Vincent S. Fan, MD, MPH; J. Michael Gaziano, MD, MPH; Robert Lew, PhD; Jean Bourbeau, MD, MSc; Sandra G. Adams, MD, MS; Sarah Leatherman, MS; Soe Soe Thwin, PhD, MS; Grant D. Huang, PhD, MPH; Richard Robbins, MD; Peruvemba S. Sriram, MD; Amir Sharafkhaneh, MD; M. Jeffery Mador, MD; George Sarosi, MD; Ralph J. Panos, MD; Padmashri Rastogi, MD; Todd H. Wagner, PhD; Steven A. Mazzuca, PhD; Colleen Shannon, MPH; Cindy Colling, RPH, MS; Matthew H. Liang, MD, MPH; James K. Stoller, MD, MS; Louis Fiore, MD, MPH; Dennis E. Niewoehner, MD
Disclaimer: The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs. Vincent S. Fan, MD, MPH; J. Michael Gaziano, MD, MPH; and Dennis E. Niewoehner, MD, had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Financial Support: By the Cooperative Studies Program (CSP #560), Veterans Affairs Office of Research and Development.
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M11-1426.
Reproducible Research Statement:Study protocol: Available from the data coordinating center at the Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC) (e-mail, mailto:MAVERIC-Info@va.gov). Statistical code: Available from Dr. Lew (e-mail, mailto:firstname.lastname@example.org). Data set: Not available.
Requests for Single Reprints: Vincent S. Fan, MD, MPH, Health Services Research and Development Center of Excellence, Veterans Affairs Puget Sound Health Care System, 1600 South Columbian Way, Seattle, WA 98108; e-mail, mailto:email@example.com.
Current Author Addresses: Dr. Fan: Veterans Affairs Puget Sound Health Care System, 1100 Olive Way, Suite 1400, Seattle, WA 98101.
Drs. Gaziano, Lew, Thwin, and Fiore; Ms. Leatherman; and Ms. Shannon: Veterans Affairs Boston Healthcare System, 150 South Huntington Avenue, Boston, MA 02130.
Dr. Bourbeau: Montreal Chest Institute, 3650 St-Urbain, Montreal, Quebec H2X 2P4, Canada.
Dr. Adams: South Texas Veterans Health Care System, 7400 Merton Minter, San Antonio, TX 78229.
Dr. Huang: Department of Veterans Affairs Cooperative Studies Program, 810 Vermont Avenue NW, MS-10P9CS, Washington, DC 20420.
Dr. Robbins: Phoenix Veterans Affairs Medical Center, 650 East Indian School Road, Phoenix, AZ 85012.
Dr. Sriram: North Florida/South Georgia Veterans Health System, 1601 SW Archer Road, Gainesville, FL 32608.
Dr. Sharafkhaneh: Michael E. DeBakey Veterans Affairs Medical Center, 2002 Holcombe Boulevard, Houston, TX 77030.
Dr. Mador: Veterans Affairs Western New York Healthcare System, 3495 Bailey Avenue, Buffalo, NY 14215.
Drs. Sarosi and Niewoehner: Minneapolis Veterans Affairs Healthcare System, 1 Veterans Drive, Minneapolis, MN 55417.
Dr. Panos: Cincinnati Veterans Affairs Medical Center, 3200 Vine Street, Cincinnati, OH 45220.
Dr. Rastogi: Dallas Veterans Affairs Medical Center, 4500 South Lancaster Road, Mail Code IIIE, Dallas, TX 75216.
Dr. Wagner: Veterans Affairs Palo Alto Healthcare System, 795 Willow Road, 152-MPD, Menlo Park, CA 94025.
Dr. Mazzuca: Indiana University School of Medicine, Long Hospital, Room 545, 1110 West Michigan Street, Indianapolis, IN 46202-5100.
Ms. Colling: Veterans Affairs Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, 2401 Centre Avenue SE, Albuquerque, NM 87106-4180.
Dr. Liang: Department of Medicine, Brigham and Women's Hospital, 75 Francis Street, PBB3, Boston, MA 02115.
Dr. Stoller: The Cleveland Clinic, 9500 Euclid Avenue, NA22, Cleveland, OH 44195.
Author Contributions: Conception and design: V.S. Fan, J.M. Gaziano, R. Lew, J. Bourbeau, S.G. Adams, G.D. Huang, T.H. Wagner, S.A. Mazzuca, M.H. Liang, J.K. Stoller, L. Fiore, D.E. Niewoehner.
Analysis and interpretation of the data: V.S. Fan, J.M. Gaziano, R. Lew, J. Bourbeau, S. Leatherman, S.S. Thwin, G.D. Huang, T.H. Wagner, S.A. Mazzuca, M.H. Liang, J.K. Stoller, D.E. Niewoehner.
Drafting of the article: V.S. Fan, R. Lew, G.D. Huang, R.J. Panos, T.H. Wagner, S.A. Mazzuca, J.K. Stoller, D.E. Niewoehner.
Critical revision of the article for important intellectual content: V.S. Fan, J.M. Gaziano, R. Lew, J. Bourbeau, S.G. Adams, G.D. Huang, A. Sharafkhaneh, M.J. Mador, S.A. Mazzuca, M.H. Liang, L. Fiore, D.E. Niewoehner.
Final approval of the article: V.S. Fan, J.M. Gaziano, R. Lew, J. Bourbeau, S.G. Adams, G.D. Huang, P.S. Sriram, A. Sharafkhaneh, M.J. Mador, G. Sarosi, R.J. Panos, T.H. Wagner, S.A. Mazzuca, C. Shannon, M.H. Liang, J.K. Stoller, L. Fiore, D.E. Niewoehner.
Provision of study materials or patients: V.S. Fan, J.M. Gaziano, S.G. Adams, R. Robbins, P.S. Sriram, A. Sharafkhaneh, M.J. Mador, G. Sarosi, R.J. Panos, P. Rastogi, L. Fiore.
Statistical expertise: R. Lew, S. Leatherman, S.S. Thwin.
Obtaining of funding: V.S. Fan, J.M. Gaziano, R. Robbins, P. Rastogi, T.H. Wagner, L. Fiore, D.E. Niewoehner.
Administrative, technical, or logistic support: J.M. Gaziano, R. Lew, S.G. Adams, T.H. Wagner, C. Shannon, C. Colling, M.H. Liang, L. Fiore.
Collection and assembly of data: V.S. Fan, J.M. Gaziano, S.G. Adams, P.S. Sriram, A. Sharafkhaneh, M.J. Mador, G. Sarosi, R.J. Panos, P. Rastogi, T.H. Wagner, C. Colling, D.E. Niewoehner.
Improving a patient's ability to self-monitor and manage changes in chronic obstructive pulmonary disease (COPD) symptoms may improve outcomes.
To determine the efficacy of a comprehensive care management program (CCMP) in reducing the risk for COPD hospitalization.
A randomized, controlled trial comparing CCMP with guideline-based usual care. (ClinicalTrials.gov registration number: NCT00395083)
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).
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.
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.
Veterans Affairs Cooperative Study Program.
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Fan VS, Gaziano JM, Lew R, Bourbeau J, Adams SG, Leatherman S, et al. A Comprehensive Care Management Program to Prevent Chronic Obstructive Pulmonary Disease Hospitalizations: A Randomized, Controlled Trial. Ann Intern Med. 2012;156:673–683. doi: 10.7326/0003-4819-156-10-201205150-00003
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Published: Ann Intern Med. 2012;156(10):673-683.
Chronic Obstructive Airway Disease, Hospital Medicine, Pulmonary/Critical Care.
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