcomes.
  
  
  OBJECTIVE
  To determine the efficacy of a comprehensive care management program (CCMP) in reducing the risk for COPD hospitalization.
  
  
  METHODS
  A randomized, controlled trial comparing CCMP with guideline-based usual care. (ClinicalTrials.gov registration number: NCT00395083) SETTING: 20 Veterans Affairs hospital-based outpatient clinics.
  
  
  METHODS
  Patients hospitalized for COPD in the past year.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  Available data could not fully explain the excess mortality in the intervention group. Ability to assess the quality of the educational sessions provided by the case managers was limited.
  
  
  CONCLUSIONS
  A CCMP in patients with severe COPD had not decreased 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.
authors.affiliation: Health Services Research and Development Center of Excellence, Veterans Affairs Puget Sound Health Care System, 1100 Olive Way, Suite 1400, Seattle, WA 98101, USA. vincent.fan@va.gov
authors.forename: Vincent S
authors.initials: VS
authors.lastname: Fan
authors.forename: J Michael
authors.initials: JM
authors.lastname: Gaziano
authors.forename: Robert
authors.initials: R
authors.lastname: Lew
authors.forename: Jean
authors.initials: J
authors.lastname: Bourbeau
authors.forename: Sandra G
authors.initials: SG
authors.lastname: Adams
authors.forename: Sarah
authors.initials: S
authors.lastname: Leatherman
authors.forename: Soe Soe
authors.initials: SS
authors.lastname: Thwin
authors.forename: Grant D
authors.initials: GD
authors.lastname: Huang
authors.forename: Richard
authors.initials: R
authors.lastname: Robbins
authors.forename: Peruvemba S
authors.initials: PS
authors.lastname: Sriram
authors.forename: Amir
authors.initials: A
authors.lastname: Sharafkhaneh
authors.forename: M Jeffery
authors.initials: MJ
authors.lastname: Mador
authors.forename: George
authors.initials: G
authors.lastname: Sarosi
authors.forename: Ralph J
authors.initials: RJ
authors.lastname: Panos
authors.forename: Padmashri
authors.initials: P
authors.lastname: Rastogi
authors.forename: Todd H
authors.initials: TH
authors.lastname: Wagner
authors.forename: Steven A
authors.initials: SA
authors.lastname: Mazzuca
authors.forename: Colleen
authors.initials: C
authors.lastname: Shannon
authors.forename: Cindy
authors.initials: C
authors.lastname: Colling
authors.forename: Matthew H
authors.initials: MH
authors.lastname: Liang
authors.forename: James K
authors.initials: JK
authors.lastname: Stoller
authors.forename: Louis
authors.initials: L
authors.lastname: Fiore
authors.forename: Dennis E
authors.initials: DE
authors.lastname: Niewoehner
mesh_terms: D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D019090:Case Management; D002423:Cause of Death; D003863:Depression / Q000209:etiology; D005260:Female; D005500:Follow-Up Studies; D006760:Hospitalization; D006801:Humans; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic; D017060:Patient Satisfaction; D011241:Prednisone / Q000627:therapeutic use; D016016:Proportional Hazards Models; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000401:mortality / Q000523:psychology; D011788:Quality of Life; D012648:Self Care; D013689:Telephone
chemical_list: D000900:Anti-Bacterial Agents; D000893:Anti-Inflammatory Agents; D011241:Prednisone